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* = Presenting author

P537. Early predictors of long term clinical response to adalimumab in Crohn's disease

M. Martinato1, T. Slongo1, M. Piovanello2, M. Rigato2, A. Ugoni2, I. Frankovic1, R. Caccaro1, G.C. Sturniolo1, R. D'Incà1, 1Università degli Studi di Padova, Padova, Italy, 2Azienda Ospedaliera di Padova, Padova, Italy

Background

During anti-TNFα treatment, clinical and laboratory monitoring should be planned in order to assess both effectiveness and safety, however predictors of long term response are not clearly defined. An effective non invasive monitoring could help clinicians in the management of Crohn's disease (CD) patients treated with adalimumab. Aim of the study is to identify early predictors of long term clinical response during treatment with adalimumab.

Methods

68 patients with moderate to severe CD referred to a nurse-led outpatient clinic were prospectively enrolled from January 2009 to December 2011. All patients were treated with a 160–80 mg every other week (eow) induction protocol and maintained with 40 mg eow. Clinical activity (Harvey Bradshaw Index – HBI), faecal lactoferrin (LF), C reactive protein (CRP) were assessed at baseline, at the end of induction and 6 and 12 months after.

Results

After induction, 42.3% of patients were in clinical remission and 37% responded showing at least a 2-points decrease in HBI. LF and CRP decreased significantly after the induction period (p < 0.001 and p = 0.02 respectively) and remained in the normal range throughout the maintenance period. 63% of patients in remission at the end of induction maintained remission at one year (p = 0.02, OR = 0.15), on the contrary only 36% of patients still active after induction were able to reach clinical remission at twelve months (p = 0.009, OR = 6.96). After twelve months 58.3% of patients were in remission according to HBI. 61% of patients achieving LF normalization at the end of induction were in clinical remission at one year (p = 0.004, OR = 0.06), while only 39% of patients with abnormal LF (p = 0.004, OR = 15.45). 95% patients with normal CRP after induction were in clinical remission at one year (p = 0.003, OR = 0.06), while only 4.5% of those showing abnormal CRP (p = 0.003, OR = 15.75). Linear regression models found that clinical remission combined with early CRP and LF normalization after induction is the best predictor of maintenance of clinical remission at one year.

Conclusion

Clinical activity and biochemical markers performed at the end of induction proved to be reliable in predicting the course of CD in the long term maintenance treatment with adalimumab, therefore clinical and laboratory monitoring should be performed routinely in these patients.