OBJECTIVE: To compare the risk of serious infections requiring hospitalization in patients with psoriasis (PsO) or psoriatic arthritis (PsA) initiating ustekinumab versus other biologics or apremilast.
METHODS: In this multi-database cohort study, we identified patients with PsO/PsA who initiated adalimumab, apremilast, certolizumab, etanercept, golimumab, ixekizumab, secukinumab, or ustekinumab between 2009 and 2018. The primary outcome was hospitalized serious infections including bacterial, viral, or opportunistic infections. We estimated hazard ratios (HR) comparing each study drugs with ustekinumab after applying propensity score fine stratification weights for confounding control in each database. Database-specific weighted HRs were combined by meta-analysis.
RESULTS: We identified 123,383 patients with PsO/PsA who initiated one of the study drugs. During a total of 117,744 person-years of follow-up, 1,514 serious infections occurred with a crude incidence of 1.29 per 100 person-years. After propensity score fine stratification and weighting, the incidence rates of serious infection among ustekinumab initiators ranged from 0.59 to 0.95 per 100 person-years. Compared with ustekinumab, the combined weighted HR (95% confidence interval) for serious infections was 1.66 (1.34-2.06) for adalimumab, 1.42 (1.02-1.96) for apremilast, 1.09 (0.68-1.75) for certolizumab, 1.39 (1.01-1.90) for etanercept, 1.74 (1.00-3.03) for golimumab, 2.92 (1.80-4.72) for infliximab, 2.98 (1.20-7.41) for ixekizumab, and 1.84 (1.24-2.72) for secukinumab.
CONCLUSIONS: Other biologics and apremilast were associated with 1.4- to 3-times higher risk of hospitalized serious infections in PsO/PsA patients when compared with ustekinumab; such safety profile should be considered when selecting appropriate treatment regimens in patients with PsO/PsA.