The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for ulcerative colitis have not been evaluated previously.
Dr Remo Panaccione and colleagues from Canada randomized, double-blind trial evaluated the efficacy and safety of 16 weeks of treatment with infliximab monotherapy, azathioprine monotherapy, or the 2 drugs combined in tumor necrosis factor-α antagonist-naive adults with moderate to severe ulcerative colitis.
Patients were assigned randomly to receive intravenous infusions of infliximab 5 mg/kg at weeks 0, 2, 6, and 14 plus daily oral placebo capsules, oral azathioprine 2.5 mg/kg daily plus placebo infusions on the infliximab schedule, or combination therapy with the 2 drugs.
Corticosteroid-free clinical remission was evaluated at weeks 8 and 16.
|Corticosteroid-free remission at week 16 was achieved by 40% of patients |
The researchers terminated before the enrolment target was reached.
A total of 239 patients were included in efficacy analyses.
The team observed that baseline characteristics were similar between treatment groups.
Corticosteroid-free remission at week 16 was achieved by 40% of patients receiving infliximab/azathioprine, compared with 22% receiving infliximab alone and 24% receiving azathioprine alone.
The research team found that mucosal healing at week 16 occurred in 63% of patients receiving infliximab/azathioprine, compared with 55% receiving infliximab and 37% receiving azathioprine.
The team noted that serious infections occurred in 2 patients.
Dr Panaccione's team concludes, "Anti–tumor necrosis factor-α–naive patients with moderate to severe ulcerative colitis treated with infliximab plus azathioprine were more likely to achieve corticosteroid-free remission at 16 weeks than those receiving either monotherapy."
"Combination therapy led to significantly better mucosal healing than azathioprine monotherapy."