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Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn's disease – a SONIC post hoc analysis
Author(s) -
Colombel J.F.,
Reinisch W.,
Mantzaris G. J.,
Kornbluth A.,
Rutgeerts P.,
Tang K. L.,
Oortwijn A.,
Bevelander G. S.,
Cornillie F. J.,
Sandborn W. J.
Publication year - 2015
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13139
Subject(s) - medicine , gastroenterology , azathioprine , infliximab , post hoc analysis , crohn's disease , randomized controlled trial , disease
Summary Background As treatment goals in Crohn's disease ( CD ) evolve, targets now include clinical remission ( CR ), mucosal healing ( MH ) and biological remission [C‐reactive protein normalisation ( CRP norm )]. 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 + CRP norm ( CRP < 0.8 mg/dL); CRP norm + MH ; and CR + CRP norm + 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 CRP norm + 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: NCT 00094458.