Adalimumab ( Humira ) is effective for induction and maintenance of remission in patients with moderate to severe ulcerative colitis.
Researchers have assessed whether Adalimumab, in addition to standard ulcerative colitis therapy, reduced the risk for hospitalization ( from all causes, from complications of ulcerative colitis, or from complications of ulcerative colitis or the drugs used to treat it ) and colectomy in patients with moderate to severe ulcerative colitis compared with placebo.
Data were combined from patients that received induction therapy ( a 160-mg dose followed by an 80-mg dose of Adalimumab ) or placebo in 2 trials ( ULTRA 1 and ULTRA 2; n = 963 ).
The risks of hospitalization and colectomy were compared between groups using unadjusted rates during the 8-week induction period, and patient-year-adjusted rates during 52 weeks.
Significant reductions in risk of all-cause, ulcerative colitis-related, and ulcerative colitis- or drug-related hospitalizations ( by 40%, 50%, and 47%, respectively; P less than 0.05 for all comparisons ) were observed within the first 8 weeks of Adalimumab therapy compared with placebo.
Significantly lower incidence rates for all-cause ( 0.18 vs 0.26; P=0.03 ), ulcerative colitis-related ( 0.12 vs 0.22; P=0.002 ), and ulcerative colitis- or drug-related ( 0.14 vs 0.24; P=0.005 ) hospitalizations were observed during 52 weeks of Adalimumab therapy compared with placebo.
Rates of colectomy did not differ significantly between patients given Adalimumab vs placebo.
In patients with moderate to severe ulcerative colitis, the addition of Adalimumab to standard of care treatment reduced the number of hospitalizations for any cause, as well as for ulcerative colitis-related and ulcerative colitis- or drug-related complications, compared with placebo. ( Xagena )
Feagan BG et al, Gastroenterology 2014;146:110-118