Efficacy endpoints at Week 24 or Week 52 of OCTAVE Sustain
REGRESSION, REMISSION
Overall, the proportion of patients who met efficacy endpoints was higher with tofacitinib than with placebo, regardless of tofacitinib dose or baseline MES. In general, the proportion of patients treated with tofacitinib who achieved efficacy endpoints at Week 52 was numerically higher for patients with a baseline MES of 0 than for those with a MES of 1. This was observed for remission, endoscopic remission, and endoscopic improvement, regardless of dose or prior TNFi exposure status (Fig. Proportion of patients achieving efficacy endpointsProportion of patients in remissionLogistic regression analyses of clinical response at Week 52 showed a significantly larger tofacitinib versus placebo treatment effect for patients with a baseline MES of 0 versus 1 in the tofacitinib 5 mg BID group (odds ratio [OR] [95% CI] 7.41 [1.21–45.52]; We next examined the proportion of patients achieving efficacy endpoints at Week 52 of OCTAVE Sustain based on the extent of change in MES from baseline to Week 8 of OCTAVE Induction 1 or 2 (Fig. Proportion of patients achieving efficacy endpointsFor patients treated with tofacitinib 5 mg BID, Cox proportional hazards regression showed that the relative risk (tofacitinib vs. placebo) of treatment failure or loss of response was significantly lower for patients with a baseline MES 0 versus 1 (hazard ratio [95% CI] for MES 0 vs. 1: 0.29 [0.10–0.84]; Cox proportional hazards regression