DOP024 Tofacitinib achieves symptomatic improvement within 3 days in moderately to severely active ulcerative colitis, regardless of prior tumour necrosis factor inhibitor treatment status: results from OCTAVE induction 1 and 2
S. Hanauer1, R. Panaccione2, S. Danese3, A. Cheifetz4, W. Reinisch5*, P.D.R. Higgins6, D.A. Woodworth7, H. Zhang7, G.S. Friedman7, N. Lawendy7, D. Quirk7, C.I. Nduaka7, C. Su7
1Northwestern University, Evanston, IL, USA, 2University of Calgary, Calgary, AB, Canada, 3Humanitas Research Hospital, IBD Center, Department of Gastroenterology, Rozzano, Milan, Italy, 4Beth Israel Deaconess Medical Center and Harvard Medical School, Department of Medicine and Division of Gastroenterology, Boston, MA, USA, 5Medical University of Vienna, Department of Internal Medicine III, Vienna, Austria, 6University of Michigan, Ann Arbor, MI, USA, 7Pfizer Inc., Collegeville, PA, USA
Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). We evaluated the timing of onset of symptomatic improvement in a post hoc analysis of patient-reported diary data and evaluated treatment effect in patients with and without prior failure of tumour necrosis factor inhibitor (TNFi) therapy.
OCTAVE Induction 1 and 2 (NCT01465763; NCT01458951) were identical, randomised, placebo-controlled Phase 3 trials in adult patients with moderately to severely active UC who had failed or were intolerant to steroids, immunomodulators or TNFi. Patients received placebo (
At baseline, the mean Mayo subscores for the placebo and tofacitinib groups were 2.5 for SF and 1.6 for RB. By Day 3, significantly more patients achieved each of the binary efficacy endpoints (defined in Table) with tofacitinib vs. placebo (all
Significant symptomatic improvements were observed with tofacitinib vs. placebo as early as Day 3. A consistent treatment effect was observed regardless of whether patients had prior TNFi treatment failure. These results support the rapid onset of tofacitinib efficacy previously reported based on significant improvement vs. placebo at 2 weeks in partial Mayo score, and extend this result to response at Day 3.1