|Trade names||Simponi, Simponi Aria|
|Main uses||Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis|
|Side effects||Upper respiratory tract infection|
|Chemical and physical data|
|Molar mass||146945.25 g·mol−1|
Golimumab, sold under the brand name Simponi, is a medication used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. It is given by injection under the skin.
Common side effects include upper respiratory tract infection. Other side effects may include sepsis, pneumonia, reactivation of hepatitis B, heart failure, allergic reactions, vasculitis, and leukemia. Use in pregnancy and breastfeeding is of unclear safety. It is a monoclonal antibody which is attaches to and blocks tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule.
Golimumab was approved for medical use in the United States and Europe in 2009. It is on the World Health Organization's List of Essential Medicines as an alternative to adalimumab. In the United Kingdom 100 mg costs the NHS about £1,500 as of 2021. In the United States this amount costs about 6,300 USD.
It is used to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is also used to treat ulcerative colitis. Golimumab can either be used via a self administered subcutaneous injection or intravenous injection.
Golimumab is approved in Canada and the United States as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis.
The typical dose is 50 to 100 mg per month.
Golimumab binds to both soluble and transmembrane forms of TNFα. The antibody was isolated from a hybridoma clone produced by transgenic mice immunized with human TNFα. The golimumab-secreting clone was selected after being assayed for human light and heavy chains and TNFα-binding. The commercial product is produced in a recombinant cell line cultured by continuous perfusion.
Society and culture
Golimumab was developed by Janssen Biotech, Inc. (formerly Centocor Biotech, Inc.) which also markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Simponi distribution rights are held by Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, distribution rights are held by Mitsubishi Tanabe Pharma Corporation.
Large, double-blind randomized controlled trials in patients with rheumatoid arthritis have shown that golimumab in combination with methotrexate was more effective than methotrexate alone. When clinically indicated, golimumab is estimated as a moderate cost-effective treatment option. National Institutes for Health and Care Excellence (NICE) stated that treatment with golimumab is not recommended for RA patients who have failed prior TNFi treatment. Unlike other TNFi treatments such as adalimumab and certolizumab pegol, there have been no reported cases of drug-induced lupus-like syndrome (DILS).
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