Background & aims: We sought to determine the efficacy of certolizumab pegol reinduction in patients with active Crohn's disease who respond to induction therapy with certolizumab pegol and then relapse during continuous or interrupted maintenance therapy.
Methods: In the Pegylated Antibody Fragment Evaluation in Crohn's Disease: Safety and Efficacy (PRECiSE) 2 trial, 428 patients who responded to induction therapy with certolizumab pegol at week 6 were randomized to continuous therapy with certolizumab pegol or placebo (drug interruption) during weeks 6 to 26. Patients who relapsed before week 26 could enter PRECiSE 4, an ongoing open-label extension trial in which patients on continuous therapy underwent recapture with a single extra 400-mg dose of certolizumab pegol, and patients who relapsed after drug interruption underwent reinduction with certolizumab pegol 400 mg at weeks 0, 2, and 4 followed by maintenance with certolizumab pegol 400 mg every 4 weeks. Disease activity was measured by the Harvey-Bradshaw Index.
Results: During PRECiSE 2, 124 patients had disease relapse and entered PRECiSE 4; 49 patients had received continuous therapy and 75 patients had drug interruption. At week 4 of PRECiSE 4, response rates were 63% in patients who relapsed on continuous therapy and 65% after drug interruption. Response was maintained in 55% and 59% of these responders, respectively, through week 52.
Conclusions: Administration of 1 additional dose of certolizumab pegol to patients who relapsed on continuous maintenance therapy, and certolizumab pegol reinduction to those who relapsed after drug interruption, are effective strategies for treating patients who have relapsed after successful induction therapy with certolizumab pegol.
Trial registration: ClinicalTrials.gov NCT00160706.
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