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