title: Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis.
abstract: OBJECTIVE
  To evaluate the effect of brodalumab on psoriasis signs and symptoms assessed by the Psoriasis Symptom Inventory (PSI) in patients with psoriatic arthritis (PsA).
  
  
  METHODS
  This prespecified analysis of a phase II study (NCT01516957) evaluated patients with active PsA and psoriasis-affected body surface area ≥ 3%, randomized to brodalumab (140 or 280 mg) or placebo every 2 weeks (Q2W) for 12 weeks with loading dose at Week 1. At Week 12, patients entering an open-label extension received brodalumab 280 mg Q2W. The PSI measures 8 psoriasis signs and symptoms: itch, redness, scaling, burning, stinging, cracking, flaking, and pain. PSI response is defined as total PSI ≤ 8 (range 0-32), each item ≤ 1 (range 0-4). PSI scores were assessed at weeks 12 and 24.
  
  
  RESULTS
  There were 107 eligible patients. At Week 12, mean improvement in PSI scores was 7.8, 11.2, and 1.5 in brodalumab 140 mg, 280 mg, and placebo groups, respectively; by Week 24, improvement was 10.2, 12.4, and 11.7. At Week 12, 75.0%, 81.8%, and 16.7% of patients receiving brodalumab 140 mg, 280 mg, and placebo, respectively, achieved PSI response; improvement was sustained through Week 24, when 83.9% of prior placebo recipients achieved response. At Week 12, 25.0%, 36.4%, and 2.8% of patients receiving brodalumab 140 mg, 280 mg, and placebo, respectively, achieved PSI 0. Percentages improved through Week 24: 40.0% brodalumab 140 mg, 42.9% brodalumab 280 mg, and 48.4% placebo.
  
  
  CONCLUSIONS
  Significantly more brodalumab-treated patients with PsA achieved patient-reported improvements in psoriasis signs and symptoms than did those receiving placebo. Improvements were comparable between brodalumab groups.
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc. pmease@philipmease.com.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Mease
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc.
authors.forename: Alex
authors.initials: A
authors.lastname: Mutebi
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc.
authors.forename: Hema N
authors.initials: HN
authors.lastname: Viswanathan
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc.
authors.forename: Dina
authors.initials: D
authors.lastname: Chau
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc.
authors.forename: Jingyuan
authors.initials: J
authors.lastname: Feng
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc.
authors.forename: Ngozi
authors.initials: N
authors.lastname: Erondu
authors.affiliation: From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA.P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc.
authors.forename: Ajay
authors.initials: A
authors.lastname: Nirula
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015535:Arthritis, Psoriatic / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D063189:Symptom Assessment; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C571216:brodalumab
keywords: BIOLOGICAL PRODUCTS; PATIENT OUTCOME ASSESSMENT; PSORIASIS; PSORIATIC ARTHRITIS