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.
This is a preview of subscription content, log in to check access.
This work was supported by the Science and Technology Commission Foundation of Beijing (No: Z121107001012005).
Wallemacq PE, Verbeeck RK (2001) Comparative clinical pharmacokinetics of tacrolimus in paediatric and adult patients. Clin Pharmacol kinet 40:283–295CrossRefGoogle Scholar
Shimojima Y, Gono T, Yamamoto K et al (2004) Efficacy of tacrolimus in treatment of polymyositis associated with myasthenia gravis. Clin Rheumatol 23:262–265CrossRefPubMedGoogle Scholar
Hassan J, van der Net JJ, van Royen-Kerkhof A (2008) Treatment of refractory juvenile dermatomyositis with tacrolimus. Clin Rheumatol 27:1469–1471CrossRefPubMedGoogle Scholar
Ando M, Miyazaki E, Yamasue M et al (2010) Successful treatment with tacrolimus of progressive interstitial pneumonia associated with amyopathic dermatomyositis refractory to cyclosporine. Clin Rheumatol 29:443–445CrossRefPubMedGoogle Scholar
American Thoracic Society, European Respiratory Society (2000) Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. Am J Respir Crit Care Med 161:646–664CrossRefGoogle Scholar
Kurita T, Yasuda S, Oba K et al (2015) The efficacy of tacrolimus in patients with interstitial lung diseases complicated with polymyositis or dermatomyositis. Rheumatology (Oxford) 54:39–44CrossRefGoogle Scholar
Yokoyama Y, Furuta S, Ikeda K et al (2015) Corticosteroid-sparing effect of tacrolimus in the initial treatment of dermatomyositis and polymyositis. Mod Rheumatol 16:1–22Google Scholar
Wilkes MR, Sereika SM, Fertig N et al (2005) Treatment of antisynthetase-associated interstitial lung disease with tacrolimus. Arthritis Rheum 52:2439–2446CrossRefPubMedGoogle Scholar
Mitsui T, Kuroda Y, Ueno S et al (2011) The effects of FK506 on refractory inflammatory myopathies. Acta Neurol Belg 111:188–194PubMedGoogle Scholar
Shimojima Y, Ishii W, Matsuda M et al (2012) Coadministration of tacrolimus with corticosteroid accelerates recovery in refractory patients with polymyositis/dermatomyositis: a retrospective study. BMC Musculoskelet Disord 13:228–233PubMedCentralCrossRefPubMedGoogle Scholar
Matsubara S, Kondo K, Sugaya K et al (2012) Effects of tacrolimus on dermatomyositis and polymyositis: a prospective, open, non-randomized study of nine patients and a review of the literature. Clin Rheumatol 31:1493–1498CrossRefPubMedGoogle Scholar
Labirua-Iturburu A, Selva-O'Callaghan A, Martínez-Gómez X et al (2013) Calcineurin inhibitors in a cohort of patients with antisynthetase-associated interstitial lung disease. Clin Exp Rheumatol 31:436–439PubMedGoogle Scholar
Ingegnoli F, Lubatti C, Ingegnoli A et al (2012) Interstitial lung disease outcomes by high-resolution computed tomography (HRCT) in Anti-Jo1 antibody-positive polymyositis patients: a single centre study and review of the literature. Autoimmun Rev 11:335–340CrossRefPubMedGoogle Scholar
Ge Y, Peng Q, Zhang S et al (2015) Cyclophosphamide treatment for idiopathic inflammatory myopathies and related interstitial lung disease: a systematic review. Clin Rheumatol 34:99–105CrossRefPubMedGoogle Scholar