MACEs Not Associated With the Use of Biologic Therapy for Psoriasis in Real-World Clinical Practice: A Canadian Multicenter Retrospective Study.

INTRODUCTION: Previous reports have shown inconsistent findings with regard to the relationship between biologic therapy and risk for major adverse cardiovascular events (MACEs). OBJECTIVES: The aim of this study was to determine the overall rate of MACEs in a cohort of 398 patients. METHODS: All patients treated with biologics for psoriasis at 2 academic centers in Toronto, Ontario, between September 2005 and September 2014 were considered for inclusion. Medical records were reviewed to identify MACEs. RESULTS: A total of 398 patients were included. The median duration of disease was 19.8 years. Median time to biologic therapy withdrawal because of an adverse event was 23.5 months. In this cohort, no MACEs were identified in patients treated with biologic therapy. CONCLUSIONS: Biologic treatment for psoriasis was not associated with increased cardiovascular risk in this cohort. These results require validation in larger studies.

Adverse events resulting in withdrawal of biologic therapy for psoriasis in real-world clinical practice: A Canadian multicenter retrospective study.

BACKGROUND: Safety profiles of biologics for treatment of psoriasis are limited to data from randomized controlled trials. There is a need for comparative safety reports of biologics based on data from clinical practice. OBJECTIVE: We sought to estimate and compare the incidence of adverse events (AEs) leading to withdrawal of biologics (etanercept, infliximab, adalimumab, and ustekinumab) in the treatment of psoriasis. METHODS: We conducted a multicenter retrospective chart review from September 2005 to September 2014. Incidence proportion and rate of AEs leading to withdrawal by biologic agent and AE were calculated. RESULTS: For 545 treatments administered in 398 patients, 22 (4.04%) AEs were associated with withdrawal, for a rate of 1.97/100 patient-years (95% confidence interval [CI] 1.32-2.94). Common AEs were injection-/infusion-site reactions (0.55%, 0.92%, 0%, and 0% for etanercept, infliximab, adalimumab, and ustekinumab, respectively); infections (0%, 0.18%, 0.55%, 0.18%); and malignancies (0.18%, 0.18%, 0%, 0.37%). LIMITATIONS: Possible incompleteness of chart details and small study population limit the conclusiveness of findings. CONCLUSION: Biologic agents for treatment of psoriasis are safe; AEs associated with withdrawal occurred in 4% of all administered biologic therapies. It does not appear that real-world patients encounter more AEs with biologics than patients in clinical trials.