FRI0231 Study on the safety and efficacy of infliximab (IFX), an anti-TNF-α antibody, in patients with refractory intestinal-behÇet’s disease (BD)
Authors: K. Saito, I. Miyagawa, S. Iwata, M. Nawata, S. Fukuyo, S. Hirata, N. Sawamukai, K. Yamaoka, Y. Tanaka
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Background</h3> Intestinal involvement is one of the intractable categories of Behçet’s disease (BD) and closely related with prognosis of patients with BD. Although various therapeutic agents are used for treatment, refractory intestinal-BD is difficult to manage, and effective treatment remains elusive. The presence and role of TNF-α in ulcerative lesions of the intestine has been reported, and several case reports including our previous study <sup>1)</sup>have shown favorable effects for infliximab (IFX) in patients with refractory intestinal-BD. <h3>Objectives</h3> In this study, we evaluate the efficacy and safety of IFX in 18 patients with intestinal-BD who were 1) refractory to conventional therapies or 2) difficult to continue treatment because of adverse effects, or 3) not able to taper the dose of corticosteroid (CS). <h3>Methods</h3> The study subjects were 18 patients with BD diagnosed based on the criteria recommended by the International Study Group for BD. The diagnosis of intestinal-BD was based on colonoscopy and it showed massive ulceration in the ileocecal region in all patients. The primary endpoint was the rate of disappearance of ileocecal ulceration at 1 year of therapy and secondary endpoints is the ameliorating effect based on the “Disease Activity Index for Intestinal Behçet’s disease” (DAIBD)<sup>2)</sup>, and the dose of CS tapered after 1 year treatment with IFX. <h3>Results</h3> Baseline characteristics were as following; the mean age was 42.6, 5 male and 13 female, 4 patients were HLA-B51 positive. 6 patients had repeated relapses (range, 1-8 times), 3 patients experienced intestinal perforation, and 3 patients required surgical treatment before IFX therapy. We used 3-6mg/body of IFX with MTX (mean 9.75mg) to all of the patients. No severe adverse event was observed. Retention rate at 1 year treatment of IFX was 88.9% (16 cases) and healing rate of ulceration evaluated by colonoscopy was 66.7% (12 cases). DAIBD was significantly decreased from 73.9 to 27.2 and 56.3% of the patients reached “Quiescent” at 1 year. The dose of CS was tapered from 12.7 to 2.7 mg. In addition, the serum TNF levels at the introduction of IFX and disease activity showed a positive correlation but IL-6 did not. In this study, we experienced a patient who achieved clinical remission by IFX and it has been successfully maintained with only low dose of MTX for 2 years after discontinuation of IFX. <h3>Conclusions</h3> IFX could ameliorate severe intestinal involvement in 12 out of 18 patients who are refractory to conventional therapy. Our data demonstrate TNF play an important role in the pathogenesis of intestinal- BD and inhibition TNF by IFX is useful for the control of disease activities of intestinal-BD. In addition, our case also suggests that the biologic-free remission is possible in refractory intestinal-BD. However, this pilot study would warrant further investigation with more subjects and longer duration. <h3>References</h3> Iwata S et al. Rheumatology 2009;48(8):1012-3. Jae Hee Cheon et al. Inflamm Bowel Dis 2011;17(2):605-13. <h3>Disclosure of Interest</h3> K. Saito: None Declared, I. Miyagawa: None Declared, S. Iwata: None Declared, M. Nawata: None Declared, S. Fukuyo: None Declared, S. Hirata: None Declared, N. Sawamukai: None Declared, K. Yamaoka: None Declared, Y. Tanaka Consultant for: Mitsubishi-Tanabe Pharma, Pfizer Inc, Speakers Bureau: Mitsubishi-Tanabe Pharma, Takeda Pharmaceutical Co Ltd, Abott, Eisai Pharma, Chugai Pharm