Similar long-term ulcerative colitis outcomes with cyclosporine or infliximab

Last Updated: 2017-01-17

By Will Boggs MD

NEW YORK (Reuters Health) - Long-term outcomes of patients with steroid-refractory acute severe ulcerative colitis (UC) are similar whether treated with cyclosporine or infliximab, researchers from France report.

"The unexpected result was the long-term colectomy rate that was the same whatever the drug," Dr. David Laharie from Hôpital Haut-Lévêque, CHU de Bordeaux told Reuters Health by email.

Both cyclosporine and infliximab provide high rates of early clinical response in patients with severe UC, with acceptable safety profiles, but little is known about the long-term outcomes.

Dr. Laharie and colleagues in the Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives assessed long-term outcomes of 115 participants (60 treated with cyclosporine and 55 treated with infliximab) in the 98-day CYSIF randomized trial, which compared cyclosporine and infliximab.

After the study, patients were treated according to clinical need as judged by their treating physicians. The median follow-up time was 5.4 years.

At follow-up, 19 cyclosporine patients and 20 infliximab patients had undergone colectomy. The two groups did not differ significantly in colectomy-free survival rates at one, two or five years, the researchers report in Gut, online January 4.

"Nearly half of patients first treated with cyclosporine will switch quickly to infliximab, within 1 year," the researchers note. "Accordingly, bridge therapy with cyclosporine to thiopurine was successful in the other half of patients."

"For daily practice, choice between both drugs should not only be guided by efficacy and safety criteria that are close, but should also take into account costs, administration route, and patient's preference," they advise.

"This means that there is still a room for cyclosporine in severe UC and that both drugs could be considered in azathioprine-naïve patients, as they have close short-term and long-term efficacy and safety," Dr. Laharie said. "Costs will favor cyclosporine over infliximab."

Dr. John G. Williams from Swansea University Medical Center in Swansea, U.K., who was chief investigator of the CONSTRUCT trial, which compared infliximab versus cyclosporine for steroid-resistant UC, told Reuters Health by email, "Cyclosporine and infliximab are both safe and effective therapies for acute severe colitis that fails to respond to steroids. The medium-term colectomy rate remains high, however, and more research is needed to identify the genotype and phenotype of those patients who are destined to fail medical treatment, so that they can be offered early colectomy."

"Cyclosporine is a safe and effective treatment, and is also cheaper than anti-TNFs," said Dr. Williams, who was not involved in the new study. "If costs matter, it should be the drug of first choice."

SOURCE: http://bit.ly/2jFfIjk

Gut 2017.