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While short-term efficacy did not differ much, patients with steroid refractory acute severe ulcerative colitis (ASUC) treated with cyclosporine fared better in the long-term than patients treated with infliximab.¹ 

A team, led by V. Karpavičiūtė, Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Gastroenterology, compared the short- and long-term efficacy and safety of cyclosporine and infliximab as potential rescue agents for patients with steroid refractory acute severe ulcerative colitis.

The Treatments

Two potential treatments for avoiding colectomies in patients with steroid refractory acute severe ulcerative colitis are cyclosporine and infliximab.

In the retrospective analysis, the investigators examined 121 patients admitted to a single gastroenterology center between 2010-2020 with acute severe ulcerative colitis, defined by the Truelove & Witts criteria. This included 119 patients who initially received intravenous corticosteroids and 2 patients who underwent an emergency colectomy on the first day.

The median age of the patient population was 33 years.

The investigators sought primary outcomes of short-term colectomy-free rate, as well as secondary outcomes of severe adverse events, re-hospitalization, or the need of treatment with steroids within 2 years because of flare ups and colectomy rate at the 2 year follow-up.

Outcomes

The results show 55% (n = 66) of the patient population responded to intravenous corticosteroids and 45% (n = 53) failed to respond to steroid therapy. In addition, 37% (n = 45) of patients received second-line rescue therapy, 29 with cyclosporine, 16 with infliximab.

There was no significant difference between the 2 drugs in short-term efficacy.

During admission, colectomies were performed in 10.3% of the cyclosporine group, compared to 12.5% of the infliximab group (P = 0.826).

For the long-term efficacy analysis, the investigators found the difference was not statistically significant (10.3% vs. 31.2%, P = 0.079).

Both group had similar rates of the need for oral steroids during follow-up (38.5% vs. 50%, P = 0.481).

Moreover, the patients that did not undergo colectomy in the infliximab group were more often re-hospitalized because to the need for intravenous corticosteroids at the 2 year follow-up compared to the cyclosporine group (7.7% vs. 50%; P = 0.002).

The safety analysis shows no severe side effects because of either medication.

“In the treatment of steroid refractory ASUC infliximab and cyclosporine were equally effective in short-term period and there was no difference in safety, however cyclosporine treated patients trended to have better long-term outcomes, with significantly rarer re-hospitalization,” the authors wrote.

The investigators also said future studies are warranted.

“Additional analysis is needed for other factors that may have contributed to differences in long-term outcomes between the cyclosporine and infliximab groups,” the investigators said.

References:

V Karpavičiūtė, G Kiudelis, J Kupčinskas, L Kupčinskas, P472 Cyclosporine versus infliximab in patients with Acute Severe Ulcerative Colitis: A single-centre retrospective study, Journal of Crohn's and Colitis, Volume 17, Issue Supplement_1, February 2023, Pages i600–i601, https://doi.org/10.1093/ecco-jcc/jjac190.0602