StemCell Therapy

-- The two-part multicenter study of 259 enrolled subjects showed >60 percent of patients achieved low disease activity (LDA) at week 12 with open-label therapy, an effect that was maintained in a proportion of patients with 12 additional weeks of treatment in the double-blind phase --

STAINES-UPON-THAMES, United Kingdom, April 15, 2020 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced the publication of findings from its randomized, placebo-controlled, double-blind Phase 4 study to assess the safety and efficacy of Acthar Gel (repository corticotropin injection, or RCI) in patients with persistently active rheumatoid arthritis (RA) despite treatment with stable background disease-modifying antirheumatic drugs (DMARDs) and low-dose glucocorticoids. Results of the study were recently published online in Rheumatology and Therapy, an open access peer-review journal. Preliminary findings from the study were presented at the European Congress of Rheumatology 2019 (EULAR) held in June.

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in RA, including juvenile RA (selected cases may require low-dose maintenance therapy).1Please see Important Safety Information for Acthar Gel below.

The study, titled "Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial," enrolled 259 adult patients (18 years of age) with RA who were treated at 60 centers in four countries between Nov. 7, 2016, and Feb. 13, 2019. Results of the study showed that Acthar Gel demonstrated the potential for effectiveness in achieving low disease activity (LDA) as assessed by DAS28-ESR2 in patients with active RA despite current treatment with low-dose glucocorticoids and one or two DMARDs.

"The results of this study suggest that there could be a reasonable risk-benefit for the short-term use of RCI over six months in appropriate patients with persistently active RA despite concurrent use of DMARDs and low-dose glucocorticoids. Many patients achieved LDA by three months with the response persisting for an additional three months in a majority of patients whether discontinuing or continuing RCI. The adverse event profile was similar in patients who continued and discontinued RCI,i" said Dr. Roy Fleischmann, Co-Medical Director of the Metroplex Clinical Research Center and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center in Dallas and the study's lead author.

"Rheumatoid arthritis is a common autoimmune disease that can damage bone and joints and greatly impact daily functioning for patients. The goal of treatment is remission or low disease activity, but for a subset of underserved patients with debilitating RA who don't achieve remission or LDA with standard therapy, additional options are greatly needed," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "We are encouraged by the results of this study that demonstrate Acthar Gel can be considered for appropriate patients in this persistently active population, and we're grateful to the patients, their families and clinicians who participated in the study."

Story continues

Key Findings3:

Open-label Period

Randomized, Placebo-Controlled, Blinded, Withdrawal Period

Methods3:

Study Limitations3:

The study was funded by Mallinckrodt.

About Rheumatoid ArthritisRA is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the jointsall symptoms and signs caused by inflammation.4 An estimated 1.5 million U.S. adults are living with RA.5 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.6 Nonsteroidal anti-inflammatory drugs are used to ease symptoms whereas glucocorticoids, and non-biologic and biologic DMARDs are used to slow down the disease activity.6

INDICATIONS

Acthar Gel (repository corticotropin injection) is indicated for:

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Adverse Reactions

Other adverse events reported are included in the full Prescribing Information.

Please see fullPrescribing Informationfor additional Important Safety Information.

ABOUT MALLINCKRODTMallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTSThis release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTSFor Trade Media InquiriesCaren BegunGreen Room Communications201-396-8551caren@greenroompr.com

For Financial/Dailies Media InquiriesRon BartlettH+K StrategiesSenior Vice PresidentM: +1 813 545 2399ron.bartlett@hkstrategies.com

Investor RelationsDaniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and theMallinckrodt Pharmaceuticalslogo are trademarks of aMallinckrodtcompany. Other brands are trademarks of aMallinckrodtcompany or their respective owners.2020Mallinckrodt.US-2000523 04/20

References

i AEs reported in 1.5% of patients in part 1 or in either group in part 2.ii ACR20=American College of Rheumatology 20% improvement; ACR50=American College of Rheumatology 50% improvement; ACR70=American College of Rheumatology 70% improvement

1 Acthar Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC.2Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate.3Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Rheumatol Ther (2020). https://doi.org/10.1007/s40744-020-00199-3.4Mayo Clinic website. Rheumatoid Arthritis. Overview. Available at: https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. Accessed April 1, 2020.5Arthritis Foundation. What is Rheumatoid Arthritis? Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed April 1, 2020.6Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. Accessed April 1, 2020.

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Mallinckrodt Announces Publication of Data on Acthar Gel (Repository Corticotropin Injection) from its Randomized, Double-Blind, Placebo-Controlled...

The COVID-19 pandemic has left many in Canadas workforce worried about their health and finances. Those worries are even greater for workers living with an underlying and invisible chronic health condition.

In the planning of health and safety responses to COVID-19 and the ultimate reopening of workplaces, employers should be aware of the unique needs of this potentially vulnerable group of workers.

Data show that some of the most commonly reported chronic health conditions experienced by Canadas working population have no visible signs or symptoms and may go unnoticed by employers.

According to the 2019 Sanofi Canada Healthcare Survey on workplace benefit plans, 54 per cent of workers reported having such a condition, with high blood pressure, arthritis and diabetes among the top five. In the same survey, employers estimated that only 29 per cent of their staff had a chronic condition, pointing to a gap in awareness within workplaces.

Our growing understanding of COVID-19 illustrates that the virus poses a particular threat to workers with underlying health conditions.

A review of 46,000 people with COVID-19 in Chinafound that the odds of having severe symptoms were two or more times higher for people with an underlying health condition. Although the data are limited, a recent analysis conducted by theCenters for Disease Control and Preventionalso shows that 38 per cent of COVID-19 cases in the United States had an underlying health condition including diabetes, cardiovascular disease, chronic lung disease and immmunocompromised conditions.

Going to work, therefore, could mean being exposed to a virus that disproportionately targets those with underlying health conditions. Of course, staying at home would be the best solution for workers with chronic health conditions. But even after the provinces ordered the closure of businesses, people in alarge cross-section of essential servicesfound themselves having to continue to show up for work.

These include people who work in health care, grocery stores, drug stores, warehouses, gas stations, fast-food chains and other restaurants, hotels, long-term care homes, among many others.

Despite the provinces encouraging workers who feel unwell to stay home and the availability of emergency relief for compensation, workers with chronic health conditions may not want to sacrifice a paycheque during a period of economic uncertainty. They may decide to accept the risk of going to work.

This is a predicament that many community groups are highlighting. AsSin Bevan, chief science officer at the Arthritis Society, puts it:

Some people in these essential roles may be fearful for their employment if their condition makes them unable to work and fearful to let their employer know about their health concerns for fear of losing their jobs. Many immunosuppressed people with rheumatic conditions are afraid to go to work, but afraid to tell their employer why.

Commendably, some employers are offering hero pay to compensate for the added risk that workers face. Yet the extra wages could also have the unintended effect of encouraging people with chronic health conditions who face income insecurity to go to work.

Growing research conducted by the Toronto-basedInstitute for Work & Healthhighlights the challenges that workers with chronic health conditions face when asking for accommodations that will allow them to continue working productively while maintaining their health. This is especially the case for those living withinvisible health conditions that may fluctuate in severity,young workers, those new to their jobs and other vulnerable groups.

In the current health and economic crisis brought about by COVID-19, the inability of these individuals to ask for protective accommodation poses a potentially serious risk to the health and safety, and the long-term employment, of people with chronic health conditions in the workforce.

These are trying times, and from many accounts, employers are doing their best to keep essential services running while safeguarding the health and safety of workers. As they continue to navigate the way forward and develop back-to-work plans, employers should acknowledge that they may have workers with a chronic health condition who could be reluctant to ask for support.

Employers should also be encouraged to open up the lines of communication with all workers so that those with underlying conditions feel supported in bringing forward their concerns. While workers are not obligated to talk about their health, more than ever, supportive workplace environments are needed to encourage people to communicate what assistance they need to stay healthy while working productively.

Laurie Proulx, vice-president of theCanadian Arthritis Patient Alliance, sums it up well. She sees the COVID-19 pandemic as:

an opportunity for employers to build credibility with their employees by listening and finding ways for workers with underlying health conditions to still make important contributions and not put themselves and their families at risk.

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Coronavirus: The risks to essential workers with hidden health conditions - The Journal Pioneer

Futuristic Reports, The growth and development of Global Rheumatoid Arthritis Therapeutics Market Report 2020 by Players, Regions, Type, and Application, forecast to 2026 provides industry analysis and forecast from 2020-2026. Global Rheumatoid Arthritis Therapeutics Market analysis delivers important insights and provides a competitive and useful advantage to the pursuers. Rheumatoid Arthritis Therapeutics processes, economic growth is analyzed as well. The data chart is also backed up by using statistical tools.

Simultaneously, we classify different Rheumatoid Arthritis Therapeutics markets based on their definitions. Downstream consumers and upstream materials scrutiny are also carried out. Each segment includes an in-depth explanation of the factors that are useful to drive and restrain it.

Key Players Mentioned in the study are Applied Research & Photonics, Bruker, Menlo Systems, Innovative Photonic Solutions, LongWave Photonics, Bridge12 Technologies, Del Mar Photonics, Digital Barriers, Northrop Grumman, Lockheed Martin, Jena-Optronik, Advantest, Novatrans, Becker Photonik

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Key Issues Addressed by Rheumatoid Arthritis Therapeutics Market: It is very significant to have Rheumatoid Arthritis Therapeutics segmentation analysis to figure out the essential factors of growth and development of the market in a particular sector. The Rheumatoid Arthritis Therapeutics report offers well summarized and reliable information about every segment of growth, development, production, demand, types, application of the specific product which will be useful for players to focus and highlight on.

Businesses Segmentation of Rheumatoid Arthritis Therapeutics Market:

On the basis on the applications, this report focuses on the status and Rheumatoid Arthritis Therapeutics outlook for major applications/end users, sales volume, and growth rate for each application, including-

HealthcareScientific ResearchManufacturingMilitary or DefenseSecurity or Public SafetyOther

On the basis of types/products, this Rheumatoid Arthritis Therapeutics report displays the revenue (Million USD), product price, market share, and growth rate of each type, split into-

Imaging DevicesSpectroscopesCommunications DevicesComputing DevicesOther

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NOTE : Our team is studying Covid-19 impact analysis on various industry verticals and Country Level impact for a better analysis of markets and industries. The 2020 latest edition of this report is entitled to provide additional commentary on latest scenario, economic slowdown and COVID-19 impact on overall industry. Further it will also provide qualitative information about when industry could come back on track and what possible measures industry players are taking to deal with current situation.

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You just drop an Email to:[emailprotected] us if you are looking for any Economical analysis to shift towards the New Normal on any Country or Industry Verticals.

Rheumatoid Arthritis Therapeutics Market Regional Analysis Includes:

Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) North America (the United States, Mexico, and Canada.) South America (Brazil etc.) The Middle East and Africa (GCC Countries and Egypt.)

Rheumatoid Arthritis Therapeutics Insights that Study is going to provide:

Gain perceptive study of this current Rheumatoid Arthritis Therapeutics sector and also possess a comprehension of the industry; Describe the Rheumatoid Arthritis Therapeutics advancements, key issues, and methods to moderate the advancement threats; Competitors In this chapter, leading players are studied with respect to their company profile, product portfolio, capacity, price, cost, and revenue. A separate chapter on Rheumatoid Arthritis Therapeutics market structure to gain insights on Leaders confrontational towards market [Merger and Acquisition / Recent Investment and Key Developments] Patent Analysis** Number of patents filed in recent years.

Table of Content:

Global Rheumatoid Arthritis Therapeutics Market Size, Status and Forecast 20261. Market Introduction and Market Overview2. Industry Chain Analysis3. Rheumatoid Arthritis Therapeutics Market, by Type4. Rheumatoid Arthritis Therapeutics Market, by Application5. Production, Value ($) by Regions6. Production, Consumption, Export, Import by Regions (2016-2020)7. Market Status and SWOT Analysis by Regions (Sales Point)8. Competitive Landscape9. Analysis and Forecast by Type and Application10. Channel Analysis11. New Project Feasibility Analysis12. Market Forecast 2020-202613. Conclusion

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Rheumatoid Arthritis Therapeutics Market Major Trends, Analysis and Outlook to 2026 | Applied Research & Photonics, Bruker, Menlo Systems - Cole...

Global Hydroxychloroquine Drugs Market: Overview

Used to treat and manage a number of conditions such as rheumatoid arthritis and the autoimmune disease called lupus, hydroxychloroquine is seen as a wonder drug by patients suffering from these painful health issues. The antimalarial is now seeing an increase in demand from certain countries as they direct efforts towards treating COVID-19, the pandemic which is being seen as a human and humanitarian crisis. Clinical trials are underway and results of these will ascertain demand for the drug for prevention and cure of the deadly viral infection.

As per Transparency Market Research, an increased number of people suffering from arthritis and lupus will lead to growth in the hydroxychloroquine drugs market from 2019 to 2027. And, due to massive use in clinical studies being carried out in a number of research and development (R&D) facilities universities and pharmaceutical companies - a significant demand is arising for the drug. This is paving way for opportunities in the future.

Global Hydroxychloroquine Drugs Market: Notable Development

The much critical and powerful hydroxychloroquine drugs are gaining increased attention in the current times owing to results from a French Study that states these are effective in treatingCoronavirus infection, plaguing the planet. However, peer review and others from the medical community take the study with a pinch of salt. Some of the notable developments in the recent time are stated below:

2020: The President of the United States of America is endorsing use of these drugs as preventive measures. And, a number of clinical studies have already begun to test efficacy. By March 18, Boulware had already started working in this direction. Additionally, the country demanded the drug from India, which is a major manufacturer and cleared export of 3.6 million tablets at the behest of President Donald Trump.

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Some of the prominent players operating in the global hydroxychloroquine drugs market are the following:

Innovation and Research and Development are areas that are highly focused on by a number of notable players in order to drive the market forward.

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Global Hydroxychloroquine Drugs Market: Key trends and driver

Hydroxychloroquine drugs market is seeing elevated demand in its landscape owing to a number of factors. A major booster as of now is now is its association with the COVID 19 treatment and prevention approvals for the same are yet to arrive from the FDA.

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Global Hydroxychloroquine Drugs Market: Regional Analysis

North American region will be a prominent regional market over the forecast period owing to factors such as a sizeable population of Lupus patients. Besides, United States is contributing immensely to the growth in the market by way of government endorsements; a large number of clinical trials are underway.

The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.

About Us

Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

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Hydroxychloroquine Drugs Market: Surged in Demand of hydroxychloroquine for the treatment of COVID-19 - BioSpace

Arthritis is a common condition that can affect people of all ages, according to the NHS. But you could lower your risk of developing painful arthritis symptoms by simply eating more limes, it's been claimed.

Arthritis pain can lead to a number of debilitating symptoms that patients will want to try and avoid.

The condition can make life more difficult when carrying out simply, every day tasks.

But, just some simple lifestyle changes could go a long way in helping to prevent arthritis symptoms from flaring up.

One of the easiest ways to lower your chances of developing symptoms is to regularly eat limes, it's been claimed.

READ MORE: Arthritis causes - does cracking your fingers cause arthritis?

"While theres no miracle diet for arthritis, fortunately, many foods can help fight inflammation and improve joint symptoms," said the Arthritis Foundation.

"For starters, a diet rich in fruits, vegetables, fish, nuts and beans but low processed foods and saturated fat, is not only great for overall health, but can also help manage disease activity.

"If this advice sounds familiar, its because these are the principles of the Mediterranean diet, which is frequently touted for its anti-aging and disease-fighting powers.

"Citrus fruits like oranges, grapefruits and limes are rich in vitamin C. Research shows getting the right amount of that vitamin aids in preventing inflammatory arthritis and maintaining healthy joints."

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Arthritis - the exotic fruit you should add to your breakfast routine to prevent symptoms - Express

Massachusetts General Hospital, Brigham and Womens Hospital, Tufts Medical Center, and Beth Israel Deaconess Medical Center are among 64 hospitals at 51 US sites where the drug is being tested. All told, about 1,000 patients are participating in the study. Sibold couldnt specify how many of them are in Massachusetts.

Patients began receiving doses the week of March 16. Sibold said its way too soon to discuss whether the drug is helping them.

We have to see the data," he said. Im hopeful in the sense that we need more solutions for COVID-19, and if this can have a positive effect on patients, thats a wonderful thing.

The primary goal of the clinical trial is to determine if Kevzara lowers fever and then curbs the need for supplemental oxygen to help patients breathe, according to a Sanofi spokeswoman.

Scientists around the world are studying at least 95 potential treatments for the coronavirus in laboratories and hospitals, according to an online tracker by the Milken Institute, a nonprofit think tank in Santa Monica, Calif. The possible treatments include several decades-old medicines approved for diseases ranging from HIV to influenza.

Kevzara was developed by Sanofi and Regeneron and approved in 2017 to treat rheumatoid arthritis, an autoimmune disorder that causes the bodys immune system to mistakenly attack tissues. Researchers believe it might be useful because many patients who become critically ill with COVID-19 experience a cytokine storm, a runaway response in which the immune system attacks the bodys organs. Some researchers believe drugs that suppress the immune system, including monoclonal antibodies such as Kevzara, might counter that.

Its a really promising approach, said Dr. Kathryn Stephenson, an assistant professor of medicine at Harvard Medical School and co-investigator in the study of Kevzara at Beth Israel. We know that theres a really prominent piece of this disease process that has to do with a huge rise in inflammation. At the point where patients are getting really sick, it looks like were going to need some intervention to turn down the immune response.

A recent study in China of 21 COVID-19 patients with acute respiratory distress found that Actemra, a similar rheumatoid arthritis medicine made by Swiss drug giant Roche, helped suppress that overreaction. The study, which wasnt peer-reviewed, found that fevers in patients who received Actemra fell rapidly and that within a matter of days, most didnt need supplemental oxygen. Roche is now running a clinical trial of that medicine in coronavirus patients, with research sites that include Boston.

Regeneron is overseeing the clinical trial of Kevzara in the United States. Sanofi, whose roughly 4,800 employees at Sanofi Genzyme make up one of the largest workforces of any drug maker in Massachusetts, is overseeing testing of Kevzara on patients in Italy, Spain, Germany, France, Canada, and Russia.

Sanofi is also launching two clinical trials of hydroxychloroquine, an old malaria drug that it sells outside the United States under the brand name Plaquenil. The medicine has been in use since the 1950s. Sanofi began making as much of it as it could in February after Chinese data indicated the medicine could help some patients with coronavirus.

One of the trials including about 210 patients will take place in the United States, France, and the Netherlands and will test the malaria drug on coronavirus outpatients during the early stage of the disease.

The second hydroxychloroquine trial will take place in France, Germany, the United Kingdom, Denmark, and the Czech Republic. It will focus on people hospitalized with moderate and severe cases of the disease, and will include about 300 patients.

President Trump has aggressively promoted the malaria drug as a treatment for COVID-19, although experts have warned that it has yet to be proved safe or effective for coronavirus.

Sanofi is also working on two potential vaccines to prevent coronavirus. One is a collaboration with Lexington-based Translate Bio and seeks to develop a new messenger RNA vaccine. The other is a collaboration with the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services, and relies on recombinant DNA.

The World Health Organization lists more than 40 potential vaccines in development globally.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com

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Sanofis rheumatoid arthritis drug will be tested on coronavirus patients at four Mass. hospitals - The Boston Globe

In a cohort of women with rheumatoid arthritis (RA) and psoriatic arthritis (PsA), the effect of their conditions considerably varied before, during, and after pregnancy, thereby emphasizing the importance of patients and clinicians working together for informed decision making at all stages, according to findings published in Scientific Reports.

Given the concerns faced by childbearing women with RA or PsA, the study investigators had the following objectives: (1) to better understand fertility within this population; (2) to describe their peripartum periods in terms of preconception counseling, time to pregnancy, requirement for infertility treatment, unplanned/planned pregnancy, number of pregnancies prior to and after inflammatory arthritis (IA) diagnosis, pregnancy outcomes, disease activity during and after pregnancy, type of delivery and breastfeeding; (3) to better understand choices made regarding RA/PsA medications; and (4) to better understand fetal and maternal outcomes in terms of neonatal, labor, and delivery complications. To this end, investigators conducted a retrospective survey-based evaluation of the peripartum period in patients with RA/PsA participating in the Rheumatoid Arthritis Pharmacovigilance Program and Outcomes Research in Therapeutics prospective cohort in northern Alberta, Canada, which is a prospective inception cohort of IA patients on biologics, ongoing since 2004.

Of the 162 patients completing the survey, 234 pregnancies occurred among 103 patients, with 164 pregnancies occurring before RA/PsA diagnosis and 70 occurring after diagnosis. Outcomes included 1.9% stillbirths, 15% therapeutic abortions, 23% miscarriages, and 96% live births. Some 33% of the participants had fewer children than desired due to RA/PsA disease activity (14/34), RA/PsA medications (15/34), social reasons (5/34), infertility (5/34), and other comorbidities (5/34).

Among the 63 pregnancies occurring after diagnosis (and excluding those ending in therapeutic abortion), 49% obtained preconception counseling. In terms of disease control, discontinuing medication, and complications including gestational diabetes, preeclampsia/eclampsia, pregnancy-induced hypertension, placental abruption, multiple pregnancies, intrauterine growth restriction, disease flares, and hospitalizations no statistically significant differences were found between those receiving preconception counseling (31/63) vs those who did not (32/63).

Although 65% (41/63) of pregnancies occurring after diagnosis described good disease control during pregnancy, 73.7% (28/38) experienced disease flares in the first 3 months postpartum (19/28, 67.9%). IA medications were discontinued in 79% of pregnancies, and 35% (22/63) of pregnancies occurred while patients were on biologics at or prior to conception. Five patients continued biologic therapy for all or part of their pregnancies (3/5 with complications: ectopic pregnancy, flare, intrauterine growth restriction, multiple birth).

Gestational age at time of delivery was 37 to 40 weeks in 66% (83/126) of prearthritis vs 58% (33/57) of postarthritis pregnancies. Comparing pregnancies before RA/PsA diagnosis with those after diagnosis, no statistically significant differences were found for fertility treatment, pregnancy planning, neonatal complications, birth defect frequency, or pregnancy and labor/delivery complications. Neonatal ICU admissions were significantly lower in prearthritis pregnancies compared with postarthritis pregnancies. No pregnancy complications were seen in 24 of 54 pregnancies in women on medications compared with 6 of 9 pregnancies in women not on medications.

Study investigators concluded that these findings show peri-partum complications in RA/PsA patients do not significantly increase in patients with good disease control; however, neonatal ICU admissions are increased in women with RA/PsA revealing the importance of decision-making before, during and after pregnancy. Most patients discontinued RA/PsA medication during pregnancy andonly a minority of patients continued biologics during pregnancy. Therefore, providing patients with medication and disease information is essential to ensure that patients make informed and educated reproductive decisions.

Reference

Dissanayake TD, Maksymowych WP, Keeling SO. Peripartum issues in the inflammatory arthritis patient: A survey of the RAPPORT registry. Sci Rep. 2020;10(1):3733.

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Outcomes Associated With Inflammatory Arthritis Diagnosis Before, During, and After Pregnancy - Rheumatology Advisor

A link between homocitrullination and the development of interstitial lung disease (ILD) in patients with rheumatoid arthritis (RA) may exist, according to the results of a cross-sectional study published in the Annals of the Rheumatic Diseases.

RA-associated ILD (RA-ILD) is associated with high mortality, therefore early detection is necessary for establishing an individualized treatment strategy in these patients. Anti-carbamylated protein antibodies (Anti-CarP) are associated with poor disease outcomes in patients with RA and have been detected in various chronic lung diseases regardless of RA history. Thus, researchers analyzed the association between Anti-CarP and ILD in RA patients.

A total 179 patients were enrolled in the study; 37 (21%) of whom were diagnosed with RA-ILD. The researchers found that Anti-CarP specificities were more frequent in patients with RA-ILD. Anti-CarP specificities showed a robust effect towards increasing the odds of ILD in a multivariate analysis. In addition, serum titers of Anti-CarP were significantly higher in patients with RA-ILD and The researchers also observed similar findings in the replication sample.

This is the first time that an association between RA-ILD and Anti-CarP was demonstrated, independent of smoking, sex, age, RA disease duration, anticitrullinated protein antibody, and rheumatoid factor.

It is important to note that this study had several limitations: a relatively small proportion of patients with RA-ILD was included and treatment and disease activity were not included. Additionally, most patients were of Mediterranean Caucasian origin, which has been associated with a less aggressive RA course and a lower prevalence of extra-articular disease.

In conclusion, a robust association between different Anti-CarP and RA-ILD was found after adjusting for multiple confounders, the researchers stated. These findings pose the debate whether a link between homocitrullination and the development of this devastating extra-articular manifestation exists. However, these results should be interpreted with caution and further studies are needed.

Reference

Castellanos-Moreira R, Rodrguez-Garca SC, Gomara MJ, et al. Anti-carbamylated proteins antibody repertoire in rheumatoid arthritis: evidence of a new autoantibody linked to interstitial lung disease [published online March 10, 2020]. Ann Rheum Dis. doi:10.1136/annrheumdis-2019-216709

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Homocitrullination May Be Linked to Interstitial Lung Disease in Rheumatoid Arthritis - Pulmonology Advisor

Compared with patients without access restrictions to biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) or with psoriatic arthritis (PsA) only, patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) whose insurance plans restrict access to these DMARDs have lower odds of treatment effectiveness, according to study results published in PharmacoEconomics Open.

According to the researchers, novel DMARDs can slow disease progression in RA and PsA; however, many health insurance plans require prior authorization or step therapy for access to these treatments. The objective of this study was to compare treatment effectiveness in patients with RA or PsA with and without plan-level access restrictions to biologic or targeted synthetic DMARDs, and also to compare medication adherence between each group.

Researchers used the IBM MarketScan Commercial Claims and Encounters Database to analyze data from patients aged 18 to 64 years with RA or PsA with 1 claims for subcutaneous biologic DMARDs between January 2014 and December 2015. Patients included in the study were stratified into 1 of 2 cohorts: RA with or without PsA, and PsA only. The primary outcome was treatment effectiveness during the 12 months after the first DMARD claim; the secondary outcome was adherence to the index medication. Multivariate analysis was used to examine differences in the primary outcome of treatment effectiveness between patients with and without DMARD access restrictions.

Researchers revealed that among patients with RA (n=3993) and PsA (n=1713), 34.2% and 35.1%, respectively, had plan-level access restrictions. Among patients with access restrictions, 70.5% and 78.9% of patients with RA and PsA, respectively, had plans that required step therapy. The odds of treatment effectiveness during the 12-month follow-up were 19% lower among patients with RA (odds ratio [OR], 0.81; 95% CI, 0.67-0.98; P =.033) and 27% lower among patients with PsA whose plans included step therapy (OR, 0.73; 95% CI, 0.5-0.98; P =.037) compared with patients whose plans did not include step therapy. The odds of medication adherence among patients enrolled in plans with vs without step therapy were 19% lower among patients with RA (OR, 0.81; 95% CI, 0.68-0.96; P =.014) and 29% lower among patients with PsA (OR, 0.71; 95% CI, 0.54-0.94; P =.017).

Study limitations included possible miscoding or undercoding of the datasets used, lack of control for several baseline characteristics and medication use behaviors in patients, and the inability to generalize data for patients who were uninsured or had other types of insurance plans.

Researchers concluded, Compared with patients in plans without access restrictions or with PsA only, patients [with] RA and PsA in insurance plans with step therapy had lower odds of treatment effectiveness, mainly [because of] lower odds of adhering to treatment, during the 12 months [after] subcutaneous [biologic] DMARD initiation.

Disclosure: This clinical trial was supported by Elli Lilly and Company. Please see the original reference for a full list of authors disclosures.

Reference

Boytsov N, Zhang X, Evans KA, Johnson BH. Impact of plan-level access restrictions on effectiveness of biologics among patients with rheumatoid or psoriatic arthritis. Pharmacoecon Open. 2020;4(1):105-117.

Originally posted here:
Lower Treatment Effectiveness in Patients With RA and PsA With Insurance Restrictions for DMARDs - Rheumatology Advisor

Magician Dynamo has told of how his pre-exisiting health conditions made his experience of coronavirus "severe."

Dynamo - real name Stephen Frayne - suffers from Crohn's disease and arthritis.

This morning he told Chris Evans' Virgin Radio Breakfast Show that he's been healing up after sticking to the guidelines by self-isolating and resting.

"I was obviously struck down by COVID," he told Chris, "My case was possibly a mild case, but it got quite severe because of my existing condition."

He added: "Last couple of weeks, I've spent a lot of time in bed.

"I've been self-isolating and following all of the rules. Now I'm definitely feeling in much better spirits."

The drugs he takes for Crohn's disease can hamper the immune system, making him high risk.

Dynamo offered a message of hope for the future, continuing: "If anything, it just in some ways shows that we shouldn't take things for granted and we should just make the most of the moments that we go through.

"I hope everyone's taking this time as well to take care of themselves, and trying to be positive and use this time wisely."

He's been open about his experience with coronavirus, even telling the Mirror that he feels he'd been helped in his fight against the big by adversity early on in his life.

"Some of my greatest triumphs have come from dark places," he revealed, "My whole outlook on life came from not having a father figure - someone to guide me.

"I had to make my own path."

Dynamo went on to compare himself to rapper Eminem, and late singer Amy Winehouse.

"If you look at Amy Winehouse," he said, "A lot of her greatness came from the negative things she'd been through.

"Eminem's best work came because he was an angry young man who hated the world and the cards he'd been dealt.

"But he took it, and made something phenomenal."

More:
Dynamo says his coronavirus became 'severe' because of his Crohn's disease and arthritis - Mirror Online

Updated with new information on April 7 at 4 p.m. ET.

The world is now desperate to find ways to slow the spread of the novel coronavirus and to find effective treatments. As of April 6, more than 200 clinical trials of COVID-19 treatments or vaccines that are either ongoing or recruiting patients. New ones are being added every day, as the case count in the U.S. (and globally) skyrockets. The drugs being tested range from repurposed flu treatments to failed ebola drugs, to malaria treatments that were first developed decades ago. Here, we take a look at several of the treatments that doctors hope will help fight COVID-19.

An oral drug called EIDD-2801 has shown promise in test-tube experiments with human lung and airway cells, scientists reported online April 6 in the journal Science Translational Medicine. The drug might even be more efficient at blocking the novel coronavirus, SARS-CoV-2, than remdesivir, a drug being tested against COVID-19 in clinical trials that began in March. While remdesivir stops the novel coronavirus from replicating entirely, EIDD-2801 introduces genetic mutations into the viruss RNA. As the RNA makes its copies, so many damaging mutations accumulate that the virus is no longer able to infect cells, Scientific American reported. The drug also seems to work against several RNA viruses, and as such, the researchers said it could be a multipurpose antiviral.

And unlike remdesivir, which needs to be given intravenously, this drug could be swallowed as a pill. "EIDD-2801 is an oral drug that could be administered at home, early after diagnosis," lead study author Timothy Sheahan, of the Department of Epidemiology at the University of North Carolina at Chapel Hill, said in a statement from the journal. "This has the potential to be as ubiquitous as Tamiflu in the future, as long as it proves to be safe and effective in people."

The research was completed by scientists at Emory University, UNC Chapel Hill and Vanderbilt University Medical Center in Nashville. The Miami, Florida-based Ridgeback Biotherapeuticshas licensed the drug and was just granted permission by the Food and Drug Administration to start human trials of the drug over the next few months, the company said in a statement.

A drug developed by Fujifilm Toyama Chemical in Japan is showing promising outcomes in treating at least mild to moderate cases of COVID-19, Live Science previously reported.

The antiviral drug, called favipiravir or Avigan, has been used in Japan to treat influenza, and last month, the drug was approved as an experimental treatment for COVID-19 infections, Pharmaceutical Technology reported.

So far, reports suggest the drug has been tested in 340 individuals in Wuhan and Shenzhen. "It has a high degree of safety and is clearly effective in treatment," Zhang Xinmin, of China's science and technology ministry, said March 17, The Guardian reported.

The drug, which works by preventing certain viruses from replicating, seemed to shorten the duration of the virus as well as improve lung conditions (as seen in X-rays) in tested patients, though the research has yet to be published in a peer-reviewed science journal.

A separate study, published April 8 to the preprint database medrXiv, which has not yet been peer-reviewed, compared favipiravir to another flu drug, umifenovir (Arbidol). In the randomized, controlled study of 240 people, favipiravir did not help people recover faster compared to umifenovir. However, favipiravir did significantly shorten the time that people had fevers or coughs, the study found.

Chloroquine and hydroxychloroquine have been approved by the U.S. Food and Drug Administration for the treatment of malaria, lupus and rheumatoid arthritis, but preliminary research in human and primate cells suggests that the drugs could effectively treat COVID-19.

A 2005 study found that chloroquine could quell the spread of SARS-CoV when applied to infected human cells in culture. SARS-CoV is closely related to the novel coronavirus, SARS-CoV-2, and caused an outbreak of severe acute respiratory syndrome in 2002. Chloroquine disrupts the ability of the SARS-CoV virus to enter and replicate in human cells, Live Science previously reported. The cell culture studies of SARS-CoV-2 revealed that the drug and its derivative hydroxychloroquine undermine the novel virus' replication in a similar way.

Doctors in China, South Korea, France and the U.S. are now giving the drug to some patients with COVID-19 with promising, albeit anecdotal, results so far. The FDA is organizing a formal clinical trial of the drug.

As of Feb. 23, seven clinical trials had been registered in the Chinese Clinical Trial Registry to test whether COVID-19 infections could be treated with hydroxychloroquine. In addition, the University of Minnesota is studying whether taking hydroxychloroquine can protect people living with infected COVID-19 patients from catching the virus themselves.

In one heavily referenced study, conducted in France, a small number of patients with COVID-19 received either hydroxychloroquine alone or hydroxychloroquine in combination with an antibiotic called azithromycin. The authors reported that detectable concentrations of SARS-CoV-2 fell significantly faster in the study participants than coronavirus patients at other French hospitals who did not receive either drug. In six patients also given azithromycin, this promising effect appeared to be amplified.

However, the CDC noted that the small, non-randomized study "did not assess clinical benefit[s]" associated with the treatment; in other words, the study did not probe whether the treated patients were more likely to recover and survive their illness. Additionally, the agency advised that doctors should be cautious when giving either drug to patients with chronic disease, such as kidney failure, and especially those "who are receiving medications that might interact to cause arrhythmias."

A Gilead Sciences drug that was originally tested in people with Ebola, remdesivir, is being repurposed to see if it can effectively treat COVID-19.

The drug was found not to be effective in Ebola, but in lab studies, it has proven effective at inhibiting the growth of similar viruses, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In a petri dish, remdesivir can prevent human cells from becoming infected with SARS-CoV-2, according to a letter published in the journal Nature in February.

The Food and Drug Administration has currently approved use of remdesivir for compassionate use, meaning only patients with severe COVID-19 disease can be approved for treatment. In other countries, requirements to receive remdesivir may be less stringent.

Five clinical trials in China and the U.S. are currently evaluating whether remdesevir can reduce complications or shorten the disease course in COVID-19 patients, the medical news site STAT reported.

Many doctors are excited about the drug's potential.

"There's only one drug right now that we think may have real efficacy," Bruce Aylward of the World Health Organization said last month, as reported by STAT. "And that's remdesivir."

George Thompson, an infectious disease specialist at UC Davis Medical Center who treated an early, severe case of COVID-19, told Science magazine that their patient got better after getting the drug, about 36 hours after diagnosis. The doctors initially thought the patient would die, Thompson said.

However, such anecdotal evidence can't demonstrate effectiveness, and the lab has yet to analyze blood samples to show that the patient's clinical improvement following the administration of remdesivir coincided with a drop in viral load (concentration of viral particles). On the flip side, a study posted to the preprint database medRXiv looked at three patients treated with remdesivir. The study, which was not peer-reviewed, found no clear time-dependent relationship between getting the drug and seeing improvements in symptoms. The patients also experienced rectal bleeding, elevated liver enzymes, vomiting and nausea, which could potentially be tied to the drug.

Another quandary is that antiviral drugs generally work better the earlier patients get them, but because remdesivir is not FDA-approved for general use, only patients with the most severe, and late-stage, disease, qualify for its use in clinical trials, Thompson told Science.

On Sunday (March 22), Gilead Sciences announced that they were temporarily halting compassionate use of remdesivir, due to "overwhelming demand." Instead, they are focusing on approving previously submitted requests and streamlining the process, while directing people to enroll in clinical trials, STAT reported.

The antiviral drug kaletra, a combination of lopinavir and ritonavir, generated early excitement. However, new data from China, published March 18 in the New England Journal of Medicine, could not detect a benefit when patients took the drug.

A total of 199 people with low oxygen levels were randomized to either receive kaletra or a placebo. While fewer people taking kaletra died, the difference was not statistically significant, meaning it could have been due to random chance. And both groups had similar levels of virus in their blood over time.

However, other studies are still ongoing, and there's still a possibility this combination could show some benefit. As with other antivirals, this drug would likely work better if given earlier in the disease course.

For some patients with COVID-19, the virus itself doesn't do the worst damage. Rather, in some people their immune system goes into overdrive and launches an all-out assault known as a cytokine storm. That immune overreaction can damage tissue and ultimately kill people.

To quiet such cytokine storms, doctors are now trying an immunosuppressant known as Actemra, or tocilizumab. The drug is approved to treat rheumatoid arthritis and juvenile rheumatoid arthritis. It blocks a cell receptor that binds something called interleukin 6 (IL-6). IL-6 is a cytokine, or a type of protein released by the immune system, that can trigger dangerous inflammatory cascades.

On March 19, pharmaceutical company Roche announced that it was launching a trial to see if tocilizumab could improve outcomes in patients with COVID-19 pneumonia. One group will receive the drug plus other standard treatments, while another group will receive a placebo, plus standard treatments.

Regeneron is enrolling patients in a clinical trial to test another IL-6 inhibitor, known as sarilumab (kevzara), for treating COVID-19 pneumonia. The logic behind using sarilumab is similar to that for tocilizumab.

Losartan is a generic blood-pressure medication that some scientists are hoping could help patients with COVID-19. The University of Minnesota has launched two clinical trials using the inexpensive, generic drug. The first would evaluate whether losartan can prevent multi-organ failure in those hospitalized with COVID-19 pneumonia. The second would evaluate if the drug can prevent hospitalizations in the first place, Reuters reported.

Losartan works by blocking a receptor, or doorway into cells that the chemical called angiotensin II uses to enter the cells and raise blood pressure. SARS-CoV-2 binds to the angiotensin-converting enzyme 2 (ACE2) receptor, and it's possible, the thinking goes, that because losartan might block those receptors, it may prevent the virus from infecting cells.

Complicating things, a paper published March 11 in the journal The Lancet has raised the possibility that common drugs for hypertension, such as ACE inhibitors and so-called angiotensin II receptor blockers (ARBs), which includes losartan, might actually spur the body to make more ACE2, thereby increasing the ability of the virus to infiltrate cells. A recent study of 355 COVID-19 patients in Italy (study in Italian) found that three-quarters of the patients who died had hypertension, and the authors propose this is one reason for their increased susceptibility.

Originally published on Live Science.

Read the original:
Treatments for COVID-19: Drugs being tested against the coronavirus - Livescience.com

Rheumatoid Arthritis MarketLatest Research Report 2020:

The Rheumatoid Arthritis report provides an independent information about the Rheumatoid Arthritis industry supported by extensive research on factors such as industry segments size & trends, inhibitors, dynamics, drivers, opportunities & challenges, environment & policy, cost overview, porters five force analysis, and key companies

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In this report, our team offers a thorough investigation of Rheumatoid Arthritis Market, SWOT examination of the most prominent players right now. Alongside an industrial chain, market measurements regarding revenue, sales, value, capacity, regional market examination, section insightful information, and market forecast are offered in the full investigation, and so forth.

Scope of Rheumatoid Arthritis Market: Products in the Rheumatoid Arthritis classification furnish clients with assets to get ready for tests, tests, and evaluations.

Major Company Profiles Covered in This Report

Company I, Company II, Company III, Company IV and more

Rheumatoid Arthritis Market Report Covers the Following Segments:

Segment by Type:Type I, Type II, Type III

Segment by Application:Application I, Application II, Application III

North America

Europe

Asia-Pacific

South America

Center East and Africa

United States, Canada and Mexico

Germany, France, UK, Russia and Italy

China, Japan, Korea, India and Southeast Asia

Brazil, Argentina, Colombia

Saudi Arabia, UAE, Egypt, Nigeria and South Africa

Market Overview:The report begins with this section where product overview and highlights of product and application segments of the global Rheumatoid Arthritis Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company:Here, the competition in the Worldwide Rheumatoid Arthritis Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data:As the name suggests, this section gives the sales data of key players of the global Rheumatoid Arthritis Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the global Rheumatoid Arthritis Market.

Market Status and Outlook by Region:In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the global Rheumatoid Arthritis Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User:This section of the research study shows how different end-user/application segments contribute to the global Rheumatoid Arthritis Market.

Market Forecast:Here, the report offers a complete forecast of the global Rheumatoid Arthritis Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion:This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

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Continue reading here:
Coronavirus Outbreak: Rheumatoid Arthritis Market is expected to grow at a CAGR of xx% during the forecast period from 2019-2025 - Curious Desk

APRIL 07, 2020 --Endocrinologists have underlined the importance that physicians consider "a stress dose" of glucocorticoids in the event of severe COVID-19 infection in endocrine, and other, patients on long-term steroids.

People taking corticosteroids on a routine basis for a variety of underlying inflammatory conditions, such as asthma, allergies, and arthritis, are at elevated risk of being infected with, and adversely affected by, COVID-19.

This also applies to a rarer group of patients with adrenal insufficiency and uncontrolled Cushing syndrome, as well as secondary adrenal insufficiency occurring in hypopituitarism, who also rely on glucocorticoids for day-to-day living.

As such, it is vitally important to recognize that "Injectable supplemental glucocorticoid therapy in this setting can reverse the risk of potentially fatal adrenal failure and should be considered in every case," Stewart and colleagues emphasize in a newly published editorial in JCEM.

They note this advice must be considered alongside World Health Organization (WHO) guidance against prescribing therapeutic glucocorticoids to treat complications of COVID-19, based on prior experience in patients with acute respiratory distress syndrome, as well as those affected by severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

The key difference here is not to use pharmacologic doses of glucocorticoids as treatment for COVID-19 (where they have no effect), but rather to prevent death from adrenal failure by using "stress" doses of replacement glucocorticoid, Stewart explained to Medscape Medical News.

"The intent here is to ensure that no patient with a history of prior exposure to chronic glucocorticoid therapy (> 3 months) by whatever route should die without consideration for parenteral glucocorticoid therapy," the editorialists write.

He advises using physiological stress doses of hydrocortisone (50-100 mg intravenously tid).

Specific Advice for Adrenal Insufficiency: Follow Sick Day Rules

A separate statement by the American Association of Clinical Endocrinologists (AACE) also emphasizes that it is particularly important for patients with adrenal insufficiency to follow advice from the Centers for Disease Control and Prevention (CDC) or similar guidance on preventing COVID-19 infection, including social distancing and frequent hand washing.

Such patients should continue to take medications as prescribed and ensure they have appropriate supplies of oral and injectable steroids, ideally for 90 days, AACE advises.

And if there is a shortage of hydrocortisone, the statement advises patients ask a pharmacist or physician about replacement hydrocortisone with different doses that might be available.

Stewart agrees that patients with adrenal insufficiency need to be hypervigilant, but says that "if they do become ill, for the most part they are well counseled to respond appropriately to intercurrent infections."

Nevertheless, it is "invaluable to reiterate 'sick day rules'" for suspected COVID-19 infection.

"Any patient who develops a dry continuous cough and fever should immediately double their daily oral glucocorticoid dose and continue on this regimen until the fever has subsided."

If a patient still deteriorates on this regimen, develops diarrhea or vomiting, or is unable to take oral glucocorticoids for other reasons, they should contact their physicians or seek urgent medical care to receive parenteral treatment with a glucocorticoid.

References

2020 WebMD, LLC. All Rights Reserved.

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Corticosteroids With COVID-19 in Asthma, Allergies, and Arthritis Patients - MedicineNet

Physician-scientists at Beth Israel Deaconess Medical Center (BIDMC), part of Beth Israel Lahey Health, are now enrolling patients in a clinical trial to evaluate a potential treatment of patients with COVID-19. Part of a multi-site investigation, the trial is evaluating the safety and efficacy of sarilumab, a biologic medication already approved for adults with moderately to severely active rheumatoid arthritis, for the treatment of COVID-19. Pulmonary specialist Robert Hallowell, MD, Medical Director of BIDMCs Pulmonary Clinic, is leading the Phase 2/3 trial, which was initiated by Regeneron and Sanofi March 16, 2020.

While the symptoms of COVID-19 are mild for many, roughly 15 percent are at risk of developing an aberrantly robust immune reaction, which in its most severe form can lead to respiratory failure and, potentially, death, said Hallowell. The ability to stop this reaction in its tracks would be a major step forward in the management of COVID-19, both for infected individuals and for hospitals on the front line of this pandemic.

An inflammatory-inhibitor, sarilumab was developed by Regeneron and Sanofi to block interleukin-6 (IL-6), an immune factor called a cytokine that is involved in the overactive inflammatory response that is a common feature of autoimmune disorders like rheumatoid arthritis. The body releases cytokines inlacing IL-6 as part of its normal immune response to injured or infected tissues. In the average person, cytokines are responsible for symptoms such as redness and swelling around a wound or infected site. In patients with autoimmune disorders, cytokines can drive the immune response that attacks otherwise healthy tissues, such as cartilage in patients with rheumatoid arthritis or the cells of the pancreas in some people with type 1 diabetes.

Similarly, an overactive inflammatory response is thought to be the cause of the lung damage and respiratory distress in a significant percentage of patients with severe COVID-19. As the immune system releases cytokines to kill the virus, infected cells in the lungs become collateral damage. In turn, this injury to the lung tissues triggers additional inflammation, and the so-called cytokine storm begins to spiral out of control. The result can be lasting lung damage and scarring, organ failure or death.

Designed to halt this cytokine surge, sarilumab has the potential to improve outcomes for patients with severe cases of COVID-19, as well as reduce the expected demand for ventilators at present the only course of treatment for acute respiratory failure for patients with severe cases of COVID-19.

We have enrolled eight patients at BIDMC since opening the trial and plan to enroll several patients a day until the trial ends as a way of offering this potential treatment to the community, said Hallowell, who is also an Assistant Professor of Medicine, Harvard Medical School.

Hallowells clinical trial is one of several efforts fostered by the BILH COVID-19 Innovation Hub, an effort led by Gyongyi Szabo, MD, PhD, Chief Academic Officer at BIDMC and Beth Israel Lahey Health to meet the emerging challenges of the COVID-19 pandemic. Other projects include research into a potential vaccine for the prevention of COVID-19, clinical trials to evaluate the antiviral medication remdesivir, and efforts to source and produce critical medical supplies and equipment.

As of now, patients with COVID-19 receive the gold standard treatment of supportive care across our hospital system, but we continue to pursue new ways to care for them, said Szabo. If this drug can prevent patients from becoming gravely ill with COVID-19 or reduce the time it takes patients to recover, it could save lives.

Hallowell's BIDMC collaborators include C. Sabrina Tan, MD, Ari L. Moskowitz, MD, Debby Ngo, MD, Noah Schoenberg, MD, Kathryn Stephenson, MD, MPH, and Gyongyi Szabo, MD, PhD.

Read more here:
Statement: BIDMC enrolling patients in clinical trials evaluating existing drug as treatment for severe COVID-19 - Wicked Local

Elderly people may have to be kept isolated until the end of the year to protect them from the coronavirus, EU chief Ursula von der Leyen said in comments published Sunday.

"Without a vaccine, we have to limit as much as possible contact with the elderly," she told the Germany daily Bild.

"I know it's difficult and that isolation is a burden, but it is a question of life or death, we have to remain disciplined and patient," she added.

"Children and young people will enjoy more freedom of movement earlier than elderly people and those with pre-existing medical conditions," she said.

ALSO READ: Over 22,000 healthcare workers infected by Covid-19 globally: WHO

She said she hoped that a European laboratory will develop a vaccine towards the end of the year.

To ensure that people can be quickly vaccinated, authorities are already in talks with producers on gearing up for world production, she added.

ALSO READ: Covid-19: Effective quarantine could cut healthcare load by 90%, says study

Social isolation for elderly can pose health risks

Social isolation or self isolation among older adults can pose as a serious health concern because of their heightened risk of physical and mental conditions: high blood pressure, heart disease, weak immune system, depression and even death.

Apart from affecting health and well-being, social isolation can also lead to osteoarthritis (arthritis) in older adults, suggests a recent study.

Some 30 per cent of adults aged 65 and older have arthritis to some degree, especially in their leg joints.

Despite that, until now there has been little research on the relationship between arthritis and social isolation.

Those who weren't socially isolated tended to be younger had higher incomes and more education. They were also more likely to be physically active, had less physical pain, had faster walking times and were in better all-around health.

Because social isolation can worsen your health, the researchers suggested that older adults with arthritis perhaps could benefit from physical activity and participating in social activities.

See the original post:
Social isolation for elderly may last until the end of the year: EU chief - Business Standard

This innovative data linking will enable us to better understand how common MSK conditions are, how they progress, what treatments are best and who needs which services and when.

It is one of two projects awarded funding in partnership with the charity Versus Arthritis, who have contributed 250,000 towards the grants.

It will link existing, and new, data in novel ways, to address key research questions and inform policy and practice:

Tim Gardam, Chief Executive of the Nuffield Foundation said: The Nuffield Foundation is committed to improving peoples lives through better understanding of the issues affecting their life chances. Together these new projects will improve our understanding of the impact of MSK conditions on both individuals and wider society. We are delighted to be partnering with Versus Arthritis to help improve the health and well-being of people living with MSK conditions by influencing future practice, policy and research.

Amanda Neylon Director of Insight Data and Technology at Versus Arthritis said: This is exceptional research that will greatly improve our understanding of the effects of arthritis and improve the way people are treated. Meaningful data are key to providing high value musculoskeletal services as its essential for understanding the health needs of local populations, the activity performed by services and the outcomes they deliver.

Our partnership with the Nuffield Foundation is an excellent example of how working with others can maximise the impact of research funding and allow us to achieve more than we could do on our own.

Read the rest here:
1.5 million for research to improve the lives of people living with musculoskeletal conditions - The University of Manchester

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However, as modern medicine extends the human lifespan, our species have learned pain in the form of osteoarthritis that can accompany the locomotion of this biomechanical masterpiece.

In a new study of the genetic features that help make this sophisticated joint possible, an international team of researchers found that the regulatory switches involved in the development of the knee also play a role in osteoarthritis, a partially heritable disease that afflicts at least 250 million people worldwide. The findings are published in the journalCell.

Terence D. Capellini, Richard B. Wolf Associate Professor in the Department of Human Evolutionary Biology and the papers corresponding author, explained it in terms of the burden our knees literally endure:

From an evolutionary standpoint, the primate knee went from something that accommodated the forces of walking on four legs to placing all the weight on two legs, he said. Going from a quadruped to a biped changes the force distribution. All our weight is being transmitted through our hips and our knees down to our ankles. The cells in the joint and the shape of the joint had to change to accommodate those new forces.

With such a specific task and limited by its origins in the older primate knee the optimized bipedal knee developed what is known as a constrained morphology, that is, it did not allow much variation. As you can imagine, when youre designing a part for an airplane, you dont want to stray too much, Capellini said.

To understand how this complex mechanism came to be, researchers looked for evidence of accelerated natural selection: the series of mutations that aided us in walking upright.

We wanted to know whether or not we could see signs of ancient evolution ancient selection in the regions of the genome that specifically sculpt the knee, said Capellini. To do this, they searched for traces of specific regulatory switches, pieces of DNA responsible for turning on and off the genetic material that make the knee a human knee.

What they found reflects what Capellini suggests is indicative of positive selection evidence that this new knee gave the fledgling bipeds an evolutionary advantage. The highest functioning knees would have been selected, reducing variation in knee shape over time by decreasing the genetic variation in the switches that control the joints formation. What variation persisted likely didnt substantially matter at that time.

Later, as human populations expand and drift, you start getting these genetic variants that slightly modify how the knee is shaped or how the knee is maintained, explained Daniel Richard, a Ph.D. candidate in human evolutionary biology and lead author on the paper. Those slight deviations, acting on this constrained knee, lead to risk for developing osteoarthritis.

Those traits did not affect the success of the bipedal knee because natural selection promotes traits that allow individuals to reach sexual maturity and successfully breed. In essence, because this new knee gave young adults an edge on passing on their genetic material, it continued despite these variants. Our eventual old age had little role in its selection.

We think that these slight modifications dont so much impact early life, said Richard. But when you keep on walking up until youre 50 or 60, over that longer time span a super small change in your knee compounds over decades. Eventually it contributes to osteoarthritis disease in the elderly.

As a proof of principle, Capellini and colleagues performed two additional experiments. By studying the knee switches in patients with osteoarthritis compared to the general population, they found that osteoarthritis patients have on average more genetic variants in switches than those who dont have the disease. They also focused on a gene called GDF5 (Growth Differentiation Factor Five) that contributes to osteoarthritis risk in Europeans and Asians. Using CRISPR editing in mice and human cells, they pinpointed a genetic variant, present in billions of people, that effects the function of a key knee switch, thus changing knee shape and increasing osteoarthritis risk.

The stiffness and soreness humans feel today, therefore, may simply have piggybacked on an evolutionary advantage: the osteoarthritis came along with the knee. However, this painful feature may pay off in the study of human evolution, the researchers stress.

The idea of tying new features with almost new diseases is a good mental framework to think of while studying these diseases of aging, said Richard. You cant really have your cake and eat it too.

HARVARD UNIVERSITY

Header Image A visual riff on the classic illustration, March of Progress, highlighting the evolution of knee osteoarthritis. Credit : Tasha McAbee, Department of Orthopedics at Boston Childrens Hospital

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The evolution of arthritic knees - HeritageDaily

Transcript

When U.S. President Donald Trump urged medical professionals to take a malaria medication to protect themselves from COVID-19, he asked: "What do you have to lose?"

Eden Robinson knows the answer to that question all too well.

The Canadian author took hydroxychloroquine for eight months to manage pain from her rheumatoid arthritis, and experienced some of the more severe side effects associated with the drug, including vision loss. Shewrote about her experience for the Globe and Mail.

Hydroxychloroquine is used to treat malaria, as well as inflammatory disorders such as rheumatoid arthritis and lupus. There is no evidence it can protect people from contracting COVID-19, the disease caused by the coronavirus.

The jury is still out on whether it can be an effective treatment for COVID-19.To test that idea further, Canada'sMcGill University isconducting a randomized trial that is expected to include as many as 1,500 people. Another 1,500 people are enrolled in a similar study in the United States.

Public health officials including Canada's chief public health officer Dr. Theresa Tam have repeatedly warned that hydroxychloroquine can be extremely dangerous, with potential side effects that include irregular heartbeat, low blood sugar, mood changes and psychosis.

Robinson spoke to As It Happens host Carol Off about her experience with the drug. Here is part of their conversation.

When you hear Donald Trump saying "What do you have to lose?" and say look at the benefits ofhydroxychloroquine, what do you say to that? What do you want to tell Donald Trump?

You knowwhen you have the commercial for drugs and at first they give you all the wonderful things they can do, and then they have that very soothing voice that comes afterwards and tells you all the possible side effects? I think we're missing that soothing voice.

Speaking strictly from my own experience, after month five, I started seeing floaters and the floaters just kept increasing. And then I started getting eye pain. And if you've ever had a migraine if you can imagine your migrainesin your eye, that was my experience withhydroxychloroquine.

If you take this medication without being medically supervised, you know, you could win the worst lottery ever if you are one of the rare people that have retinal detachment as your side effect.

If you are taking it just because you, like, bought it off the internet, you thought Donald Trump made a point, if you start seeing halos around everything that you're looking at, you are in danger of losing your eyesight.

This is, of course, not reversible. This is a permanent damage you're talking about.

This is permanent damage.

When you are given Plaquenil [a brand name forhydroxychloroquine] from a doctor or a rheumatologist, there's a protocol that you have to follow, and you have to get a baseline eye exam from an ophthalmologist. And you go back every six months so that they can monitor if there's any buildup in your eye.

Towards the end of the eight months Iwas on Plaquenil,I was seeing so many floaters, it was like a snow globe. So it made it really hard to drive, really hard to read, really hard to do anything that required near sight.

We know that because of what Donald Trump's had to say, it has given a tremendous bump to sales of hydroxychloroquine.... So what do you say to those people who are now not just thinking they can treat COVID-19, but lots of people trying to get ahold of the drug because they believe what the president said that it can prevent them from getting it?

If you're hoarding this drug to prevent or treat COVID-19, you know, there's no real studies yet to say that it can do this and you are risking your own health to take this.

And at the same time, you are taking drugs away from people who actually need it. You're taking drugs away from a very vulnerable population.

People with rheumatoid arthritis and people with lupus who do well on this drug need to take it regularly. If you don't take your arthritis medication regularly, you risk capping an arthritic flare.When you have a flare, your symptoms come back and sometimes they come roaring back.

If you are taking this for lupus, that's even more critical. Lupus is an autoimmune disorder that attacks your body the same way that arthritis does. But if itstarts attacking one of your organs because you can't take your medication regularly, then that puts you at risk for organ failure.

And if you have one of your organs failing during a pandemic when your immune system is compromised, you know, the results are pretty grim.

For yourself, why did you feel it was necessary to put this message out?

When Donald Trump was talking I just wanted to be thelittle voice that comes after on the commercial that tells you these are the possible side effects just to raise people's awareness that, you know, these aren't Tic Tacs. These have potentially life-altering side effects.

Written by Sheena Goodyear with files from AminaZafar and CBC News.Interview produced by Chloe Shantz-Hilkes. Q&A has been edited for length and clarity.

Excerpt from:
'These aren't Tic Tacs': Author Eden Robinson on her experience with hydroxychloroquine - CBC.ca

President Trump has been a cheerleader for the drug hydroxychloroquine, pointing in a tweet and in person to a French study as evidence that one particular drug combination might be one of the biggest game changers in the history of medicine.

But now the medical society that published the French research has issued a statement saying theyre reviewing the study again and a correction to the scientific record may be considered.

Dr. Kevin Tracey, president and CEO of the Feinstein Institutes for Medical Research in New York City, gave an even more pointed assessment of the French research.

The study was a complete failure, he said.

It was pathetic, added Art Caplan, head of the division of medical ethics at the New York University School of Medicine.

The small French study of 20 people found that taking hydroxychloroquine was associated with the viral load reduction/disappearance in COVID-19 patients, noting that the effect was reinforced with azithromycin, an antibiotic better known as a Z-pack.

Tracey and Caplan pointed out that several patients who took the drug, and ended up faring poorly, dropped out of the trial, and their outcomes were not factored into the studys final conclusions.

The International Society of Antimicrobial Chemotherapy published the study online in its journal, the International Journal of Antimicrobial Agents, on March 20.

The society and the publisher of the journal, Elsevier, issued a joint statement that concerns have been raised regarding the content, the ethical approval of the trial and the process that this paper underwent to be published within International Journal of Antimicrobial Agents.

According to the statement, the study authors had been contacted to address concerns, and that additional independent peer review is ongoing to ascertain whether concerns about the research content of the paper have merit.

One of the studys co-authors, Jean-Marc Rolain, is also editor-in-chief of the journal.

The statement noted that Rolain was not involved in the peer review of the manuscript.

The statement from the society and Elsevier is dated April 3, but a previous statement with the same date was on the same webpage and has since been removed.

That statement by Andreas Voss, president of the society, said the study does not meet the Societys expected standard and that although ISAC recognises it is important to help the scientific community by publishing new data fast, this cannot be at the cost of reducing scientific scrutiny and best practices.

Voss, Rolain and Didier Raoult, a lead study author, did not immediately respond to CNN emails seeking comment.

Rarely does one unproven drug make such headlines, but hydroxychloroquine did due to Elon Musk, conservative media and Trump.

A recent article in Vanity Fair laid out the sequence of events.

On March 16, Musk, the Tesla CEO, tweeted that it maybe worth considering chloroquine for C19. Hydroxychloroquine is a derivative of chloroquine, and C19 is Covid-19, the medical term for the disease caused by the coronavirus.

Two days later, Breitbart and The Blaze wrote glowing articles about chloroquine.

The day after that, Trump said chloroquine was possibly a game changer at a White House briefing.

Two days later, on March 21, Trump referred to the French study in a tweet, saying that the combination of hydroxychloroquine and azithromycin have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains Thank You!

Trumps enthusiasm for hydroxychloroquine hasnt waned with time, even though its one of many drugs being studied to prevent or treat coronavirus, and none of them have been proven to be safe or effective.

We have some very good results and some very good tests. Youve seen the same test that I have, he said at an April 5 briefing. In France, they had a very good test.

In its statement, the society that published the paper mentioned concerns about the lack of better explanations of the inclusion criteria in the study, which took place at the Mditerranne Infection University Hospital Institute in Marseille, France.

The study started out with 26 patients taking the hydroxychloroquine, but six were lost in follow up during the survey because of early cessation of treatment, according to the study.

Three left because they ended up in the intensive care unit, another patient died, and a fifth stopped treatment due to nausea. It turned out the sixth patient didnt actually have coronavirus.

Leaving out the five patients who took the drug and didnt fare well is cherry picking, said Caplan, the bioethicist.

Thats not science, he said. Youve got your thumb on the scale.

The remaining 20 patients took hydroxychloroquine, some with the antibiotic azithromycin and some without, and their outcomes were compared with patients who did not take either drug.

The study authors wrote that 100% of patients who took the drug combination were virologically cured compared to 57.1% of the patients who took hydroxychloroquine alone and 12.5% of the control group. The authors did not fully explain what they meant by virologically cured.

Caplan added that even without the cherry picking issue, a study with such a small number of patients is basically meaningless.

Its just a jumbled mess, he said.

Several centers are doing clinical trials on hydroxychloroquine to prevent or treat coronavirus, including Harvard, Columbia, New York University and Henry Ford Health System in Detroit.

Tracey, the researcher at the Feinstein Institutes in New York City, is also conducting a study on the drug. He said despite the French study being seriously flawed, its still worth looking at hydroxychloroquine to see if its safe and effective for a subset of coronavirus patients.

First, he noted that hydroxychloroquine has anti-inflammatory properties. The US Food and Drug Administration has approved its use against lupus and rheumatoid arthritis, both diseases that involve inflammation.

Hydroxychloroquine might help coronavirus patients who experience whats called a cytokine storm, a potentially deadly inflammatory process.

And small studies other than the seriously flawed French one have shown that the drug might work, he added.

Theres a lot of small studies in humans and in the lab that frame an appropriate question thats never been answered in a clinical trial, he said. Its important to know if it works and if its safe in some people with coronavirus.

Originally posted here:
Publisher of hydroxychloroquine study touted by Trump says the research didn't meet its standards - KVIA El Paso

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