Golimumab

(Simponi®)

Simponi®

Drug updated on 12/11/2024

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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  • This summary is based on the review of 30 systematic review(s)/meta-analysis(es). [1-30]
  • Psoriatic Arthritis (PA): Golimumab demonstrated very low certainty of evidence in achieving Psoriatic Arthritis Response Criteria (PsARC) at 6 months, showing less effectiveness compared to Etanercept, Infliximab, and Certolizumab Pegol. It was not among the top treatments for achieving American College of Rheumatology (ACR) 50 at 6 months, as Secukinumab, Infliximab, and Adalimumab were more effective.
  • Fatigue in Rheumatic and Musculoskeletal Diseases (I-RMDs): In rheumatoid arthritis, Golimumab significantly reduced fatigue at 24 weeks compared to placebo (mean difference (MD)=-5.27, p<0.001).
  • Ankylosing Spondylitis (AS): Golimumab led to significant improvements in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), total back pain, Jenkins Sleep Evaluation Questionnaire (JSEQ), SF-36 Physical Component Summary (PCS), and SF-36 Mental Component Summary (MCS) scores relative to placebo. The 100 mg dose showed greater efficacy than the 50 mg dose but was associated with a higher incidence of serious adverse events.
  • Juvenile Idiopathic Arthritis-associated Uveitis (JIA-U): Golimumab achieved a 65% (95% confidence interval (CI) 42-86%) rate of intraocular inflammation control, higher than Infliximab but lower than Adalimumab.
  • Etanercept and Golimumab were associated with a lower risk of serious infection compared to other tumor necrosis factor (TNF) inhibitors, with Golimumab specifically noted to have fewer safety concerns relative to Certolizumab Pegol and Infliximab, which had higher risks of serious infections.
  • For Psoriatic Arthritis, Golimumab, along with Secukinumab and Adalimumab, exhibited very low certainty of evidence for safety, with no significant differences observed in the risk of serious adverse events between Golimumab and placebo.
  • In long-term follow-ups and observational studies, Golimumab demonstrated a stable safety profile comparable to other biologics, showing no increase in adverse events with dose escalation in conditions like Ulcerative Colitis and Crohn's Disease.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Simponi (golimumab) Prescribing Information.2019Janssen Biotech, Inc., Titusville, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparisons of infection events associated with tumor necrosis factor inhibitors in patients with inflammatory arthritis: A systematic review and network meta-analysis2024Frontiers in Pharmacology
Effectiveness and safety of biological and target synthetic drugs treatment for psoriatic arthritis: a systematic review with network meta-analysis2024Advances in Rheumatology (london, England)
Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis2024Annals of the Rheumatic Diseases
Efficacy of pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases2023Rmd Open
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-analysis2023European Review for Medical and Pharmacological Sciences
Dose Escalation Patterns of Advanced Therapies in Crohn's Disease and Ulcerative Colitis: A Systematic Literature Review2023Advances in Therapy
Cost-Effectiveness Analysis of Tofacitinib Compared with Biologics in Biologic-Naive Patients with Moderate-to-Severe Ulcerative Colitis in Japan2023Pharmacoeconomics
Systematic Literature Review of Real-World Evidence on Dose Escalation and Treatment Switching in Ulcerative Colitis2023Clinicoeconomics and Outcomes Research : Ceor
Comparative Efficacy of Biologic Disease-Modifying Anti-Rheumatic Drugs for Non-Radiographic Axial Spondyloarthritis: A Systematic Literature Review and Bucher Indirect Comparisons2023Rheumatology and Therapy
Comparative efficacy of advanced treatments in biologic-naive or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis2023International Journal of Clinical Pharmacy
Cost-Utility Analysis of Biologic Disease-Modifying Antirheumatic Drugs for Patients With Psoriatic Arthritis in Thailand2023Value in Health Regional Issues
Gender-Based Differences in Response to Tumor Necrosis Factor Inhibitor Therapies for Ulcerative Colitis: Individual Participant Data Meta-Analyses of Clinical Trials2023Inflammatory Bowel Diseases
Biologic Disease-Modifying Antirheumatic Drugs for Preventing Radiographic Progression in Psoriatic Arthritis: A Systematic Review and Network Meta-Analysis2022Pharmaceutics
De-Escalation of Anti-Tumor Necrosis Factor Alpha Agents and Reduction in Adverse Effects: A Systematic Review2022Biomedicines
Targeted systemic therapies for psoriatic arthritis: a systematic review and comparative synthesis of short-term articular, dermatological, enthesitis and dactylitis outcomes2022Rmd Open
The Risk of Adverse Effects of TNF-alpha Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis2022Frontiers in Immunology
Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis2022The Lancet. Gastroenterology & Hepatology
Efficacy and Safety of Anti-TNFalpha Therapy for Uveitis Associated with Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis2021Rheumatology and Therapy
Integrating efficacy and safety of vedolizumab compared with other advanced therapies to assess net clinical benefit of ulcerative colitis treatments: a network meta-analysis2021Expert Review of Gastroenterology & Hepatology
Comparative of the Effectiveness and Safety of Biological Agents, Tofacitinib, and Fecal Microbiota Transplantation in Ulcerative Colitis: Systematic Review and Network Meta-Analysis2021Immunological Investigations
Biological therapy in pediatric age2020Pharmacological Research
Fourteen small molecule and biological agents for psoriatic arthritis: A network meta-analysis of randomized controlled trials2020Medicine
Patients with ankylosing spondylitis treatment by golimumab: a systematic review and meta-analysis2020European Spine Journal : Official Publication of the European Spine Society, the
Pharmacological treatment of psoriatic arthritis: a systematic literature research for the 2019 update of the EULAR recommendations for the management of psoriatic arthritis2020Annals of the Rheumatic Diseases
A systematic review and network meta-analysis of current and investigational treatments for active ankylosing spondylitis2020Clinical Rheumatology
Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis2020Rmd Open
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis2020Annals of the Rheumatic Diseases
Efficacy of ustekinumab vs. advanced therapies for the treatment of moderately to severely active ulcerative colitis: a systematic review and network meta-analysis2020Current Medical Research and Opinion
Efficacy and safety of biologic agents and tofacitinib in moderate-to-severe ulcerative colitis: A systematic overview of meta-analyses2019United European Gastroenterology Journal
Comparative efficacy and safety of targeted DMARDs for active psoriatic arthritis during induction therapy: A systematic review and network meta-analysis2019Seminars in Arthritis and Rheumatism

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