期刊
GASTROENTEROLOGY
卷 143, 期 1, 页码 62-U575出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2012.04.010
关键词
Clinical Trial; Inflammatory Bowel Disease; IBD; T-Cell Signaling Inhibitor
资金
- Abbott
- ActoGeniX NV
- AGI Therapeutics Inc
- Alba Therapeutics Corp
- Albireo
- Alfa Wasserman
- Amgen
- AM-Pharma BV
- Anaphore
- Astellas
- Athersys Inc
- Atlantic Healthcare Ltd
- Aptalis
- BioBalance Corp
- Boehringer-Ingelheim
- Bristol-Myers Squibb
- Celgene
- Celek Pharmaceuticals
- Cellerix SL
- Cerimon Pharmaceuticals
- ChemoCentryx
- CoMentis
- Cosmo Technologies
- Coronado Biosciences
- Cytokine Pharmasciences
- Eagle Pharmaceuticals
- EnGene Inc
- Eli Lilly
- Enteromedics
- Exagen Diagnostics Inc
- Ferring Pharmaceuticals
- Flexio Therapeutics Inc
- Funxional Therapeutics Ltd
- Genzyme Corp
- Gilead Sciences
- Given Imaging
- GSK
- Human Genome Sciences
- Ironwood Pharmaceuticals
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera Corp
- Meda Pharmaceuticals
- Merck Research Laboratories
- Merck Serono
- Millenium Pharmaceuticals
- Nisshin Kyorin Pharmaceuticals
- Novo Nordisk
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics Inc
- PDL Biopharma
- Pfizer
- Procter and Gamble
- Prometheus Laboratories
- ProtAb Ltd
- Purgenesis Technologies Inc
- Relypsa Inc
- Roche
- Salient Pharmaceuticals
- Salix Pharmaceuticals
- Santarus
- Schering Plough
- Shire Pharmaceuticals
- Sigmoid Pharma Ltd
- Sirtris Pharmaceuticals
- SLA Pharma UK Ltd
- Targacept
- Teva Pharmaceuticals
- Therakos
- Tilliotts Pharma AG
- TxCell SA
- UCB Pharma
- Viamet Pharmaceuticals
- Vascular Biogenics Ltd
- Warner Chilcott UK Ltd
- Wyeth
- Genentech
- Janssen
- Milennium Pharmaceuticals
- Novartis
- ActoGenix
- Albireo Pharma
- AstraZeneca
- Bayer
- Biogen Idec
- Centocor
- Danone
- Elan Pharma
- Giuliani
- Merck
- Hutchinson Medi Pharma
- Takeda
- Neovacs
- Ocerra Therapeutics Inc
- Otsuka American Pharmaceuticals
- Ribovacs Biotech
- Sanofi-Aventis
- Schering-Plough
- Shire Pharma
- Synta Pharma
- Teva Pharma
- Ferring
- Shire
- Advanced Biotherapeutics
- Avaxia Biologics
- Ironwood Pharma
- Merrimack Pharma
- Otsuka America Pharmaceuticals
- Resolvyx Pharma
- Vertx Pharma
- Viamet Pharma
- Cerimon Pharma
- Millennium Pharma
- Otsuka America Pharma
- Axis Healthcare Communications
- IMEDEX
- Potomac Center for Medical Education
- Strategic Consultants International
- UCB
- Genentech-Roche
- Millennium-Takeda
- Robarts
- Johnson Johnson
- Genexion
- MSD
- Bristol-Myers Squibb (Princeton, NJ)
BACKGROUND & AIMS: The efficacy of abatacept, a selective costimulation modulator, in Crohn's disease (CD) and ulcerative colitis (UC) is unknown. METHODS: Four placebo-controlled trials evaluated the efficacy and safety of abatacept as induction (IP) and maintenance (MP) therapy in adults with active, moderate-to-severe CD (CD-IP; CD-MP) and UC (UC-IP1; UC-MP). In CD-IP and UC-IP1, 451 patients with CD and 490 patients with UC were randomized to abatacept 30, 10, or 3 mg/kg (according to body weight) or placebo, and dosed at weeks 0, 2, 4, and 8. In MP, 90 patients with CD and 131 patients with UC who responded to abatacept at week 12 in the induction trials were randomized to abatacept 10 mg/kg or placebo every 4 weeks through week 52. RESULTS: In CD-IP, 17.2%, 10.2%, and 15.5% of patients receiving abatacept 30, 10, and 3 mg/kg achieved a clinical response at weeks 8 and 12, vs 14.4% receiving placebo (P = .611, P = .311, and P = .812, respectively). In UC-IP1, 21.4%, 19.0%, and 20.3% of patients receiving abatacept 30, 10, and 3 mg/kg achieved a clinical response at week 12, vs 29.5% receiving placebo (P = .124, P = .043, and P = .158, respectively). In CD-MP, 23.8% vs 11.1% of abatacept vs placebo patients were in remission at week 52. In UC-MP, 12.5% vs 14.1% of patients receiving abatacept vs placebo were in remission at week 52. Safety generally was comparable between groups. CONCLUSIONS: The studies showed that abatacept is not efficacious for the treatment of moderate-to-severe CD or UC.
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