Effectiveness and Tolerability of Anti-Tumor Necrosis Factor Alpha Therapy in Refractory Intestinal Behçet's Disease: A Large Single-Center Study.

BACKGROUND/AIMS: Intestinal Behçet's disease (BD) is a rare, chronic intestinal vascular disorder often refractory to conventional therapy. We aimed to assess the effectiveness and tolerability of anti-tumor necrosis factor alpha (anti-TNF-α) therapy in patients with moderate to severe refractory intestinal BD.

METHODS

Clinical remission, clinical response, and biological response rates at 4, 12, and 24 months, as well as the adverse effects of anti-TNF-α therapy were investigated at the Inflammatory Bowel Disease Center of Severance Hospital, Seoul, Korea. We also examined the relapse rates and predictive factors for disease relapse.

RESULTS

Of the 119 patients, 15 (12.6%) were bio-exposed, 68 (57.1%) received concomitant immunomodulators, and 56 (47.1%) received concomitant corticosteroids at anti-TNF-α treatment induction. At 4, 12, and 24 months, clinical remission rates were 23.5%, 40.3%, and 42.0%; 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 patients (52.9%) relapsed, with a mean relapse time of 2.8 years. Higher initial C-reactive protein levels (hazards ratio [HR], 1.013; 95% confidence interval [CI], 1.008 to 1.018; p<0.001), history of previous intestinal surgery (HR, 4.282; 95% CI, 2.379 to 7.709; p<0.001), concomitant immunomodulator use (HR, 0.455; 95% CI, 0.267 to 0.775; p=0.004), and clinical response at 4 months (HR, 0.353; 95% CI, 0.181 to 0.687; p=0.002) were independent factors associated with the disease relapse. No mortality was observed during the study period; 26 (21.8%) and three patients (2.5%) experienced mild infection and infusion reactions, respectively.

CONCLUSIONS

Anti-TNF-α therapy could be an effective and tolerable option for refractory intestinal BD.