PO:36:243 | Drug survival, discontinuation reasons and disease activity in patients with Behçet's disease treated with infliximab - a real-life study

Antonello Sulis¹, Federica Di Cianni¹, Maria Laura Manca², Rosaria Talarico¹, Marta Mosca¹. | ¹Rheumatology Unit of Pisa, University of Pisa, Pisa, Italy, Pisa, Italy; ²Department of Clinical and Experimental Medicine and Department of Mathematics, University of Pisa, Italy, Pisa, Italy.

Background. Behçet's Disease (BD) is a rare multisystemic vasculitis that can result in life-threatening manifestations when involving the central nervous system or vascular system. Infliximab (IFX) is an immunosuppressive drug widely used for the treatment of BD with major organ involvement or refractory to therapies. The objective of the study was to evaluate the drug survival, discontinuation reasons, safety profile and disease activity of a cohort of patients diagnosed with BD receiving IFX.

Materials and Methods. We conducted a retrospective observational study examining all the patients affected by BD according to ISG criteria treated with Infliximab. Patient demographics and background data were collected. Disease activity was assessed using the BDCAF (Behçet’s Disease Current Activity Form 2006) index, and clinical remission was evaluated with a score <= 2 points; the safety outcomes were the incidence of adverse drug reactions (ADRs). IFX 5 mg/kg was administered as an intravenous infusion at weeks 0, 2, and 6, and at 6-8 week intervals thereafter. We performed statistical analysis using descriptive statistics (mean ± standard deviation), median (interquartile range IQR), Odds Ratio, Chi-square test, Student’s t-test or Mann Whitney test, statistical significance was assessed for p < 0.05.

Results. A total of 60 BD patients (56.7% female, 43.3% male) were treated with IFX from 2003 to 2025. Their mean age of disease onset was 30.9 years (range 8-63), with a mean age at the introduction of Infliximab of 41.6 years. The main cumulative reasons for starting therapy were: oral and genital recurrent aphthae (71.7% and 35%), cutaneous manifestations (35%), articular involvement (inflammatory arthralgias in 23.3% and arthritis in 23.3%), ocular involvement was found in 28% and SNC involvement in 15%. Analyzing the duration of treatment, it was observed that therapy is currently being followed by 27 patients (drug survival 45%) with a median treatment duration of 37 months (IQR 17-72); drug survival at one year is 78%, at two years of 63.3%, and at five years of 35%. The main causes of discontinuation of therapy were allergic reactions (13%), loss of efficacy (13%), inefficacy (13%), and de novo manifestations (12%) mainly because of recurrent aphthous manifestation. Analyzing the BDCAF index, it emerged that 92.6% of patients currently undergoing treatment with IFX show an improvement in BDCAF, as well as 89.3% of patients who discontinued treatment, with an average reduction of this index by 4 points.

Conclusions. This study showed that IFX is associated with low rates of discontinuation due to adverse events in patients with BD. Notably, 12% of patients experienced de novo organ manifestations. Drug survival was 45%, with a median treatment duration of 37 months. The drug led to a significant reduction in the BDCAF index in the analyzed patients, demonstrating a good safety profile and effectiveness in real life.