PMID- 22356258
OWN - NLM
STAT- MEDLINE
DCOM- 20120920
LR  - 20220316
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 166
IP  - 4
DP  - 2012 Apr
TI  - Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: 
      results from the PHOENIX 1 trial through up to 3 years.
PG  - 861-72
LID - 10.1111/j.1365-2133.2012.10901.x [doi]
AB  - BACKGROUND: An unmet need remains for safe and effective long-term treatments of 
      psoriasis. OBJECTIVES: To evaluate ustekinumab efficacy and safety for up to 3 
      years in the PHOENIX 1 trial. METHODS: Patients (n = 766) with moderate-to-severe 
      psoriasis were randomized to ustekinumab 45 mg or 90 mg at weeks 0 and 4, and 
      then every 12 weeks, or placebo at weeks 0 and 4, with crossover to ustekinumab 
      at week 12. Ustekinumab responders [>/= 75% improvement from baseline in the 
      Psoriasis Area and Severity Index (PASI 75) at weeks 28 and 40] were 
      re-randomized at week 40 to continue or withdraw from treatment until psoriasis 
      recurrence. Partial responders (week 28: PASI 50-74; week 40: < PASI 75) switched 
      to dosing every 8 weeks. Clinical efficacy was assessed by PASI, the Physician's 
      Global Assessment (PGA), and the Dermatology Life Quality Index (DLQI) measures. 
      RESULTS: Overall, 79.8% of the ustekinumab-treated patients remained in the study 
      for 3 years. PASI 75 response rates (45 mg: 61.2%; 90 mg: 72.4%) at week 76 were 
      maintained through year 3 (45 mg: 62.7%; 90 mg: 72.2%); PGA response was 
      similarly durable. At year 3, 80.9% (45 mg) and 82.7% (90 mg) of week 40 
      responders continuing treatment every 12 weeks achieved a PASI 75 response, while 
      42.6% (45 mg) and 58.0% (90 mg) achieved a PASI 90 response. Among partial 
      responders adjusted to dosing every 8 weeks, 50.9% (45 mg) and 52.0% (90 mg) had 
      a PASI 75 response at year 3. DLQI responses paralleled the PASI responses. 
      Through year 3, no dose response was observed in rates of adverse events (AEs), 
      overall infections, serious AEs, or AEs leading to discontinuation; nor was there 
      evidence of cumulative organ toxicity. CONCLUSIONS; Continuous, stable, 
      maintenance dosing with ustekinumab was generally well tolerated and sustained 
      durable efficacy for up to 3 years of treatment.
CI  - (c) 2012 The Authors. BJD (c) 2012 British Association of Dermatologists.
FAU - Kimball, A B
AU  - Kimball AB
AD  - Department of Dermatology, Harvard Medical School, Boston, MA 02114, USA. 
      harvardskinstudies@partners.org
FAU - Gordon, K B
AU  - Gordon KB
FAU - Fakharzadeh, S
AU  - Fakharzadeh S
FAU - Yeilding, N
AU  - Yeilding N
FAU - Szapary, P O
AU  - Szapary PO
FAU - Schenkel, B
AU  - Schenkel B
FAU - Guzzo, C
AU  - Guzzo C
FAU - Li, S
AU  - Li S
FAU - Papp, K A
AU  - Papp KA
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Dermatologic Agents)
RN  - FU77B4U5Z0 (Ustekinumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized
MH  - Cross-Over Studies
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Patient Dropouts/statistics & numerical data
MH  - Psoriasis/*drug therapy
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Ustekinumab
EDAT- 2012/02/24 06:00
MHDA- 2012/09/21 06:00
CRDT- 2012/02/24 06:00
PHST- 2012/02/24 06:00 [entrez]
PHST- 2012/02/24 06:00 [pubmed]
PHST- 2012/09/21 06:00 [medline]
AID - 10.1111/j.1365-2133.2012.10901.x [doi]
PST - ppublish
SO  - Br J Dermatol. 2012 Apr;166(4):861-72. doi: 10.1111/j.1365-2133.2012.10901.x.