Pulse Cyclophosphamide for Ocular Lesions of Behcet's Disease: double blind crossover study.


Abstract: Introduction: Ocular lesions of Behcet's Disease (BD) need aggressive treatment to prevent from severe loss of vision or blindness. Cytotoxic drugs are thought to be effective, but no control study has yet been done to show their efficacy. This study was designed to evaluate the short-term efficacy of pulse cyclophosphamide (PCP) in a randomized double blind control study. Materials & methods: PCP was used as lg per square meter of body surface in one liter of normal saline by intravenous infusion, once monthly, for the PCP group. Normal saline was administered alone for the placebo group. Prednisolone was given to both groups as 0.5 mg/kg/ daily. After 3 months, the two groups were interchanged. Inclusion Criteria: 1- Fulfilling the Classification Tree for BD. 2- Existence of active posterior uveitis (PU) and/or retinal vasculitis (RV). A Disease Activity Index (DAI) was calculated for each patient and for each section of each eye (anterior chamber, uvea, retina) upon their inflammatory state. Visual acuity (VA) was calculated by the Snellen chart. Results: The mean VA improved from 3.7 to 4.9 (t=3.309, p<0.002) for the PCP group and from 4.4 to 4.5 (t= 0.317, p=0.75) for the placebo group. The difference was significant (t =2.402, p< 0.02). The mean DAI for AU improved from 1.2 to 0.4 (t-- 3.273, p<0.003) for the PCP group and from 1.2 to 0.7 (t=1.972, p=0.057) for the placebo group. However, the difference between the two groups was not significant (t= 0.595, p=0.55). The mean DA1 for PU improved from 2.2 to 1.8 (t=1.898, p=0.063) for the PCP group and from 2.1 to 1.8 (t=1.27, p=0.21) for the placebo group. The difference between the two groups was not significant (t=0.495, p=0.62). The mean DAI for RV didn't change (DAI=1.2, t= 0.127, p=0.9) for the PCP group while it aggravated from 0.9 to 1.1 (t= 1.27, p=0.21) for the placebo group. The difference between the two groups was not significant (t=0.507, p=0.61). Conclusion: VA improved in patients receiving PCP and prednisolone, but not in those under steroids alone (statistical significance). Inflammatory indexes improved in both groups, but the difference between the two groups was not significant (short term study, use of steroids in both groups).