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P224. Use of adalimumab in anti-TNF naive Crohn's disease patients: Clinical experience in a multicenter cohort

V. Ollero1, M. Barreiro2, S. Pereira3, A. Echarri1, A. Fernandez4, D. Martinez3, V. Hernández3, D. Carpio5, J. Castro1, A. Lorenzo2

1Arquitecto Marcide Hospital, Ferrol, Spain; 2Clinic Hospital, Santiago Compostela, Spain; 3Vigo Hospital, Vigo, Spain; 4POVISA Hospital, Vigo, Spain; 5Pontevedra Hospital, Pontevedra, Spain

Aim: Controlled clinical trials have demonstrated the efficacy and safety of adalimumab (ADA), either as a first or second line biologic therapy, in the treatment of moderate to severe Crohn's disease (CD). However, experience with antiTNF-naïve CD patients treated with ADA in clinical practice has rarely been reported. Our aim was to assess the efficacy and safety of ADA in CD patients in a multicenter cohort of anti-TNF naïve patients as well as to determine predictive factors of response.

Materials and Methods: A retrospective study of our cohort of antiTNF-naïve CD patients treated with ADA was performed and followed up over a period of 52 weeks (range 10–108 weeks, median 54 weeks). All patients received 160/80 mg at Week 0/2 as induction dose followed by 40 mg/eow if responders. In case of loss of response, a weekly treatment was performed. Clinical assessment was evaluated with the Harvey-Bradshaw index at Weeks 8, 26 and 52. Endoscopic activity was scored with the Simple Endoscopic Score for CD (SES-CD) at Weeks 26 and 52. Endpoints included steroid-free remission (Harvey-Bradshaw Index <4 and steroid-free) and steroid-free remission with mucosal healing (Harvey-Bradshaw <4, steroid-free and SES-CD score <2). Concomitant immunosuppressant therapy with azathioprine (AZA) and smoking status were evaluated.

Results: 67 patients with active CD (36 females, mean age 36±9.7 years, 45% smokers) were included. 34 patients (50%) had been diagnosed within the previous five years and 45% of patients were treated with concomitant AZA. Steroid-free remission was achieved in 58%, 74% and 70% of patients at weeks 8, 26 and 52, respectively. Steroid-free remission together with mucosal healing was achieved in 20% of patients at Week 26 and in 48% at Week 52. The remission rate was not influenced by gender, smoking status or concomitant therapy with AZA. During maintenance 11 patients (17%) lost response to ADA and therefore switched to weekly dosage. 14 patients (21%) stopped ADA treatment due to primary failure (8), adverse events (4), and pregnancy (2).

Conclusion: Our data suggest that ADA is an effective and well tolerated therapeutic option in inducing and maintaining steroid-free remission with mucosal healing in antiTNF-naïve patients with active CD. Concomitant immunosuppressant therapy with AZA, gender or smoking habit appears to have no influence in response.