title: Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial.
abstract: BACKGROUND
  Psoriasis affecting sites such as the hands, feet and nails can be particularly difficult to treat. There are limited data on the efficacy of biological agents to treat these specific localizations.
  
  
  OBJECTIVE
  This analysis of a phase 2 regimen-finding study evaluated the efficacy of secukinumab in subjects with moderate-to-severe psoriasis and non-pustular involvement of the hands, feet and/or nails.
  
  
  METHODS
  Subjects were randomized (1 : 2 : 2 : 1) to one of three subcutaneous secukinumab 150-mg induction regimens [Single (Week 0), Monthly (Weeks 0, 4, 8), Early (Weeks 0, 1, 2, 4)] or placebo. In the subgroup (n = 131) with hand and/or foot psoriasis [baseline 5-point hand/foot Investigator's Global Assessment (IGA) score ≥2], efficacy was assessed as percentage of subjects achieving an IGA response [a score of 0 (clear) or 1 (minimal) and an improvement of ≥2 points on the 5-point hand/foot scale vs. baseline] at Week 12. In the subgroup (n = 304) with fingernail psoriasis (baseline composite score ≥1), efficacy was assessed as mean percentage change from baseline to Week 12 in a composite score.
  
  
  RESULTS
  At Week 12, a markedly higher percentage of subjects with hand and/or foot psoriasis achieved an IGA response with the Early regimen vs. placebo (54.3% vs. 19.2%, P = 0.005). The composite fingernail score improved with the Early and Monthly regimens, but worsened with placebo [percentage mean change from baseline (SE): -19.1% (6.12) and -10.6% (7.06) vs. 14.4% (11.92); P = 0.010 vs. placebo for Early, P = 0.027 for Monthly). Secukinumab was well tolerated.
  
  
  CONCLUSIONS
  Secukinumab demonstrated a beneficial effect on psoriasis of the hands/feet/nails in this short-term assessment.
authors.affiliation: Paul Sabatier University, Toulouse, France.
authors.forename: C
authors.initials: C
authors.lastname: Paul
authors.forename: K
authors.initials: K
authors.lastname: Reich
authors.forename: A B
authors.initials: AB
authors.lastname: Gottlieb
authors.forename: U
authors.initials: U
authors.lastname: Mrowietz
authors.forename: S
authors.initials: S
authors.lastname: Philipp
authors.forename: J
authors.initials: J
authors.lastname: Nakayama
authors.forename: E
authors.initials: E
authors.lastname: Harfst
authors.forename: A
authors.initials: A
authors.lastname: Guettner
authors.forename: C
authors.initials: C
authors.lastname: Papavassilis
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005528:Foot / Q000473:pathology*; D006225:Hand / Q000473:pathology*; D006801:Humans; D009262:Nails / Q000473:pathology*; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; C555450:secukinumab