Whan B Kim1, Joseph E C Marinas1, Judy Qiang2, Ali Shahbaz3, Simon Greaves4, Jensen Yeung5. 1. Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada. 2. School of Medicine, University of Toronto, Toronto, Ontario, Canada. 3. School of Medicine, University of Ottawa, Ottawa, Ontario, Canada. 4. Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada. 5. Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Women's College Hospital, Toronto, Ontario, Canada. Electronic address: jensen.yeung@utoronto.ca.
Abstract
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.
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.
Authors: Mayara Costa de Camargo; Bruna Cipriano Almeida Barros; Izabela Fulone; Marcus Tolentino Silva; Miriam Sanches do Nascimento Silveira; Iara Alves de Camargo; Silvio Barberato-Filho; Fernando de Sá Del Fiol; Luciane Cruz Lopes Journal: Front Pharmacol Date: 2019-09-11 Impact factor: 5.810
Authors: A Campanati; V Brisigotti; F Diotallevi; G M D'Agostino; M Paolinelli; G Radi; G Rizzetto; C Sapigni; C Tagliati; A Offidani Journal: J Eur Acad Dermatol Venereol Date: 2020-08 Impact factor: 9.228