To compare the impact of CyP and RTM on SSc clinical manifestation,activity,and the safety of these agents in the open-label prospective non-randomized study.
107 patients with the confirmed SSc diagnosis and ILD were enrolled into the study. 36 patients(Group A) received CyP for 12±6 months at total dose 10.6±5g. 71 patients(Group B) received RTM at total dose 1.43±0.66g over the follow-up period 13.2±2 months. The time courses FVC(%), modified skin count(mRss), activity index(EScSG), left ventricle ejection fraction (LVEF,%), mean pulmonary arterial pressure, and cardiac rhythm and conductivity disorders were evaluated.
In Groups A and B the therapy was associated with significant decrease in mRss (р=0.009 and 0,001) and EScSG (р=0.000165 and 0.001). Increase in LVEF was observed only in RTM-treated patients.
Evaluation of FVC time course in Groups A and B revealed significant FVC increase(р= 0.034 and 0.000045, with median increment about 5%.
In Group A 10% FVC increase was found in the third of the patients thus exceeding respective parameter in Group B(р=0.2).
During the follow-up period no change of the other studied parameters was observed.
The therapy was better tolerated in RTM-treated group.
Both agents effectively alleviated mRss, EScSG, and significantly improved FVC. CyP use slightly more frequently resulted in clinically significant FVC increase,probably due to low RTM cumulative dose. RTM was better tolerated. The study findings substantiate potential use of RTM both as a first-line agent for ILD treatment in SSc, and in the event of CyP inefficacy of poor tolerability, especially in the patients with cardiopathy.