AB0732 Efficacy and safety of rituximab in systemic sclerosis: french retrospective study and literature review
Authors: M. Thiébaut, D. Launay, S. Rivière, T. Mahévas, S. Bellakhal, E. Hachulla, O. Fain, A. Mekinian
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Interstitial lung disease occurs in 42% of diffuse SSc patients and have a major impact on the overall survival.<sup>1</sup> Cyclophosphamide and mycophenolate mofetil can allow the lung disease stabilisation.<sup>2,3</sup> Recently several case-reports and little series reported the efficacy of rituximab in SSc, showing a possible improvement of pulmonary involvements.<sup>4,5,6</sup> Large studies are lacking to determine the factors associated with rituximab response, the maintenance regimen and the long term efficacy of rituximab in SSc. <h3>Objectives</h3> To describe safety and efficacy of rituximab in patients with systemic sclerosis. <h3>Methods</h3> We included 13 patients with systemic sclerosis treated with rituximab and pooled with 40 additional patients from the literature. SSc rituximab untreated patients were matched to rituximab treated ones. <h3>Results</h3> Thirteen patients who received rituximab and 26 rituximab-untreated patients were included. In comparison to 26 patients who did not received rituximab, FVC changes were not significantly different, whereas DLCO improved in 13 patients who received rituximab (0 [-4; 4] vs loss of −7 [−19; 0]; p=0.05). Considering 7 rituximab treated and 14 untreated diffuse SSc, FVC was improved during the 24<sup>12; 46</sup> months of follow up in dSSc who received rituximab (gain of 12 [7.5:14]% vs loss of 1.5 [-16.8; 2.5], (p=0.003). Pooled analysis of 53 patients (40 literature patients and 13 from personal series) showed significant improvement of median mRSS from 18<sup>8; 32</sup> at baseline to 9<sup>4; 18</sup> at M6 (p=0.007), 13<sup>8; 18</sup> at M12 (p=0.008) and 10<sup>4; 16</sup> at the last follow-up (p=0.0002). FVC increased from 71%<sup>66; 80</sup> at baseline to 84%<sup>75; 90</sup> at M12 (p=0.001). DLCO increased from 58%<sup>39; 65</sup> at M0% to 63%<sup>53; 78</sup> at M12 (p=0.04). <h3>Conclusions</h3> Our personal data and pooled literature analysis suggest the efficacy of rituximab in the subset of diffuse SSc in particular in skin and interstitial disease involvements. The safety of rituximab seems to be reasonable and similar to previous data in other autoimmune diseases. <h3>References</h3> [1] Nihtyanova SI, Schreiber BE, Ong VH, et al. Prediction of pulmonary complications and long-term survival in systemic sclerosis. Arthritis Rheumatol Hoboken NJ2014;66:1625–35. [2] Tashkin DP, Elashoff R, Clements PJ, et al. Cyclophosphamide in scleroderma lung disease. N Engl J Med2006;355:1173–1174. [3] Tashkin DP, Roth MD, Clements PJ, et al. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial. Lancet Respir Med2016;4:708–19. [4] Lafyatis R, Kissin E, York M, et al. B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis. Arthritis Rheum2009;60:578–83. [] 5) Bosello S, De Santis M, Lama G et al. B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial. Arthritis Res Ther2010;12:1. [6] Daoussis D, Liossis S-NC, Tsamandas AC, et al. Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study. Rheumatology2010;49:271–80. <h3>Disclosure of Interest</h3> None declared