TRIUMPH: Tofacitinib as rescue option for acute severe ulcerative colitis

Tofacitinib appeared to be an effective treatment for steroid-refractory patients with acute severe ulcerative colitis (UC), displaying a swift onset of action and a high clinical response rate in bio-naïve and bio-experienced patients in the phase 2 TRIUMPH trial. The authors suggest that tofacitinib could be a treatment option for hospitalised patients with severe UC.

“Currently, cyclosporine and infliximab are the rescue therapies for patients with acute severe UC,” stated Dr Neeraj Narula (McMaster University, Canada) [1]. “Cyclosporine delivers efficacy in the short-term but may lead to complications in the long-term [2]. Infliximab is a good option but not in patients who are exposed to prior TNF inhibitors.” The JAK inhibitor tofacitinib may be an alternative option for this patient population. It displayed clinical improvements within 3 days in patients with moderate-to-severe UC and proved efficacious in patients with prior exposure to anti-TNF agents or other biologic therapies [3].

In the TRIUMPH study (NCT04925973), 24 hospitalised patients with severe steroid-refractory UC were treated with tofacitinib to assess its utility in this setting. “Of these 24 patients, 8 had failed on a prior biologic therapy,” mentioned Dr Narula, who presented the results of a 26-week interim analysis [1]. The primary endpoint was clinical response at day 7.

The clinical response rate at day 7 was 58% and exactly one-third of the included patients were in steroid-free clinical remission at week 26. Moreover, 33.3% of them displayed endoscopic improvement after a half year of follow-up. “The mean time to response was 2.4 days and no new safety issues were identified,” added Dr Narula.

“With a rapid onset of action and a high clinical response rate in both bio-naïve and bio-experienced patients, tofacitinib should be considered for hospitalised patients with acute severe UC,” concluded Dr Narula.

1. Narula N, et al. Tofacitinib for hospitalized acute severe ulcerative colitis (TRIUMPH): interim analysis to 26 weeks. DOP46, 19^th Congress of ECCO, 21–24 February 2024, Stockholm, Sweden.
2. Lichtiger S, et al. N Engl J Med 1994;330(26):1841-1845.
3. Sandborn WJ, et al. N Engl J Med 2017;376(18):1723-1736.

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Posted on 18 April, 202418 April, 2024