DE-ESCALATING THERAPY IN PATIENTS WITH CROHN'S DISEASE RECEIVING ADALIMUMAB: SUBGROUP ANALYSIS OF THE CALM STUDY

Introduction This analysis evaluated the impact of de-escalating therapy on mucosal healing 48 weeks (wks) after randomization in patients (pts) with Crohn’s disease (CD) in the CALM study. Methods Pts with moderate-to-severe CD naive to immunomodulators and biologics were randomized 1:1 to a tight control group (TCG) or clinical management group (CMG) after 8 wks of prednisone therapy. Treatment was escalated from no treatment to 40 mg adalimumab (ADA) every other wk (EOW) to 40 mg ADA every wk (EW) to 40 mg ADA EW+2.5 mg/kg azathioprine (AZA)/day at 12, 24, and 36 wks after randomization based on failure criteria (CD Activity Index [CDAI]=200 or decrease Results 15 pts in the CMG and 31 pts in the TCG de-escalated treatment during the study. Of those, 2 pts in the CMG and 8 pts in the TCG re-escalated to 40 mg ADA EW. Overall, 54% of pts in the CMG and 61% of pts in the TCG who de-escalated to 40 mg ADA EOW ± AZA achieved the primary endpoint (table 1). Of the pts who re-escalated to ADA EW, 0% in the CMG, and 75% in the TCG achieved the primary endpoint (table 1). The overall adverse event rates have been previously reported (Colombel, 2018) Conclusions Our data suggest that repeated dose optimization based on tight control is a more refined approach resulting in mucosal healing compared with clinical management. Larger data sets are needed to confirm our observation on repeated dose optimization. Reference Colombel, et al. Lancet 2018;390:2779–89.