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2. Background Infliximab, a chimeric monoclonal anti-TNF antibody,has been found to increase the risk of seriousinfections compared to etanercept (a TNF receptorfusion protein) It is unclear whether the risk varies by patientcharacteristics 2 3. Objective To assess if the relative risk of serious infectionscomparing infliximab and etanercept varies by fivepatient characteristics (age, sex, race/ethnicity, andbody mass index, smoking status) 3 4. Study cohort 4 5. Exposure Infliximab: Administered through infusion; eachinfusion covers 56 days Etanercept: Self-administered via injection; eachinjection covers 7 days and each dispensingcontaining 4 injections5 6. Outcome Serious infections, defined as infections requiring hospitalization or opportunistic infections Used previously validated algorithms to identify serious infection cases (PPV of 80%)Grijalva et al, JAMA 2011;306: 2331-2339 6 7. Potential confounders & effect modifiers Age; sex; race/ethnicity; body mass index; smoking status Type of insurance; proportion of household below the povertyline in the census block in which the patient lived Charlson comorbidity score; diagnosis of rheumatoid arthritis,psoriatic arthritis, psoriasis, ankylosing spondylitis, diabetes, orCOPD Use of methotrexate, hydroxychloroquine, leflunomide,sulfasalazine, NSAIDs, opioids, corticosteroids, or antibiotics Number of inpatient visits, outpatient visits, and uniquemedications dispensed 7 8. Statistical analysis Calculated the incidence rate and 95% CI Propensity score stratified (by quintiles) Cox model toadjust for potential confounders HRs and 95% CIs comparing infliximab vs. etanercept An intention-to-treat analysis Follow-up started from treatment initiation to the earliest occurrence of the outcome, death, disenrollment, 12/31/2007, or 365 days after treatment initiation 0-3, 0-6, and 0-12 months after treatment initiation 8 9. Statistical analysis (cont) Stratified the analysis by Age: