Golimumab
TNFα | |
Clinical data | |
---|---|
Trade names | Simponi, Simponi Aria |
Other names | CNTO-148[1] |
AHFS/Drugs.com | Monograph |
MedlinePlus | a610010 |
License data | |
Pregnancy category |
|
Subcutaneous injection | |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
ECHA InfoCard | 100.226.360 |
Chemical and physical data | |
Formula | C6530H10068N1752O2026S44 |
Molar mass | 146945.25 g·mol−1 |
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Golimumab, sold under the brand name Simponi, is a
It is on the World Health Organization's List of Essential Medicines.[9]
Medical uses
The European Medicines Agency (EMA) has approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[5][10] Golimumab was approved for the treatment by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) in 2013 for the treatment of ulcerative colitis.[11][12]
Golimumab is approved in Canada[13] and the United States[14] as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis.[15][16]
Adverse effects
The most common adverse reactions (incidence >5%) are
Development
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.[18]
Society and culture
Availability
Golimumab was developed by
Research
Rheumatoid arthritis
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.[20] 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 recommended for RA patients who have failed prior TNFi treatment.[21] Unlike other TNFi treatments such as adalimumab and certolizumab pegol, there have been no reported cases of drug-induced lupus-like syndrome (DILS).[22]
Uveitis
There is preliminary evidence for golimumab as a treatment option for ocular inflammation.[23]
References
- PMID 20065639.
- FDA. Retrieved 22 October 2023.
- ^ a b c "Simponi- golimumab injection, solution". DailyMed. 30 September 2019. Retrieved 11 November 2020.
- ^ "Simponi Aria- golimumab solution". DailyMed. 2 October 2020. Retrieved 11 November 2020.
- ^ a b c d "Simponi EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 11 November 2020.
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council – Golimumab Archived 20 February 2012 at the Wayback Machine, American Medical Association.
- PMID 24161836.
- PMID 24161836.
- hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
- ^ "Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis". www.drugs.com. Retrieved 9 May 2016.
- PMID 24648749.
- ^ "Johnson & Johnson Reports 2008 First-Quarter Results". Archived from the original on 7 October 2008. Retrieved 28 April 2008.
- ^ "Health Canada Approves Simponi (Golimumab) For Treatment Of Rheumatoid Arthritis, Psoriatic Arthritis And Ankylosing Spondylitis". Archived from the original on 2 February 2010.
- ^ FDA Approves Simponi
- ^ "FDA clears potential blockbuster arthritis drug". North County Times. Lee Enterprises. Associated Press. 24 April 2009. Retrieved 23 October 2010.[permanent dead link]
- PMID 25887212.
- ^ FDA Professional Drug Information
- PMID 20065639.
- ^ "Simponi Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis". Johnson & Johnson (Press release). Archived from the original on 19 May 2016. Retrieved 9 May 2016.
- S2CID 195685167.
- S2CID 23085023.
- S2CID 21538173.
- S2CID 391892.