As new pharmaceuticals are approved for the treatment of inflammatory bowel disease, and UC in particular, head-to-head comparative studies are essential to determine safety, and to further evaluate clinically meaningful measures of efficacy.
A phase 3 study (GARDENIA) was conducted at 14 centers involving 397 patients with moderate-to-severe UC.
The patients were randomized to the etrolizumab (n=199) or infliximab (n=198) group; 95 and 103 patients in the etrolizumab and infliximab groups completed the study, respectively. Etrolizumab (105 mg q4w sc) or infliximab (5 mg at weeks 0, 2, and 6, then q8w x 52w iv) was administered.
The outcomes were clinical response at 10 weeks and clinical remission at 54 weeks.
Thirty-seven (18.6%) and 39 (19.7%) of patients in the etrolizumab and infliximab groups met the primary endpoint at week 54. Adverse events were similar in both groups (77% and 76%, respectively).