Treatment with Rituximab is associated with significantly improved cutaneous sclerosis: real-world observations in an Indian cohort.

Abstract

Background: Rituximab, is effective in both SSc-associated ILD and cutaneous sclerosis. However, most studies report improvement in skin sclerosis as secondary outcomes, leaving a gap in literature on rituximab's dermatological impact. Hence this study evaluates rituximab's effectiveness in reducing skin sclerosis.

Materials and methods: This retrospective study was conducted at a tertiary care center in northern India. Records of SSc patients from 2016 to 2023 were reviewed. Clinical assessments, investigations and standard treatment for end organ damage was done according to clinical presentation and EULAR guidelines. Rituximab was administered at a dose of 1g 2 weeks apart to patients having a baseline mRSS of 14 or higher, with or without ILD or a baseline mRSS of greater than seven1 and less than 14 in the presence of ILD, by a departmental protocol. Patients were divided into two groups: those receiving rituximab (rituximab group) and rituximab-naïve patients. Treatment response was evaluated based on change in mRSS and overall survival.

Results: Among 98 SSc patients, 37 received rituximab, and 61 were rituximab - naïve. The rituximab group had higher percentage of DSS patients (70.3% vs 29.5%) and higher baseline mRSS (20.1 vs. 11.5). There was significantly greater percentage reduction in mRSS (47.9% vs. 31.2%, p=0.013) in the Rituximab group as compared to the Rituximab naïve group. Overall survival was 65.8% at 140 months in the rituximab group as compared to 53.2% at 95 months in rituximab-naïve group (p=0.851). Patients with LSS had a better survival (77.8% at 100 months) as compared to those with DSS (46.9% at 140 months, p=0.048). On multivariate analysis, a greater percentage reduction in mRSS was the strongest predictor of survival (p=0.039).

Conclusion: Rituximab shows significant reduction in skin sclerosis even in patients with more severe baseline skin sclerosis, though it did not demonstrate any survival benefit.