SSc-ILD: Combination of rituximab and mycophenolate mofetil not superior to treatment with either agent alone

Combining rituximab with mycophenolate mofetil in patients with systemic sclerosis (SSc)-associated interstitial lung disease (ILD) did not significantly improve lung function compared to monotherapy. The proportion of patients with a percent predicted forced vital capacity (%pFVC) increase >3.3% was, however, numerically higher with the combination therapy.

Using the EUSTAR database, a cohort study was conducted to investigate the efficacy of combination therapy with rituximab plus mycophenolate mofetil versus treatment with either agent alone in patients with SSc-ILD [1]. Mixed-effect models were used to compare the changes in %pFVC and diffusing capacity of the lung for carbon monoxide (DLCO) on the different regimens over 12 months.

The study included 425 patients, distributed in 3 treatment groups with varying sample sizes: MMF (n=250), rituximab (n=154), and combination therapy (n=21). Dr Devis Benfaremo (Università Politecnica delle Marche, Italy) highlighted that the baseline characteristics indicated a likelihood of more aggressive disease in combination-treated patients.

Results showed increases in %pFVC in both the MMF monotherapy group (mean change +2.28%) and the combination group (+1.83%), with no statistically significant difference between them (P=0.867). Mean changes in DLCO were also comparable for MMF (-1.35%) and the combination (-2.05%; P=0.882).

Moreover, the comparison of rituximab with the combination led to similar results with no difference for mean changes in %pFVC (P=0.315) or DLCO (P=0.781). However, the proportion of patients achieving a >3.3% increase in %pFVC was numerically higher in the combination group (45.2%) compared to MMF (33.9%) and rituximab (33.5%).

“This EUSTAR cohort analysis confirms the effectiveness of both mycophenolate mofetil and rituximab for SSc-ILD and may support the use and feasibility of upfront combination therapy with these agents,” Dr Benfaremo concluded, indicating the need for further studies.

1. Benfaremo D, et al. Outcomes of upfront combination vs monotherapy with rituximab or mycophenolate mofetil for systemic sclerosis interstitial lung disease (SSc-ILD): results from an EUSTAR cohort study. OP0085, EULAR 2025, 11–14 June, Barcelona, Spain.

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Posted on 20 June 202520 June 2025