Xeljanz extended induction effective in UC
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A majority of patients with ulcerative colitis treated with Xeljanz achieved clinical response after 8 or 16 weeks induction, according to study results.
Bruce Sands, MD, from the Icahn School of Medicine, and colleagues wrote that the drug (tofacitinib, Pfizer) has been assessed in several randomized controlled trials, as well as an ongoing open-label extension study.
“Here, we assessed short- and long-term efficacy and safety of extended induction with tofacitinib 10 mg twice daily in patients who failed to respond to initial induction treatment,” they wrote.
For the study, researchers evaluated the efficacy and safety of tofacitinib in delayed responders, defined as patients who achieved clinical response following extended induction (16 weeks).
Sands and colleagues found that 52.2% of patients who did not initially achieved clinical response at week 8 went on to achieved clinical response after extended induction.
At month 12 of the OCTAVE open trial, 70.3% of delayed responders maintained clinical response, 56.8% maintained endoscopic improvement and 44.6% maintained remission. At month 36 of the trial, the corresponding values were 56.1%, 52% and 44.6%, respectively.
Additionally, investigators found that the safety profile of tofacitinib in the subsequent 8 weeks of extended induction was similar to the initial 8 weeks.
Sands and colleagues wrote that the UC clinical trial program for tofacitinib further supports the recommended dosing of 10 mg twice daily for 8 weeks of induction or 16 weeks of extended induction.
“The majority of patients who responded to extended induction maintained a clinical response up to 36 months,” they wrote. “However, patients who fail to achieve adequate therapeutic benefit from tofacitinib by week 16 should discontinue treatment.”