Rituximab for systemic sclerosis safely improves skin fibrosis
Treatment with rituximab in patients with systemic sclerosis (SSc) is relatively safe and produces improvements in skin but not lung fibrosis, a study has shown.
Researchers used data from the European Scleroderma Trials and Research (EUSTAR) network and identified 254 SSc patients (median age, 51 years; 71 percent female) treated with rituximab. They assessed the safety of the drug and its effect on skin fibrosis improvement, lung fibrosis worsening and steroids use.
In the cohort, rituximab was indicated for lung involvement in 58 percent of patients and for skin involvement in 32 percent. After a median follow-up of 2 years, the majority (70 percent) of patients did not develop any side effects.
An analysis comparing the 254 rituximab-treated SSc patients with 9,575 propensity-score matched patient controls showed rituximab treatment to be associated with a higher likelihood of skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; odds ratio [OR], 2.79, 95 percent CI, 1.47–5.32; p=0.002).
On the other hand, there were no significant between-group differences observed in rates of forced vital capacity (FVC) >10 percent (OR, 1.03, 0.55–1.94; p=0.93) or in carbon monoxide diffusing capacity (DLCO) <70 percent (OR, 1.68, 0.68–4.2; p=0.27).
Compared with controls, rituximab-treated patients were more likely to stop or reduce steroids (OR, 2.34, 1.56–3.53; p<0.0001). Furthermore, patients who received mycophenolate mofetil concomitantly tended to have better outcomes than those who received rituximab alone (delta FVC: OR, 3, 0.66–5.35; p=0.012) and controls (OR, 5.22, 0.83–9.62; p=0.019).
The study was limited by its observational design, according to researchers, adding that the potential stabilization of lung fibrosis by rituximab has to be addressed in a randomized trial.