title: OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.
abstract: BACKGROUND
  OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis.
  
  
  OBJECTIVE
  We sought to assess long-term etanercept safety and effectiveness.
  
  
  METHODS
  Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required. Key outcome measures included serious adverse events, serious infectious events, events of medical interest, psoriasis-affected body surface area, physician global assessment score, and Dermatology Life Quality Index score. Safety outcomes were assessed relative to data from the MarketScan database.
  
  
  RESULTS
  For 2510 patients, 5-year cumulative incidence was 22.2% (95% confidence interval [CI] 20.3%-24.2%) for serious adverse events; 6.5% (95% CI 5.4%-7.7%) for serious infectious events; 3.2% (95% CI 2.3%-4.1%) for malignancies excluding nonmelanoma skin cancer; 3.6% (95% CI 2.7%-4.5%) for nonmelanoma skin cancer; 2.8% (95% CI 2.0%-3.6%) for coronary artery disease; 0.7% (95% CI 0.3%-1.2%) for psoriasis worsening; 0.2% (95% CI 0.0%-0.4%) for central nervous system demyelinating disorder; 0.1% (95% CI 0.0%-0.3%) for lymphoma and for tuberculosis; and 0.1% (95% CI 0.0%-0.2%) for opportunistic infection and for lupus; 55 fatal events were reported. Rates of malignancies, lymphomas, nonmelanoma skin cancer, and hospitalization-associated infections were not higher than expected relative to administrative claims data. The percentage of patients rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years.
  
  
  CONCLUSIONS
  No internal comparator group was included; rare events may not have been detected.
  
  
  CONCLUSIONS
  No new safety signals were observed with long-term, real-world etanercept use.
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts. Electronic address: harvardskinstudies@partners.org.
authors.forename: Alexa B
authors.initials: AB
authors.lastname: Kimball
authors.affiliation: RTI Health Solutions, RTI International, Research Triangle Park, North Carolina.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Rothman
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Gregory
authors.initials: G
authors.lastname: Kricorian
authors.affiliation: Eastern Virginia Medical School and Virginia Clinical Research Inc, Norfolk, Virginia.
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.affiliation: Dermatology Institute and Skin Care Center, Santa Monica, California.
authors.forename: Paul S
authors.initials: PS
authors.lastname: Yamauchi
authors.affiliation: Baylor Research Institute, Dallas, Texas.
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.affiliation: Bellaire Dermatology Associates, Bellaire, Texas.
authors.forename: Craig F
authors.initials: CF
authors.lastname: Teller
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Girish
authors.initials: G
authors.lastname: Aras
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Neil A
authors.initials: NA
authors.lastname: Accortt
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Michele
authors.initials: M
authors.lastname: Hooper
authors.affiliation: Amgen Inc, Thousand Oaks, California.
authors.forename: Kara Creamer
authors.initials: KC
authors.lastname: Rice
authors.affiliation: University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
authors.forename: Joel M
authors.initials: JM
authors.lastname: Gelfand
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068800:Etanercept; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011565:Psoriasis / Q000188:drug therapy*; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use; D012042:Registries; D013997:Time Factors; D055815:Young Adult
chemical_list: D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept
keywords: adverse events; etanercept; infections; malignancy; plaque psoriasis; registry; safety; surveillance