58% of acute severe UC patients responded ‘within 2 days’ of starting Xeljanz



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Key takeaways:

  • Nearly 60% of patients with acute severe ulcerative colitis responded to tofacitinib treatment by day 7.
  • One-third of patients achieved steroid-free remission by 6 months.

WASHINGTON — Nearly 60% of patients with acute severe ulcerative colitis responded to Xeljanz 10 mg twice daily by day 7, with one-third of patients in steroid-free remission by 6 months, according to interim analysis data presented here.

“There are few recommended therapies for acute severe UC management given the need for rapidly acting therapies,” Neeraj Narula, MD, MPH, FRCPC, director of the IBD Clinic at Hamilton Health Sciences and associate professor of medicine at McMaster University, told Healio. “Patients with prior anti-TNF failure who present with acute severe UC are challenging to manage and often end up being referred for colectomy. JAK inhibitors, such as tofacitinib, were demonstrating quick time to response in clinical trials and practice in moderate to severe UC patients, [so] a prospective study evaluating the use of tofacitinib in acute severe UC was warranted.”

“In a tough-to-treat population, including one-third with prior anti-TNF failure, almost 60% of patients [with ulcerative colitis] treated with tofacitinib 10 mg BID were able to attain clinical response.” – Neeraj Narula, MD, MPH, FRCPC

In an interim analysis of the phase 4 TRIUMPH study, Narula and colleagues examined data from patients with acute severe UC (n = 24; mean baseline Mayo score = 10.1) who had previously failed 3 days of IV corticosteroids and were administered Xeljanz (tofacitinib, Pfizer) 10 mg twice daily while in the hospital.

Given that one-third of the patients (n = 8) had already failed a prior anti-TNF agent, the primary outcome was set as clinical response at day 7, assessed by a reduction from baseline on the Modified Truelove and Witts Severity Index of at least three but no more than 10.

Secondary outcomes included rapidity of clinical and biomarker improvements during the first 7 days of therapy, colectomy over the course of 1 year as well as corticosteroid-free clinical remission (total Mayo score < 2), endoscopic improvement (endoscopic Mayo score 0 or 1) and adverse events at 3, 6 and 12 months.

According to results, 58.3% of patients achieved a clinical response by day 7, with most achieving response within 2.4 days after therapy was started. Responders exhibited a marked reduction in C-reactive protein as early as 1 day after tofacitinib was initiated compared with non-responders.

“In a tough-to-treat population, including one-third with prior anti-TNF failure, almost 60% of patients treated with tofacitinib 10 mg BID were able to attain clinical response,” Narula told Healio. “Symptomatic and biochemical response were noted to be significant within 2 days of initiating therapy in those with clinical response, suggesting that tofacitinib may represent a suitable option for some patients with acute severe UC.”

The researchers reported that colectomy occurred in 16.7% of patients by day 7 and 25% by 6 months. At 6 months, 45.8% of patients continued tofacitinib, with 33.3% of patients having achieved endoscopic improvement and corticosteroid-free clinical remission. Only six patients reported adverse events, one of which was deemed to be severe.

Narula highlighted that more studies are needed to compare tofacitinib with other JAK inhibitors, such as Rinvoq (upadacitinib, AbbVie), against standard of care therapies to determine how best to position these therapies in a hospitalized setting.

“Gastroenterologists should be aware that tofacitinib is an option for patients with acute severe UC — depending on jurisdiction, access and costs of therapy, it may even be considered before infliximab,” Narula said. “Further studies are needed to understand how to position JAK inhibitors against infliximab in this setting, and whether patients who fail one medical rescue therapy in hospital could be considered for treatment with a second medical rescue therapy or referred for colectomy.”

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