Drug updated on 9/4/2024
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.
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Summary
- Simponi (golimumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, for the treatment of adult patients with active psoriatic arthritis (PsA) alone or in combination with methotrexate, for the treatment of adult patients with active ankylosing spondylitis (AS), and for the treatment of adult patients with moderate to severe ulcerative colitis (UC) with an inadequate response or intolerance 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.
- This summary is based on the review of 27 systematic review(s)/meta-analysis(es). [1-27]
- Golimumab demonstrated lower clinical remission and response rates compared to upadacitinib, infliximab, and adalimumab in the treatment of ulcerative colitis (UC), particularly in biologic-experienced patients.
- Endoscopic mucosal healing outcomes with golimumab were inferior to those achieved with filgotinib and other advanced therapies.
- Golimumab was less effective in achieving early symptomatic remission compared to upadacitinib, infliximab, and adalimumab.
- In some analyses, golimumab’s effectiveness was comparable to vedolizumab and ozanimod, though it generally showed lower efficacy than infliximab, adalimumab, and upadacitinib in clinical remission, response, and endoscopic improvement.
- Golimumab's safety profile was comparable to other treatments, with no significant differences in overall adverse events. Common adverse events included nasopharyngitis, upper respiratory tract infections, injection site reactions, headache, and diarrhea. No significant differences were observed in serious adverse events between golimumab and other treatments. However, golimumab was associated with a lower risk of serious infections compared to infliximab combined with DMARDs.
- Observational studies and real-world data indicated that golimumab did not show new safety risks and demonstrated similar or better persistence compared to other TNFis in treating immune-mediated rheumatic diseases.
- Golimumab's effectiveness varies by patient subgroup, with biologic-naïve patients showing relatively better outcomes compared to biologic-experienced patients, though still less effective than other treatments. Additionally, men are less likely to achieve clinical remission, mucosal healing, and clinical response during induction treatment with TNFi therapies, including golimumab, compared to women, but no gender differences were observed during the maintenance phase.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Simponi (golimumab) Prescribing Information. | 2019 | Janssen Biotech, Inc., Horsham, PA |