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Xeljanz Induces Remission, Early Response Predicts Efficacy in UC
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LAS VEGAS — Xeljanz as induction therapy for patients with moderate-to-severe ulcerative colitis led to remission as early as 2 weeks; the early response rates correlated with efficacy results at 8 weeks, according to data from the OCTAVE induction trials presented during a plenary session at ACG 2016.
William J. Sandborn, MD, professor of medicine, chief of the division of gastroenterology and director of University of California San Diego Inflammatory Bowel Disease Center, and colleagues investigated how response and remission based on partial Mayo score (PMS) at 2 weeks correlated with clinical efficacy endpoints at 8 weeks of therapy with Xeljanz (tofacitinib, Pfizer) or placebo.
William Sandborn
The researchers randomly assigned adults with moderately to severely active UC to therapy with 10 mg of tofacitinib IBD (n = 905) or placebo (n = 234) for up to 9 weeks. The safety and efficacy of tofacitinib for induction therapy for these patients who failed previous therapy with corticosteroids, azathioprine, 6-mercaptopurine and/or tumor necrosis factor inhibitors (TNFi) had already been validated in previous OCTAVE 1 and 2 phase 3 trials. This study investigated PMS response and PMS remission at 2 weeks and its correlation with remission, mucosal healing and clinical response at 8 weeks.
Of the patients treated with tofacitinib, 53.9% achieved PMS response at 2 weeks; 66.6% achieved PMS response at 4 weeks; and 69.1% achieved PMS response at 8 weeks. Also among this group, 21.3% achieved PMS remission at 2 weeks; 34% achieved PMS remission at 4 weeks; and 43.2% achieved PMS remission at 8 weeks.
“A greater proportion of patients treated with tofacitinib 10 mg IBD achieved remission,” Sandborn said during his presentation.
Both PMS response and remission were associated with clinical endpoints including clinical response, mucosal healing and remission (P < .0001).
The study showed tofacitinib 10 mg twice daily is useful for induction therapy in patients with moderately to severe UC. Efficacy at 2 weeks is a good predictor of efficacy at 8 weeks, regardless of prior TNFi therapy, according to the presentation.
“Evidence of early response is a good predictor for what will happen later,” Sandborn concluded. “Not having an early response may still lead to improvements in Mayo score later on.” – by Melinda Stevens
Reference:
Sandborn WJ, et al. Abstract #28. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 14-19, 2016; Las Vegas, NV.
Disclosure: Sandborn reports consulting for AbbVie, Actavis, Amgen, Celgene, Genentech, Jansen, Prometheus Laboratories, Pfizer, Shire, Salix, Takeda and UCB Pharma; and has received grant and research support from AbbVie, Amgen, Celgene, Genentech, Jansen, Prometheus Laboratories, Pfizer and Takeda. Please see the abstract for a list of all other researchers’ relevant financial disclosures.
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