title: Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE).
abstract: BACKGROUND
  Secukinumab is a fully human anti-interleukin-17A monoclonal antibody.
  
  
  OBJECTIVE
  Determine the efficacy, safety and usability of secukinumab administered via autoinjector/pen.
  
  
  METHODS
  This phase III trial randomized subjects with moderate to severe plaque psoriasis to secukinumab 300 mg, 150 mg or placebo self-injection once weekly to Week 4, then every 4 weeks. Co-primary end points at Week 12 were ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) and clear/almost clear skin by investigator's global assessment 2011 modified version (IGA mod 2011 0/1). Secondary end points included autoinjector usability, assessed by successful, hazard-free self-injection and subject-reported acceptability on Self-Injection Assessment Questionnaire.
  
  
  RESULTS
  Week 12 PASI 75 and IGA mod 2011 0/1 responses were superior with secukinumab 300 mg (86.7% and 73.3%, respectively) and 150 mg (71.7% and 53.3%, respectively) vs. placebo (3.3% and 0%, respectively) (P < 0.0001 for all). All subjects successfully self-administered treatment at Week 1, without critical use-related hazards. Subject acceptability of autoinjector was high throughout 12 weeks. Adverse events were higher with secukinumab (300 mg, 70.0%; 150 mg, 63.9%) vs. placebo (54.1%), with differences largely driven by mild/moderate nasopharyngitis.
  
  
  CONCLUSIONS
  Secukinumab delivered by autoinjector/pen is efficacious, well-tolerated and associated with high usability in moderate to severe plaque psoriasis.
authors.affiliation: Department of Dermatology, Paul Sabatier University, Toulouse, France.
authors.forename: C
authors.initials: C
authors.lastname: Paul
authors.affiliation: Department of Dermatology, University Hospital of Nice, Nice, France.
authors.forename: J-P
authors.initials: JP
authors.lastname: Lacour
authors.affiliation: Medicum Ltd, Tallinn, Estonia.
authors.forename: L
authors.initials: L
authors.lastname: Tedremets
authors.affiliation: Städtische Kliniken Bielefeld, Bielefeld, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Kreutzer
authors.affiliation: Alliance Dermatology and MOHS Center, Phoenix, Arizona, USA.
authors.forename: S
authors.initials: S
authors.lastname: Jazayeri
authors.affiliation: University of Calgary, Calgary, Alberta, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Adams
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: C
authors.initials: C
authors.lastname: Guindon
authors.affiliation: Beijing Novartis Pharma Co. Ltd, Shanghai, China.
authors.forename: R
authors.initials: R
authors.lastname: You
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: C
authors.initials: C
authors.lastname: Papavassilis
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004867:Equipment Design; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007279:Injections, Subcutaneous; D020381:Interleukin-17 / Q000037:antagonists & inhibitors; D008297:Male; D008875:Middle Aged; D009304:Nasopharyngitis / Q000139:chemically induced; D017060:Patient Satisfaction; D011537:Pruritus / Q000139:chemically induced; D011565:Psoriasis / Q000188:drug therapy*; D012646:Self Administration / Q000295:instrumentation; D020377:Self Efficacy; D012720:Severity of Illness Index; D013594:Syringes; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D020381:Interleukin-17; C555450:secukinumab