PMID- 21145618
OWN - NLM
STAT- MEDLINE
DCOM- 20110223
LR  - 20191210
IS  - 1097-6787 (Electronic)
IS  - 0190-9622 (Linking)
VI  - 64
IP  - 2
DP  - 2011 Feb
TI  - Efficacy and safety of ABT-874, a monoclonal anti-interleukin 12/23 antibody, for 
      the treatment of chronic plaque psoriasis: 36-week observation/retreatment and 
      60-week open-label extension phases of a randomized phase II trial.
PG  - 263-74
LID - 10.1016/j.jaad.2010.01.030 [doi]
AB  - BACKGROUND: ABT-874, an anti-interleukin-12 and -23 antibody, was previously 
      shown to be significantly more effective compared with placebo during a 12-week 
      phase II study of psoriasis. We report here safety and efficacy data of ABT-874 
      during subsequent phases of this study. OBJECTIVE: We sought to examine the 
      preliminary efficacy and safety of ABT-874 for moderate to severe psoriasis 
      beyond 12 weeks. METHODS: Patients with chronic plaque psoriasis who responded to 
      ABT-874 during the initial randomized, placebo-controlled, 12-week study phase 
      were eligible for a 36-week observation/retreatment phase. During the subsequent 
      60-week, open-label extension phase, eligible patients were retreated with one of 
      two ABT-874 dosages. Efficacy was measured using Psoriasis Area and Severity 
      Index and physician global assessment scores; safety was monitored by adverse 
      events (AEs), laboratory parameters, and vital signs. RESULTS: During the 
      observation/retreatment phase, 130 of 180 patients were eligible for retreatment. 
      After 12-week retreatment with ABT-874, 55% to 94% of retreated patients (n = 58) 
      achieved a 75% or greater reduction in Psoriasis Area and Severity Index score. 
      Among patients receiving ABT-874 through the first 48 weeks, there were no deaths 
      and 4 patients with serious AEs; one patient discontinued because of an AE. 
      During the open-label extension (N = 105), there were no deaths or serious 
      infections, and 3 serious AEs. LIMITATIONS: Lack of placebo or active comparator 
      groups limited statistical analysis in later study phases. Dosing differences 
      existed between groups, and only week-12 responders were eligible for 
      retreatment. CONCLUSION: ABT-874 continued to show good efficacy and safety 
      during withdrawal and reinitiation of therapy.
CI  - Copyright A(c) 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. 
      All rights reserved.
FAU - Kimball, Alexa B
AU  - Kimball AB
AD  - Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. 
      harvardskinstudies@partners.org
FAU - Gordon, Kenneth B
AU  - Gordon KB
FAU - Langley, Richard G
AU  - Langley RG
FAU - Menter, Alan
AU  - Menter A
FAU - Perdok, Renee J
AU  - Perdok RJ
FAU - Valdes, Joaquin
AU  - Valdes J
CN  - ABT-874 Study Investigators
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101209
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  - 187348-17-0 (Interleukin-12)
RN  - 978I8M0P8X (briakinumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Interleukin-12/immunology
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy
EDAT- 2010/12/15 06:00
MHDA- 2011/02/24 06:00
CRDT- 2010/12/15 06:00
PHST- 2009/09/21 00:00 [received]
PHST- 2010/01/14 00:00 [revised]
PHST- 2010/01/18 00:00 [accepted]
PHST- 2010/12/15 06:00 [entrez]
PHST- 2010/12/15 06:00 [pubmed]
PHST- 2011/02/24 06:00 [medline]
AID - S0190-9622(10)00110-6 [pii]
AID - 10.1016/j.jaad.2010.01.030 [doi]
PST - ppublish
SO  - J Am Acad Dermatol. 2011 Feb;64(2):263-74. doi: 10.1016/j.jaad.2010.01.030. Epub 
      2010 Dec 9.