Golimumab

(Simponi®)

Simponi®

Drug updated on 9/4/2024

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.

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Summary
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  • 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 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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