• Dimitrios Daoussis, Konstantinos Melissaropoulos, Georgios Sakellaropoulos, Ioannis Antonopoulos, Theodora E Markatseli, Theodora Simopoulou, Panagiotis Georgiou, Andrew P Andonopoulos, Alexandros A Drosos, Lazaros Sakkas, and Stamatis-Nick Liossis.
• Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, University of Patras Medical School, 26504 Rion, Patras, Greece. Electronic address: jimdaoussis@hotmail.com.
• Semin. Arthritis Rheum. 2017 Apr 1; 46 (5): 625-631.

ObjectivesRituximab (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.MethodsA total of 51 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).ResultsPatients 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 < 0.01, compared to baseline). Direct comparison between the 2 groups showed a significant benefit for the RTX group in FVC (p = 0.013). Improvement of skin thickening was found in both the RTX and the standard treatment group; however, direct comparison between groups strongly favored RTX at all-time points. Adverse events were comparable between groups.ConclusionsOur data indicate that RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc. Randomized controlled studies are highly needed.Copyright © 2017 Elsevier Inc. All rights reserved.

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