title: Evidence-based adverse effects of biologic agents in the treatment of moderate-to-severe psoriasis: Providing clarity to an opaque topic.
abstract: BACKGROUND
  Biologic agents have greatly enhanced the treatment of moderate-to-severe plaque psoriasis. Previous reviews of the safety of biologic agents have included patients with conditions other than psoriasis and/or have not used statistical significance as the primary analytic focus. Our aim was to review the current literature to identify significantly increased adverse events associated with the use of etanercept, adlimumab and ustekinumab for the treatment of moderate-to-severe plaque psoriasis.
  
  
  METHODS
  We performed a search of Ovid MEDLINE and the Cochrane Library to identify clinical trials, open-label extension studies and meta-analyses reporting statistical analysis of adverse events associated with the use of etanercept, adlimumab and ustekinumab for the treatment of moderate-to-severe plaque psoriasis.
  
  
  RESULTS
  We identified 17 clinical trials, 2 open-label extension studies and 8 meta-analyses. Adverse events reported to be significantly increased included squamous cell carcinoma (SCC), injection-site reaction, and headache associated with etanercept, overall nonmelanoma skin cancer (NMSC), SCC, and upper respiratory tract infection associated with adalimumab, and no significantly increased adverse events associated with ustekinumab.
  
  
  CONCLUSIONS
  Current evidence suggests that when analyzed among patients with plaque psoriasis, few adverse effects of the biologic agents etanercept, adalimumab and ustekinumab have reached statistical significance. Further long-term studies conducting analysis of statistical significance should be performed.
authors.affiliation: a Keck School of Medicine of the University of Southern California , Los Angeles , CA , USA and.
authors.forename: Eric
authors.initials: E
authors.lastname: Sorenson
authors.affiliation: b Department of Dermatology , University of California San Francisco Psoriasis Treatment Center , San Francisco , CA , USA.
authors.forename: John
authors.initials: J
authors.lastname: Koo
mesh_terms: D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D001685:Biological Factors / Q000009:adverse effects / Q000627:therapeutic use*; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D011565:Psoriasis / Q000188:drug therapy*; D000069549:Ustekinumab / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D001685:Biological Factors; D000069549:Ustekinumab; D000068879:Adalimumab; D000068800:Etanercept
keywords: Adalimumab; dermatology; etanercept; safety; ustekinumab