Certolizumab pegol

(Cimzia®)

Cimzia®

Drug updated on 10/2/2024

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.

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Summary
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  • Cimzia (certolizumab pegol) is indicated for reducing signs and symptoms of Crohn’s disease and maintaining a clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy; treatment of adults with moderately to severely active rheumatoid arthritis; treatment of adult patients with active psoriatic arthritis; treatment of adults with active ankylosing spondylitis; treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation; and treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Non-Radiographic Spondyloarthritis (nr-axSpA): Certolizumab Pegol (CZP) demonstrated significant improvement in achieving ASAS20/40 response, ASDAS-inactive disease status, and BASDAI and BASFI scores at 12-16 weeks compared to etanercept (ETN), ixekizumab (IXE), and secukinumab (SEC). CZP was particularly effective in patients with objective signs of inflammation, outperforming ETN and SEC in achieving ASAS40.
  • Crohn's Disease (CD): CZP significantly reduced the failure to maintain clinical remission at week 26 compared to placebo and showed a significant benefit in clinical remission at week 8. Data on dose escalation patterns for CZP were limited, with more comprehensive evidence available for ustekinumab and vedolizumab.
  • Psoriatic Arthritis (PsA): In a network meta-analysis, CZP reduced the total radiographic score but was not highlighted as superior to other biologics, such as adalimumab, infliximab, and etanercept.
  • Psoriasis: CZP had one of the lowest numbers needed to treat (NNTs) for achieving PASI responses at various time points, indicating high short-term efficacy.
  • In rheumatoid arthritis (RA) patients, adverse events (AEs) were more common with Certolizumab Pegol (CZP) combined with DMARDs compared to placebo and DMARDs alone, but serious adverse events (SAEs) were not significantly increased.
  • In Crohn's Disease (CD) patients, serious adverse events were observed in 8.7% of CZP-treated patients compared to 6.2% in the placebo group; this difference was not statistically significant.
  • In psoriasis patients, over 144 weeks, the incidence rates of treatment-emergent adverse events (TEAEs) and serious TEAEs were comparable between the 200 mg and 400 mg Q2W doses of CZP, with no new safety signals identified.
  • There is no population types or subgroups information available in the reviewed studies.

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
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