Rituximab Safe, Effective in Patients With Systemic Sclerosis

Rituximab treatment improved skin fibrosis in a cohort of patients with SSc, but no significant change was observed in lung fibrosis.

The use of rituximab was safe and effective in a cohort of patients with systemic sclerosis (SSc), according to study results published in the Annals of the Rheumatic Diseases.

Researchers conducted a prospective cohort study of 254 patients with SSc treated with varying doses of rituximab. Participants were recruited from the European Scleroderma Trials and Research (EUSTAR) network and subsequently matched with rituximab-naive controls. Safety outcomes measured were the occurrence of adverse effects, while efficacy parameters included steroid use, worsening of lung fibrosis, and improvement of skin fibrosis.

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After analysis, the researchers found that after a median follow-up of 2 years, almost 70% of patients treated with rituximab reported no adverse effects. However, when assessed at a treatment center, 9% of patients had discontinued treatment due to an adverse effect.

With respect to efficacy, patients administered rituximab had a greater likelihood of having skin fibrosis improvement compared with propensity-score matched controls (22.7 vs 14.03 events per 100 person-years; odds ratio [OR], 2.79; 95% CI, 1.47-5.32; P =.002). In addition, participants who received rituximab were more likely to stop or reduce steroid use (OR, 2.34; 95% CI, 1.56–3.53; P <.0001).

One key limitation of the study was its observational design.

“Significant change was observed on skin fibrosis, but not on lung,” the researchers wrote. “The potential stabilization of lung fibrosis by rituximab has to be addressed by a randomized trial,” they concluded.


Elhai M, Boubaya M, Distler O, et al. Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study [published online April 9, 2019]. Ann Rheum Dis. doi:10.1136/annrheumdis-2018-214816