The purpose of this study is to examine the efficacy and safety of
tacrolimus (
FK506) in the management of
polymyositis (PM)/
dermatomyositis (DM). The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, and China National Knowledge Infrastructure (CNKI) were searched to find articles published between May 1980 and April 2015 concerning
tacrolimus therapy in PM/DM. The initial search yielded 107 articles. In the end, eight studies met our inclusion criteria and involved a total of 134 patients who received
tacrolimus therapy for DM/PM. All studies were non-randomized. Oral
tacrolimus of 0.075 mg/kg/day or 1.0-3.5 mg/d was administered twice daily or once daily together with
glucocorticoids (GCs). According to comprehensive analysis of the studies, 93.3 % (42/45) and 64.7 % (11/17) of patients showed improvement in muscle strength and physical function status. The
creatine kinase (CK) levels of 100 % (68/68) of patients decreased. The average dosage of GCs was reduced from 33.8 to 11.5 mg/day in PM/DM patients after the addition of
tacrolimus. In the subject population, 65 patients had
interstitial lung disease (ILD).
After treatment, the forced vital capacity (FVC) and diffusing capacity for
carbon monoxide (DLCO) improved or stabilized in 89.3 % (25/28) and 81.3 % (13/16) of patients, respectively. The commonly adverse events were nephrotoxicity, hypomagnesemia,
tremors, and
hypertension, but they were slight among these patients. Current evidence appears to support the use of
tacrolimus in refractory PM/DM and PM/DM-ILD patients.
Tacrolimus seems to be a safe
drug that improves both muscle strength and lung function, and it is well tolerated by patients. However, this conclusion should be confirmed by large-sample, randomized controlled studies.