title: Open-label study of etanercept treatment in patients with moderate-to-severe plaque psoriasis who lost a satisfactory response to adalimumab.
abstract: Some patients with plaque psoriasis experience secondary failure of tumour necrosis factor inhibitor therapy.
  
  
  
  To evaluate efficacy, safety and patient-reported outcomes (PROs) with etanercept in patients with secondary adalimumab failure.
  
  
  
  This phase IV open-label single-arm estimation study (NCT01543204) enrolled patients on adalimumab who had achieved static Physician's Global Assessment (sPGA) score 0/1 (clear/almost clear). Patients subsequently lost response, defined as sPGA ≥ 3 or loss of 50% improvement in Psoriasis Area and Severity Index (PASI 50). At baseline, patients had involved body surface area ≥ 10%, sPGA ≥ 3 and PASI ≥ 10. Antiadalimumab antibodies (ADAs) were measured at screening. Patients received etanercept 50 mg twice weekly for 12 weeks, followed by 50 mg weekly. The primary end point was sPGA 0/1 at week 12 (intention-to-treat analysis; no hypothesis tested). Additional outcomes included rates of sPGA 0/1, PASI responses, safety, PROs of itch, pain and flaking, Dermatology Life Quality Index, treatment satisfaction and Work Productivity and Activity Impairment questionnaire.
  
  
  
  Sixty-four patients enrolled; 67% had ADAs. sPGA 0/1 rates at week 12 were 39·7% [95% confidence interval (CI) 27·6-52·8; primary end point] and 45% (95% CI 29·3-61·5) for patients positive for ADAs and 35% (95% CI 15·4-59·2) for patients negative for ADAs. PASI 75 response rates at week 12 were 47·5% (95% CI 31·5-63·9) for patients who were positive for ADAs and 50% (95% CI 27·2-72·8) for patients negative for ADAs. No new safety signals were observed. PROs of itch, pain and flaking consistently improved at week 12 and were maintained through week 24.
  
  
  
  Patients with psoriasis who experienced secondary failure of adalimumab achieved satisfactory response to etanercept regardless of ADA status.
authors.affiliation: Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, U.S.A.
authors.forename: J
authors.initials: J
authors.lastname: Bagel
authors.affiliation: University of Texas Health Science Center and Center for Clinical Studies, Houston, TX, U.S.A.
authors.forename: S
authors.initials: S
authors.lastname: Tyring
authors.affiliation: Amgen Inc., Thousand Oaks, CA, U.S.A.
authors.forename: K C
authors.initials: KC
authors.lastname: Rice
authors.affiliation: Amgen Inc., Thousand Oaks, CA, U.S.A.
authors.forename: D H
authors.initials: DH
authors.lastname: Collier
authors.affiliation: Amgen Inc., Thousand Oaks, CA, U.S.A.
authors.forename: G
authors.initials: G
authors.lastname: Kricorian
authors.affiliation: Amgen Inc., Thousand Oaks, CA, U.S.A.
authors.forename: J
authors.initials: J
authors.lastname: Chung
authors.affiliation: Amgen Inc., Thousand Oaks, CA, U.S.A.
authors.forename: J
authors.initials: J
authors.lastname: Iles
authors.affiliation: Amgen Inc., Thousand Oaks, CA, U.S.A.
authors.forename: B S
authors.initials: BS
authors.lastname: Stolshek
authors.affiliation: Amgen Inc., Thousand Oaks, CA, U.S.A.
authors.forename: A
authors.initials: A
authors.lastname: Kaliyaperumal
authors.affiliation: Probity Medical Research, Ontario, Canada.
authors.forename: K A
authors.identifier: 0000-0001-9557-3642
authors.initials: KA
authors.lastname: Papp
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects; D000279:Administration, Cutaneous; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D000068800:Etanercept / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents; D000068879:Adalimumab; D000068800:Etanercept