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Abstract Number: 1736

Effectiveness and Safety of Tofacitinib vs. Calcineurin Inhibitor in Interstitial Lung Disease Secondary to Anti-Melanoma Differentiation-Associated Gene 5-Positive Dermatomyositis: A Multi-Center Cohort Study with Propensity Score-Based Inverse Probability of Treatment Weighting

Wanlong Wu1, Bingpeng Guo2, Wenjia Sun3, Dan Chen4, Wenwen Xu5, Zhiwei Chen5, Yakai Fu5, Yan Ye5, Xia Lyu6, Zhixin Xue5, Kaiwen Wang5, Jiangfeng Zhao7, Chunhua Ye5, Min Dai5, Wei Fan5, Jia Li5, Xiaodong Wang5, Yu Xue8, Weiguo Wan8, Li Sun4, Huaxiang Wu9, Qun Luo2, Qian Han2, Qiong Fu1 and Shuang Ye1, 1Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China (People's Republic), 2State Key Laboratory of Respiratory Disease, National Clinical Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China (People's Republic), 3The Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China (People's Republic), 4The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China (People's Republic), 5Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China (People's Republic), 6Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China (People's Republic), 7Department of Rheumatology, Jiading Branch, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China (People's Republic), 8Department of Rheumatology, Huashan Hospital, Fudan University, shanghai, China (People's Republic), 9Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China (People's Republic)

Meeting: ACR Convergence 2024

Keywords: dermatomyositis, interstitial lung disease

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Session Information

Date: Sunday, November 17, 2024

Title: Abstracts: Muscle Biology, Myositis & Myopathies – Basic & Clinical Science I

Session Type: Abstract Session

Session Time: 3:00PM-4:30PM

Background/Purpose: The current management of anti-melanoma differentiation-associated gene 5-positive dermatomyositis (MDA5+DM) is challenging and largely empirical rather than evidence-based. Small-sized proof-of-concept trial and case series have reported favorable treatment response using tofacitinib in both new-onset and refractory interstitial lung disease (ILD) secondary to MDA5+DM. This study aimed to compare the effectiveness and safety of tofacitinib (TOF) versus calcineurin inhibitor (CNI) as initial immunosuppressive regimen for MDA5+DM-ILD in a large multi-center cohort.

Methods: Adult Chinese patients with newly-diagnosed MDA5+DM-ILD (ILD course < 3 months), which fulfilled the 239th European Neuromuscular Center (ENMC) criteria for dermatomyositis, from five tertiary referral centers between April 2014 and January 2023 were included for this cohort study. Dummy variable was applied to address missing data. Propensity score-based inverse probability of treatment weighting (IPTW) with 14 confounding covariates for survival was applied for adjustment in this real-world study. Kaplan-Meier curves were plotted and log-rank test results were reported to compare the lung transplantation-free survival within 1 year between TOF and CNI group based on IPTW dataset. Sensitivity and exploratory subgroup analyses were also performed.

Results: In the eligible cohort (Figure 1), a total of 94 (32.4%) and 105 (46.7%) patients died or underwent lung transplantation within 1 year in the TOF group (n=290) and the CNI group (n=225), respectively. With baseline prognostic factors well-balanced by IPTW, patients’ lung transplantation-free survival rate within 1 year was significantly higher in the TOF group compared to the CNI group (log-rank P=0.015) (Figure 2). Multivariable Cox analysis performed in the IPTW dataset revealed the hazard ratio of TOF versus CNI for 1-year survival was 0.70 (95% CI, 0.51 to 0.95, P=0.022). The adjusted difference of survival rate was 9.9% (95%CI 3.4% to 16.4%) between treatment groups. Alternative analytic strategies yielded consistent results, including multivariable Cox regression using multiple imputation addressing missing data followed by IPTW (HR, 0.68; 95% CI, 0.53 to 0.87), and multivariable Cox regression using dummy variable addressing missing data in the raw dataset (HR, 0.70; 95% CI, 0.52 to 0.96). In the exploratory subgroup analysis stratified by baseline prognostic factors (Figure 3), based on P values for interaction, patients < 60 years old might be associated with a lower mortality when treated with tofacitinib (HR, 0.55; 95% CI, 0.38 to 0.81). Patients without rapidly progressive interstitial lung disease (RPILD) probably benefit more from TOF than CNI (HR, 0.13; 95% CI, 0.04 to 0.50). Patients with baseline PaO2/FiO2 ≥ 300mmHg might also benefit more from tofacitinib (HR, 0.34; 95% CI, 0.19 to 0.59). Opportunistic infection was the major treatment-related serious adverse event, with generally comparable incidence (41.0% vs. 46.2%, P=0.239).

Conclusion: In this large multi-center cohort study, tofacitinib showed significantly more benefits for 1-year lung transplantation-free survival than calcineurin inhibitors in MDA5+DM-ILD.

Supporting image 1

Study cohort

Supporting image 2

Inverse Probability of Treatment–Weighted lung transplantation-free survival curves among anti-MDA5-positive DM-ILD patients treated with tofacitinib or calcineurin inhibitors

Supporting image 3

Subgroup analyses


Disclosures: W. Wu: None; B. Guo: None; W. Sun: None; D. Chen: None; W. Xu: None; Z. Chen: None; Y. Fu: None; Y. Ye: None; X. Lyu: None; Z. Xue: None; K. Wang: None; J. Zhao: None; C. Ye: None; M. Dai: None; W. Fan: None; J. Li: None; X. Wang: None; Y. Xue: None; W. Wan: None; L. Sun: None; H. Wu: None; Q. Luo: None; Q. Han: None; Q. Fu: None; S. Ye: None.

To cite this abstract in AMA style:

Wu W, Guo B, Sun W, Chen D, Xu W, Chen Z, Fu Y, Ye Y, Lyu X, Xue Z, Wang K, Zhao J, Ye C, Dai M, Fan W, Li J, Wang X, Xue Y, Wan W, Sun L, Wu H, Luo Q, Han Q, Fu Q, Ye S. Effectiveness and Safety of Tofacitinib vs. Calcineurin Inhibitor in Interstitial Lung Disease Secondary to Anti-Melanoma Differentiation-Associated Gene 5-Positive Dermatomyositis: A Multi-Center Cohort Study with Propensity Score-Based Inverse Probability of Treatment Weighting [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/effectiveness-and-safety-of-tofacitinib-vs-calcineurin-inhibitor-in-interstitial-lung-disease-secondary-to-anti-melanoma-differentiation-associated-gene-5-positive-dermatomyositis-a-multi-center-coh/. Accessed .
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