1. OP0063 SAFETY OF MYCOPHENOLATE MOFETIL TREATMENT IN SYSTEMIC SCLEROSIS IN REAL LIFE: REPORT FROM A SINGLE CENTER LARGE COHORT OBSERVATIONAL STUDY
- Author
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Serena Vettori, Maria Sofia Ciliento, Rossella Chieffo, Veronica Giacco, and Giuseppe Scalise
- Subjects
medicine.medical_specialty ,Cyclophosphamide ,business.industry ,Interstitial lung disease ,Prevalence ,medicine.disease ,Single Center ,law.invention ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Outpatient clinic ,Observational study ,Adverse effect ,business ,medicine.drug - Abstract
Background 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. Objectives We aimed to analyze the period prevalence and the type of adverse events (AEs) associated to MMF treatment in a single center large cohort. Methods 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. Results 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 Conclusion 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. Disclosure of Interests 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
- Published
- 2019