Figure 1.

Incidence of [A] deaths,^a [B] serious infections,^b,c [C] HZ [non-serious and serious],^b [D] opportunistic infections,^b,d,e and [E] HZ opportunistic infections,^b,d by cohort.

^aFor the Induction and Maintenance Cohorts, events that occurred >28 days after the last dose of the study drug were excluded; for the Overall [Dec 2016] and Overall plus P3b/4 [2020] Cohorts, all events, including those 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 requires hospitalization or parenteral antimicrobials, or meets other criteria that require the infection to be classified as a serious AE.

^dAdjudicated events; for the Overall plus P3b/4 [2020] Cohort, N = 922 and N = 1124 for the PD tofacitinib 10 mg BID and tofacitinib all groups, respectively [excludes phase 2 study data, as the phase 2 induction study took place prior to the establishment of the adjudication committees].

^eExcludes tuberculosis and HZ with two adjacent dermatomes.

^fIncludes data previously reported by Sandborn et al.⁷; the previously reported Overall [Dec 2016] Cohort included data from OCTAVE Open up to December 2016 [≤4.4 years of exposure].

^gThe Overall plus P3b/4 [2020] Cohort includes final data from OCTAVE Open [final data cut-off: August 24, 2020], and data from RIVETING [interim data cut-off: February 20, 2020; ≤7.8 years of exposure].

^hIncludes data previously reported by Winthrop et al.¹⁰

ⁱIncludes data previously reported by Winthrop et al.⁹

AE, adverse event; BID, twice daily; CI, confidence interval; HZ, herpes zoster; IR, incidence rate [unique patients with events/100 PY of exposure]; N, number of patients treated in the treatment group; n, number of unique patients with a particular AE; PD, predominant dose; PY, patient-years.