LAUSR

To the Editor: As the Medical Strategy Head Gastroenterology and Global Medical Lead for Xeljanz ulcerative colitis (UC), Inflammation and Immunology Medical Affairs, at Pfizer Inc., I read with great interest the article by Antonelli and colleagues entitled “Inhibitors of the Janus kinases: a new oral treatment option for ulcerative colitis.”1 The article incorrectly defines the primary endpoint of the OCTAVE phase 3 trials, in which the efficacy of tofacitinib was evaluated in patients with active UC. This should be brought to the attention of the authors and your readers. On page 2, in the section discussing the OCTAVE trials, the authors incorrectly stated that in the phase 3 OCTAVE Induction 1 and 2 trials of tofacitinib, the primary endpoint was “remission (Mayo score<2, rectal bleeding=0)” and omitted the additional requirement of no individual Mayo subscore being >1. The correct definition of remission used throughout the OCTAVE clinical trial programme, including in the OCTAVE Induction, OCTAVE Sustain and OCTAVE Open trials described by Antonelli and colleagues and as published in the article by Sandborn et al2 in The New England Journal of Medicine in 2017, is as follows: “Remission, a total Mayo score of ≤ 2, with no subscore > 1 and a rectal bleeding subscore of 0.” I hope you will agree that with the clinical trial landscape in UC evolving, and study endpoints changing, the correct definition of endpoints is crucial in the readers’ understanding of the data presented.