OP0063 SAFETY OF MYCOPHENOLATE MOFETIL TREATMENT IN SYSTEMIC SCLEROSIS IN REAL LIFE: REPORT FROM A SINGLE CENTER LARGE COHORT OBSERVATIONAL STUDY
Authors: Rossella Chieffo, Maria Sofia Ciliento, Veronica Giacco, Giuseppe Scalise, Serena Vettori
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Mycophenolate mofetil (MMF) has been increasingly used in the treatment of early diffuse cutaneous Systemic Sclerosis (dcSSc) and SSc-associated interstitial lung disease (SSc-ILD), and a recent Randomized Controlled Trial confirmed its efficacy and safety in SSc-ILD. However, the safety of this drug in the long term use has not been assessed in a real life setting. <h3>Objectives</h3> We aimed to analyze the period prevalence and the type of adverse events (AEs) associated to MMF treatment in a single center large cohort. <h3>Methods</h3> Charts of all SSc patients meeting the 2013 ACR/EULAR classification criteria consecutively visited at our outpatient clinic from January 1st 2017 to December 31st 2017 were retrospectively analyzed. Demographics, clinical, serological, functional, imaging data, treatments, and AEs were recorded. Patients were subgrouped according to the immunosuppressant (IS) taken during the observation period (e.g. MMF, azathiprine- AZA, or cyclophosphamide- CYC, no IS). The period prevalence of AEs was calculated and correlations of between AEs and patient features were investigated by univariate and multivariate analyses. <h3>Results</h3> Two-hundred and thirty-seven patients were included (92.4% were females, aged 56.4±11.3 years, with a median disease duration of 17 years, range 1-60). Among them, 85 (35.9%) were taking MMF, 34 (14.3%) AZA or CYC, 118 (49.8%) had no current IS treatment. Prevalence of the dcSSc subset was higher in the MMF group (34.1% versus 17.6% in the AZA/CYC group and 5.9% in the no IS group; p &lt;0.05), while prevalence of ILD was similar in the MMF and in the AZA/CYC group and higher than the no IS group (89.4% and 82.3% versus 41.5%; p&lt;0.05 for both), as well as the prevalence of the anti-topoisomerase I antibody positivity (60.7% and 52.9% versus 26.3%; p&lt;0.05). Both patients treated with MMF and AZA/CYC had more frequently concomitant low-dose glucocorticoid (GC) therapy than patients without IS (76.5% for both groups versus 39%; p&lt;0.05). In regard of total AEs, their prevalence was higher in the MMF group (71.7% versus 67% in the AZA/CYC group and 49% in the no IS group; p&lt;0.05 MMF vs no IS). In particular, patients treated with MMF had a higher prevalence of total infectious AEs (55.7% versus 30.4% in the AZA/CYC group and 27.6% in the no IS group; p&lt;0.05), predominantly airway infections (41.2% of all infectious AEs). Given so, we investigated the correlations of the infectious AEs in the MMF group with ILD, smoking history, and concurrent GC. However, we didn't find any significant association with these variables. When we looked for correlations of infectious AEs in the MMF group with other disease features, we found that they were correlated with the duration of the disease (median= 4 years; r=0.25; p=0.02) and with the presence of digital ulcers and/or pitting scars (r=0.22; p=0.03). No AE required hospitalization and resolved after treatment suspension. <h3>Conclusion</h3> The period prevalence of AEs recorded during MMF treatment appeared as high as 71.7% in our real life setting. Even though we did not record any serious AE, our analysis suggests a close monitoring of this therapy in SSc. <h3>Disclosure of Interests</h3> Rossella Chieffo: None declared, Maria Sofia Ciliento: None declared, Veronica Giacco: None declared, GIUSEPPE SCALISE: None declared, Serena Vettori Consultant for: Boehringer Ingelheim Italia SpA