Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease and Secondary Failure to Infliximab

BACKGROUND & AIMS: Patients with moderate to severe Crohn's disease who receive infliximab may experience secondary failure (loss of response and/or hypersensitivity) Data on the utility of switching to certolizumab pegol in these patients are limited METHODS: A total of 539 patients with active Crohn's disease and secondary failure to infliximab were enrolled in a 26-week trial Patients received open-label induction with subcutaneous certolizumab pegol 400 mg at weeks 0, 2, and 4 Those in clinical response at week 6 were randomized to certolizumab pegol 400 mg every 2 or every 4 weeks through week 24 The primary end point was response at week 6 Secondary end points included remission at week 6 and response and remission at week 26 RESULTS: At week 6, 334 of 539 patients (62 0%) achieved response and 212 of 539 (39 3%) achieved remission A total of 329 patients were randomized and received maintenance therapy At week 26, 39 9% (67 of 168) and 36 6% (59 of 161) of patients in the every-4-weeks and every-2-weeks groups were in clinical response, respectively (P = SS) Corresponding remission rates at week 26 were 29 2% and 304%. respectively (P = 81) Serious infections occurred in 9 of 539 (1 7%) and 12 of 373 (3 2%) of patients during induction and maintenance, respectively A single malignancy (skin carcinoma) occurred in a patient receiving every-4-weeks maintenance therapy CONCLUSIONS: Response to open-label induction therapy with certolizumab pegol was achieved by 62% of patients with moderate to severely active Crohn's disease and secondary failure to infliximab. Among these patients, certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remission.