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Interferon Alfa-2a in the Treatment of Behçet Disease
A Randomized Placebo-Controlled and Double-blind Study
Erkan Alpsoy, MD;
Cicek Durusoy, MD;
Ertan Yilmaz, MD;
Yilmaz Ozgurel, MD;
Oya Ermis, MD;
Sahin Yazar, MD;
Erdal Basaran, MD
Arch Dermatol. 2002;138:467-471.
Objective To determine the therapeutic efficacy of interferon alfa-2a in the treatment
of Behçet disease.
Design A randomized placebo-controlled and double-blind study.
Setting University referral center.
Patients Fifty patients with Behçet disease were involved in the study.
Intervention The patients were given interferon alfa-2a, 6 x 106
IU, subcutaneously 3 times per week or placebo for 3 months, and examined
clinically at weekly intervals.
Main Outcome Measures For each mucocutaneous lesion and articular symptom, the mean frequency
and duration were evaluated during the 3-month pretreatment, treatment, and
follow-up periods. Pain for oral and genital ulcers was scored on a scale
of 0 to 3. The ocular inflammatory score, the frequency of attacks, and changes
in visual acuities for patients with ocular involvement were assessed before
the study, at the end of treatment, and during the follow-up periods. In addition,
overall responses at the end of the treatment period were graded as follows:
complete remission, disappearance of all clinical signs and symptoms during
treatment; partial remission, greater than a 50% decrease in the frequency,
duration, and severity of pain for oral and genital ulcers and/or a decrease
in the severity and frequency of ocular attacks; stable disease, less than
a 50% change in the clinical signs and symptoms; and no effect or deterioration,
ineffectiveness or worsening of clinical signs and symptoms.
Results Twenty-three interferon alfa-2a– and 21 placebo-treated patients,
ranging in age from 16 to 55 years (mean ± SD age, 32.38 ± 7.94
years), were evaluable for efficacy. Interferon alfa-2a treatment significantly
decreased the duration (P = .02) and pain (P = .01)
of oral ulcers and the frequency of genital ulcers (P = .03) and
papulopustular lesions (P = .01). The mean frequency and duration
of erythema nodosum–like lesions (P = .77 and .27, respectively),
thrombophlebitis (P = .29 and .61, respectively), and articular
symptoms (P = .92 and .74, respectively) also decreased. But there
were no statistically significant differences. An improvement in the severity
and the frequency of ocular attacks occurred in 5 of 6 patients in the interferon
alfa-2a–treated group and in 1 of 3 patients in the placebo-treated
group. Of the 23 patients in the interferon alfa-2a–treated group, 15
responded to treatment (2 complete and 13 partial responses); and of the 21
patients in the placebo group, 3 responded to treatment (3 partial responses)
(P<.005).
Conclusion Interferon alfa-2a is an effective alternative treatment for Behçet
disease, particularly for the management of the mucocutaneous lesions of the
disease.
From the Department of Dermatology, Akdeniz University School of Medicine
(Drs Alpsoy, Durusoy, Yilmaz, Ermis, Yazar, and Basaran), and the Department
of Ophthalmology, Antalya State Hospital (Dr Ozgurel), Antalya, Turkey.
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