Certolizumab pegol

(Cimzia®)

Certolizumab pegol

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Drug updated on 5/17/2024

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 Crohn’s 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.

Summary
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  • Certolizumab pegol (Cimzia) is indicated for reducing signs and symptoms of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis with objective signs of inflammation, and moderate-to-severe plaque psoriasis. It has shown superior efficacy compared to other drugs like etanercept and ixekizumab in achieving key clinical outcomes.
  • The information originated from 14 systematic reviews/meta-analyses focused on certolizumab pegol across various indications.
  • In the treatment of non-radiographic axial spondyloarthritis (nr-axSpA), certolizumab pegol demonstrates significant improvements over several competitors, especially in patients with objective signs of inflammation.
  • For treating psoriasis and psoriatic arthritis, it shows competitive efficacy in achieving PASI response and quality of life improvements at various time points. Furthermore, it's more effective than placebo for preventing radiographic progression in psoriatic arthritis.
  • When used for Crohn's Disease, certolizumab pegol significantly reduces the rate of failure to maintain clinical remission at 26 weeks, indicating its effectiveness in maintaining remission in this condition.
  • Across diseases treated by certolizumab pegol, such as rheumatoid arthritis or plaque psoriasis, the safety profile appears manageable without any new safety concerns even after long-term use or increased dosage exposure. However, there are specific increases in adverse events occurrences compared to other biologic therapies, specifically within rheumatoid arthritis where etanercept monotherapy might be favored due to lower AE rates.
  • In terms of population-specific considerations, analysis of dosing patterns indicates variances by region and disease, with some escalations beyond guidelines hinting at clinician-driven adjustments to optimize responses.
  • The findings suggest that switching from a TNF inhibitor to another TNF inhibitor or a different mechanism of action (MOA) drug can achieve good outcomes in rheumatoid arthritis, indirectly supporting the flexibility and efficacy of certolizumab pegol switch or rotation strategy.

Product Monograph / Prescribing Information

Document TitleYearSource
Cimzia (certolizumab pegol) Prescribing Information.2022UCB, Inc., Smyrna, GA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy of biologic disease-modifying anti-rheumatic drugs for non-radiographic axial spondyloarthritis: a systematic literature review and bucher indirect comparisons.2023Rheumatology and Therapy
Dose escalation patterns of advanced therapies in Crohn’s disease and ulcerative colitis: a systematic literature review.2023Advances in Therapy
The risk of adverse effects of TNF-α inhibitors in patients with rheumatoid arthritis: a network meta-analysis.2022Frontiers Immunology
Certolizumab pegol for maintenance of medically induced remission in Crohn's disease.2022The Cochrane Database of Systematic Reviews
Number needed to treat network meta-analysis to compare biologic drugs for moderate-to-severe psoriasis.2022Advances in Therapy
Biologic disease-modifying antirheumatic drugs for preventing radiographic progression in psoriatic arthritis: a systematic review and network meta-analysis.2022Pharmaceutics
Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data.2021Journal of American Academy of Dermatology
Comparative safety and benefit-risk profile of biologics and oral treatment for moderate-to-severe plaque psoriasis: a network meta-analysis of clinical trial data.2021Journal of American Academy of Dermatology
Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies.2021The British Journal of Dermatology
Systematic review and network meta-analysis: comparative efficacy and safety of biosimilars, biologics and JAK1 inhibitors for active Crohn disease.2021Frontiers in Pharmacology
Impact of tumor necrosis factor α inhibitors on MRI inflammation in axial spondyloarthritis assessed by spondyloarthritis research consortium Canada score: a meta-analysis.2020PLOS ONE
Patient characteristics as effect modifiers for psoriasis biologic treatment response: an assessment using network meta-analysis subgroups.2020Systematic Reviews
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis.2020Annals of the Rheumatic Diseases
Certolizumab pegol for induction of remission in Crohn's disease.2019The Cochrane Database of Systematic Reviews

Clinical Practice Guidelines