Background/Purpose: Infliximab (IFX) is a monoclonal antibody against tumor necrosis factor-a (TNF-a) and is increasingly used in various immune-related diseases including rheumatoid arthritis (RA), ankylosing spondylitis, inflammatory bowel diseases and Behcet’s disease (BD). Among patients with RA, serious hospitalized infection rates were previously reported as 8.16 (IFX) and 7.78 (nonbiological regimens) per 100 person-years and 2-year continuation rates of IFX were previously reported as around 40%. On the other hand, there are few reports regarding the long-term safety and persistent response of IFX therapy in BD patients. It is of importance to assess the safety and the efficacy of IFX for BD, since the backgrounds of these diseases are different.

Methods: We retrospectively studied consecutive 109 patients who met the established criteria by the Behcet’s Disease Research Committee of Japan for the diagnosis of BD, and were continuously followed up between January 2007 and December 2011 in a single center (Department of Clinical Immunology and Rheumatology/Infectious Disease of Kyushu University Hospital). During this period, 39 patients with BD received IFX therapy and 70 did not. Among the 39 patients, 36 were treated with IFX for uveitis. Serious hospitalized infections and the discontinuations of IFX were investigated based on medical records. The frequency data were compared using Chi-square test. The continuous data were compared using Wilcoxon non-parametric tests. The time-course data were analyzed by Kaplan-Meier method.

Results: Between patients with and without IFX, there were no significant differences in median [IQR] age (37 [26-42] vs 43 [32-54] years), median duration of disease (4.1 [0.7-7.8] vs 4.2 [1.0-11.0] years), median follow-up period (2.4 [1.4-3.9] vs 2.4 [0.9-5.0] years), and percentage of concomitant prednisolone (>10mg/day) user (10.3% vs 14.3%). On the other hand, significant (p<0.01) differences were observed in the proportion of males (76.9% vs 41.4%), manifestation of uveitis (92.3% vs 37.1%) and genital ulcers (48.7% vs 78.6%), and concomitant use of immunosuppressive drugs (41.0% vs 17.1%). Serious infection rates were comparable between two group; 2.01 with IFX and 1.54 without IFX per 100 person-years. Among BD patients with IFX therapy, bacterial colitis and pelvic inflammatory disease occurred in 2 patients and both occurred within 1 year from initiation of IFX therapy. IFX infusion was interrupted in 5 of the 39 patients due to adverse events (n=3) and removals (n=2). Two-year continuation rate was estimated as 85.3%.

Conclusion: In the treatment of BD, IFX therapy was not associated with an increased risk of hospitalizations for serious infections. In addition, 2-year continuation rate of IFX was considerably higher than that previously reported in RA patients.

ACR Meeting Abstracts - https://acrabstracts.org/abstract/long-term-infliximab-therapy-in-patients-with-behcets-disease-is-well-tolerated-without-increasing-risk-of-serious-infections/