Golimumab

(Simponi®)

Golimumab

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Drug updated on 4/17/2024

Dosage FormInjection (subcutaneous; 50 mg/0.5 mL, 100 mg/mL)
Drug ClassTumor 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
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  • 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 TitleYearSource
Simponi (golimumab) Prescribing Information.2019Janssen Biotech, Inc., Horsham, PA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The comparative efficacy and safety of biologics and small molecules for treating patients with ulcerative colitis in Portugal: a systematic literature review and network meta-analysis.2023European Review for Medical and Pharmaceutical Sciences
Comparative speed of early symptomatic remission with advanced therapies for moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2023American Journal of Gastroenterology
Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.2023International Journal of Clinical Pharmacy
Systematic literature review of real-world evidence on dose escalation and treatment switching in ulcerative colitis.2023ClinicoEconomics and Outcomes Research
Gender-based differences in response to tumor necrosis factor inhibitor therapies for ulcerative colitis: individual participant data meta-analyses of clinical trials.2023Inflammatory Bowel Diseases
Defining the failure of medical therapy for inflammatory bowel disease in the era of advanced therapies: a systematic review.2023Biomedicines
Efficacy and safety of biological DMARDs: a systematic literature review informing the 2022 update of the ASAS-EULAR recommendations for the management of axial spondyloarthritis.2023Annals of Rheumatic Diseases
Efficacy and safety of nail psoriasis targeted therapies: a systematic review.2023American Journal of Clinical Dermatology
Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: systematic review and meta-analysis.2022Frontiers in Pharmacology
Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2022The Lancet. Gastroenterology & Hepatology
The efficacy of golimumab against non-infectious uveitis: a prisma-compliant systematic review and meta-analysis.2022Ocular Immunology and Inflammation
The risk of adverse effects of TNF-α inhibitors in patients with rheumatoid arthritis: a network meta-analysis.2022Frontiers in Immunology
Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.2022International Journal of Clinical Pharmacology
Differences in biologics for treating ankylosing spondylitis: the contribution of network meta-analysis.2021European Review for Medical and Pharmacological Sciences
Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis.2021Expert Review of Gastroenterology & Hepatology
Drug survival of biologics in treating ankylosing spondylitis: a systematic review and meta-analysis of real-world evidence.2020BioDrugs
A systematic review and network meta-analysis of current and investigational treatments for active ankylosing spondylitis.2020Clinical Rheumatology
Fourteen small molecule and biological agents for psoriatic arthritis: a network meta-analysis of randomized controlled trials.2020Medicine
Efficacy of ustekinumab vs. advanced therapies for the treatment of moderately to severely active ulcerative colitis: a systematic review and network meta-analysis.2020Current Medical Research and Opinion
Longterm drug survival of tumor necrosis factor inhibitors in patients with rheumatoid arthritis.2020Journal of Rheumatology
Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis.2020RMD Open
Model-based meta-analysis in ankylosing spondylitis: a quantitative comparison of biologics and small targeted molecules.2019Clinical Pharmacology and Therapeutics
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: a systematic review and network meta-analysis.2019Seminars in Arthritis and Rheumatism
Different original and biosimilar TNF inhibitors similarly reduce joint destruction in rheumatoid arthritis-A network meta-analysis of 36 randomized controlled trials.2019International Journal of Molecular Sciences
Network meta-analysis of tofacitinib versus biologic treatments in moderate-to-severe rheumatoid arthritis patients.2019Journal of Clinical Pharmacy and Therapeutics
Real-world treatment persistence of golimumab in the management of immune-mediated rheumatic diseases in Europe: a systematic literature review.2019BMJ Open
Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: a systematic overview of meta-analyses.2019United European Gastroenterology Journal

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