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P163. Quality of life for patients with deep remission vs. clinical remission and deep remission vs. absence of mucosal ulceration: 3-year data from CHARM/ADHERE

J.-F. Colombel1, R. Panaccione2, E. Louis3, M. Yang4, M. Skup4, P.F. Pollack4, R.B. Thakkar4, A. Camez4, P.M. Mulani4, J. Chao4, W.J. Sandborn5, 1Centre Hospitalier Universitaire de Lille, Hôpital Claude Huriez, Lille, France, 2University of Calgary, Calgary, Alberta, Canada, 3University of Liège and CHU Liège, Liège, Belgium, 4Abbott Laboratories, Abbott Park, IL, United States, 5University of California, San Diego, La Jolla, CA, United States

Background

Deep remission (DR), defined as clinical remission (CR) + absence of mucosal ulceration (AMU), is an emerging treatment goal in Crohn's disease (CD). We compared quality of life (QOL) outcomes for up to 3 years in patients with DR vs. CR only and DR vs. AMU only.

Methods

The 56-week CHARM trial and its 2-year open-label extension ADHERE were analyzed. Endoscopies were not performed in CHARM/ADHERE; thus, AMU was predicted via an index derived from a combination of biomarkers and patient self-reported symptoms.[1] DR was defined as Crohn's Disease Activity Index (CDAI) value <150 + predicted AMU. The QOL outcomes included the achievement of normal status on the Short Form 36 [SF-36] physical component summary (SF-36 PCS >50)/mental component summary (SF-36 MCS >50) and Inflammatory Bowel Disease Questionnaire remission (IBDQ >170). Multivariate logistic regression, adjusting for adalimumab (yes/no) and baseline QOL status, was conducted using the observed values at each visit from Week 26 to Week 164 to assess QOL differences between DR vs. CR and DR vs. AMU. Average QOL changes from baseline were calculated.

Results

A total of 778 patients were included in this assessment regardless of the treatment patients were randomized to. Odds of achieving normal status on SF-36 physical component summary and IBDQ remission were significantly greater for patients who achieved DR vs. CR or AMU only (Table 1). DR was associated with greater likelihood of SF-36 normal mental health status vs. AMU. IBDQ score improvements from baseline were significantly greater for DR vs. AMU at various time points. Improvements were also seen for DR vs. CR only (Table 2). Results for SF-36 improvements between DR vs. CR or AMU only were similar (data not shown).

Table 1. Adjusted odds ratios for QOL remission over the 3-year study period
 OR (95% CI)
 DR vs. CR OnlyDR vs. AMU Only
SF-36 PCS >502.0a (1.5, 2.8)5.5a (3.4, 7.8)
SF-36 MCS >501.0 (0.7, 1.4)4.1a (2.9, 5.8)
IBDQ >1702.5a (1.7, 3.6)11.1a (7.5, 16.4)
aP < 0.001.
Table 2. Unadjusted differences in IBDQ change from baseline
 IBDQ increase from baseline
 Wk 26Wk 56Wk 92Wk 116Wk 140Wk 164
DR vs. AMU27.4a22.8a23.9a30.1a32.7a20.4a
DR vs. CR5.11.17.312.3a10.2a11.5a
aP < 0.05.

Conclusion

Patients with CD who achieved predicted DR maintained better physical and disease-specific QOL outcomes for up to 3 years compared with patients who achieved only CR or AMU.

1. Sandborn WJ, et al. (2012), J Crohns Colitis 6(1Suppl): S3.