Drug updated on 4/17/2024
| Dosage Form | Injection (subcutaneous; 50 mg/0.5 mL, 100 mg/mL) |
| Drug Class | Tumor necrosis factor (TNF) blockers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.
- Indicated for the treatment of adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate.
- Indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
- Indicated for the treatment of adult patients with moderate to severe ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy: inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, and achieving and sustaining clinical remission in induction responders.
Summary
- Golimumab (Simponi) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe ulcerative colitis. It can be used alone or in combination with methotrexate.
- The information comes from 27 systematic reviews/meta-analyses focusing on the efficacy and safety of Simponi in managing these conditions compared to other biologics and small molecule inhibitors.
- In the management of ulcerative colitis, golimumab was found to be less effective than upadacitinib at inducing clinical remission and response, as well as endoscopic improvement, during both induction and maintenance phases. However, no significant differences were observed between their safety profiles.
- Upadacitinib also outperformed golimumab in achieving symptomatic remission more rapidly among patients with moderate to severe ulcerative colitis, although golimumab still demonstrated efficacy, albeit at a slower pace.
- Gender-based differences have been observed in the use of TNF inhibitor therapies like golimumab for ulcerative colitis: men might be less likely to achieve clinical remission during induction treatment than women, but no significant gender-related differences were noted during the maintenance phase.
- For axial spondyloarthritis management, golimumab has shown strong performance alongside certolizumab and compared favorably against IL17-inhibitors. Additionally, it demonstrated substantial improvements in nail outcomes within psoriatic arthritis cases, indicating its effectiveness in this area as well.
- While some studies suggested the superiority of other therapies such as upadacitinib, notably in ulcerative colitis due to rapid achievement of symptomatic remission and maintaining clinical response, overall across various assessments comparing it with others, golimumab consistently exhibited robust long-term persistence and comparable or superior performance, especially among those naive to biologic treatments.
- Golimumab's role in managing rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis is confirmed by its comparative effectiveness and safety relative to other treatments. This underscores the importance of personalized treatment plans based on patient characteristics, previous therapy response, and specific treatment goals.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Simponi (golimumab) Prescribing Information. | 2019 | Janssen Biotech, Inc., Horsham, PA |