Research News

Ciclosporin no better than infliximab for acute refractory ulcerative colitis

BMJ 2012; 345 doi: (Published 17 October 2012) Cite this as: BMJ 2012;345:e6923

High dose intravenous corticosteroids are the first line treatment for people with a severe exacerbation of ulcerative colitis. When steroids can’t control an acute episode, doctors can choose between ciclosporin and infliximab as rescue treatments, say researchers. Patients responded equally well to both drugs in the first head to head trial.

The researchers used a broad primary outcome—treatment failure—that combined colectomy, death, serious adverse events, relapse, and absence of a clinical response defined using two well known scores of symptoms and mucosal appearance at sigmoidoscopy. They found no significant differences between the two treatments over 98 days of follow-up (35/58 patients given ciclosporin and 31/57 given infliximab reached the primary outcome; absolute risk difference 6%, 95% CI −7 to 19). There were no deaths, and 22 of the 115 patients analysed needed a colectomy. More than four fifths of the patients in both groups had a clinical response in the first week, a prespecified secondary outcome. Five of the 58 patients given ciclosporin and four of the 57 patients given infliximab developed severe infections.

The trial was on the small side, designed to look for a relative difference of at least 30% between treatments. Smaller differences may have been missed, says a linked editorial (doi:10.1016/S0140-6736(12)61259-8). Even so, doctors now have a legitimate choice for these patients, and many will choose infliximab. Safe use of ciclosporin requires expertise and monitoring that isn’t available everywhere. The drug has a poor safety record long term and can’t be given as maintenance treatment.


Cite this as: BMJ 2012;345:e6923