Maintenance Therapy With Certolizumab Pegol After Induction Therapy for Active Crohn's Disease: 6-Month Results

Abstract

Purpose To assess remission rates in patients who received certolizumab pegol for 6 months (26 weeks) in PRECiSE 2, and for a further 4.5 years in PRECiSE 3, and to determine if remission rates are affected in patients without previous tumor necrosis factor (TNF) inhibitor exposure. Methods Patients completing PRECiSE 2 (NCT00152425) were eligible to enter PRECiSE 3 (NCT00160524) and receive certolizumab pegol 400 mg every 4 weeks. Efficacy and safety data for patients who received certolizumab pegol in PRECiSE 2 and continued with open-label certolizumab pegol treatment in PRECiSE 3 are presented. The HarveyBradshaw Index (HBI) was used to measure disease activity (remission = score of ≤4). Remission rates were analyzed from the baseline of PRECiSE 2 in the PRECiSE 3 ITT population and in a subset of this population who had never received infliximab (IFXnaive). Remission rates were calculated using observed case analyses and nonresponder imputation (NRI). Results Of the 141 patients in the PRECiSE 3 population, 114 were IFXnaive. At the start of PRECiSE 3 (Week 0), 75% (105/141) and 78% (89/114) of the total and IFX-naive populations were in remission, respectively. Remission rates for the total PRECiSE 3 population after 1, 2, 3, 4, and 5 years (observed case) were 75%, 84%, 82%, 79%, and 91%, respectively, and 76%, 83%, 82%, 81%, and 89%, respectively, for the IFXnaive patients (Table). Remission rates for the total PRECiSE 3 population after 1, 2, 3, 4, and 5 years (NRI) were 65%, 49%, 35%, 23%, and 21%, respectively, and 65%, 47%, 37%, 25%, and 21%, respectively, for the IFX-naive patients. No new safety signals were observed and there were no unexpected serious adverse events. Conclusions Among patients who initially responded to certolizumab pegol induction therapy and remained in PRECiSE 3, continuous certolizumab pegol 400 mg therapy provided long-term remission for 5 years, including a subset of PRECiSE 3 patients receiving certolizumab pegol with no previous exposure to infliximab.