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

Abstract

To assess the efficacy of rituximab (RTX) in SSc. 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/m(2))] 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. 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 (DL(CO)) 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 DL(CO) 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). 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.