Assessment of the Safety of Certolizumab Pegol Associated with the Time of Previous Biologic Treatment of Crohnʼs Disease at a Single North American Site

Abstract

Purpose: During prior clinical trials, adalimumab (ADA) and infliximab (IFX) were discontinued at a minimum of eight weeks prior to patients initiating therapy with certolizumab pegol (CZP). In clinical practice, the interval from discontinuation of ADA or IFX to initiating CZP is not standardized and often is shorter than 8 weeks. As there is little data available regarding the safety of this practice, we evaluated whether there are any adverse events (AEs) associated with the practice of initiating CZP within a variable interval relative to the time since discontinuation of another similar therapy. Methods: Study Design: This study was a retrospective chart review of CZP treated CD patients seen at the University of Washington's Inflammatory Bowel Diseases Clinic (IBD) between April 1, 2008 and August 1, 2009. Safety Evaluation: Patients seen in the University of Washington's IBD clinic are evaluated for AEs to current clinical treatment at each visit. For this safety evaluation, the number of AEs associated with CZP within 90 days of initiation were captured and assessed in relation to the time since discontinuation of prior biologic therapy. Results: Sixty six patients (34 women, 32 men) were included in the overall analysis. The average time from the discontinuation of the prior biologic to the start of certolizumab pegol was 43.2 weeks. Twenty two patients (9 women, 13 men) had a washout period of less than 8 weeks (average 3.14 weeks). Of these patients, 23% reported an adverse event, including infectious events (66%), 1 suspected drug reaction to CZP (17%), and 1 case of Hodgkins Lymphoma (17%). Forty four patients (25 women, 19 men) had a washout period of at least 8 weeks (average 63.2 weeks). Of these patients, 20% reported an adverse event, including infectious events (46%), 4 suspected drug reactions to CZP (31%), and 3 complications due to CD (23%). This difference in the proportion of patients with AEs was not statistically significant (p=0.42). Conclusion: At a single North American site, the initiation of certolizumab pegol for the treatment of Crohn's Disease (CD) within less than 8 weeks from the discontinuation of prior biologic therapy was not associated with a significant increase in the proportion of adverse events reported by patients. As the interval prior to beginning therapy with CZP in clinical practice is not standardized, these results are encouraging for patients who are having active symptoms on a similar biologic and require initiation of CZP therapy prior to 8 weeks. Disclosure: Scott D. Lee, MD-Consultant: UCB Pharma; Speakers Bureau: UCB Pharma; Grant/Research Support: UCB Pharma Ghassan T. Wahbeh, MD-Consultant: UCB Pharma; Speakers Bureau: UCB Pharma.