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* = Presenting author

P114 Predictors of clinical response during adalimumab therapy in Crohn’s disease patients: a German non-interventional study

I. Blumenstein*1, R. Atreya2, G. Greger3, B. Bokemeyer4, P. Nurwakagari3, M. F. Neurath2, B. Wittig3

1Goethe-University Frankfurt, Gastroenterology, Frankfurt am Main, Germany, 2University Erlangen, Erlangen, Germany, 3AbbVie Deutschland GmbH & Co.KG, Wiesbaden, Germany, 4Gastroenterology Practice, Minden, Germany

Background

The Harvey–Bradshaw Index (HBI) is frequently used in daily clinical practice to assess disease activity in patients with Crohn’s disease (CD). The goal of this study was to evaluate therapeutic response and predictors of response in CD patients treated with adalimumab (ADA) for 12 months during routine clinical care.

Methods

We analysed data from a large German multicentre observational study of patients with active CD who initiated ADA therapy during routine clinical care. Key outcome measures included mean HBI (scale of 0 to 16; lower scores indicate better health status) and the proportion of patients achieving HBI remission (≤ 4) over 12 months. Stepwise regression analyses were performed to assess the effect of clinically important demographic and disease variables, including smoking status, age, sex, duration of illness, disease severity, and CD-related surgeries, on therapeutic response as assessed by change in the HBI from baseline (BL) to month 12. T-tests were used to assess the change in HBI from BL month 12.

Results

Of 1 863 patients in the full analysis set, 611 patients had available data on HBI at BL and mo 12. The mean age of the patients at BL (before initiation of ADA) was 37.4 ± 12.7 years; the age at first diagnosis was 27.7 ± 11.5 years; and mean disease duration was 9.7 ± 8.3 years. The majority of patients (63.5%) were female. At BL, the mean HBI was 9.9 ± 5.1. After initiation of ADA treatment, this value fell to 4.3 ± 4.3 at month 3, 4.0 ± 4.2 at month 6, and 4.2 ± 4.3 at month 12 (p < 0.001 for change in HBI from BL to month 12). The remission rate (proportion of patients with HBI ≤ 4) was 58.3% at month 3, 62.5% at month 6, and 62.8% at month 12. Significant negative predictors for improvement of HBI from BL to month 12 were smoking, older age, and CD-related surgeries before initiation of ADA therapy. Subgroup analyses of HBI values for these predictors are shown in the Table. A high baseline HBI value was also a negative predictor.

Conclusion

HBI improvement was observed by month 3 after initiation of ADA treatment, and this effect was maintained throughout the 12-month observation period. Over 60% of ADA-treated patients achieved HBI defined remission by month 12. Smoking, CD-related surgeries before ADA treatment, and older age at BL reduced the response to therapy.