title: Investigator-initiated, open-label trial of ustekinumab for the treatment of moderate-to-severe palmoplantar psoriasis.
abstract: BACKGROUND
  Palmoplantar psoriasis is a variant of psoriasis resistant to many forms of treatment.
  
  
  METHODS
  Twenty subjects with moderate-to-severe psoriasis of the palms and soles, 50% with pustules at baseline, were treated with ustekinumab at weeks 0, 4, and 16. All subjects had previously failed topical corticosteroids. Dosing was 45 mg subcutaneously for subjects weighing <100 kg and 90 mg for subjects weighing ≥100 kg. The primary endpoint was the percent of subjects achieving clinical clearance at week 16, defined as Palm-Sole Physician's Global Assessment ≤1. The study received Tufts Medical Center IRB approval.
  
  
  RESULTS
  After 16 weeks of treatment, 35% (7/20) of subjects achieved clinical clearance. Sixty percent (12/20) improved two or more points on the Palm-Sole Physician's Global Assessment scale. Sixty-seven percent (6/9) of those receiving the 90 mg ustekinumab dose achieved clinical clearance compared with nine percent (1/11) receiving 45 mg (p = 0.02). At 24 weeks, mean values showed 56% improvement in Dermatology Life Quality Index, and 34% improvement in pain Visual Analogue Scale score (all p < 0.05).
  
  
  CONCLUSIONS
  Assessment tools for palmoplantar psoriasis are not yet validated. Five subjects withdrew or were lost to follow-up.
  
  
  CONCLUSIONS
  This study demonstrates that ustekinumab dosed at 90 mg is effective in controlling signs and symptoms of palmoplantar psoriasis.
authors.affiliation: Department of Dermatology, Tufts Medical Center, Boston, MA 02111, USA. SAu@tuftsmedicalcenter.org
authors.forename: Shiu-Chung
authors.initials: SC
authors.lastname: Au
authors.forename: Ari M
authors.initials: AM
authors.lastname: Goldminz
authors.forename: Noori
authors.initials: N
authors.lastname: Kim
authors.forename: Nicole
authors.initials: N
authors.lastname: Dumont
authors.forename: Melissa
authors.initials: M
authors.lastname: Michelon
authors.forename: Eva
authors.initials: E
authors.lastname: Volf
authors.forename: Meghan
authors.initials: M
authors.lastname: Hession
authors.forename: Paul F
authors.initials: PF
authors.lastname: Lizzul
authors.forename: Israel D
authors.initials: ID
authors.lastname: Andrews
authors.forename: Todd
authors.initials: T
authors.lastname: Kerensky
authors.forename: Andrew
authors.initials: A
authors.lastname: Wang
authors.forename: Shimrat
authors.initials: S
authors.lastname: Yaniv
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D018664:Interleukin-12 / Q000037:antagonists & inhibitors; D053759:Interleukin-23 / Q000037:antagonists & inhibitors; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000276:immunology; D011788:Quality of Life; D016896:Treatment Outcome; D000069549:Ustekinumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003879:Dermatologic Agents; D053759:Interleukin-23; D018664:Interleukin-12; D000069549:Ustekinumab