Add-on tacrolimus provides short-term survival gains in PM/DM-interstitial pneumonia

Initial treatment with tacrolimus and glucocorticoids (GCs) appears to improve short-term mortality in polymyositis (PM)/dermatomyositis (DM)-interstitial pneumonia patients, according to a recent study.

A total of 25 patients (mean age, 55.4 years; 76 percent female) received initial combination treatment with tacrolimus (0.075 mg/kg/day, adjusted for the target whole-blood trough levels between 5 and 10 ng/ml) and glucocorticoids (0.6–1.0 mg/kg/day of prednisolone followed by a slow taper) for 52 weeks.

The primary outcome of overall survival at 52 weeks was 88.0 percent (95 percent CI, 67.3–96.0 percent). Progression-free survival rate was 76.4 percent (51.8–89.5 percent).

Whole-blood tacrolimus trough levels were preserved within the targeted range of 5 and 10 ng/ml throughout the study period (average, 6.6 ng/ml), with an average daily dose of 3.81 mg/day (0.072 mg/kg/day).

The safety profile of the combination treatment was consistent with the known adverse event (AE) profile of tacrolimus and high-dose GCs individually. A total of 11 patients (44 percent) developed serious adverse events, which included four opportunistic infections.

In total, there were 475 AEs recorded, of which 357 (75.2 percent) were deemed possibly, probably or definitely associated with tacrolimus or GCs by treating physicians.

The current prospective clinical investigation was the first to be conducted according to the Good Clinical Practice Guideline of the International Conference on Harmonization for the treatment of PM/DM-interstitial pneumonia.