The efficacy and safety of XELJANZ for the treatment of adult patients with moderately to severely active ulcerative colitis was demonstrated in three Phase III randomised, double-blind, placebo ­controlled trials (RCTs): OCTAVE Induction 1 and 2, and OCTAVE Sustain¹

• OCTAVE Induction 1 and 2 were two identical studies of patients with moderately to severely active disease to assess the efficacy and safety of XELJANZ in inducing remission.¹
• OCTAVE Sustain was a study of patients who had achieved clinical response in the two OCTAVE Induction studies to assess the efficacy and safety of XELJANZ in maintaining remission.¹
• Patients in the OCTAVE Phase III trial programme were eligible to enter an open-label extension study, OCTAVE Open.¹

In the OCTAVE Phase III studies, outcomes were measured for disease activity, health-related quality of life and health utility using multiple endpoints^1,3:

• The primary and key secondary endpoints were clinical outcomes based on the Mayo score.
• The Mayo endoscopic subscore, based on mucosal appearance during endoscopy, was assessed by central and local readings. Central assessment was by a central reader using video recorded during the procedure; local assessment was done by the study site investigator.
• The central reading was used for eligibility and primary efficacy endpoint analysis. The OCTAVE programme was the first in ulcerative colitis to use central reads to assess primary efficacy endpoints.
• Local readings are more likely to reflect clinical practice where physicians use their own assessment of endoscopic findings to complement other data to make clinical decisions.

Please refer to the XELJANZ Summary of Product Characteristics for full prescribing information

In the OCTAVE UC trials, remission was defined more stringently than in previous clinical trials for UC, by including the requirement of a rectal bleeding subscore of 0.³