Interferon alfa-2b, colchicine, and benzathine penicillin versus colchicine and benzathine penicillin in Behcet's disease: a randomised trial

Background Sight-threatening eye involvement is a serious complication of B ehcet's disease. Extraocular complications such as arthritis, vascular occl usive disorders, mucocutaneous lesions, and central-nervous-system disease may lead to morbidity and even death. We designed a prospective study in ne wly diagnosed patients without previous eye disease to assess whether preve ntion of eye involvement and extraocular manifestations, and preservation o f visual acuity are possible with combination treatments with and without i nterferon alfa-2b. Methods Patients were randomly assigned 3 million units interferon alfa-2b subcutaneously every other day for the first 6 months plus 1.5 mg colchicin e orally daily and 1.2 million units benzathine penicillin intramuscularly every 3 weeks (n=67), or colchicine and benzathine penicillin alone (n=68). The primary endpoint was visual-acuity loss. Analysis was by intention to treat. Findings Significantly fewer patients who were treated with interferon had eye involvement than did patients who did not receive interferon (eight vs 27, relative risk 0.21 [95% CI 0.09-0.50], p<0.001). Ocular attack rate was 0.2 (SD 0.62) per year with interferon therapy and 1.02 (1.13) without int erferon therapy (p=0.0001). Visual-acuity loss was significantly lower amon g patients treated with interferon than in those without interferon (two vs 13, relative risk 0.13 [95% CI 0.03-0.60], p=0.003). Arthritis episodes, v ascular events, and mucocutaneous lesions were also less frequent in patien ts treated with interferon than in those not receiving interferon. No serio us side-effects were reported. Interpretation Therapy with interferon alfa-2b, colchicine, and benzathine penicillin seems to be an effective regimen in Behcet's disease for the pre vention of recurrent eye attacks and extraocular complications, and for the protection of vision.