P0874 Efficacy and tolerability of anti-tumor necrosis factor alpha therapy in refractory intestinal Behçet’s disease

Abstract Background Intestinal Behçet’s disease (BD) is a rare chronic intestinal vasculitic disorder and it is often refractory to conventional therapies such as corticosteroids and immunomodulators. We aimed to assess the efficacy and tolerability of anti-tumor necrosis factor alpha (TNF ɑ) in patients with moderate to severe intestinal BD who refractory to conventional therapy. Methods We analyzed patients with intestinal BD treated with anti-TNF ɑ more than 4 months registered at the Inflammatory Bowel Disease Clinic of Severance Hospital, Seoul, Korea. Clinical remission rates, clinical response rates, biological response rates at 4, 12, 24 months, and adverse events of anti-TNF ɑ treatment were investigated. We also examined relapse rates and predictive factors of relapse based on the BD-related surgery and admission. Results A total of 119 patients with intestinal BD were selected for the anti-TNF ɑ therapy, 15 (12.6%) were bio-exposed patients, 68 (57.1%) received concomitant immunomodulatory therapy, and 56 (47.1%) received concomitant corticosteroids at anti- TNF ɑ induction. At 4, 12, and 24 months after anti-TNF ɑ therapy, clinical remission rates were 23.5%, 40.3%, and 42%; clinical response rates were 84.0%, 62.2%, and 62.2%; and biological response rates were 61.3%, 68.9%, and 58.8%, respectively. Sixty-three (52.9%) patients presented disease relapse during follow-up period. The mean time before relapse was 2.8 years (median, 1.8 years). Higher initial CRP (hazards ratio [HR]: 1.013, 95% CI: 1.008-1.018, p < 0.001), previous surgery (HR: 4.282, 95% CI: 2.379-7.709, p < 0.001), concomitant immunomodulator (HR: 0.455, 95% CI: 0.27-0.775, p = 0.004), and clinical response at 4 months (HR: 0.353, 95% CI: 0.181-0.687, p = 0.002) were independent factors associated with the disease relapse in multivariate Cox regression analysis. There was no mortality in using anti-TNF ɑ agent. Twenty-six (21.8%) patients experienced infection, and 3 (2.5%) patients experienced infusion reaction. Conclusion Anti-TNF ɑ therapy could be a useful therapeutic option for refractory intestinal BD with an acceptable efficacy and tolerability profiles. References 1.Hisamatsu T, Ueno F, Matsumoto T, Kobayashi K, Koganei K, Kunisaki R, et al. The 2nd edition of consensus statements for the diagnosis and management of intestinal Behcet's disease: indication of anti-TNFalpha monoclonal antibodies. J Gastroenterol 2014;49(1):156-62. 2.Hibi T, Hirohata S, Kikuchi H, Tateishi U, Sato N, Ozaki K, et al. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study. Medicine (Baltimore) 2016;95(24):e3863. 3.Zou J, Ji DN, Cai JF, Guan JL, Bao ZJ. Long-Term Outcomes and Predictors of Sustained Response in Patients with Intestinal Behcet's Disease Treated with Infliximab. Dig Dis Sci 2017;62(2):441-7. 4.Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, et al. Long-term safety and efficacy of adalimumab for intestinal Behcet's disease in the open label study following a phase 3 clinical trial. Intest Res 2017;15(3):395-401.