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. 2022 Aug 3;81(11):1491–1503. doi: 10.1136/ard-2022-222405

Figure 5.

Figure 5

HRs (95% CIs) of potential baseline and time-dependent risk factors for (A) SIEs, (B) NSIs and (C) all HZ (non-serious/serious) in ORAL Surveillance (multivariable Cox analyses across treatments). For patients randomised to the tofacitinib 10 mg two times per day group who had their dose of tofacitinib reduced to 5 mg two times per day, the data collected after patients were switched to tofacitinib 5 mg two times per day were counted in the tofacitinib 10 mg two times per day group. *p<0.05, **p<0.01; ***p<0.001. HRs are shown on a logarithmic scale. †HRs were based on a backward model selection algorithm on a multivariable Cox model, including effects of treatment group (tofacitinib 5 mg two times per day, 10 mg two times per day and TNFi) and a set of candidate baseline risk factors previously selected via a simple Cox model; risk factors with p<0.10 in the simple model (see online supplemental table 3) were entered into the multivariable model, and the risk factors with p<0.10 were retained in the multivariable model, with p<0.05 interpreted as predictive. ‡In North America (the USA, Puerto Rico and Canada), patients randomised to TNFi received adalimumab 40 mg once every 2 weeks; in the ROW, patients randomised to TNFi received etanercept 50 mg once weekly. §HRs were based on a multivariable Cox time-dependent model including the fixed effects of treatment group (tofacitinib 5 mg two times per day, tofacitinib 10 mg two times per day and TNFi), the final set of baseline covariates selected from the previous multivariable Cox model, using a backward selection algorithm and a time-dependent covariate (a separate model was generated for each individual time-dependent risk factor). All HZ events (non-serious/serious) include HZ adjudicated as opportunistic infections and non-adjudicated HZ events from the clinical database. BID, two times per day; BMI, body mass index; COPD, chronic obstructive pulmonary disease; DAS28-4(CRP), Disease Activity Score in 28 joints, C-reactive protein; eGFR, estimated glomerular filtration rate; HDL-C, high-density lipoprotein cholesterol; HR, hazard ratio; HZ, herpes zoster; ILD, interstitial lung disease; LDL-C, low-density lipoprotein cholesterol; NSI, non-serious infection; ROW, rest of the world; SIE, serious infection event; TNFi, tumour necrosis factor inhibitors.