The researchers assessed the use of infliximab in the treatment of severe active steroid-refractory ulcerative colitis (UC).
They reported their results in the May issue of Inflammatory Bowel Disease.
11 patients with steroid-refractory UC were enrolled in the double-blind, placebo-controlled trial.
Patients who had active disease for at least 2 weeks, and were receiving at least 5 days of intravenous corticosteroids, were eligible to receive Infliximab. A single intravenous infusion of infliximab at 5, 10, or 20 mg/kg body weight was administered.
The primary endpoint used in the study was treatment failure at 2 weeks after infusion.
Treatment failure was defined as any of the following: (1) unachieved clinical response, as defined by a modified Truelove and Witts severity score; (2) increase in corticosteroid dosage; (3) addition of immunosuppressants; (4) colectomy; or (5) death.
Safety evaluations were conducted. These included physical examination, clinical chemistry and hematology laboratory tests, and occurrence of adverse experiences.
Patients responding to infliximab had improvements in:|
- erythrocyte sedimentation rate
- C-reactive protein serum concentration
- interleukin-6 serum concentration
|Inflamm Bowel Dis|
4 out of 8 patients who received infliximab were considered treatment successes at 2 weeks, compared with none of 3 patients who received placebo.
Improvement in erythrocyte sedimentation rate was associated with the clinical response observed in patients receiving infliximab. Improvements in serum concentrations of C-reactive protein and interleukin-6 also correlated with infliximab responders.
The investigators found that infusion with infliximab produced no significant adverse events.
Bruce E. Sands, of the Center for the Study of Inflammatory Bowel Disease, Massachusetts General Hospital, concluded on behalf of his colleagues, "Infliximab was well tolerated and may provide clinical benefit for some patients with steroid-refractory ulcerative colitis."