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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.

AbstractBACKGROUND:
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.
AuthorsAlexa B Kimball, Kenneth B Gordon, Richard G Langley, Alan Menter, Renee J Perdok, Joaquin Valdes, ABT-874 Study Investigators
JournalJournal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 64 Issue 2 Pg. 263-74 (Feb 2011) ISSN: 1097-6787 [Electronic] United States
PMID21145618 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Chemical References
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Interleukin-12
  • briakinumab
Topics
  • Adult
  • Antibodies, Monoclonal (adverse effects, therapeutic use)
  • Antibodies, Monoclonal, Humanized
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Interleukin-12 (immunology)
  • Male
  • Middle Aged
  • Psoriasis (drug therapy)

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