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Introduction Combination treatment with rituximab (RTX) and mycophenolate mofetil (MMF) is increasingly employed in systemic sclerosis (SSc). However, data on the safety of this combination therapy are scarce. We aimed to compare the safety of combination treatment with mycophenolate and rituximab (MMF-RTX) vs. rituximab monotherapy (RTX) in a single-center cohort of patients affected by SSc.Material and Methods In this retrospective cohort study, patients with SSc (ACR/EULAR 2013 criteria) treated at our center between 2012 and 2023 with either RTX or MMF-RTX were enrolled. Patients with a follow-up of at least 12 months and up to 36 months after the start of therapy were considered. Demographic, serological and clinical data were recorded, along with the following adverse events (AEs): infusion-related reactions, infections (any), severe infections (requiring hospitalization), hypogammaglobulinemia (IgG < 4 g/L), leukopenia (WBC < 4000/mm3). Patients were followed up until the occurrence of an adverse event (AE) or until the end of the observation period.Results 15 patients in the RTX group and 17 patients in the MMF-RTX group were included. The two groups were similar in terms of sex, disease duration and cutaneous form. All patients had normal IgG blood levels at baseline. Cardiac involvement was more frequent in the combination therapy group (p=0.003) ( table 1).During follow-up, which was similar between the two groups, two therapy-unrelated deaths occurred in the MMF-RTX group vs. 0 in RTX groups. At the end of follow-up, a total of 15 AEs were recorded, of which 6 in the RTX group and 9 in the MMF-RTX group (p=0.464) (table 2). Six infections were recorded in the RTX group: community-acquired pneumonia (CAP) (2), bacterial bronchitis (2, one requiring hospitalization), SARS-CoV-2 lower respiratory tract infection (LRTI) (1) complicated by pericarditis (requiring hospitalization), HZV infection (1). Seven infections were recorded in the MMF-RTX group: CAP (3, one requiring hospitalization), viral bronchitis (2), SARS-CoV-2 LRTI (1) complicated by symptomatic myocarditis and gastro-intestinal infection by C. jejuni (1). In the MMF-RTX group, two other AEs were recorded: hypogammaglobulinemia (IgG 350 mg/dL) and one infusion-related reaction (cutaneous rash). The occurrence of adverse events did not differ between the two groups, with a similar event-free survival (figure 1).Conclusions In conclusion, in patients with SSc, combination therapy with MMF and RTX appears to be safe and may be considered in severe SSc cases.Abstract P.284 Table 1Clinical and demographic characteristics of patients treated with RTX or RTX-MMFAbstract P.284 Table 2Number of patients affected by an adverse event and type of adverse event in the RTX group vs. RTX-MMF groupAbstract P.284 Figure 1Event-free survival analysis with Kaplan-Meier estimate in patients treated with RTXvs. RTX-MMF