Journal
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Volume 41, Issue 8, Pages 734-746Publisher
WILEY
DOI: 10.1111/apt.13139
Keywords
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Funding
- Abbott Laboratories
- Abbvie
- Aesca
- Janssen Biotech, Inc.
- Falk Pharma GmbH
- MSD
- AstraZeneca
- Merck Sharpe and Dohme
- Menarini
- Genesis
- Millenium/Takeda
- Santarus
- Prometheus
- Salix Pharmaceuticals
- Pfizer
- Bristol Myers Squibb
- Merck Research Laboratories
- UCB Pharma
- ActoGeniX NV
- AGI Therapeutics Inc
- Alba Therapeutics Corp
- Albireo
- Alfa Wasserman
- Amgen
- AM-Pharma BV
- Anaphore
- Astellas
- AthersysInc
- Atlantic Healthcare Ltd
- Aptalis
- BioBalance Corp
- BoehringerIngelheim
- Bristol-Myers Squibb
- Celgene
- Celek Pharmaceuticals
- Cellerix SL
- Cerimon Pharmaceuticals
- ChemoCentryx
- CoMentis
- Cosmo Technologies
- Coronado Biosciences
- Cytokine Pharmasciences
- Eagle Pharmaceuticals
- EnGeneInc
- Eli Lilly
- Enteromedics
- Exagen Diagnostics Inc
- Ferring Pharmaceuticals
- Flexio Therapeutics Inc
- Funxional Therapeutics Ltd
- Genzyme Corp
- Gilead Sciences
- Given Imaging
- GlaxoSmithKline
- Human Genome Sciences
- Ironwood Pharmaceuticals
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera Corp
- Meda Pharmaceuticals
- Merck Serono
- Millenium Pharmaceuticals
- Nisshin Kyorin Pharmaceuticals
- Novo Nordisk
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics Inc
- PDL Biopharma
- Procter and Gamble
- Prometheus Laboratories
- ProtAb Ltd
- Purgenesis Technologies Inc
- RelypsaInc
- Roche
- Salient Pharmaceuticals
- Schering Plough
- Shire Pharmaceuticals
- Sigmoid Pharma Ltd
- Sirtris Pharmaceuticals
- SLA Pharma UK Ltd
- Targacept
- Teva Pharmaceuticals
- Therakos
- TilliottsPharma AG
- TxCell SA
- Viamet Pharmaceuticals
- Vascular Biogenics Ltd
- Warner Chilcott UK Ltd
- Wyeth
- Genentech
- Janssen Pharmaceutical Research & Development, LLC
- Milennium Pharmaceuticals
- Novartis
- Johnson Johnson
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BackgroundAs treatment goals in Crohn's disease (CD) evolve, targets now include clinical remission (CR), mucosal healing (MH) and biological remission [C-reactive protein normalisation (CRPnorm)]. AimsTo evaluate the association of baseline factors and treatment with the achievement of different composite remission parameters at week 26. MethodsThis post hoc analysis of the SONIC trial evaluated different composite remission measures at week 26 in a subgroup of patients with Crohn's disease activity index (CDAI) scores, CRP, and endoscopic data available at baseline and week 26 (N=188). Assessed composite remission measures were: CR (CDAI<150) and MH (absence of any mucosal ulcerations), previously referred to as deep remission;' and alternative composite endpoints: CR+CRPnorm (CRP<0.8mg/dL); CRPnorm+MH; and CR+CRPnorm+MH. ResultsAmong analysed patients, 136/188 (72.3%) achieved CR and 90/188 (47.9%) achieved MH at week 26. All composite outcomes were significantly greater (Bonferroni significance level, P0.016) with combination therapy (i.e. infliximab and azathioprine; 52.3-63.6%) vs. azathioprine monotherapy (12.9-29.0%; p 0.005 for all comparisons). Composite remission rates including MH were significantly greater with combination therapy (52.3-56.9%) vs. infliximab (25.6-32.3%; P0.015 for all comparisons except CRPnorm+MH, P=0.017) and vs. azathioprine monotherapy (12.9-20.4%; P0.002 for all comparisons). Median serum trough infliximab concentrations among patients who achieved MH or CR+MH were greater when compared with those among patients who did not achieve MH (P=0.018) or CR+MH (P=0.053). Among the subgroup of patients with early Crohn's disease, MH alone or in combination with composite remission criteria significantly improved clinical outcomes of patients who received combination therapy. ConclusionsCombination therapy was more effective in achieving various composite remission measures vs. azathioprine or infliximab monotherapy. These data illustrate that deep remission' is achievable with combination therapy in a high percentage of patients with early Crohn's disease. ClinicalTrials.gov number: NCT00094458.
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