title: Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis.
abstract: BACKGROUND
  ESPRIT is an ongoing, 10-year, observational registry, evaluating long-term safety and effectiveness of adalimumab treatment in routine clinical practice for patients with moderate to severe, chronic plaque psoriasis.
  
  
  OBJECTIVE
  Initial 5-year results are reported.
  
  
  METHODS
  Two populations were analyzed: the "all-treated" population received 1 or more adalimumab doses in registry, continuing adalimumab treatment from a current prescription or previous study participation, and included the "new-prescription" population initiating adalimumab 4 weeks or earlier preregistry entry.
  
  
  RESULTS
  Data were collected from September 26, 2008, through November 30, 2013, for all-treated (n = 6059), which included new-prescription (n = 2580, 42.6%); median registry exposure was 765 and 677 days, respectively. In all-treated, rate (events per 100 patient-years of total adalimumab exposure [E/100PY]) of serious treatment-emergent adverse events (inside or outside of the registry) was 4.3 E/100PY, serious infection 1.0 E/100PY, malignancies 0.9 E/100PY (nonmelanoma skin cancers 0.6 E/100PY; melanomas <0.1 E/100PY). Standardized mortality ratio was 0.30 (95% confidence interval 0.19-0.44). Physician Global Assessment clear or minimal (effectiveness parameter) was achieved by 57.0% at 12 months and 64.7% at 60 months of treatment.
  
  
  CONCLUSIONS
  Observational data are subject to outcome-reporting bias.
  
  
  CONCLUSIONS
  No new safety signals were observed with adalimumab treatment during this initial 5-year registry review. Observed number of deaths was below expected. As-observed effectiveness remained stable through 60 months.
authors.affiliation: Baylor University Medical Center, Dallas, Texas. Electronic address: amderm@gmail.com.
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.affiliation: Comprehensive Center for Inflammation Medicine, University Medical School Schleswig Holstein, Campus Lübeck, Lübeck, Germany.
authors.forename: Diamant
authors.initials: D
authors.lastname: Thaçi
authors.affiliation: Probity Medical Research, Waterloo, Ontario, Canada.
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.affiliation: Kaiser Permanente Los Angeles Medical Center, Los Angeles, California.
authors.forename: Jashin J
authors.initials: JJ
authors.lastname: Wu
authors.affiliation: AbbVie Deutschland GmbH and Co KG, Ludwigshafen, Germany.
authors.forename: Mareike
authors.initials: M
authors.lastname: Bereswill
authors.affiliation: AbbVie Inc, North Chicago, Illinois.
authors.forename: Henrique D
authors.initials: HD
authors.lastname: Teixeira
authors.affiliation: AbbVie Deutschland GmbH and Co KG, Ludwigshafen, Germany.
authors.forename: Simone
authors.initials: S
authors.lastname: Rubant
authors.affiliation: AbbVie Inc, North Chicago, Illinois.
authors.forename: David A
authors.initials: DA
authors.lastname: Williams
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage* / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D002170:Canada; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D000068879:Adalimumab
keywords: adalimumab; adverse events; long-term safety; malignancy; registry; serious infections