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P099 Efficacy, safety and predictors of response to Adalimumab in Crohn's disease (CD)- a nation-wide cohort study

C. Preda*1, L. Fulger1, C. Tieranu1, M. Ionescu2, L. Gheorghe1, C. Gheorghe1, M. Manuc1, A. Goldis3, G. Constantinescu4, M. Tantau5, L. Negreanu6, B. Mateescu7, A. Trifan8, S. Bataga9, R. Iacob1, M. Diculescu1

1Clinical Institute Fundeni, Gastroenterology and Hepatology, Bucharest, Romania, 2University of Medicine and Pharmacy "Carol- Davila", General Medicine, Bucharest, Romania, 3Clinical Hospital No 1, Gastroenterology and Hepatology, Timisoara, Romania, 4Emergency Hospital Floreasca, Gastroenterology and Hepatology, Bucharest, Romania, 5Regional Institute of Gastroenterology and Hepatology, Gastroenterology and Hepatology, Cluj, Romania, 6University Emergency Hospital Bucharest, Gastroenterology and Hepatology, Bucharest, Romania, 7Clinical Hospital Colentina, Gastroenterology and Hepatology, Bucharest, Romania, 8Emergency Hospital " Sf. Spiridon", Gastroenterology and Hepatology, Iasi, Romania, 9Emergency Hospital Targu Mures, Gastroenterology and Hepatology, Targu Mures, Romania

Background

Adalimumab, a human anti-TNF, is an effective induction and maintenance therapy for patients with moderate to severe Crohn's disease, The aim of this study was to evaluate its efficacy in a large Romanian population and to identify predictor factors of response

Methods

We performed a retrospective cohort study using data from Romanian National Insurrance House. 136 patients with CD received Adalimumab (ADA) between December 2008 and June 2014. Binary logistic regression was performed with the aid of statistical program SPSS, in order to identify predictors of response to ADA .

Results

Patients were half women, with a median age of 36 years, a median disease duration of 2 years, and most of them (82%) received Azathioprine before biologic therapy. Mean therapy duration was 20 months (standard deviation 10 months). 67% of patients had moderate flare of the disease, while 16% had mild disease activity. Regarding disease extension, most of them had ileocolonic involvement (49%), followed by colonic extension (29%), and inflammatory behaviour predominates (61%). 21% of subjects suffered surgical resections of small bowel and/or colon before ADA, and 12% had perianal disease. 104 patients (77%) had complete response on Adalimumab, while secondary loss of response was recorded in 24(17.7%). Non-response appeared in 5 cases (3.7%), and 3 patients responded partially. Adverse events reported were: local erythema 1, tuberculosis (located in lymph nodes) 1, psoriasis 1, fever of unexplained origin 1, arthralgia 3. 2 deaths were reported, both disease related, and not-related to Adalimumab. Predictors of poor response to ADA were: severe active disease (CDAI more than 450 points): OR 5.67 ( 95% CI 0.17, 185.65), presence of perianal fistulae: OR 5.87 (95% CI 0.26, 131.15), fistulising behaviour of the disease OR 3.71 ( 95% CI 0.18, 73.72).

Conclusion

Adalimumab is higly efficient and well tolerated in Crohn's disease, with a complete response rate of 77%. Predictors of poor response to ADA were: severe active disease, perianal disease and fistulising behaviour.