Randomised clinical trial: deep remission in biologic and immunomodulator naive patients with Crohn's disease - a SONIC post hoc analysis

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.