title: Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE).
abstract: BACKGROUND
  Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, demonstrated efficacy and safety in moderate-to-severe plaque psoriasis when administered via subcutaneous injection. Self-administration by pre-filled syringe (PFS) can offer patients clinical benefits of a drug, with increased convenience.
  
  
  OBJECTIVE
  To assess efficacy, safety and usability of secukinumab administration via PFS in subjects with moderate-to-severe plaque psoriasis.
  
  
  METHODS
  Subjects in this phase 3 trial were randomized 1 : 1 : 1 to secukinumab 300 or 150 mg or matching placebo. Results to week 12 are presented here. Each treatment was delivered using a PFS once weekly to week 4, and again at week 8. Co-primary endpoints were secukinumab superiority over placebo for week 12 PASI 75 (≥ 75% reduction in Psoriasis Area and Severity Index) and IGA mod 2011 (2011 modified Investigator's Global Assessment) 0/1 response rates. Secondary endpoints included PFS usability, determined by observer rating of successful, hazard-free self-injection and subject rating of acceptability by the Self-Injection Assessment Questionnaire (SIAQ).
  
  
  RESULTS
  Co-primary endpoints were met, with demonstration of superiority for each secukinumab dose vs. placebo at week 12 (PASI 75: 75·9%, 69·5% and 0% for secukinumab 300 mg, 150 mg and placebo; IGA mod 2011 0/1: 69·0%, 52·5% and 0%, respectively; P < 0·0001 for all comparisons vs. placebo). PFS usability was high: 100% of subjects successfully self-administered treatment at week 1, and subjects reported high SIAQ-assessed acceptability of the PFS throughout the trial. No new/unexpected safety signals were observed.
  
  
  CONCLUSIONS
  Secukinumab administration by PFS was effective, with an acceptable safety profile and high usability. The PFS provides a reliable, convenient form of secukinumab administration in subjects with moderate-to-severe plaque psoriasis.
authors.affiliation: Oregon Medical Research Center, 9495 SW Locust Street, Suite G, Portland, OR, 97223, U.S.A.
authors.forename: A
authors.initials: A
authors.lastname: Blauvelt
authors.forename: J C
authors.initials: JC
authors.lastname: Prinz
authors.forename: A B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: K
authors.initials: K
authors.lastname: Kingo
authors.forename: H
authors.initials: H
authors.lastname: Sofen
authors.forename: M
authors.initials: M
authors.lastname: Ruer-Mulard
authors.forename: V
authors.initials: V
authors.lastname: Singh
authors.forename: R
authors.initials: R
authors.lastname: Pathan
authors.forename: C
authors.initials: C
authors.lastname: Papavassilis
authors.forename: S
authors.initials: S
authors.lastname: Cooper
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; 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; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011565:Psoriasis / Q000188:drug therapy*; D012646:Self Administration; D013594:Syringes; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; C555450:secukinumab