PULSE CYCLOPHOSPHAMIDE IN OCULAR MANIFESTATIONS OF BEHCET’S DISEASE: A DOUBLE BLIND CONTROLLED CROSSOVER STUDY

Background –The ocular lesions of Behcet’s disease (BD) naturally progress toward severe loss of vision or blindness. Cytotoxic drugs are the main treatment. To the best of our knowledge, no controlled study has ever been performed to show their efficacy. This study was designed to evaluate the short-term efficacy of intravenous pulse cyclophosphamide (PCP). Methods – In a randomized double blind controlled crossover study, 35 consecutive patients meeting both the International and Classification Tree criteria for BD and suffering from active posterior uveitis and/or retinal vasculitis were randomly assigned to either PCP or placebo group. Both groups received prednisolone (0.5 mg/kg/day). PCP was administered as 1 g per square meter of the body surface once monthly to the PCP group and normal saline to the placebo group. After 3 months, the two groups were interchanged. Disease activity index (DAI) and visual acuity (VA) were calculated. The study was done at Behcet’s Unit, Rheumatology Research Center, Tehran University of Medical Sciences after approval of the Ethics Committee and patients’ consent Results – The mean VA improved from 3.7 to 4.9 (t = 3.309, p < 0.002) in the PCP group and from 4.4 to 4.5 (t = 0.317, p = 0.75) in the placebo group. The difference was significant (t = 2.402, p < 0.02). Other parameters improved more remarkably in the PCP group than in the placebo group, but differences were not statistically significant Conclusion – This study shows the efficacy of the combination of PCP and prednisolone over prednisolone alone.