Drug updated on 5/17/2024
Dosage Form | Injection (subcutaneous; 200 mg [200 mg/mL]) |
Drug Class | Tumor 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.
Latest News
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Summary
- 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 Title | Year | Source |
---|---|---|
Cimzia (certolizumab pegol) Prescribing Information. | 2022 | UCB, Inc., Smyrna, GA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease. | 2021 | American Gastroenterological Association: Gastroenterology |
Canadian Association of Gastroenterology clinical practice guideline for the management of luminal Crohn’s disease. | 2019 | Journal of the Canadian Association of Gastroenterology |
Crohn's disease - treatment with biological medication. | 2019 | Revista da Associação Médica Brasileira |