P371. Short- and long-term efficacy of infliximab in intestinal Behcet's disease refractory to conventional medications indicates a major role for tumour necrosis factor-alpha
H. Kinoshita1, R. Kunisaki1, S. Tomohiko1, H. Kimura1, S. Maeda2, 1Yokohama City University Medical Center, Inflammatory Bowel Disease Center, Yokohama, Japan, 2Yokohama City University, Department of Gastroenterology, Yokohama, Japan
Behcet's disease (BD) is a chronic relapsing-remitting immune disorder with diverse clinical manifestations like orogenital aphthae, ocular, and gastrointestinal lesions. Among these, intestinal BD is a debilitating inflammatory condition with evidence for tumour necrosis factor (TNF)-alpha as a major pathologic factor. This study was undertaken to investigate the efficacy and safety of the anti-TNF-alpha, infliximab (IFX) in patients with intestinal BD.
Among 43 consecutive patients with intestinal BD who were regularly followed at our medical centre between July 2005 and October 2011, 15 had active disease in spite of receiving conventional medications, which included mesalazine, prednisolone, azathioprine and colchicine for >8 weeks. Intestinal BD activity was determined similar to Crohn's disease activity index (CDAI) as well as by the disease activity index for intestinal Behçet's disease (DAIBD) according to Cheon, et al (Inflamm Bowel Dis 2001;17:605–13). Patients received IFX infusions (5 mg/kg bodyweight) at weeks 0, 2, 6, and then every 8 weeks up to 24 months as maintenance therapy, and were clinically and endoscopically evaluated at baseline, week 10 (short-term efficacy), at 12 and 24 months (long-term efficacy). Remission meant complete disappearance of intestinal symptoms and normal C-reactive protein (CRP), while clinical response was defined as improvements of intestinal symptoms (>50 decrease in CDAI).
The response rate at week 10 was 12 of 15 patients (80%), 8 in remission (53%). The 3 non-responders had fulminant intestinal BD. Further, at 12 months, 7 of 11 available patients (64%), and at 24 months, 4 of 8 patients (50%) had maintained response to IFX. Seven patients were on prednisolone at entry and steroid-sparing was possible in 5 responders by halving the IFX infusion interval. Fulminant intestinal BD (P < 0.001) and BD activity index (P < 0.013) were predictors of no response to IFX. One patient had infusion reaction, and one developed fever.
The outcome of this study validates the role of TNF-alpha in the immunopathogenesis of intestinal BD. In patients who respond to IFX, steroid tapering may provoke a clinical relapse. However, patients with extensive intestinal bleeding (fulminant BD) may not respond to IFX and required surgical interventions. Accordingly, fulminant BD appeared to be a predictive factor for lack of response to IFX.