title: Adverse events resulting in withdrawal of biologic therapy for psoriasis in real-world clinical practice: A Canadian multicenter retrospective study.
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%).
  
  
  CONCLUSIONS
  Possible incompleteness of chart details and small study population limit the conclusiveness of findings.
  
  
  CONCLUSIONS
  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.affiliation: Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Whan B
authors.initials: WB
authors.lastname: Kim
authors.affiliation: Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Joseph E C
authors.initials: JE
authors.lastname: Marinas
authors.affiliation: School of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Judy
authors.initials: J
authors.lastname: Qiang
authors.affiliation: School of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Ali
authors.initials: A
authors.lastname: Shahbaz
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Simon
authors.initials: S
authors.lastname: Greaves
authors.affiliation: 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.
authors.forename: Jensen
authors.initials: J
authors.lastname: Yeung
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D001691:Biological Therapy / Q000009:adverse effects* / Q000379:methods; D002170:Canada; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000009:adverse effects; D015994:Incidence; D007239:Infections / Q000139:chemically induced / Q000453:epidemiology; D000069285:Infliximab; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced / Q000453:epidemiology; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D000069549:Ustekinumab; D028761:Withholding Treatment / Q000706:statistics & numerical data*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000069285:Infliximab; D000069549:Ustekinumab; D000068879:Adalimumab; D000068800:Etanercept
keywords: adverse event; biologic; clinical practice; psoriasis; real world; safety; tumor necrosis factor inhibitor