Long-term safety of nine systemic medications for psoriasis: A cohort study using the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry

Abstract

Background: Registry studies broadly describing the safety of systemic drugs in psoriasis are needed.

Objective: To describe the safety findings of the systemic drugs acitretin, adalimumab, apremilast, cyclosporine, etanercept, infliximab, methotrexate, secukinumab, and ustekinumab used for the treatment of moderate to severe psoriasis in patients included in the Spanish Registry of Adverse Events for Biological Therapy in Dermatological Diseases (BIOBADADERM) Registry.

Methods: The incidence rate ratio (IRR) and adjusted IRR (including propensity scores) of identified adverse events for each drug, using methotrexate as reference, were determined by means of a prospective cohort.

Results: Our study included 2845 patients (8954 treatment cycles; 9642 patient-years). Ustekinumab and secukinumab had the lowest rate of adverse events for several of the system organ classes, with a statistically significant decreased rate ratio (IRR of <1), whereas cyclosporine and infliximab had the highest, with an increased rate ratio (IRR of ≥5).

Limitations: Observational study, drug allocation not randomized, depletion of susceptibles, and prescribed doses not registered.

Conclusion: Our data provide comparative safety information in the real-life setting that could help clinicians selecting between available products.

Keywords: adverse effects; anti-TNF; anti-inflammatory agents; biologic agents; immunosuppressive agents; long-term follow-up; pharmacovigilance; prospective cohort; psoriasis/drug therapy; registries; safety.