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March 10, 2021
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Xeljanz effective for UC regardless of prior TNFi failure

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Regardless of prior tumor necrosis factor inhibitor failure status, Xeljanz was efficacious in patients with ulcerative colitis, according to a study published in Clinical Gastroenterology and Hepatology.

“Prior TNFi failure has been suggested as a predictor of poor prognosis, and patients who have previously failed TNFi therapy may be more difficult to treat than those who have not,” William J. Sandborn, MD, from the division of gastroenterology at the University of California, San Diego, and colleagues wrote. “Therefore, there is an unmet need for alternative therapies in patients with prior TNFi failure.”

Sandborn and colleagues assessed the efficacy of Xeljanz (tofacitinib Pfizer), using pooled data from the phase 3 OCTAVE Induction 1&2 studies (n = 1,139), the phase 3 OCTAVE Sustain maintenance study (n = 593), and the dose escalation subpopulation of the open-label, long-term extension OCTAVE Open study (n = 59. Safety was also assessed using data from several studies where patients were stratified by experiencing no prior TNFi failure or prior TNFi failure.

Investigators reported the dose escalation subpopulation received tofacitinib 10 mg twice daily in OCTAVE Induction 1&2, 5 mg twice daily in OCTAVE Sustain, and 10 mg twice daily in OCTAVE Open.

Regardless of prior TNFi failure status, tofacitinib had greater efficacy compared with placebo.

“In OCTAVE Sustain and the Overall Cohort, [herpes zoster] (non-serious and serious) rates were numerically higher in tofacitinib-treated patients vs. without prior TNFi failure,” Sandborn and colleagues wrote.

According to researchers, clinical response for most patients was recaptured with dose escalation to tofacitinib 10 mg twice daily. In the dose escalation vs. the overall cohort, herpes zoster rates were numerically higher.