title: Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3).
abstract: BACKGROUND
  Scalp is a frequently affected and difficult-to-treat area in psoriasis patients.
  
  
  OBJECTIVE
  We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI).
  
  
  METHODS
  In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224) and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every two weeks (Q2W) or every four weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12. Additional UNCOVER-2 and UNCOVER-3 cohorts were randomized to 50 mg bi-weekly etanercept through Week 12. Patients entering the open-label long-term extension (LTE) (UNCOVER-3) received ixekizumab Q4W; UNCOVER-1 and UNCOVER-2 included a blinded maintenance period in which static physician global assessment (sPGA) 0/1 responders were re-randomized to placebo, ixekizumab Q4W, or 80 mg ixekizumab every 12 weeks (Q12W) through Week 60.
  
  
  RESULTS
  In patients with moderate-to-severe psoriasis with baseline scalp involvement, PSSI 90 and 100 were achieved at Week 12 in higher percentages of patients treated with ixekizumab Q2W (81.7% and 74.6%) or ixekizumab Q4W (75.6% and 68.9%) compared with patients treated with placebo (7.6% and 6.7%; p < .001 each ixekizumab arm versus placebo) or etanercept (55.5% and 48.1%; p < .001 each ixekizumab arm versus etanercept). These outcomes were maintained through Week 60 of the maintenance (UNCOVER-1 and UNCOVER-2) and LTE (UNCOVER-3) period in patients who continued on ixekizumab Q4W.
  
  
  CONCLUSIONS
  Ixekizumab was efficacious in treating scalp psoriasis in patients with moderate-to-severe psoriasis, with most patients achieving complete or near-complete resolution of scalp psoriasis and maintaining this response over 60 weeks.
authors.affiliation: a Dermatologikum Hamburg and SCIderm GmbH , Hamburg , Germany.
authors.forename: Kristian
authors.initials: K
authors.lastname: Reich
authors.affiliation: b Department of Dermatology , Saint Louis University School of Medicine , St Louis , MO , USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Leonardi
authors.affiliation: c Department of Dermatology , Icahn School of Medicine at Mount Sinai , New York , NY , USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.affiliation: d Florida Academic Dermatology Center , Miami , FL , USA.
authors.forename: Francisco
authors.initials: F
authors.lastname: Kerdel
authors.affiliation: e Department of Dermatology , Tokyo Medical University , Shinjuku , Tokyo , Japan.
authors.forename: Yukari
authors.initials: Y
authors.lastname: Okubo
authors.affiliation: f Department of Dermatology Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo , São Paulo , Brazil.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Romiti
authors.affiliation: g Eli Lilly and Company , Indianapolis , IN , USA.
authors.forename: Orin
authors.initials: O
authors.lastname: Goldblum
authors.affiliation: g Eli Lilly and Company , Indianapolis , IN , USA.
authors.forename: Ellen B
authors.initials: EB
authors.lastname: Dennehy
authors.affiliation: g Eli Lilly and Company , Indianapolis , IN , USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Kerr
authors.affiliation: h Department of Medicine, Division of Dermatology , UCLA David Geffen School of Medicine , Los Angeles , CA , USA.
authors.forename: Howard
authors.initials: H
authors.lastname: Sofen
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D000068800:Etanercept / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011565:Psoriasis / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D012536:Scalp Dermatoses / Q000150:complications; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D007166:Immunosuppressive Agents; C549079:ixekizumab; D000068800:Etanercept
keywords: Psoriasis; UNCOVER; clinical trial; interleukin-17A; ixekizumab; scalp