A recent study on the benefits of abatacept for patients with moderate-to-severe Crohn’s disease or ulcerative colitis was terminated early because of lack of efficacy for both conditions.
In four placebo-controlled trials conducted at 142 medical centers between December 2006 and November 2009, patients with Crohn’s disease (CD) (n=451) or ulcerative colitis (UC) (n=490) randomly received induction therapy of 3 mg/kg, 10 mg/kg or 30 mg/kg of body weight of intravenous abatacept or placebo at enrollment and after 2, 4 and 8 weeks. Patients who indicated response after 12 weeks then randomly received maintenance therapy of either 10 mg/kg abatacept or placebo every 4 weeks through 52 weeks.
Response to induction therapy among patients with CD was 15.5% for 3 mg/kg, 10.2% for 10 mg/kg and 17.2% for 30 mg/kg compared with 14.4% in the placebo group (P=.812, P=.311 and P=.611, respectively). In the UC induction therapy group, response rates were 20.3% for 3 mg/kg, 19.0% for 10 mg/kg and 21.4% for 30 mg/kg compared with 29.5% of those in the placebo group (P=.158, P=.043 and P=.124, respectively).
Ninety patients in the CD group and 131 in the UC group went on to maintenance therapy, but because of early cessation of the study only 24 of the CD patients and 26 of the UC patients completed treatments. After 52 weeks, 23.8% of treated patients with CD and 12.5% of treated patients with UC experienced remission compared with 11.1% of patients with CD (P=.082) and 14.1% with UC who each received placebo (P=.740).
“These studies showed that abatacept is not efficacious for the treatment of moderate-to-severe CD or UC,” the researchers concluded. “There was no evidence of efficacy in any patient subgroups, including concomitant immunomodulator use, disease duration, high sensitivity C-reactive protein and type of, or reason for, prior treatment failure.”
Disclosure: See the study for a full list of relevant disclosures.