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P212. Clinical outcomes in patients with moderate versus severe Crohn's disease at baseline: Analysis from CARE

R. Löfberg1, E. Louis2, W. Reinisch3, A. Robinson4, M. Kron5, A. Camez5, P. Pollack4

1Karolinska Institutet and Sophiahemmet, Stockholm, Sweden; 2University of Liège and CHU Liège, Department of Gastroenterology, Liège, Belgium; 3AKH Wien, Department of Internal Medicine IV, Vienna, Austria; 4Abbott Laboratories, Illinois, United States; 5Abbott GmbH & Co. KG, Ludwigshafen, Germany

Background: Data about the efficacy and safety of adalimumab (ADA) by baseline severity of Crohn's disease (CD) are limited. We assessed clinical outcomes and safety in patients with moderate or severe CD in the CARE trial.

Methods: Adult patients (N = 945) with a diagnosis of CD for >4 months and Harvey–Bradshaw Index (HBI) ≥7 enrolled in this multicenter, single-arm, 20-week open-label study of the safety and effectiveness of ADA. Patients received subcutaneous ADA, 160 mg/80 mg (weeks 0/2), then 40 mg every other week, until week 20 or local marketing approval of ADA. Dose adjustments were allowed for CD-related concomitant medications (from week 8) and ADA (from week 12). Clinical remission (HBI <5) and clinical response (HBI reduction ≥3) were analyzed through week 20 for patients with moderate (HBI 7–10, n = 569) or severe (HBI ≥11, n = 373) CD at baseline, using non-responder imputation for patients with missing data or escalation to weekly dosing. Three patients with HBI <7 were excluded from the analysis. Comparisons were made using Fisher's exact test or ANOVA (baseline demographics) or the chi-square test (response and remission). Treatment emergent adverse events were assessed through 70 days after the last ADA dose.

Results: Patients with severe CD were more likely to be female and had significantly greater baseline CRP and prior anti‑TNF exposure than those with moderate CD; other baseline characteristics (including disease duration) were generally similar between the subgroups. Clinical remission was significantly higher in the moderate CD vs. the severe CD subgroup at both week 4 (51% vs. 30%, P < 0.001) and week 20 (54% vs. 36%, P < 0.001). Clinical response was significantly higher for the severe subgroup at week 4 (82%, vs. moderate: 71%, P < 0.001), but was similar at week 20 (severe: 60%; moderate: 61%, P = 0.576). The overall incidence of adverse events was similar between the 2 subgroups, although infections (including serious and opportunistic infections) were more common in the severe cohort.

Conclusions: This post hoc analysis of patients in the CARE study by baseline severity of CD suggests that the probability of achieving remission with ADA was higher in patients with moderate than severe CD, in agreement with previous logistic regression showing baseline HBI as an independent predictor of remission [1]. Further analyses of the risk-benefit profile in patients with moderate CD are warranted.

1. Löfberg R, et al. IBD J. 2011; on-line.