Etanercept therapy in Behçet's disease. The tight control strategy in refractory disease

The goal of the present study was to investigate patient outcome when using the TNF receptor fusion protein etanercept in addition to conventional immunosuppressive drugs in ameliorating disease intensity and reducing relapses in refractory Behçet's disease (BD).

A single center, prospective study was conducted over 1 year. A total of 15 patients with the established diagnosis of BS were enrolled (mean age: 36.5 ± 6.75 years, mean disease duration: 3.86 ± 1.30 years). Clinical features were classified as refractory if the patients failed to achieve the desired response within 6 months of immunosuppressive and oral glucocorticoid therapy or flare of lesions developed while on the maximum tolerable doses of these drugs. The study included 2 patients who were on previous infliximab therapy for refractory disease. Inflammatory biomarkers (ESR and CRP) were investigated.

Baseline clinical features in the study prior to inclusion showed recurrent oro-genital ulcers were observed in 100 % of patients, the pathergy test was positive in 17.6 %, ocular involvement was observed in 86.7 %, and acne lesions were recorded in 73.3 %. The following values were also recorded: mean ESR 22 ± 16.97 mm/h, mean CRP level 6.87 ± 4.44 mg/l, mean visual analog score 5.46 ± 1.55, and mean patient global score 5.13 ± 1.30. At the beginning of the study, all patients were on oral prednisolone (mean dose: 20.16 ± 11.81 mg/day), azathioprine (mean dose: 126.66 ± 25.81 mg/day), and oral colchicine (mean dose: 1.08 ± 0.10 mg/day), then etanercept was added at a regular weekly dose of 50 mg subcutaneously for 1 year. By 8 weeks, 100 % of the patients achieve the primary endpoint, which included clinical resolution of refractory mucocutaneous, joint, and active ocular lesions with normalization of the acute phase symptoms.

Patients with refractory BD who received a 12-month treatment with etanercept in addition to conventional immunosuppressive therapy achieved a good therapeutic response with successful reduction of oral prednisolone to a mean dose of 6.66 ± 2.24 mg/day. No serious infections or drug-related adverse events reported.