FIGURE 1.

IRs (unique patients with events per 100 PY of exposure) for (a) deaths, (b) SIs, (c) all HZ (non‐serious and serious), (d) serious HZ, (e) OIs, and (f) HZ OIs in the tofacitinib UC clinical program, by cohort. Data for the Maintenance Cohort have been reported previously. ⁵ , ⁶ Briefly, the Maintenance Cohort comprised patients who received placebo or tofacitinib 5 or 10 mg b.i.d. for 52 weeks in OCTAVE Sustain ⁵ , ⁶ ; and the Overall Cohort comprised patients who received ≥1 dose of tofacitinib 5 or 10 mg b.i.d. in any phase 2/3/OLE study plus final data from the phase 3b/4 data as of 18 April 2022 (≤9.2 years of exposure). Exact Poisson distribution was used to calculate IR 95% CI. AE, adverse event; b.i.d., twice daily; CI, confidence interval; HZ, herpes zoster; IR, incidence rate (unique patients with events per 100 PY of exposure); N, number of patients treated in the treatment group; n, number of unique patients with a particular adverse event; OI, opportunistic infection; OLE, open‐label, long‐term extension; PD, predominant dose; SI, serious infection; PY, patient‐years; UC, ulcerative colitis. ^aFor the Maintenance Cohorts, events that occurred >28 days after the last dose of the study drug were excluded; for the Overall Cohort, events outside the 28‐day risk period were included. ^bEvents that occurred >28 days after the last dose of the study drug were excluded. ^cDefined as any infection AE that required hospitalization or parenteral antimicrobials or met other criteria that required the infection to be classified as a serious AE. ^dIRs of HZ in the Maintenance Cohort were numerically higher with tofacitinib 5 mg b.i.d. versus placebo and statistically higher with tofacitinib 10 mg b.i.d. versus placebo. ^eData are from baseline of OCTAVE Induction 1&2; for the Overall Cohort, N = 905 and N = 1124 for the PD tofacitinib 10 mg b.i.d. and tofacitinib all groups, respectively (excludes phase 2). ^fAdjudicated events. ^gExcludes tuberculosis and HZ with two adjacent dermatomes. ^hDisseminated or multidermatomal HZ events were considered to be HZ OIs.