title: Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up.
abstract: BACKGROUND
  Evaluation of the dosing flexibility and long-term efficacy of biological agents is limited.
  
  
  OBJECTIVE
  To evaluate the long-term efficacy and safety of ustekinumab with and without dosing adjustment in the 5-year PHOENIX 2 study.
  
  
  METHODS
  Patients were randomized to placebo or ustekinumab (45 or 90 mg) at weeks 0, 4, then every 12 weeks; patients receiving placebo crossed-over at week 12. Dosing adjustments were permitted at/beyond week 28 for early adjusters (weeks 28 or 40 per response); late adjusters (during long-term extension per investigator judgement); and nonadjusters (maintained randomized treatment throughout the study). Efficacy and safety were evaluated through weeks 244 and 264, respectively.
  
  
  RESULTS
  In the overall population, 70% (849 of 1212) of ustekinumab-treated patients completed treatment through week 244, with high proportions of patients responding to the 45-mg and 90-mg doses, respectively: 75% improvement in Psoriasis Area and Severity Index (PASI 75) (76·5% and 78·6%) and PASI 90 (50·0% and 55·5%). Approximately 20% of patients were early adjusters, 30% were late adjusters and 50% were nonadjusters. Approximately half of the late adjusters initiated adjustments after already achieving PASI 75. Improved response was generally observed following dosing adjustments. Through week 264, safety event rates did not increase and event rates were generally comparable between dose groups and between patients with and without dosing adjustment.
  
  
  CONCLUSIONS
  Treatment with ustekinumab for up to 5 years was safe and effective. Improved response was generally demonstrated following dosing adjustments; further investigations are required to quantify actual incremental benefits. The results also suggest that some patients may desire treatment goals beyond PASI 75.
authors.affiliation: Dalhousie University, 4195 Dickson Building, 5820 University Avenue, Halifax, NS, Canada.
authors.forename: R G
authors.initials: RG
authors.lastname: Langley
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A.
authors.forename: M
authors.initials: M
authors.lastname: Lebwohl
authors.affiliation: University of Utah Health Sciences Center, Salt Lake City, UT, U.S.A.
authors.forename: G G
authors.initials: GG
authors.lastname: Krueger
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA, U.S.A.
authors.forename: P O
authors.initials: PO
authors.lastname: Szapary
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA, U.S.A.
authors.forename: Y
authors.initials: Y
authors.lastname: Wasfi
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA, U.S.A.
authors.forename: D
authors.initials: D
authors.lastname: Chan
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA, U.S.A.
authors.forename: M C
authors.initials: MC
authors.lastname: Hsu
authors.affiliation: Janssen Research & Development, LLC, Spring House, PA, U.S.A.
authors.forename: Y
authors.initials: Y
authors.lastname: You
authors.affiliation: Centre de Recherche Dermatologique du Quebec Metropolitain, Universite Laval, Quebec City, QC, Canada.
authors.forename: Y
authors.initials: Y
authors.lastname: Poulin
authors.affiliation: University Hospitals Case Medical Center, Cleveland, OH, U.S.A.
authors.forename: N
authors.initials: N
authors.lastname: Korman
authors.affiliation: University of Munich, Munich, Germany.
authors.forename: J C
authors.initials: JC
authors.lastname: Prinz
authors.affiliation: Dermatologikum Hamburg, Hamburg, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Reich
mesh_terms: D001835:Body Weight; D018592:Cross-Over Studies; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D016896:Treatment Outcome; D000069549:Ustekinumab / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D003879:Dermatologic Agents; D000069549:Ustekinumab