Are high doses of prednisone necessary for treatment of interstitial lung disease in systemic sclerosis?

INTRODUCTION Interstitial lung disease (ILD) as part of systemic sclerosis (SS) is a leading cause of morbidity and mortality. OBJECTIVES To evaluate the use of intravenous pulse cyclophosphamide combined with low and high doses of prednisone in the treatment of ILD in SS is equally effective. METHOD An experimental, exploratory and randomized single-blind clinical trial was conducted at Hermanos Ameijeiras Clinical Surgical Hospital from September 2006 to December 2009, including 23 patients with SS and ILD. Two treatment schedules were evaluated and randomly assigned. Group A was composed of 13 patients with a monthly dose of cyclophosphamide (ev) for 6 months and a twice-monthly dose for the remaining 6 months, prednisone (1 mg × kg × day) 4 weeks and then the dose was lowered to 5mg every 2 weeks up to 10mg. Group B: 10 patients with cyclophosphamide (ev), oral prednisone 10mg daily. RESULTS There are significant differences at onset of CVF and the honeycomb pattern between both groups, where the high dose group was at a disadvantage. At the end of treatment the low dose group achieved improvement of radiologic lesions and the Warrick index, unlike the high dose group. The remaining variables experienced improvement in both groups without marked inequality. Similarly, slight adverse reactions were present in both groups. Two patients dropped out of the study. CONCLUSIONS A combination of low dose steroids with cyclophosphamide is effective in interstitial lung disease treatment especially in active disease, and results did not showe differences regarding the high dose group but the sample size and the evolutionary severity of high dose patients oblige other studies to verify this data.