Objectives Investigate the benefit of one year treatment with etanercept, a TNF- receptor fusion protein in ameliorating disease intensity and reducing relapses in patient refractory to conventional immunosuppressive drugs.
Methods Single center prospective study over a period of one year. Patients with the established diagnosis of BD based on the criteria of the international study group  who were classified as having refractory ocular or muco-cutaneous disease while on conventional immuno-suppressive therapy were enrolled. Laboratory workup including markers of acute inflammatory disease including erythrocyte sedimentation rate ESR and C- reactive protein CRP.
Results The study included 15 patients with the established diagnosis of BS, they included 14 males and 1 female, their ages ranged between 24-45 (mean 36.5+-6.75years), disease duration 2-7 years (mean 3.86+-1.30years). Baseline clinical assessment showed recurrent oro-genital ulcers in 100% of patients, pathergy test was positive in 17.6%, recurrent uveitis (> 1attack/year) and refractory retinitis in 86.7% of cases, acne lesions in 73.3%, deep venous thrombosis in 33.3%. Laboratory investigations showed ESR a mean of (22+-16.97) a range from 4-65mm/hr, mean CRP 6.87+-4.44 mg/l, medication history showed 100% of the patients were on oral prednisolone 10-60mg/day (mean 20.16+-11.81mg/day), azathioprine 100-150mg/day (mean126.66+-25.81mg/day) and oral colchicine 1-1.2mg/day (1.08+-0.10), 20% were on cyclophosphamide pulse therapy (750 mg), 17.6% were on oral cyclosporine (5-10mg/kg/day) in addition to topical steroids, oral anticoagulants in 33,3%. Etanercept was initiated at regular weekly dose of 50mg subcutaneously over a period of one year. Assessment at the end of study period showed 86.6% (13 patients) to have <1 attack of recurrent oro-genital ulcers, acne lesions, arthralgias/arthritis, with 100% of the patients having 0 recurrences of uveitis and remission of retinal vasculitic lesions. Laboratory markers of inflammation revealed a mean ESR of 6.2+-3.82 mm/hr(2-14mm/hr), a mean CRP 2.90+-2.11mg/l (0.2-5.6mg/l). The dose of oral prednisolone was successfully reduced with etanercept reaching a mean of 6.66+-2.24 mg/day (5-10mg/day) with a statistically significant difference between the pre-post TNF-I therapy inflammatory markers including mean ESR (t= 4.13, P= 0.001), mean CRP (t= 3.9, P= 0.008), and mean prednisolone dose (t= 4.39, P= 0.001).
Conclusions Patient with refractory BD received a 12-month treatment with etanercept achieved a good therapeutic response. No serious infections or drug related adverse events reported.
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Disclosure of Interest: None Declared