title: Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study.
abstract: BACKGROUND
  Safe and effective therapies are needed for pediatric patients with psoriasis.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate ustekinumab in patients age 12 to 17 years who had moderate-to-severe psoriasis.
  
  
  METHODS
  Patients (n = 110) were randomly assigned to ustekinumab standard dosing (SD; 0.75 mg/kg [≤60 kg], 45 mg [>60-≤100 kg], and 90 mg [>100 kg]) or half-standard dosing (HSD; 0.375 mg/kg [≤60 kg], 22.5 mg [>60-≤100 kg], and 45 mg [>100 kg]) at weeks 0 and 4 and every 12 weeks or placebo at weeks 0 and 4 with crossover to ustekinumab SD or HSD at week 12. Clinical assessments included the proportion of patients achieving a Physician's Global Assessment of cleared/minimal (PGA 0/1), at least 75% improvement in Psoriasis Area and Severity Index (PASI 75), and at least 90% in PASI (PASI 90). Adverse events (AEs) were monitored through week 60.
  
  
  RESULTS
  At week 12, 67.6% and 69.4% of patients receiving ustekinumab HSD and SD, respectively, achieved PGA 0/1 versus 5.4% for placebo (P < .001). Significantly greater proportions receiving ustekinumab achieved PASI 75 (HSD, 78.4%; SD, 80.6%; placebo, 10.8%) or PASI 90 (HSD, 54.1%; SD, 61.1%; placebo, 5.4%) at week 12 (P < .001). Through week 12, 56.8% of placebo patients, 51.4% of HSD patients, and 44.4% of SD patients reported at least one AE; through week 60, 81.8% reported AEs.
  
  
  CONCLUSIONS
  The study was small relative to adult trials.
  
  
  CONCLUSIONS
  In this patient population (12-17 years), the standard ustekinumab dose provided response comparable to that in adults with no unexpected AEs through 1 year.
authors.affiliation: Memorial University of Newfoundland, St. Johns, Newfoundland, Canada. Electronic address: landells@nexusresearch.com.
authors.forename: Ian
authors.initials: I
authors.lastname: Landells
authors.affiliation: Janssen Research & Development, LLC., Spring House, Pennsylvania.
authors.forename: Colleen
authors.initials: C
authors.lastname: Marano
authors.affiliation: Janssen Research & Development, LLC., Spring House, Pennsylvania.
authors.forename: Ming-Chun
authors.initials: MC
authors.lastname: Hsu
authors.affiliation: Janssen Research & Development, LLC., Spring House, Pennsylvania.
authors.forename: Shu
authors.initials: S
authors.lastname: Li
authors.affiliation: Janssen Research & Development, LLC., Spring House, Pennsylvania.
authors.forename: Yaowei
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: University of California, San Diego, California.
authors.forename: Lawrence F
authors.initials: LF
authors.lastname: Eichenfield
authors.affiliation: University of Hamburg and Catholic Children's Hospital, Hamburg, Germany.
authors.forename: Peter H
authors.initials: PH
authors.lastname: Hoeger
authors.affiliation: Baylor University Medical Center and Texas A&M Health Science Center School of Medicine, Dallas, Texas.
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Amy S
authors.initials: AS
authors.lastname: Paller
authors.affiliation: Bordeaux University Hospitals, University of Bordeaux, Bordeaux, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Taieb
authors.affiliation: Department of Dermatology and Allergy, Charité Universitätsmedizin Berlin, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Philipp
authors.affiliation: Janssen Research & Development, LLC., Spring House, Pennsylvania.
authors.forename: Philippe
authors.initials: P
authors.lastname: Szapary
authors.affiliation: Janssen Research & Development, LLC., Spring House, Pennsylvania; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Bruce
authors.initials: B
authors.lastname: Randazzo
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome; D000069549:Ustekinumab / Q000008:administration & dosage*
chemical_list: D000911:Antibodies, Monoclonal; D000069549:Ustekinumab
keywords: adolescent; biologic; children; pediatric; psoriasis; systemic therapy; ustekinumab