Safety and Tolerability of Two Different Formulations of Mycophenolate (Mycophenolate Mofetil and Mycophenolate Sodium) among Patient with Connective Tissue Disease Associated Interstitial Lung Disease (CTD-ILD) in a Tertiary Care Hospital

Abstract

Background: One of the leading cause of mortality in various connective tissue diseases(CTD) like systemicsclerosis(SSc)is Interstitial lung disease(ILD). The various CTD which may present as ILD include systemicsclerosis (SSc), rheumatoid arthritis(RA),dermatomyositis (DM), primary Sjogren’s syndrome(pSS), mixtedconnective tissue disease(MCTD) and systemic lupus erythematosus (SLE).Objective: To compare the safety and tolerability of two salts of mycophenolate,i.e. mycophenolate mofetiland mycophenolate sodium in our patients with CTD-ILD.Patients and Method: Ourstudy was retrospective observational study; involving 70 patients diagnosedwith CTD-ILD and was treated with two formulations of Mycophenolate (Mofetil and Sodium) minimumfor six months with at least one follow-up during the period of May 2013 to April 2017 at tertiary carehospital from India. Fifty-six patients received MPS and fourteen patients received MMF. The details ofpatients obtained from case records were recorded in a proforma. Statistical analysis was performed usingGraph pad for frequency, mean and percentages.Results: In our study,most of the patients receivedMycophenolate sodium (n=56) with the BD dose regimenof 720 mg (n=36), 540 mg (n=18) and 180 mg (n=2). Patients treated with MMF 1000 mg (n=12) and 750mg (n=2) as BD dose regimen.The adverse events reported in this study were GI (diarrhoea), herpes zosterinfection, cytopenia, malignancies or any other infections. The incidence of diarrhea is most commonlyobserved in this study population. Out of 26 reported cases, 14 patients had an episode of diarrhea at leastonce and 12 patients had diarrhea attack twice the preceding year.Conclusions: Both formulations of Mycophenolate were tolerated well, and have low-dose corticosteroiduse with no discontinuation of therapy.