A multi-center, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease

Abstract Objectives Rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc). We aimed to assess long term efficacy and safety of RTX in SSc compared to standard treatment. Methods Fifty one patients with SSc-associated interstitial lung disease were recruited and treated with RTX (n=33) or conventional treatment (n=18). Median follow-up was 4 years (range 1-7). Conventional treatment consisted of azathioprine (n=2), methotrexate (n=6) and mycophenolate mofetil (n=10). Results Patients in the RTX group showed an increase in FVC at 2 years (mean ± SD of FVC: 80.60 ± 21.21 vs 86.90 ± 20.56 at baseline vs 2 years, respectively, p =0.041 compared to baseline). In sharp contrast, patients in the control group had no change in FVC during the first 2 years of follow up. At the 7 year time point the remaining patients in the RTX group (n=5) had higher FVC compared to baseline (mean ± SD of FVC: 91.60 ± 14.81, p =0.158 compared to baseline) in contrast to patients in the control group (n=9) where FVC deteriorated ( p