PMID- 21930328
OWN - NLM
STAT- MEDLINE
DCOM- 20120605
LR  - 20151119
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 66
IP  - 5
DP  - 2012 May
TI  - Long-term safety experience of ustekinumab in patients with moderate-to-severe 
      psoriasis (Part I of II): results from analyses of general safety parameters from 
      pooled Phase 2 and 3 clinical trials.
PG  - 731-41
LID - 10.1016/j.jaad.2011.06.011 [doi]
AB  - BACKGROUND: Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of 
      moderate-to-severe psoriasis. OBJECTIVE: To evaluate overall pooled study data to 
      assess the safety profile of ustekinumab through 3 years of treatment. METHODS: 
      Cumulative safety data were pooled from studies in 3117 ustekinumab-treated 
      patients. RESULTS: During the placebo-controlled periods (Phase 2, PHOENIX 1, 
      PHOENIX 2), rates of adverse events (AEs) were comparable among patients treated 
      with placebo (50.4%), with ustekinumab 45 mg (57.6%), or with ustekinumab 90 mg 
      (51.6%); similar findings were observed during the controlled period of the 
      ACCEPT trial (etanercept: 70.0%; ustekinumab 45 mg: 66.0%; and ustekinumab 90 mg: 
      69.2%). Rates of serious AEs (SAEs) through the controlled periods were low and 
      comparable among all groups (1.2% to 1.9%). Through 3 years, rates of AEs per 100 
      patient-years of follow-up (/100 patient-yrs) (45 mg: 305.2/100 patient-yrs; 90 
      mg: 305.9/100 patient-yrs) and SAEs (45 mg: 6.8/100 patient-yrs; 90 mg: 8.2/100 
      patient-yrs) were comparable between ustekinumab doses. No cases of demyelination 
      or tuberculosis were reported in these trials. No dose response in rates of AEs, 
      overall infections, or SAEs was apparent through 3 years. Rates of AEs, 
      infections, SAEs, and AEs leading to study agent discontinuation remained 
      generally stable or decreased over time. LIMITATIONS: Controlled periods did not 
      extend beyond 12 to 20 weeks. Only 1247 of the 3117 ustekinumab-treated patients 
      were treated for 2 or more years. CONCLUSIONS: The safety profile of continued 
      ustekinumab exposure through up to 3 years is favorable and consistent with 
      previous short-term reports.
CI  - Copyright (c) 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. 
      All rights reserved.
FAU - Lebwohl, Mark
AU  - Lebwohl M
AD  - Mount Sinai School of Medicine, New York City, New York 10029, USA. 
      Lebwohl@aol.com
FAU - Leonardi, Craig
AU  - Leonardi C
FAU - Griffiths, Christopher E M
AU  - Griffiths CE
FAU - Prinz, Jorg C
AU  - Prinz JC
FAU - Szapary, Philippe O
AU  - Szapary PO
FAU - Yeilding, Newman
AU  - Yeilding N
FAU - Guzzo, Cynthia
AU  - Guzzo C
FAU - Li, Shu
AU  - Li S
FAU - Hsu, Ming-Chun
AU  - Hsu MC
FAU - Strober, Bruce
AU  - Strober B
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110917
PL  - United States
TA  - J Am Acad Dermatol
JT  - Journal of the American Academy of Dermatology
JID - 7907132
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - FU77B4U5Z0 (Ustekinumab)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/*adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Etanercept
MH  - Evaluation Studies as Topic
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Immunoglobulin G/adverse effects/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/diagnosis/*drug therapy
MH  - Receptors, Tumor Necrosis Factor/therapeutic use
MH  - Risk Assessment
MH  - Safety Management
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
MH  - Ustekinumab
EDAT- 2011/09/21 06:00
MHDA- 2012/06/06 06:00
CRDT- 2011/09/21 06:00
PHST- 2011/01/05 00:00 [received]
PHST- 2011/05/26 00:00 [revised]
PHST- 2011/06/07 00:00 [accepted]
PHST- 2011/09/21 06:00 [entrez]
PHST- 2011/09/21 06:00 [pubmed]
PHST- 2012/06/06 06:00 [medline]
AID - S0190-9622(11)00683-9 [pii]
AID - 10.1016/j.jaad.2011.06.011 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2012 May;66(5):731-41. doi: 10.1016/j.jaad.2011.06.011. Epub 
      2011 Sep 17.