Efficacy and safety analysis of glucocorticoid and tacrolimus in the treatment of anti-synthetase syndrome-associated interstitial lung disease_Chinese Journal of Respiratory and Critical Care Medicine

Authors：

ZHAO Qi , ZOU Ruyi , TIAN Yaqiong , YAN Xin , GAO Yujuan , LIU Yin , CAO Min , DAI Jinghong ,  CAI Hourong

Department of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, Jiangsu 210008, P. R. China;

Corresponding author：

CAI Hourong, Email: caihourong2013@163.com

Keywords：

Anti-synthetase syndrome; tacrolimus; interstitial lung disease; polymyositis; dermatomyositis

DOI：

10.7507/1671-6205.202210010

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Objective To evaluate the efficacy and safety of glucocorticoids (GC) monotherapy and GC combined with tacrolimus (TAC) therapy in patients with anti-synthetase syndrome-associated interstitial lung disease (ASS-ILD). Methods Through retrospective analysis and propensity score matching (PSM) analysis, the 2-year progression-free survival (PFS) and related side effects of ASS-ILD patients in TAC+GC group and GC monotherapy group were compared. Predictors associated with PFS were analyzed with COX. Results The 2-year PFS rate of TAC+GC group was better than that of GC group [P=0.0163; hazard ratio (HR) 0.347]; Univariate and multivariate analysis of the COX regression model for 2-year PFS in the two groups suggested that creatine kinase level (P=0.0019, HR 1.002) and initial treatment selection [(TAC+GC) vs. GC, P=0.0197, HR 0.207] were independent predictors of PFS; PSM analysis showed that the 2-year PFS rate of TAC+GC group (54.5%) was higher than that of GC group (18.2%) (P=0.0157, HR 0.275). In terms of adverse effect, there was no significant increase in GC+TAC group compared with GC group. Conclusion Compared with GC monotherapy, initial TAC+GC treatment significantly prolonged PFS in ASS-ILD patients and did not increase the incidence of drug-related complications.

Citation： ZHAO Qi, ZOU Ruyi, TIAN Yaqiong, YAN Xin, GAO Yujuan, LIU Yin, CAO Min, DAI Jinghong, CAI Hourong. Efficacy and safety analysis of glucocorticoid and tacrolimus in the treatment of anti-synthetase syndrome-associated interstitial lung disease. Chinese Journal of Respiratory and Critical Care Medicine, 2023, 22(3): 176-181. doi: 10.7507/1671-6205.202210010 Copy

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2.	Mirrakhimov AE. Antisynthetase syndrome: a review of etiopathogenesis, diagnosis and management. Curr Med Chem, 2015, 22(16): 1963 - 1975.
3.	Lega JC, Fabien N, Reynaud Q, et al. The clinical phenotype associated with myositis-specific and associated autoantibodies: a meta-analysis revisiting the so-called antisynthetase syndrome. Autoimmun Rev, 2014, 13(9): 883-891.
4.	Fujisawa T, Hozumi H, Kamiya Y, et al. Prednisolone and tacrolimus versus prednisolone and cyclosporin A to treat polymyositis/dermatomyositis-associated ILD: a randomized, open-label trial. Respirology, 2021, 26(4): 370-377.
5.	Sharma N, Putman MS, Vij R, et al. Myositis-associated interstitial lung disease: predictors of failure of conventional treatment and response to tacrolimus in a US Cohort. J Rheumatol, 2017, 44(11): 1612-1618.
6.	Long K, Danoff SK. Interstitial lung disease in polymyositis and dermatomyositis. Clin Chest Med, 2019, 40(3): 561-572.
7.	Connors GR, Christopher-Stine L, Oddis CV, et al. Interstitial lung disease associated with the idiopathic inflammatory myopathies: what progress has been made in the past 35 years?. Chest, 2010, 138(6): 1464–1474.
8.	Hozumi H, Fujisawa T, Nakashima R, et al. Comprehensive assessment of myositis-specific autoantibodies in polymyositis/dermatomyositis-associated interstitial lung disease. Respir Med, 2016, 121: 91-99.
9.	Mathai SC, Danoff SK. Management of interstitial lung disease associated with connective tissue disease. BMJ, 2016, 352: h6819.
10.	American Thoracic Society. Idiopathic pulmonary fibrosis: Diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med, 2000, 161(2): 646-664.
11.	Hozumi H, Fujisawa T, Nakashima R, et al. Efficacy of glucocorticoids and calcineurin inhibitors for anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a propensity score-matched analysis. J Rheumatol, 2019, 46(5): 509-517.
12.	Wilkes MR, Sereika SM, Fertig N, et al. Treatment of antisynthetase-associated interstitial lung disease with tacrolimus. Arthritis Rheum, 2005, 52(8): 2439-2446.
13.	Takada K, Nagasaka K, Miyasaka N. Polymyositis/dermatomyositis and interstitial lung disease: a new therapeutic approach with T-cell-specific immunosuppressants. Autoimmunity, 2005, 38: 383-392.
14.	Rigby AL, Plit M, Glanville AR. Tacrolimus rescue therapy for severe respiratory failure in the anti-synthetase syndrome. Respirol Case Rep, 2014, 2(2): 70-72.
15.	Takada K, Katada Y, Ito S, et al. Impact of adding tacrolimus to initial treatment of interstitial pneumonitis in polymyositis/dermatomyositis: a single-arm clinical trial. Rheumatology (Oxford), 2020, 59(5): 1084-1093.
16.	Kurita T, Yasuda S, Oba K, et al. The efficacy of tacrolimus in patients with interstitial lung diseases complicated with polymyositis or dermatomyositis. Rheumatology (Oxford), 2015, 54(1): 39-44.
17.	Takei R, Yamano Y, Kataoka K, et al. Predictive factors for the recurrence of anti-aminoacyl-tRNA synthetase antibody-associated interstitial lung disease. Respir Investig, 2020, 58(2): 83-90.
18.	Nakazawa M, Kaneko Y, Takeuchi T. Risk factors for the recurrence of interstitial lung disease in patients with polymyositis and dermatomyositis: a retrospective cohort study. Clin Rheumatol, 2018, 37(3): 765-771.
19.	Mecoli CA, Christopher-Stine L. Management of interstitial lung disease in patients with myositis specific autoantibodies. Curr Rheumatol Rep, 2018, 20(5): 27.

1. Malik A, Hayat G, Kalia JS, et al. Idiopathic inflammatory myopathies: clinical approach and management. Front Neurol, 2016, 7: 64.
2. Mirrakhimov AE. Antisynthetase syndrome: a review of etiopathogenesis, diagnosis and management. Curr Med Chem, 2015, 22(16): 1963 - 1975.
3. Lega JC, Fabien N, Reynaud Q, et al. The clinical phenotype associated with myositis-specific and associated autoantibodies: a meta-analysis revisiting the so-called antisynthetase syndrome. Autoimmun Rev, 2014, 13(9): 883-891.
4. Fujisawa T, Hozumi H, Kamiya Y, et al. Prednisolone and tacrolimus versus prednisolone and cyclosporin A to treat polymyositis/dermatomyositis-associated ILD: a randomized, open-label trial. Respirology, 2021, 26(4): 370-377.
5. Sharma N, Putman MS, Vij R, et al. Myositis-associated interstitial lung disease: predictors of failure of conventional treatment and response to tacrolimus in a US Cohort. J Rheumatol, 2017, 44(11): 1612-1618.
6. Long K, Danoff SK. Interstitial lung disease in polymyositis and dermatomyositis. Clin Chest Med, 2019, 40(3): 561-572.
7. Connors GR, Christopher-Stine L, Oddis CV, et al. Interstitial lung disease associated with the idiopathic inflammatory myopathies: what progress has been made in the past 35 years?. Chest, 2010, 138(6): 1464–1474.
8. Hozumi H, Fujisawa T, Nakashima R, et al. Comprehensive assessment of myositis-specific autoantibodies in polymyositis/dermatomyositis-associated interstitial lung disease. Respir Med, 2016, 121: 91-99.
9. Mathai SC, Danoff SK. Management of interstitial lung disease associated with connective tissue disease. BMJ, 2016, 352: h6819.
10. American Thoracic Society. Idiopathic pulmonary fibrosis: Diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med, 2000, 161(2): 646-664.
11. Hozumi H, Fujisawa T, Nakashima R, et al. Efficacy of glucocorticoids and calcineurin inhibitors for anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a propensity score-matched analysis. J Rheumatol, 2019, 46(5): 509-517.
12. Wilkes MR, Sereika SM, Fertig N, et al. Treatment of antisynthetase-associated interstitial lung disease with tacrolimus. Arthritis Rheum, 2005, 52(8): 2439-2446.
13. Takada K, Nagasaka K, Miyasaka N. Polymyositis/dermatomyositis and interstitial lung disease: a new therapeutic approach with T-cell-specific immunosuppressants. Autoimmunity, 2005, 38: 383-392.
14. Rigby AL, Plit M, Glanville AR. Tacrolimus rescue therapy for severe respiratory failure in the anti-synthetase syndrome. Respirol Case Rep, 2014, 2(2): 70-72.
15. Takada K, Katada Y, Ito S, et al. Impact of adding tacrolimus to initial treatment of interstitial pneumonitis in polymyositis/dermatomyositis: a single-arm clinical trial. Rheumatology (Oxford), 2020, 59(5): 1084-1093.
16. Kurita T, Yasuda S, Oba K, et al. The efficacy of tacrolimus in patients with interstitial lung diseases complicated with polymyositis or dermatomyositis. Rheumatology (Oxford), 2015, 54(1): 39-44.
17. Takei R, Yamano Y, Kataoka K, et al. Predictive factors for the recurrence of anti-aminoacyl-tRNA synthetase antibody-associated interstitial lung disease. Respir Investig, 2020, 58(2): 83-90.
18. Nakazawa M, Kaneko Y, Takeuchi T. Risk factors for the recurrence of interstitial lung disease in patients with polymyositis and dermatomyositis: a retrospective cohort study. Clin Rheumatol, 2018, 37(3): 765-771.
19. Mecoli CA, Christopher-Stine L. Management of interstitial lung disease in patients with myositis specific autoantibodies. Curr Rheumatol Rep, 2018, 20(5): 27.

Chinese Journal of Respiratory and Critical Care Medicine

Efficacy and safety analysis of glucocorticoid and tacrolimus in the treatment of anti-synthetase syndrome-associated interstitial lung disease

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