Fig. 2.

IRs for SIEs a resulting in hospitalization or b requiring parenteral antimicrobials in an emergency department setting or resulting in hospitalization over 12 months across cohorts. The tofacitinib dose-comparison cohort included patients who were randomized to receive either tofacitinib 5 mg BID or 10 mg BID (n = 474) in the two phase III studies (12 or 6 months’ duration). For the observational comparison cohort, follow-up was truncated at 1 year because of the possible time-varying hazard between PsA treatments and infections to ensure equal follow-up time. Observational comparison cohort outcomes were weighted based on previous TNFi use (identified using all available data: TNFi naïve vs. TNFi experienced), concomitant MTX use (identified using data from the index date to 90 days before the index date: MTX only vs. no MTX or with other csDMARDs), and concomitant steroid use (identified on the index date: steroid use vs. no steroid use); the weights were derived using the all-tofacitinib comparison cohort data. For bDMARD, bDMARD + csDMARD, TNFi, and TNFi + csDMARD, n refers to “treatment episodes” rather than patients, as the patients in these groups may have initiated more than one drug in the given class. bDMARD biologic DMARD, BID twice daily, CI confidence interval, csDMARD conventional synthetic DMARD, DMARD disease-modifying antirheumatic drug, IR incidence rate (patients with event/100 PY), MTX methotrexate, PsA psoriatic arthritis, PY patient-years, SIEs serious infections, TNFi tumor necrosis factor inhibitor, tofa tofacitinib