Certolizumab pegol

(Cimzia®)

Cimzia®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 200 mg [200 mg/mL])
Drug ClassTumor necrosis factor (TNF) blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for reducing signs and symptoms of Crohns disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Indicated for treatment of adults with moderately to severely active rheumatoid arthritis
  • Indicated for treatment of adult patients with active psoriatic arthritis
  • Indicated for treatment of adults with active ankylosing spondylitis
  • Indicated for treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation
  • Indicated for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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Summary
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  • This summary is based on the review of 32 systematic review(s)/meta-analysis(es). [1-31]
  • Psoriatic Arthritis (PA): Certolizumab pegol (CZP) demonstrated moderate effectiveness in PA, including achieving American College of Rheumatology 50 (ACR 50) and Psoriatic Arthritis Response Criteria (PsARC) improvements at six months, though it was less effective compared to Secukinumab and Adalimumab in these outcomes. Additionally, CZP prevented radiographic progression but was outperformed by other biologics like Adalimumab, Infliximab, and Etanercept.
  • Rheumatoid Arthritis (RA): CZP was significantly effective in achieving low disease activity or remission within three months in RA patients, with an odds ratio of 6.31 compared to placebo, showing substantial effectiveness in this population.
  • Non-Radiographic Axial Spondyloarthritis (nr-AxSpA): In nr-AxSpA, CZP provided superior responses on Assessment of SpondyloArthritis International Society (ASAS) criteria (ASAS 20/40) and achieved better inactive disease scores (ASDAS) compared to other biologics, indicating its relative effectiveness in this subgroup.
  • Crohn's Disease (CD): For CD, CZP showed significant benefits in maintaining clinical remission and response at week 26 compared to placebo, positioning it as an effective maintenance therapy in this condition.
  • Psoriatic Arthritis and Rheumatoid Arthritis: CZP showed an increased risk of infections compared to placebo and some other tumor necrosis factor (TNF) inhibitors, although rates of serious adverse events (SAEs) were not significantly different from placebo in psoriatic arthritis and were comparable to other TNF inhibitors in rheumatoid arthritis.
  • Non-Radiographic Axial Spondyloarthritis: In this population, CZP demonstrated a safety profile similar to other biologics, with a generally comparable rate of adverse events despite achieving higher efficacy in some outcomes.
  • Crohn's Disease and Psoriasis: CZP did not show a significant difference in serious adverse events compared to placebo in Crohn's disease, and in psoriasis, long-term exposure revealed no new safety signals, with lower SAE rates compared to placebo.

Product Monograph / Prescribing Information

Document TitleYearSource
Cimzia (certolizumab pegol) Prescribing Information.2024UCB, Inc., Smyrna, GA

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
Cost-effectiveness analysis of bimekizumab for the treatment of active psoriatic arthritis in Sweden2023Journal of Medical Economics
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2023The Cochrane Database of Systematic Reviews
Estimating Patient-Specific Relative Benefit of Adding Biologics to Conventional Rheumatoid Arthritis Treatment: An Individual Participant Data Meta-Analysis2023Jama Network Open
Dose Escalation Patterns of Advanced Therapies in Crohn's Disease and Ulcerative Colitis: A Systematic Literature Review2023Advances in Therapy
Comparative Efficacy of Biologic Disease-Modifying Anti-Rheumatic Drugs for Non-Radiographic Axial Spondyloarthritis: A Systematic Literature Review and Bucher Indirect Comparisons2023Rheumatology and Therapy
Biologic Disease-Modifying Antirheumatic Drugs for Preventing Radiographic Progression in Psoriatic Arthritis: A Systematic Review and Network Meta-Analysis2022Pharmaceutics
Certolizumab pegol for maintenance of medically induced remission in Crohn's disease2022The Cochrane Database of Systematic Reviews
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
Number Needed to Treat Network Meta-Analysis to Compare Biologic Drugs for Moderate-to-Severe Psoriasis2022Advances in Therapy
The Risk of Adverse Effects of TNF-alpha Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis2022Frontiers in Immunology
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year2022The Journal of Dermatological Treatment
Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis2021Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis2021The Lancet. Gastroenterology & Hepatology
Systematic Review and Network Meta-Analysis: Comparative Efficacy and Safety of Biosimilars, Biologics and JAK1 Inhibitors for Active Crohn Disease2021Frontiers in Pharmacology
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2021The Cochrane Database of Systematic Reviews
Efficacy and Safety of Anti-TNFalpha Therapy for Uveitis Associated with Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis2021Rheumatology and Therapy
Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: A network meta-analysis of clinical trial data2021Journal of the American Academy of Dermatology
Cost per cumulative clinical benefit of biologic therapies for patients with plaque psoriasis: a systematic review2021Journal of Managed Care & Specialty Pharmacy
Model-Based Meta-Analysis Compares DAS28 Rheumatoid Arthritis Treatment Effects and Suggests an Expedited Trial Design for Early Clinical Development2021Clinical Pharmacology and Therapeutics
Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies2021The British Journal of Dermatology
Impact of tumor necrosis factor alpha inhibitors on MRI inflammation in axial spondyloarthritis assessed by Spondyloarthritis Research Consortium Canada score: A meta-analysis2020Plos One
Fourteen small molecule and biological agents for psoriatic arthritis: A network meta-analysis of randomized controlled trials2020Medicine
The pharmacological and clinical aspects behind dose loading of biological disease modifying anti-rheumatic drugs (bDMARDs) in auto-immune rheumatic diseases (AIRDs): rationale and systematic narrative review of clinical evidence2020Bmc Rheumatology
Patient characteristics as effect modifiers for psoriasis biologic treatment response: an assessment using network meta-analysis subgroups2020Systematic Reviews
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
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis2020The Cochrane Database of Systematic Reviews
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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