Abstract | BACKGROUND: AIMS: To evaluate the association of baseline factors and treatment with the achievement of different composite remission parameters at week 26. METHODS: This 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 < 0.8 mg/dL); CRPnorm + MH; and CR + CRPnorm + MH. RESULTS: Among 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, P ≤ 0.016) 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%; P ≤ 0.015 for all comparisons except CRPnorm + MH, P = 0.017) and vs. azathioprine monotherapy (12.9-20.4%; P ≤ 0.002 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. CONCLUSIONS: Combination 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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Authors | J-F Colombel, W Reinisch, G J Mantzaris, A Kornbluth, P Rutgeerts, K L Tang, A Oortwijn, G S Bevelander, F J Cornillie, W J Sandborn |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 41
Issue 8
Pg. 734-46
(Apr 2015)
ISSN: 1365-2036 [Electronic] England |
PMID | 25728587
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 John Wiley & Sons Ltd. |
Chemical References |
- Antibodies, Monoclonal
- Gastrointestinal Agents
- Immunosuppressive Agents
- C-Reactive Protein
- Infliximab
- Azathioprine
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Topics |
- Adult
- Antibodies, Monoclonal
(administration & dosage, therapeutic use)
- Azathioprine
(administration & dosage, therapeutic use)
- C-Reactive Protein
(metabolism)
- Crohn Disease
(drug therapy)
- Drug Therapy, Combination
- Endoscopy, Gastrointestinal
- Female
- Gastrointestinal Agents
(administration & dosage, therapeutic use)
- Humans
- Immunosuppressive Agents
(administration & dosage, therapeutic use)
- Infliximab
- Intestinal Mucosa
(metabolism)
- Male
- Patient Acuity
- Quality of Life
- Remission Induction
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