Tofacitinib effective as induction, maintenance therapy in ulcerative colitis treatment — 6 key notes

Pfizer published results from its phase III oral clinical trials for tofacitinib in ulcerative colitis in The New England Journal of Medicine.

Study investigator and UC San Diego School of Medicine Professor William Sandborn, MD, and colleagues conducted three phase III, randomized, double-blind, placebo controlled trials of tofacitinib therapy in adults with ulcerative colitis.

Induction trial 1 and induction trial 2 had 598 and 541 patients with moderate to several ulcerative colitis, respectively, despite previous conventional therapies. Researchers randomly assigned patients to receive 10 mg of tofacitinib (twice daily) or a placebo for eight weeks.

In the Sustain trial, 593 patients who had a clinical response to the induction trial received either 5 mg or 10 mg of tofacitinib (twice daily) or a placebo for 52 weeks.

Here's what they found.

1. In the Induction 1 trial, remission at eight weeks occurred in 19.5 percent of the tofacitinib group and 8.2 percent of the placebo group.

2. In the Induction 2 trial, remission occurred in 16.6 percent of patients versus 3.6 control patients.

3. In the Sustain trial, remission at 52 weeks occurred in 34.4 percent of 5 mg tofacitinib patients and 40.6 percent of 10 mg tofacitinib patients versus 11.1 percent of the placebo group.

4. In the Induction 1 and 2 trials, overall infection and serious infection rates were higher with tofacitinib.

5. In the Sustain trial, serious infection rate was similar across all treatment groups and overall infection rate and herpes zoster infection rates were higher with tofacitinib patients than with the placebo.

6. Across all trials, adjudicated nonmelanoma skin cancer occurred in five patients receiving tofacitinib and one who received a placebo. Adjudicated cardiovascular events occurred in five who received tofacitinib. Tofacitinib increased lipid levels.

Researchers concluded, "In patients with moderately to severely active ulcerative colitis, tofacitinib was more effective as induction and maintenance therapy than placebo."

Pfizer funded the studies.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

ASC_GI_300x250

Featured Webinars

Featured Whitepapers

Featured Podcast