期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 362, 期 15, 页码 1383-1395出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa0904492
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资金
- Centocor Ortho Biotech
- Schering-Plough
- ActoGeniX
- AstraZeneca
- BayerSchering Pharma
- Biogen Idec
- Boehringer Ingelheim
- BristolMyers Squibb
- Cellerix
- ChemoCentryx
- Cosmo Technologies
- Danone France
- Elan Pharmaceuticals
- Genentech
- Giuliani SPA
- Given Imaging
- GlaxoSmithKline
- Merck
- Millennium Pharmaceuticals
- Neovacs
- Ocera Therapeutics
- Otsuka America Pharmaceuticals
- PDL Biopharma
- Pfizer
- RiboVacs Biotech
- Shire Pharmaceutical
- Synta Pharmaceutical
- Teva Pharmaceuticals
- Therakos
- UCB Pharma
- Wyeth
- Elan
- Falk Pharma
- Ferring Pharmaceuticals
- Shire Pharmaceuticals
- Synta Pharma
- Bristol-Myers Squibb
- Chiltem
- Lesaffre
- Danisco
- Roquette
- Mapi Naxis
- Dysphar
- AGI Therapeutics
- Alba Therapeutics
- Albireo
- M-Pharma
- Amgen
- Ardea Biosciences
- Aspreva Pharmaceuticals
- Astellas Pharma
- Athersys
- Atlantic Healthcare Limited
- Axcan Pharma
- BioBalance
- Celgene
- Celek Pharmaceuticals
- Cerimon Pharmaceutical
- CombinatoRx
- CoMentis
- Cytokine Pharmasciences
- Eagle Pharmaceuticals
- Eisai Medical Genome Sciences
- Hutchison Medipharma
- Ironwood Pharmaceuticals
- KaloBios Pharmaceuticals
- Merck Research Laboratories
- MerckSerono
- Nisshin Kyorin Pharmaceutical
- Novo Nordisk
- Procter Gamble
- Prometheus Laboratories
- Purgenesis Technologies
- Salient Pharmaceuticals
- Salix Pharmaceuticals
- Santarus
- Sigmoid Pharma
- Sirtris Pharmaceuticals
- S.L.A. Pharma
- Tillotts Pharma
- Tioga Pharmaceuticals
- Vascular Biogenics
- Ventech
- Viamet Pharmaceuticals
- Celltech
- Novartis
- Robarts Research Institute
- Abbott Laboratories
- Osiris Pharmaceuticals
- Ferring
- Tramedico
- Ely Broad Foundation
- Erasmus Medical Center
- Italifarmako
Background: The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for Crohn's disease are unknown. Methods: In this randomized, double-blind trial, we evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy, and the two drugs combined in 508 adults with moderate-to-severe Crohn's disease who had not undergone previous immunosuppressive or biologic therapy. Patients were randomly assigned to receive an intravenous infusion of 5 mg of infliximab per kilogram of body weight at weeks 0, 2, and 6 and then every 8 weeks plus daily oral placebo capsules; 2.5 mg of oral azathioprine per kilogram daily plus a placebo infusion on the standard schedule; or combination therapy with the two drugs. Patients received study medication through week 30 and could continue in a blinded study extension through week 50. Results: Of the 169 patients receiving combination therapy, 96 (56.8%) were in corticosteroid-free clinical remission at week 26 (the primary end point), as compared with 75 of 169 patients (44.4%) receiving infliximab alone (P=0.02) and 51 of 170 patients (30.0%) receiving azathioprine alone (P<0.001 for the comparison with combination therapy and P=0.006 for the comparison with infliximab). Similar numerical trends were found at week 50. At week 26, mucosal healing had occurred in 47 of 107 patients (43.9%) receiving combination therapy, as compared with 28 of 93 patients (30.1%) receiving infliximab (P=0.06) and 18 of 109 patients (16.5%) receiving azathioprine (P<0.001 for the comparison with combination therapy and P=0.02 for the comparison with infliximab). Serious infections developed in 3.9% of patients in the combination-therapy group, 4.9% of those in the infliximab group, and 5.6% of those in the azathioprine group. Conclusions: Patients with moderate-to-severe Crohn's disease who were treated with infliximab plus azathioprine or infliximab monotherapy were more likely to have a corticosteroid-free clinical remission than those receiving azathioprine monotherapy.
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