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 - 10/08/11
, Kenneth B. Gordon, MD b, Richard G. Langley, MD c, Alan Menter, MD d, Renee J. Perdok, MS e, Joaquin Valdes, MD fABT-874 Study Investigators
Reprint requests: Alexa B. Kimball, MD, MPH, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital, Harvard Medical School, 50 Staniford St, No. 246, Boston, MA 02114.Abstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : ABT-874, interleukin-12, interleukin-23, plaque, psoriasis, Psoriasis Area and Severity Index, retreatment
Abbreviations used : AE, EOW, IL, PASI, PASI 50, PASI 75, PASI 90, PGA
Plan
| Financial support for the study and for editorial assistance was provided by Abbott. |
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| Disclosure: Dr Kimball has been a consultant and investigator for Amgen, Abbott, and Centocor; and investigator for Pfizer, Genzyme, Novartis, and Boehringer Ingelheim. Dr Gordon has been an investigator and consultant for Abbott and Amgen; investigator for Centocor and Nova Nordisk; and consultant for Galderma. Dr Langley has been an investigator for Abbott, Amgen, Astellas Pharma Inc, Boehringer Ingelheim, Celgene, Centocor, Genentech, Novartis, Ortho Biotech, Pfizer, and Schering-Plough; served on the scientific advisory board for Abbott, Amgen, Astellas Pharma Inc, Boehringer Ingelheim, Centocor, Genentech, and Ortho Biotech; and received lecture fees from Abbott, Amgen/Wyeth, Astellas Pharma Inc, Centocor, Genentech, and Novartis. Dr Menter has been an investigator for Abbott, Allergan, Amgen, Astellas, Asubio, Celgene, Centocor, DUSA, Eli Lilly, Genentech, Novartis, Novo Nordisk, Pfizer, Promius, Stiefel, Warner Chilcott, and Wyeth; served on the scientific advisory board for Abbott, Amgen, Astellas, Centocor, Galderma, Genentech, and Warner Chilcott; and received lecture fees from Abbott, Amgen, Astellas, Centocor, Galderma, Genentech, and Wyeth. Ms Perdok and Dr Valdes are employees of Abbott Laboratories. |
Vol 64 - N° 2
P. 263-274 - février 2011 Retour au numéro
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