Efficacy and safety of systemic recombinant interferon-alpha in Behçet's disease.

OBJECTIVE

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.

METHODS

An open clinical study.

METHODS

Departments of Dermatology and Ophthalmology, University of Patras, Greece and Department of Dermatology, Heinrich-Heine University of Düsseldorf, Germany.

METHODS

Twelve patients (aged 23-52 years) with active BD who had previously been unsuccessfully treated with systemic steroids and/or immunosuppressives.

METHODS

IFN-alpha was administered subcutaneously at a dose of 6 X 10(6) IU per day 3 times per week for 2 months.

METHODS

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.