EVALUATION OF THE EFFICACY OF TOFACITINIB IN PATIENTS WITH ULCERATIVE COLITIS UTILIZING THE MODIFIED MAYO SCORE: DATA FROM THE OCTAVE PROGRAM

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Categoria Primary study
GiornaleGastroenterology
Year 2020

This article is not included in any systematic review

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Introduction: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Safety and efficacy of tofacitinib were evaluated in 2 Phase 3 induction studies (OCTAVE Induction 1 & 2, & ), a 52-week (wk), Phase 3 maintenance study (OCTAVE Sustain, NCT01458574),1 and an ongoing open-label, long-term extension study (NCT01470612).2 In these trials, endpoint definitions were based on the conventional Mayo score comprising 4 subscores (stool frequency, rectal bleeding, endoscopic findings, Physician Global Assessment [PGA]). The FDA recommend the use of a modified Mayo (mMayo) score in which the PGA subscore is omitted (a subjective measure, and a recognized Mayo score limitation) as an endpoint measure for UC clinical trials.3 In this post hoc analysis, we assessed the efficacy of tofacitinib using endpoint definitions based on mMayo score. Methods: In OCTAVE Induction 1 & 2, patients received placebo or tofacitinib 10 mg twice daily (BID) for 8 wks; clinical responders were re-randomized into OCTAVE Sustain for 52 wks and received placebo, tofacitinib 5 or 10 mg BID. Trial endpoints included remission, symptomatic remission, and clinical remission (Table), assessed at Wk 8 in OCTAVE Induction 1 & 2 and Wk 52 in OCTAVE Sustain. Treatment effects (ie difference from placebo) using mMayo and Mayo scores were evaluated and compared. Results: In OCTAVE Induction 1 & 2, numerically more patients achieved remission using the mMayo score (7.7% placebo; 24.8% tofacitinib 10 mg BID) compared with the Mayo score (6.0% placebo; 17.6% tofacitinib 10 mg BID), with a greater difference from placebo with mMayo scores (Table). Likewise, the proportion of patients achieving clinical remission was numerically greater with mMayo scores (7.7% placebo; 25.0% tofacitinib 10 mg BID) compared with Mayo scores (6.0% placebo; 17.7% tofacitinib 10 mg BID), whereas the same proportion of patients achieved symptomatic remission with both scores. The same trends were noted in OCTAVE Sustain, with numerically more patients in placebo and tofacitinib groups achieving remission and clinical remission using mMayo scores compared with Mayo scores (Table), and symptomatic remission achieved by the same proportion of patients with both scores. Conclusion: In this post hoc analysis, a statistically significant effect of tofacitinib treatment vs placebo was demonstrated across endpoints based on the mMayo score, agreeing with previously reported data based on the Mayo score.1 Treatment effect sizes for endpoints based on the mMayo score without PGA were the same or numerically greater than corresponding endpoints based on the Mayo score. 1. Sandborn et al. N Engl J Med 2017;376:1723-36. 2. Lichtenstein et al. Am J Gastroenterol 2018;113(S1):571. 3. FDA. 2016. [Formula presented]
Epistemonikos ID: 422f33c99212ab1f1d6e1c25a5e198008b1ed582
First added on: Mar 23, 2022