Drug updated on 10/2/2024
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
Summary
- 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 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 |