Long term safety of nine systemic medications for psoriasis: a cohort study using the Biobadaderm Registry

Abstract Background Registry studies broadly describing the safety of systemic drugs in psoriasis are needed. Objective To describe the safety findings of systemic drugs (acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, ustekinumab) used for the treatment of moderate-to-severe psoriasis in patients included in Biobadaderm. Methods The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events (AE) for each drug, using methotrexate as reference, were determined by means of a prospective cohort. Results Our study included 2,845 patients (8,954 treatment cycles; 9,642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ class with statistically significant decreased rate ratio (IRR Limitations Observational study, drug allocation not randomized, depletion of susceptibles, prescribed doses not registered. Conclusion Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.