期刊
INFLAMMATORY BOWEL DISEASES
卷 22, 期 8, 页码 1881-1886出版社
OXFORD UNIV PRESS INC
DOI: 10.1097/MIB.0000000000000860
关键词
budesonide foam; corticosteroid; ulcerative proctitis; ulcerative proctosigmoiditis; 5-aminosalicylic acid
资金
- Salix Pharmaceuticals
- Abbott
- ActoGeniX NV
- AGI Therapeutics Inc.
- Alba Therapeutics Corporation
- Albireo
- Alfa Wassermann
- Amgen
- AM-Pharma BV
- Anaphore, Inc.
- Astellas
- Athersys, Inc.
- Atlantic Healthcare Ltd.
- Aptalis
- BioBalance Corp.
- Boehringer-Ingelheim
- Bristol-Myers Squibb
- Celgene
- Celek Pharmaceuticals
- Cellerix SL
- Cerimon Pharmaceuticals
- ChemoCentryx
- CoMentis, Inc.
- Cosmo Technologies
- Coronado Biosciences
- Cytokine Pharmasciences
- Eagle Pharmaceuticals, Inc.
- EnGene, Inc.
- Eli Lilly
- EnteroMedics, Inc.
- Exagen Diagnostics, Inc.
- Ferring Pharmaceuticals
- Flexion Therapeutics, Inc.
- Funxional Therapeutics Ltd.
- Genzyme Corp.
- Gilead Sciences
- Given Imaging
- GlaxoSmithKline
- Human Genome Sciences
- Ironwood Pharmaceuticals
- Janssen Pharmaceutical Research and Development, LLC
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera Corp.
- Meda Pharmaceuticals, Inc.
- Merck Research Laboratories
- Merck Serono
- Millennium Pharmaceuticals
- Nisshin Kyorin Pharmaceuticals
- Novo Nordisk
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics, Inc.
- PDL Biopharma, Inc.
- Pfizer
- Procter and Gamble
- Prometheus Laboratories
- ProtAb Ltd.
- Purgenesis Technologies, Inc.
- Relypsa, Inc.
- Roche
- Salient Pharmaceuticals
- Santarus, Inc.
- Schering Plough
- Shire Pharmaceuticals
- Sigmoid Pharma Ltd.
- Sirtris Pharmaceuticals, Inc.
- SLA Pharma UK Ltd
- Targacept, Inc.
- Teva Pharmaceuticals
- Therakos, Inc.
- Tilliotts Pharma AG
- TxCell SA
- UCB Pharma
- Viamet Pharmaceuticals, Inc.
- Vascular Biogenics Ltd.
- Warner Chilcott UK Ltd.
- Wyeth
- Abbott Laboratories
- Genentech
- Novartis
- AbbVie
- Amgen Genentech
- Janssen
- Shire
- Takeda Pharmaceutical Co., Ltd.
- UCB
Background:Rectal budesonide foam is a second-generation corticosteroid efficacious for active mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. This subgroup analysis examined the impact of baseline oral 5-aminosalicylic acid (5-ASA) on the efficacy and safety of budesonide foam in patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis.Methods:Patients received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo, with or without continued stable dosing of baseline oral 5-ASAs, for remission induction at week 6 (primary endpoint) in 2 identically designed, randomized, double-blind, phase 3 studies.Results:Of the 267 and 279 patients randomized to treatment with budesonide foam or placebo (pooled population), 55.1% and 55.2%, respectively, reported baseline 5-ASA use. A significantly greater percentage of patients achieved remission with budesonide foam versus placebo, either with (42.2% versus 31.8%, respectively; P = 0.03) or without (40.0% versus 14.4%; P < 0.0001) baseline 5-ASA use at week 6. A significantly greater percentage of patients achieved a Modified Mayo Disease Activity Index rectal bleeding subscale score of 0 at week 6, regardless of baseline 5-ASA use (5-ASA, 50.3% versus 35.7%; P = 0.003: no 5-ASA, 45.8% versus 19.2%; P < 0.0001). The frequency of adverse events was comparable between groups, regardless of baseline 5-ASA use.Conclusions:Budesonide foam was efficacious and safe for induction of remission of mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis in patients receiving oral 5-ASA at baseline and those who were not (Clinicaltrials.gov: NCT01008410 and NCT01008423).
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