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

• DOI: 10.1111/apt.13139
• Publication Date: 2015-03-01T23:54:51Z
• 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
• Keywords: Post-hoc analysis

Summary Background As treatment goals in Crohn's disease ( CD ) evolve, targets now include clinical remission CR ), mucosal healing MH and biological [C‐reactive protein normalisation CRP norm )]. Aims To evaluate the association of baseline factors with achievement different composite parameters at week 26. Methods This post hoc analysis SONIC trial evaluated measures 26 a subgroup patients activity index CDAI scores, , endoscopic data available N = 188). Assessed were: < 150) (absence any ulcerations), previously referred to as ‘deep remission;’ alternative endpoints: + 0.8 mg/dL); ; . Results Among analysed patients, 136/188 (72.3%) achieved 90/188 (47.9%) All outcomes were significantly greater (Bonferroni significance level, P ≤ 0.016) combination therapy (i.e. infliximab azathioprine; 52.3–63.6%) vs. azathioprine monotherapy (12.9–29.0%; p 0.005 for all comparisons). Composite rates including (52.3–56.9%) (25.6–32.3%; 0.015 comparisons except 0.017) (12.9–20.4%; 0.002 Median serum trough concentrations among who or when compared those did not achieve 0.018) 0.053). early disease, alone criteria improved received therapy. Conclusions Combination was more effective achieving various monotherapy. These illustrate that remission’ is achievable high percentage disease. ClinicalTrials.gov number: NCT 00094458.