Letter: effectiveness of split‐dose certolizumab pegol for Crohn's disease

Abstract

Several controlled clinical trials demonstrate the efficacy of certolizumab pegol (CZP) for Crohn's Disease (CD).1-6 However, there are limited published data evaluating the effectiveness of CZP in clinical practice, with even less regarding the effectiveness of split-dose modification (200 mg every 2 weeks).7 We evaluated the efficacy of CZP split-dose modification in CD patients who experienced active symptoms despite a standard maintenance dose of CZP (400 mg once monthly). We conducted a retrospective chart review of CZP-treated CD patients seen in our Inflammatory Bowel Disease Clinic. Remission was defined as steroid-free with evidence of inactive disease on imaging or histology. Response was defined as any decrease in: Harvey-Bradshaw Index, patient symptoms or objective assessment of inflammation. Fifty-six patients (35 women, 63%; mean age when starting therapy, 36.3 years) were switched from standard dosing after a median time of 6 months (range, 2–29). Twenty-six patients had active inflammatory disease and 30 fistulising disease. The majority had ileocolonic disease. Thirty-four patients had previously failed two anti-TNFs, 19 had failed one anti-TNF and 3 had no previous anti-TNF treatment. Sixteen patients (29%) achieved clinical remission, with a median time to remission from dose splitting of 8 months (range, 3–14). Another 27 patients (48%) had a response, but did not achieve remission, with a median time to response of 3 months following dose modification (range, 1–21). Clinical remission in a relatively refractory cohort was achieved in 29% of CD patients with split-dose modification after experiencing recurrent active symptoms. In addition, 48% of patients recaptured or gained clinical response with this dosing strategy. Although limited by small sample size, the strategy of initiating split dosing appears to be beneficial. Flexible dosing regimens rather than dose escalation per se warrant further investigation for patients with active CD. Declaration of personal interests: Drs Kane and Loftus have served as consultants to UCB. Declaration of funding interests: This study was conducted with the support of UCB Pharma.