PMID- 22011907
OWN - NLM
STAT- MEDLINE
DCOM- 20120224
LR  - 20220330
IS  - 1523-1747 (Electronic)
IS  - 0022-202X (Linking)
VI  - 132
IP  - 2
DP  - 2012 Feb
TI  - A phase III, randomized, controlled trial of the fully human IL-12/23 mAb 
      briakinumab in moderate-to-severe psoriasis.
PG  - 304-14
LID - 10.1038/jid.2011.304 [doi]
AB  - A previous phase II trial demonstrated that the fully human anti-IL-12/23 mAb 
      briakinumab was efficacious in moderate-to-severe psoriasis. A subsequent 
      52-week, double-blind, placebo-controlled phase III study evaluated induction and 
      maintenance treatment. Patients were randomized 2:1 to briakinumab (200 mg at 
      weeks 0 and 4 and 100 mg at week 8) or placebo; those with physician's global 
      assessment "clear" or "minimal" (PGA "clear/minimal") at week 12 were then 
      re-randomized 2:2:1 to briakinumab 100 mg every 4 weeks (q4-wk), every 12 weeks 
      (q12-wk), or to matching placebo to week 52. Primary analyses conducted by 
      nonresponder imputation compared proportions achieving PGA "clear/minimal" (weeks 
      12 and 52) and >/=75% improvement in psoriasis area and severity index (PASI 75; 
      week 12). In all, 76.0% of briakinumab vs. 4.3% of placebo-treated patients 
      achieved PGA "clear/minimal," and 80.7% vs. 4.5%, respectively, achieved PASI 75 
      at week 12 (P<0.001 each). At week 52, 79.2% of q4-wk-treated patients achieved 
      PGA "clear/minimal" compared with 41.6% and 6.0% of q12-wk and placebo-treated 
      patients, respectively (P<0.001 for all treatment comparisons). Higher numbers of 
      the following adverse events (AEs) of interest were observed with briakinumab 
      during the placebo-controlled period, suggesting the need for surveillance for 
      these events: serious infections (five vs. one event with briakinumab vs. 
      placebo, respectively), nonmelanoma skin cancers (NMSCs; four vs. zero squamous 
      cell carcinomas (SCCs)), and major adverse cardiovascular events (MACEs; five vs. 
      zero events).
FAU - Gordon, Kenneth B
AU  - Gordon KB
AD  - Division of Dermatology, NorthShore University HealthSystem and University of 
      Chicago, Pritzker School of Medicine, Chicago, Illinois 60077, USA. 
      kgordon@northshore.org
FAU - Langley, Richard G
AU  - Langley RG
FAU - Gottlieb, Alice B
AU  - Gottlieb AB
FAU - Papp, Kim A
AU  - Papp KA
FAU - Krueger, Gerald G
AU  - Krueger GG
FAU - Strober, Bruce E
AU  - Strober BE
FAU - Williams, David A
AU  - Williams DA
FAU - Gu, Yihua
AU  - Gu Y
FAU - Valdes, Joaquin M
AU  - Valdes JM
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111020
PL  - United States
TA  - J Invest Dermatol
JT  - The Journal of investigative dermatology
JID - 0426720
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Interleukin-23)
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  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Interleukin-12/*antagonists & inhibitors
MH  - Interleukin-23/*antagonists & inhibitors
MH  - Male
MH  - Middle Aged
MH  - Psoriasis/*drug therapy
EDAT- 2011/10/21 06:00
MHDA- 2012/03/01 06:00
CRDT- 2011/10/21 06:00
PHST- 2011/10/21 06:00 [entrez]
PHST- 2011/10/21 06:00 [pubmed]
PHST- 2012/03/01 06:00 [medline]
AID - S0022-202X(15)35601-3 [pii]
AID - 10.1038/jid.2011.304 [doi]
PST - ppublish
SO  - J Invest Dermatol. 2012 Feb;132(2):304-14. doi: 10.1038/jid.2011.304. Epub 2011 
      Oct 20.