Drug updated on 4/17/2024
| Dosage Form | Injection (subcutaneous; 200 mg (200 mg/ml)) |
| Drug Class | Tumor necrosis factor (TNF) blockers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- For treatment of adults with moderately to severely active rheumatoid arthritis.
- For treatment of adult patients with active psoriatic arthritis.
- For treatment of adults with active ankylosing spondylitis.
- For treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
- For treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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 in adults.
- Five systematic reviews/meta-analyses were reviewed to gather information about the drug's effectiveness and safety profile.
- In patients with non-radiographic axial spondyloarthritis who had failed at least one non-steroidal anti-inflammatory drug treatment, certolizumab pegol showed significant improvement over etanercept (ETN), ixekizumab (IXE), secukinumab (SEC) in achieving ASAS20/40 response and ASDAS-inactive disease status within 12-16 weeks.
- Among patients showing objective signs of inflammation such as elevated C-reactive protein levels or inflammation on MRI at baseline; certolizumab pegol was found superior to ETN and SEC in achieving ASAS40 response while being comparable to golimumab across different subgroups.
- A meta-analysis demonstrated a slightly increased overall infection risk but not serious infection risk among patients receiving tumor necrosis factor inhibitors like certolizumab pegol for treating psoriatic diseases; only etanercept and certiloziumag were associated with an increased risk of overall infections respectively using fixed effects model analysis.
- For rheumatoid arthritis patients where efficacy is similar between treatments; monotherapy with etanercept was considered optimal based on lower adverse events compared to combination therapy involving adalimumb + DMARDs or cerltoziumag + DMARDs which showed higher incidence rates according to another review study.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cimzia (certolizumab pegol) Prescribing Information. | 2022 | UCB, Inc., Smyrna, GA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative efficacy of biologic disease-modifying anti-rheumatic drugs for non-radiographic axial spondyloarthritis: a systematic literature review and bucher indirect comparisons. | 2023 | Rheumatology and Therapy |
| Infection risk in psoriatic patients receiving tumour necrosis factor inhibitors: a 20-year systematic review and meta-analysis of randomized controlled trials. | 2022 | Journal of the European Academy of Dermatology & Venereology |
| The risk of adverse effects of TNF-α inhibitors in patients with rheumatoid arthritis: a network meta-analysis. | 2022 | Frontiers Immunology |
| 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. | 2021 | Journal of American Academy of Dermatology |
| Impact of tumor necrosis factor α inhibitors on MRI inflammation in axial spondyloarthritis assessed by spondyloarthritis research consortium Canada score: a meta-analysis. | 2020 | PLOS ONE |
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 |
| ACG clinical guideline: management of Crohn's disease in adults. | 2018 | The American Journal of Gastroenterology |
| Canadian Association of Gastroenterology clinical practice guideline for the management of luminal Crohn’s disease. | 2018 | Journal of the Canadian Association of Gastroenterology |