Hanauer S, et al. - In patients with ulcerative colitis (UC) (OCTAVE Induction 1 and 2), researchers assessed the onset of symptom improvement in post-hoc analyses of data from 2 phase 3 trials of induction therapy with tofacitinib. Significant improvements in symptoms among patients given tofacitinib compared with placebo within 3 days were found in a post-hoc analysis of data from phase 3 trials of induction therapy with tofacitinib in patients with UC. They discovered the rapid onset of the impact of this drug in patients with UC.

Methods

• Study participants were patients with moderate to severe active UC who were intolerant to, or failed by previous treatment with, corticosteroids, thiopurines, and/or tumor necrosis factor (TNF) antagonists.
• For this investigation, patients received tofacitinib (10 mg twice daily, n=905) or placebo (n=234) for 8 weeks.
• Using diary data from the first 15 days of therapy, daily Mayo stool frequency and rectal bleeding subscores were calculated.
• Data from subgroups were analyzed including failure of prior anti-TNF therapy, baseline corticosteroid use, and baseline serum levels of C-reactive protein.

Results

• The study results showed that mean changes were significantly greater in subjects given tofacitinib vs placebo in reductions from baseline stool frequency subscore (tofacitinib: –0.27 vs placebo: –0.11; P<.01), total number of daily bowel movements (–1.06 vs –0.27; P < .0001), and rectal bleeding subscore (–0.30 vs –0.14; P < .01) by day 3.
• It was observed that more tofacitinib-treated subjects had reductions from baseline in stool frequency subscore (by ≥1 point for tofacitinib, 241/837, 28.8% vs placebo, 39/218, 17.9%) (P < .01) and rectal bleeding subscore (by ≥1 point for tofacitinib, 266/830, 32.0% vs placebo, 43/214, 20.1%) (P < .01) by day 3 compared with placebo.
• In all subgroups, a consistent effect of tofacitinib was noted.