Certolizumab Pegol Treatment in Patients With Crohn's Disease: Final Safety Data From the SECURE Registry

Overview

Journal Crohns Colitis 360

Publisher Oxford University Press

Date 2025 Feb 3

PMID 39895830

Authors

Gary R Lichtenstein

Scott D Lee

Brian G Feagan

Edward V Loftus Jr

Samson Ng

Kaitlin Dehlin

Paul Quinn

Jason Coarse

Theresa Rosario-Jansen

Catherine Arendt

Jeffrey L Stark

Affiliations

Soon will be listed here.

Abstract

Background: Crohn's disease (CD) treatment is associated with increased risks of infection and malignancies. Although the safety of certolizumab pegol (CZP) is well established, long-term data from community-based observational studies are lacking.

Aim: This study aimed to evaluate long-term safety outcomes of patients from the SECURE registry receiving CZP relative to other CD treatments, including corticosteroids, immunosuppressants, and biologics. The primary outcome of this observational study was the evaluation of malignancies.

Methods: Adult patients with CD were prospectively monitored for up to 8 years. Pre-specified data were collected for all enrolled patients. Adverse events of interest (AEoIs) were reported per 100 patient-years (PY) of exposure. Incidence rate ratios (IRRs) were calculated for AEoIs using multivariate regression analysis accounting for exposure to multiple treatments. Malignancies reported after any exposure to CZP were attributed to CZP. Post-hoc analyses were conducted to evaluate non-melanoma skin cancer (NMSC), lymphoma, and pregnancy outcomes.

Results: A total of 3072 patients were enrolled in the study. The risk of AEoIs was similar between patients with only CZP exposure versus comparator exposure. Among patients with any CZP exposure, there was a higher frequency of serious infections (IRR: 2.56 [95% confidence interval (CI): 2.00, 3.29]) and hypersensitivity or anaphylactic reactions (IRR: 4.11 [95% CI: 1.80, 9.38]) versus patients with comparator exposure. Malignancy rates were similar across groups; however, concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]). Most cases of lymphoma (5/7) occurred in patients with exposure to thiopurines. Pregnancy outcomes were similar across groups.

Conclusions: No new safety signals were identified for CZP; the use of thiopurines was identified as a risk factor for NMSC.

Trial Registration: NCT00844285.

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