Objectives: To evaluate the therapeutic efficacy and safety of systemic recombinant interferon alpha-2a (IFN-alpha) in patients with Behcet's disease (BD) and to determine the incidence of episodes in complete responders during the one-year pretreatment period and follow-up.
Design: An open clinical study.
Setting: Departments of Dermatology and Ophthalmology, University of Patras, Greece and Department of Dermatology, Heinrich-Heine University of Düsseldorf, Germany.
Subjects: Twelve patients (aged 23-52 years) with active BD who had previously been unsuccessfully treated with systemic steroids and/or immunosuppressives.
Interventions: IFN-alpha was administered subcutaneously at a dose of 6 X 10(6) IU per day 3 times per week for 2 months.
Main outcome measures: Change of area or number of mucocutaneous lesions, grading score for thrombophlebitis and ocular inflammation, haematological and biochemical parameters and number of episodes during the pretreatment period and the follow-up. Evaluation of IFN-alpha side effects.
Results: Nine patients (75.0%) revealed a complete remission, two (16.6%) a partial remission and one patient (8.3%) showed no response. During the follow-up in five out of the nine complete responders (55.5%) no episodes of BD were seen, whereas, the other four patients (44.5%) had 1-2 episodes, as compared to 5-8 and 5-12 episodes, respectively, during the pretreatment period. An influenza-like syndrome (fever, nausea and myalgias) appeared during the early phase of therapy in all (but one) patients. No patient had to discontinue IFN-alpha because of intolerance.
Conclusions: Subcutaneous human recombinant interferon alpha-2a appears to be an effective and fairly well tolerated therapy for BD.