SIMPONI ARIA (golimumab) is a fully human monoclonal antibody used for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA). Credit: Janssen Biotech, Inc. The 4ml single-use vial of SIMPONI ARIA contains 50mg of golimumab. Credit: A2-33. SIMPONI ARIA acts as a tumor necrosis factor (TNF)-blocker.
SIMPONI ARIA (golimumab) is a fully human anti-tumour necrosis factor (TNF) alpha monoclonal antibody.
It is indicated for the treatment of moderate-to-severe active rheumatoid arthritis (RA) and active ankylosing spondylitis (AS) in adult patients, as well as active polyarticular juvenile idiopathic arthritis (pJIA) and active psoriatic arthritis (PsA) in patients aged two years and older.
SIMPONI ARIA is available in a single-use vial as a colourless to a light-yellow solution in 50mg / 4ml (12.5mg / ml) dosage strength for intravenous administration.
Discovered and developed by Janssen Biotech, golimumab was initially approved as a subcutaneous injection under the trade name Simponi by the US Food and Drug Administration (FDA) for the treatment of RA, PsA and AS in adult patients in 2009.
SIMPONI was approved in Europe for the treatment of moderate-to-severe RA, active and progressive PsA, severe, active AS, active ulcerative colitis, severe active non-radiographic axial spondyloarthritis and pJIA.
In July 2013, the intravenous form of golimumab obtained FDA approval under the trade name Simponi Aria for the treatment of moderate-to-severe active RA in combination with methotrexate (MTX).
The company submitted two supplemental biologics license applications (sBLAs) for Simponi Aria to the FDA for the treatment of PsA and AS in adult patients in December 2016. The applications were approved in October 2017.
The FDA also received two sBLAs for Simponi Aria for the treatment of active pJIA and PsA in paediatric patients in April 2020. The drug was approved for the indications in September 2020.
SIMPONI ARIA is marketed in 24 countries for one or more of the aforementioned indications.
Juvenile idiopathic arthritis (JIA), previously known as juvenile rheumatoid arthritis, is an arthritis-like inflammatory condition in children characterised by joint swelling, stiffness and pain, persistent for at least six weeks.
The polyarticular form of JIA is most common and is characterised by inflammation in more than four joints, closely resembling adult RA.
PsA is a chronic inflammatory disease characterised by both joint inflammation and skin lesions associated with psoriasis. PsA in paediatric patients is one of the rarest forms of JIA, observed in 2% to 11% of JIA patients.
Other characteristics of psoriatic arthritis include finger and nail defects or complications with the eye.
Golimumab is an anti-TNF biologic agent that binds to soluble and transmembrane bioactive forms of human TNF-alpha, a cytokine protein whose overproduction in the body leads to several chronic inflammatory diseases.
Inhibition of the interaction of TNF-alpha to its receptors inhibits its biological activity.
FDA approval of SIMPONI ARIA for pJIA is based on results from the open-label, multi-centre, phase three clinical trial, GO-VIVA.
SIMPONI ARIA is available in a single-use vial as a colourless to a light-yellow solution in 50mg / 4ml (12.5mg / ml) dosage strength for intravenous administration.
The trial evaluated the safety and efficacy of SIMPONI ARIA in 127 patients with pJIA aged two years to 17 years, following MTX treatment for at least two months.
The efficacy of the drug was consistent with responses in adult patients with RA through 52 weeks.
SIMPONI ARIAs pharmacokinetic (PK) exposure was consistent with the two pivotal phase three clinical trials in adult patients with moderate-to-severe active RA and active PsA.
The safety profile established for SIMPONI ARIA in paediatric patients was also consistent with the results in adult RA and PsA patients.
Common side-effects of SIMPONI ARIA reported in patients during the clinical trial are viral infections, upper respiratory tract infection, increased levels of alanine aminotransferase and aspartate aminotransferase, decreased neutrophil count, rash, bronchitis and high blood pressure.
Continue reading here:
SIMPONI ARIA (golimumab) for the Treatment of pJIA - Clinical Trials Arena
- Pharmacist explains best diet to reduce arthritis, inflammation and joint pain - The Mirror - March 10th, 2024
- Teen Raises Funds to Fight Arthritis - Arthritis Foundation - March 10th, 2024
- Is there a higher risk of depression among specific populations of patients with rheumatoid arthritis? - News-Medical.Net - March 10th, 2024
- Here's How to Explain Your Arthritis Pain to Your Doctor So They Actually Get It - Northwest Georgia News - March 10th, 2024
- Despite Their Prevalence, Arthritis, Neck and Back Pain Receive Few Research Dollars, Analysis Finds | BIDMC of ... - Beth Israel Deaconess Medical... - March 10th, 2024
- This Is the Difference Between Rheumatoid and Psoriatic Arthritis - Prescott Daily Courier - March 10th, 2024
- The #1 Early Sign of Arthritis Most People Miss, According to a Rheumatologist - Northwest Georgia News - March 10th, 2024
- The Efficacy and Safety of Apremilast in the Management of Psoriatic Arthritis: A Systematic Review and Meta-Analysis - Cureus - March 10th, 2024
- MU Researchers Participating in International Clinical Study Targeting Prevention of Osteoarthritis - University of Missouri School of Medicine - March 10th, 2024
- Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5 - The Center for Biosimilars - March 10th, 2024
- A Gender-Bias-Mitigated, Data-Driven Precision Medicine System to Assist in the Selection of Biological Treatments of ... - Cureus - March 10th, 2024
- Young arthritis cases are on the rise, new research suggests - The Examiner - March 10th, 2024
- Quiz: ACR Guideline for the Treatment of Psoriatic Arthritis - MD Magazine - February 10th, 2024
- Psoriatic arthritis: What to know about medications for children - Medical News Today - February 10th, 2024
- Ancient Egyptian woman had holes on her bones. Experts say its rare case of disease - Miami Herald - February 10th, 2024
- Arthritis and Pregnancy: Fertility, Gestation, Postpartum - Verywell Health - February 10th, 2024
- 3500-year-old burial of Nubian woman reveals 1 of world's earliest known cases of rheumatoid arthritis - Livescience.com - February 10th, 2024
- Impact of frailty severity and severe pain on cognitive function for community-dwelling older adults with arthritis: a cross ... - Nature.com - February 10th, 2024
- IHL-675A: Advancing Towards Innovative Arthritis Solutions, with Mark Bleackley, PhD - MD Magazine - February 10th, 2024
- Insomnia, Shorter Sleep Duration Linked to the Risk of Autoimmune Arthritis - MD Magazine - February 10th, 2024
- Advancements in Psoriatic Arthritis Treatment for Children: A Beacon of Hope - Medriva - February 10th, 2024
- Breakthrough Molecule RvT4 Reverses Inflammation and Clears Arterial Blockages in Rheumatoid Arthritis Patients - SciTechDaily - February 10th, 2024
- Personal Experience with Psoriatic Arthritis and Atopic Dermatitis - Medriva - February 10th, 2024
- EULAR Recommendations on Imaging in Crystal-Induced Arthropathies (CiA) - Medriva - February 10th, 2024
- The Importance of Ultrasound-Guided Synovial Biopsy in the Workup of Seronegative Inflammatory Arthritis: A Case ... - Cureus - February 10th, 2024
- Autoimmune diseases like lupus, MS, and rheumatoid arthritis strike far more women than men. Scientists now think they know why - Fortune - February 2nd, 2024
- Multiple Ulcers in the Ileum and Lymphadenopathy Following the Usage of Methotrexate in a Patient With Rheumatoid ... - Cureus - February 2nd, 2024
- These are the best arthritis creams of 2024, according to health experts - Yahoo Life - February 2nd, 2024
- Do Your Joints Ache When a Storm Is Brewing? Here's What's Really Happening - DISCOVER Magazine - February 2nd, 2024
- Olympic bronze medalist opens up about balancing arthritis with motherhood and triathlon - TRI247 - February 2nd, 2024
- Some Dinosaurs May Have Had Arthritis 90 Million Years Ago - IFLScience - February 2nd, 2024
- 3500-year-old remains of ancient Egyptian suffering from rheumatoid arthritis uncovered - Xinhua - February 2nd, 2024
- Lupus and other autoimmune diseases strike far more women than men. Now there's a clue why - The Associated Press - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day on February 2: What you need to know - CNBCTV18 - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day 2024: Signs, Symptoms, Diagnosis, and Prevention - News18 - February 2nd, 2024
- Improving arthritis in cold weather | Health Smart - WPMT FOX 43 - February 2nd, 2024
- Rheumatoid Arthritis Awareness Day: History, Significance And All You Need To Know - ABP Live - February 2nd, 2024
- Dietary Factors Tied to Osteoarthritis Pain | MedPage Today - Medpage Today - February 2nd, 2024
- Cold-weather coping tips for people with arthritis, osteoporosis and lung diseases - Southernminn.com - February 2nd, 2024
- How to manage arthritis and joint pain: Effective tips for knee pain relief - Health shots - February 2nd, 2024
- New study illuminates the genetics of thumb arthritis treatment - News-Medical.Net - January 25th, 2024
- Rheumatoid arthritis: 30 minutes of walking may lower blood pressure - Medical News Today - January 25th, 2024
- RA Disease Activity Assessed Too Little After Starting TNFi - Medscape - January 25th, 2024
- Lifestyle tips for youth's bone health: Avoid these habits to prevent arthritis - Hindustan Times - January 25th, 2024
- Best arthritis pain relief cream of 2024, according to experts - AOL - January 25th, 2024
- Vasculitis, an Early Unusual Presentation of Rheumatoid Arthritis: A Case Report - Cureus - January 25th, 2024
- Patients with later menarche, earlier menopause have higher risk for rheumatoid arthritis - Healio - January 25th, 2024
- Investigating Maternal Inflammatory Arthritis and Pregnancy Outcomes < Yale School of Medicine - Yale School of Medicine - January 25th, 2024
- Rheumatoid Arthritis and Diabetes: What's the Connection? - Health Central - January 25th, 2024
- Oxidative DNA Damage and Zinc Status in Patients With Rheumatoid Arthritis in Duhok, Iraq - Cureus - January 25th, 2024
- Changes Afoot for the Treatment of Psoriatic Arthritis with Marked Gains in Preference and Utilization of IL-17 Inhibitors - Yahoo Finance - January 25th, 2024
- The Connection Between Potassium and Rheumatoid Arthritis - Health Central - January 25th, 2024
- What Is the ACR20 (American College of Rheumatology) Criteria? - Health Central - January 25th, 2024
- RA Treatment Advances and Where They Are Headed - Health Central - January 25th, 2024
- TMC Medical Minutes- Arthritis & Cold Weather - KXII - January 25th, 2024
- How to deal with joint and arthritis pain in the cold weather - Crossroads Today - January 25th, 2024
- Arthritis: Regular exercises, calcium-rich diet and other habits to keep your bones strong and healthy - Moneycontrol - January 25th, 2024
- Men With Arthritis Have Higher Fertility Rates, Study Finds - Zenger.News - January 25th, 2024
- Pain on Top of Foot: 5 Causes, Swelling, Treatment - Verywell Health - January 25th, 2024
- Understanding Rheumatoid Arthritis in Women: Genetics, Hormones, and Impact - Medriva - January 25th, 2024
- Arthritis | Johns Hopkins Medicine - January 9th, 2024
- Ideal cardiovascular health metrics have better identification of arthritis - BMC Public Health - BMC Public Health - January 9th, 2024
- Acupuncture for Arthritis: Benefits and Risks - Verywell Health - January 9th, 2024
- Why do arthritic horses have more trouble during the winter? - EQUUS Magazine - January 9th, 2024
- Rather than roll over and die, I'm like, 'No, I still want to play': Steve Morse says arthritis diagnosis forced him to ... - Guitar.com - January 9th, 2024
- Top Signs that Your RA Treatment May No Longer Be Working - Health Central - January 9th, 2024
- What Is The Life Expectancy Of Rheumatoid Arthritis? A Review By Doctors - MSN - January 9th, 2024
- Nature Coast Orthopaedics | arthritis care | medicare and most insurance accepted | Beverly Hills, FL | chronicleonline ... - Citrus County Chronicle - January 9th, 2024
- Millions of arthritis patients could struggle to get blockbuster drug, as CVS pulls it from pharmacies - Daily Mail - January 9th, 2024
- What Is Arthritis? | Arthritis Foundation - May 17th, 2023
- Procedure to Surgery for Arthritis Is Recommended After First Failed Non-Operative Therapy - DocWire News - March 29th, 2023
- Higher Prevalence of Sarcopenia Reported in Patients with Rheumatoid Arthritis - Rheumatology Network - October 7th, 2022
- Exploring the Relationship Between Psoriatic Arthritis and Psoriasis - Dermatology Times - October 7th, 2022
- Are Tomatoes Bad For Arthritis? Here's What An MD Has To Say - Women's Health - October 7th, 2022
- Tocilizumab for Treating ICI-Induced Arthritis and Colitis - DocWire News - October 7th, 2022
- Why Arthritis Is A Clear And Present Danger, And How We Can Fight It - CNBCTV18 - October 7th, 2022
- Arthritis: Five cruciferous veg 'block inflammatory process' - backed by 10-year study - Express - October 7th, 2022
- 5 Exercise Habits for Arthritis in Your 50s - Eat This, Not That - October 7th, 2022
- Arthritis: 8 types of fish can cause acid crystals to build up in joints - 'very painful' - Express - October 7th, 2022
- EMA Issues Positive Opinion on the Safety of Filgotinib - Medscape - October 7th, 2022