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Rheumatology Advance Access published online on May 15, 2009

Rheumatology, doi:10.1093/rheumatology/kep093
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© The Author 2009. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study

Dimitrios Daoussis1,*, Stamatis-Nick C. Liossis1,*, Athanassios C. Tsamandas2, Christina Kalogeropoulou3, Alexandra Kazantzi3, Chaido Sirinian2, Maria Karampetsou1, Georgios Yiannopoulos1 and Andrew P. Andonopoulos1

1Division of Rheumatology, Department of Internal Medicine,2Department of Pathology and 3Department of Radiology, Patras University Hospital, University of Patras Medical School, Patras, Greece

Correspondence to: Dimitrios Daoussis, Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, 26504 Rion, Patras, Greece. E-mail: jimdaoussis{at}hotmail.com


   Abstract

Objective. To assess the efficacy of rituximab (RTX) in SSc.

Methods. Fourteen patients with SSc were evaluated. Eight patients were randomized to receive two cycles of RTX at baseline and 24 weeks [each cycle consisted of four weekly RTX infusions (375 mg/m2)] in addition to standard treatment, whereas six patients (control group) received standard treatment alone. Lung involvement was assessed by pulmonary function tests (PFTs) and chest high-resolution CT (HRCT). Skin involvement was assessed both clinically and histologically.

Results. There was a significant increase of forced vital capacity (FVC) in the RTX group compared with baseline (mean ± S.D.: 68.13 ± 19.69 vs 75.63 ± 19.73, at baseline vs 1-year, respectively, P = 0.0018). The median percentage of improvement of FVC in the RTX group was 10.25%, whereas that of deterioration in the controls was 5.04% (P = 0.002). Similarly, diffusing capacity of carbon monoxide (DLCO) increased significantly in the RTX group compared with baseline (mean ± S.D.: 52.25 ± 20.71 vs 62 ± 23.21, at baseline vs 1-year respectively, P = 0.017). The median percentage of improvement of DLCO in the RTX group was 19.46%, whereas that of deterioration in the control group was 7.5% (P = 0.023). Skin thickening, assessed with the Modified Rodnan Skin Score (MRSS), improved significantly in the RTX group compared with the baseline score (mean ± S.D.: 13.5 ± 6.84 vs 8.37 ± 6.45 at baseline vs 1-year, respectively, P < 0.001).

Conclusion. Our results indicate that RTX may improve lung function in patients with SSc. To confirm our encouraging results we propose that larger scale, multicentre studies with longer evaluation periods are needed.

KEY WORDS: Scleroderma, Systemic sclerosis, Rituximab, Interstitial lung disease, Fibrosis, B cells


*Dimitrios Daoussis and Stamatis-Nick C. Liossis contributed equally to this work.

Submitted 23 January 2009; Accepted 19 March 2009


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