title: Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials.
abstract: BACKGROUND
  Secukinumab is a human interleukin-17A antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The objective of this analysis was to measure the treatment response on psoriasis-related itching, pain, and scaling via the Psoriasis Symptom Diary (PSD)(©).
  
  
  METHODS
  ERASURE (n = 738) and FIXTURE (n = 1306) were double-blind, multicenter phase 3 studies in adults randomized to secukinumab (300, 150 mg, n = 1144) or placebo (n = 574) (administered at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks) or a biologic active control (FIXTURE only). Patient-reported itching, pain, and scaling were assessed during the first 12 weeks of treatment using the PSD. The results reported here are limited to subjects in the secukinumab and placebo treatment groups who completed the PSD. The proportions of subjects achieving prespecified responses (improvement:reduction of at least 2.2 points for itching, 2.2 points for pain, or 2.3 points for scaling) were compared for secukinumab versus placebo.
  
  
  RESULTS
  Overall, 39% of subjects completed the PSD at baseline and Week 12 (n = 453 secukinumab; 225 placebo). Subjects treated with secukinumab achieved significantly greater improvements in itching, pain, and scaling at Week 12 versus placebo (all P < 0.0001) and had significantly greater proportions of itching, pain, and scaling responders at Week 12 versus placebo (all P < 0.05).
  
  
  CONCLUSIONS
  Secukinumab significantly improves patient-reported itching, pain, and scaling in adults with moderate to severe psoriasis compared with placebo.
authors: University of Connecticut, Farmington, CT, USA.|Probity Medical Research, Waterloo, ON, Canada.
authors: Bruce
authors: B
authors: Strober
authors: Department of Dermatology, Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
authors: Bárður
authors: B
authors: Sigurgeirsson
authors: Licca Clinical Research Institute, Augsburg, Germany.
authors: Georg
authors: G
authors: Popp
authors: University of Melbourne, Melbourne, VIC, Australia.
authors: Rodney
authors: R
authors: Sinclair
authors: Total Skin and Beauty Dermatology Center, Birmingham, AL, USA.
authors: James
authors: J
authors: Krell
authors: A. Navickas Outpatient Clinic, Klaipeda, Lithuania.
authors: Sigitas
authors: S
authors: Stonkus
authors: Ventspils Poliklīnika, Ventspils, Latvia.
authors: Marcis
authors: M
authors: Septe
authors: University of Alabama at Birmingham, Birmingham, AL, USA.
authors: Boni E
authors: BE
authors: Elewski
authors: Tufts Medical Center, Boston, MA, USA.
authors: Alice B
authors: AB
authors: Gottlieb
authors: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors: Yang
authors: Y
authors: Zhao
authors: Consultant, Fort Lee, NJ, USA.
authors: Mary H
authors: MH
authors: Tran
authors: Novartis Pharma AG, Basel, Switzerland.
authors: Alexander
authors: A
authors: Karpov
authors: RTI Health Solutions, Research Triangle Park, NC, USA.
authors: Lori D
authors: LD
authors: McLeod
authors: RTI Health Solutions, Ann Arbor, MI, USA.
authors: Margaret
authors: M
authors: Mordin
authors: Novartis Pharma AG, Basel, Switzerland.
authors: Charis
authors: C
authors: Papavassilis
authors: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors: Judit
authors: J
authors: Nyirady
authors: Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors: Mark
authors: M
authors: Lebwohl
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D000071066:Patient Reported Outcome Measures; D011537:Pruritus / Q000209:etiology; D011565:Psoriasis / Q000150:complications* / Q000188:drug therapy*; D012720:Severity of Illness Index; D063189:Symptom Assessment
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; C555450:secukinumab