title: Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study.
abstract: BACKGROUND
  Ongoing evaluation of biological agents in patients with moderate-to-severe psoriasis is needed to support their long-term use.
  
  
  OBJECTIVE
  To evaluate long-term efficacy and safety of ustekinumab through 5 years in the PHOENIX 1 study.
  
  
  METHODS
  Patients were randomized to placebo or ustekinumab (45 mg or 90 mg) at Weeks 0, 4 and every-12-weeks thereafter; placebo patients crossed-over to ustekinumab at Week 12. Clinical response through Week 244 was evaluated using the Psoriasis Area and Severity Index (PASI) in the Overall Population (i.e. patients receiving ≥ 1 dose of ustekinumab), Initial Responders (i.e. PASI 75 responders [Weeks 28/40] re-randomized at Week 40 to continue every-12-week maintenance) and Partial Responders (i.e. <PASI 75 responders adjusted to every-8-week maintenance at Weeks 28 or 40). Safety endpoints were evaluated through Week 264 for the Overall Population.
  
  
  RESULTS
  Overall, 68.7% (517/753) of ustekinumab-treated patients completed treatment through Week 244. Initial clinical responses were generally maintained through Week 244 (PASI 75: 63.4% and 72.0%; PASI 90: 39.7% and 49.0%; PASI 100: 21.6% and 26.4%) for patients receiving 45 mg and 90 mg, respectively. Similarly, PASI 75 responses were generally maintained among Initial Responders [79.1% (45 mg) and 80.8% (90 mg)] and Partial Responders [57.6% (45 mg) and 55.1% (90 mg)]. With 3104 patient-years of follow-up, rates of overall adverse events (AEs), serious AEs, serious infections, malignancies and major adverse cardiovascular events were generally consistent over time and comparable between doses.
  
  
  CONCLUSIONS
  Through 5 years of continuous treatment, ustekinumab demonstrated stable clinical response and a safety profile consistent with previous reports.
authors.affiliation: Harvard Medical School and Massachusetts General Hospital, Boston, MA, USAProbity Medical Research, Waterloo, ON, CanadaJanssen Research & Development, LLC, Spring House, PA, USAInnovaderm Research, Inc., Montreal, QC, CanadaDermatology Research Associates, Los Angeles, CA, USANorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: A B
authors.initials: AB
authors.lastname: Kimball
authors.forename: K A
authors.initials: KA
authors.lastname: Papp
authors.forename: Y
authors.initials: Y
authors.lastname: Wasfi
authors.forename: D
authors.initials: D
authors.lastname: Chan
authors.forename: R
authors.initials: R
authors.lastname: Bissonnette
authors.forename: H
authors.initials: H
authors.lastname: Sofen
authors.forename: N
authors.initials: N
authors.lastname: Yeilding
authors.forename: S
authors.initials: S
authors.lastname: Li
authors.forename: P
authors.initials: P
authors.lastname: Szapary
authors.forename: K B
authors.initials: KB
authors.lastname: Gordon
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome; D000069549:Ustekinumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; D000069549:Ustekinumab