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Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group

(2015) ANNALS OF THE RHEUMATIC DISEASES. 74(6). p.1188-1194
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Abstract
Objectives: To assess the effects of Rituximab (RTX) on skin and lung fibrosis in patients with systemic sclerosis (SSc) belonging to the European Scleroderma Trial and Research (EUSTAR) cohort and using a nested case-control design. Methods: Inclusion criteria were fulfilment of American College of Rheumatology classification criteria for SSc, treatment with RTX and availability of follow-up data. RTX-treated patients were matched with control patients from the EUSTAR database not treated with RTX. Matching parameters for skin/lung fibrosis were the modified Rodnan Skin Score (mRSS), forced vital capacity (FVC), follow-up duration, scleroderma subtype, disease duration and immunosuppressive co-treatment. The primary analysis was mRSS change from baseline to follow-up in the RTX group compared with the control group. Secondary analyses included change of FVC and safety measures. Results: 63 patients treated with RTX were included in the analysis. The case-control analysis in patients with severe diffuse SSc showed that mRSS changes were larger in the RTX group versus matched controls (N=25; -24.05.2% vs -7.7 +/- 4.3%; p=0.03). Moreover, in RTX-treated patients, the mean mRSS was significantly reduced at follow-up compared with baseline (26.6 +/- 1.4 vs 20.3 +/- 1.8; p=0.0001). In addition, in patients with interstitial lung disease, RTX prevented significantly the further decline of FVC compared with matched controls (N=9; 0.4 +/- 4.4% vs -7.7 +/- 3.6%; p=0.02). Safety measures showed a good profile consistent with previous studies in autoimmune rheumatic diseases. Conclusions: The comparison of RTX treated versus untreated matched-control SSc patients from the EUSTAR cohort demonstrated improvement of skin fibrosis and prevention of worsening lung fibrosis, supporting the therapeutic concept of B cell inhibition in SSc.
Keywords
Treatment, TIGHT-SKIN MOUSE, B cells, Systemic Sclerosis, INTERSTITIAL LUNG-DISEASE, RESEARCH GROUP DATABASE, B-CELL DEPLETION, RHEUMATOID-ARTHRITIS, AUTOIMMUNE-DISEASES, CD19/CD22 LOOP, DOUBLE-BLIND, FIBROSIS, SCORE

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Chicago
Jordan, Suzana, Jörg HW Distler, Britta Maurer, Dörte Huscher, Jacob M van Laar, Yannick Allanore, Oliver Distler, on behalf of the EUSTAR Rituximab study group, and Vanessa Smith. 2015. “Effects and Safety of Rituximab in Systemic Sclerosis: An Analysis from the European Scleroderma Trial and Research (EUSTAR) Group.” Annals of the Rheumatic Diseases 74 (6): 1188–1194.
APA
Jordan, S., Distler, J. H., Maurer, B., Huscher, D., van Laar, J. M., Allanore, Y., Distler, O., et al. (2015). Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group. ANNALS OF THE RHEUMATIC DISEASES, 74(6), 1188–1194.
Vancouver
1.
Jordan S, Distler JH, Maurer B, Huscher D, van Laar JM, Allanore Y, et al. Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group. ANNALS OF THE RHEUMATIC DISEASES. 2015;74(6):1188–94.
MLA
Jordan, Suzana et al. “Effects and Safety of Rituximab in Systemic Sclerosis: An Analysis from the European Scleroderma Trial and Research (EUSTAR) Group.” ANNALS OF THE RHEUMATIC DISEASES 74.6 (2015): 1188–1194. Print.
@article{8039034,
  abstract     = {Objectives: To assess the effects of Rituximab (RTX) on skin and lung fibrosis in patients with systemic sclerosis (SSc) belonging to the European Scleroderma Trial and Research (EUSTAR) cohort and using a nested case-control design. 
Methods: Inclusion criteria were fulfilment of American College of Rheumatology classification criteria for SSc, treatment with RTX and availability of follow-up data. RTX-treated patients were matched with control patients from the EUSTAR database not treated with RTX. Matching parameters for skin/lung fibrosis were the modified Rodnan Skin Score (mRSS), forced vital capacity (FVC), follow-up duration, scleroderma subtype, disease duration and immunosuppressive co-treatment. The primary analysis was mRSS change from baseline to follow-up in the RTX group compared with the control group. Secondary analyses included change of FVC and safety measures. 
Results: 63 patients treated with RTX were included in the analysis. The case-control analysis in patients with severe diffuse SSc showed that mRSS changes were larger in the RTX group versus matched controls (N=25; -24.05.2% vs -7.7 +/- 4.3%; p=0.03). Moreover, in RTX-treated patients, the mean mRSS was significantly reduced at follow-up compared with baseline (26.6 +/- 1.4 vs 20.3 +/- 1.8; p=0.0001). In addition, in patients with interstitial lung disease, RTX prevented significantly the further decline of FVC compared with matched controls (N=9; 0.4 +/- 4.4% vs -7.7 +/- 3.6%; p=0.02). Safety measures showed a good profile consistent with previous studies in autoimmune rheumatic diseases. 
Conclusions: The comparison of RTX treated versus untreated matched-control SSc patients from the EUSTAR cohort demonstrated improvement of skin fibrosis and prevention of worsening lung fibrosis, supporting the therapeutic concept of B cell inhibition in SSc.},
  author       = {Jordan, Suzana and Distler, Jörg HW and Maurer, Britta and Huscher, Dörte and van Laar, Jacob M and Allanore, Yannick and Distler, Oliver and EUSTAR Rituximab study group, on behalf of the and Smith, Vanessa},
  issn         = {0003-4967},
  journal      = {ANNALS OF THE RHEUMATIC DISEASES},
  keywords     = {Treatment,TIGHT-SKIN MOUSE,B cells,Systemic Sclerosis,INTERSTITIAL LUNG-DISEASE,RESEARCH GROUP DATABASE,B-CELL DEPLETION,RHEUMATOID-ARTHRITIS,AUTOIMMUNE-DISEASES,CD19/CD22 LOOP,DOUBLE-BLIND,FIBROSIS,SCORE},
  language     = {eng},
  number       = {6},
  pages        = {1188--1194},
  title        = {Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group},
  url          = {http://dx.doi.org/10.1136/annrheumdis-2013-204522},
  volume       = {74},
  year         = {2015},
}

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