A RANDOMIZED CONTROLLED TRIAL TO COMPARE THE EFFICACY AND SAFETY OF TACROLIMUS WITH MYCOPHENOLATE MOFETIL IN PATIENTS WITH SYSTEMIC SCLEROSIS – INTERSTITIAL LUNG DISEASE (INSIST TRIAL)
Authors: Shefali Khanna Sharma et al.
Interstitial lung disease in systemic sclerosis (SSc-ILD) has limited therapeutic options. This single center open labelled, prospective study randomized 26 mostly anti-topoisomerase positive SSc patients with progressive ILD (FVC decline >10%) to receive either MMF (2gm/day) or tacrolimus (max dose-0.075 mg/kg/day; target trough levels- 4- 10ng/ml).
At 24 weeks, the mean change in FVC was 4.4% and 6.9% in the MMF and tacrolimus groups, respectively. All patients on tacrolimus and 85% of patients on MMF had stabilization or improvement (ΔFVC% >10%). The mean tacrolimus levels were 4.9 ng/ml and the median dose needed to achieve these levels was 4mg/d. No serious adverse events were noted. Gastrointestinal disturbances were noted in 23% of patients receiving mycophenolate and new onset hypertension, minor infection and diarrhea in 1 patient each in the tacrolimus arm.
In patients with SSc, tacrolimus improved FVC comparable to MMF with a favorable safety profile. Larger studies with longer follow up are needed.