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P447 Early initiation of adalimumab significantly diminishes post-operative Crohn's Disease recurrence, and is superior to immunomodulator therapy. Preliminary results from the POPART trial

E. Scapa*1, N. Maharshak2, Y. Kariv3, S. Ben-Horin4, I. White5, E. Santo6, H. Tulchinsky7, I. Dotan2

1Tel-Aviv Sourasky Medical Center, Gastroenterology, Tel-Aviv, Israel, 2Tel Aviv Medical Center, IBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv, Israel, 3Tel Aviv Sourasky Medical Center, affiliated to Sackler Faculty of Medicine, Tel Aviv University, Proctology Unit, Department of Surgery, Tel Aviv, Israel, 4Chaim Sheba Medical Center, Gastroenterology, Ramat Gan, Israel, 5Meir Medical Center, Surgery, Kfar Saba, Israel, 6Tel Aviv Medical Center, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Department of Gastroenterology and Liver Diseases, Tel Aviv, Israel, Tel Aviv, Israel, 7Tel Aviv Medical Center affiliated to Sackler Faculty of Medicine, Tel Aviv university, Surgery, Tel Aviv, Israel

Background

A sizable proportion of Crohn's disease (CD) patients will undergo intestinal resection, but most will experience early endoscopic and clinical disease recurrence. Prevention of post-operative recurrence using a risk-stratified approach was recently demonstrated to be superior when anti-TNF agents were compared to placebo and immunomodulators, but the value of early anti-TNF in an all-comers patients population has not been examined to date. Aim: To evaluate the efficacy of an early unstratified approach comparing anti-TNF (adalimumab) and thiopurine (6-mercaptopurine, 6MP) therapy on the natural history of post operative CD recurrence. Aim: To evaluate the efficacy of an early unstratified approach comparing anti-TNF (adalimumab) and thiopurine (6-mercaptopurine, 6MP) therapy on the natural history of post operative CD recurrence.

Methods

All CD patients undergoing a first ileocecectomy for inflammatory complications were prospectively recruited to the Post OPerative Adalimumab Recurrence Trial (POPART). Patients were randomized within 45 days to receive either adalimumab 160mg/80mg and then 40 mg every other week, or 6MP 1.5mg/kg/day. All patients underwent ileocolonoscopy at 6 and 12 months to asses for endoscopic recurrence as defined by the Rutgeert's score. Endoscopic remission was defined as a Rutgeert's score of i0-i1, while advanced lesions were defined as i2-i4.

Results

Nineteen patients have reached the 24 week time point. The mean ages of patients in the 6MP (n=8) and adalimumab (n=11) arms (30.5 ± 2.3 vs 34.4 ± 2.5 years, respectively) as well as the smoking status (1/11 vs3/8smokers/total) were comparable. Fifty percent (4/8) of the 6MP-treated patients had advanced lesions (i2), compared to only 9% (1 of 11) of the adalimumab-treated patients (p<0.05). Furthermore median fecal calprotectin levels were 186 in the 6MP (n=6) arm and 27 in the adalimumab arm (n=3), and adalimumab-treated patients gained more weight (6.5kg vs 3.5kg increase in the 6MP group, p=0.06) during the 24 weeks follow-up. CD activity index, histological scores, C-reactive protein, and quality of life as represented by the IBDQ score were comparable. Importantly, a Rutgeerts score of i2 was the most advanced score recorded in both groups, mostly due to discrete perianastomotic ulcers.

Conclusion

Early treatment of post operative CD patients with adalimumab is significantly superior to 6MP, regardless of risk stratification. Applying such therapy may modify the natural history of post-operative CD.