Despite treatment with corticosteroids, severe to moderately severe attacks of ulcerative colitis have a high colectomy rate.
Cyclosporin A imposes a high risk of side effects and cyclosporine-related mortality.
Dr Järnerot and colleagues intended to find a rescue therapy other than cyclosporin A.
|7 patients in the infliximab group had a colectomy versus 14 with placebo|
The researchers designed a randomized double-blind trial of infliximab or placebo including 45 patients.
The research team analyzed moderately severe ulcerative colitis not responding to conventional treatment according to the intention-to-treat principle.
The team randomized 24 patients to infliximab and 21 to placebo on day 4 after the initiation of corticosteroid treatment.
Patients were randomized if they fulfilled the index criteria for fulminant ulcerative colitis.
Patients were also randomized on day 3 or on day 6 to 8 if they fulfilled index criteria on day 5 to 7 for a acute attack of ulcerative colitis.
The primary end point that the researchers considered was colectomy or death 3 months after randomization.
Secondary end points were clinical and endoscopic remission at that time in patients who did not undergo operation.
The researchers reported that no patients died and no serious side effects occurred.
The team found that 7 patients in the infliximab group and 14 in the placebo group had a colectomy within 3 months after randomization.
In addition, the researchers noted that 3 patients in the placebo group required operation for septic complications.
Dr Järnerot concludes, “Infliximab 4 to 5 mg/kg is an effective and safe rescue therapy in patients experiencing an acute severe or moderately severe attack of ulcerative colitis not responding to conventional treatment.”