Statistical analyses
REGRESSION, EVENTS, EVENT
The proportion of patients who achieved binary efficacy endpoints at Week 24 or 52 of OCTAVE Sustain was evaluated descriptively according to treatment group (tofacitinib 5 or 10 mg BID or placebo), OCTAVE Sustain baseline MES (0 vs. 1), and prior TNFi therapy.In addition, the difference in treatment effect between baseline OCTAVE Sustain MES subgroups (0 vs. 1) was assessed using a logistic regression model, which included prior TNFi exposure status, treatment allocation, baseline MES, and treatment by baseline MES interaction. These analyses tested the null hypothesis that the tofacitinib 5 or 10 mg BID versus placebo difference (treatment effect) was the same for patients with a baseline MES of 0 as it was for those with a MES of 1.Cox proportional hazards regression was used to model the difference in treatment effect between baseline MES (0 vs. 1) for time to treatment failure and time to loss of response. The model included prior TNFi exposure status, treatment allocation, baseline MES, and treatment by baseline MES interaction. These analyses tested whether the difference in the risk of the event between tofacitinib 5 or 10 mg BID and placebo was the same for patients with a baseline MES of 0 as it was for those with a baseline MES of 1.Incidence rates, defined as the number of unique patients with events per 100 patient-years of exposure, were evaluated for AEs of special interest, which were counted up to 28 days beyond the last dose of study treatment. Confidence intervals (CIs) were calculated according to the Exact Poisson method, adjusted for patient-years.