Propensity-Score Matched Analysis of the Effectiveness of Baricitinib in Patients With Coronavirus Disease 2019 (COVID-19) Using Nationwide Real-World Data: An Observational Matched Cohort Study From the Japan COVID-19 Task Force

Author:

Tanaka Hiromu1,Chubachi Shotaro1ORCID,Namkoong Ho2ORCID,Sato Yasunori3,Asakura Takanori1,Lee Ho1,Azekawa Shuhei1,Otake Shiro1,Nakagawara Kensuke1,Fukushima Takahiro1,Watase Mayuko1,Sakurai Kaori1,Kusumoto Tatsuya1,Kondo Yasushi4ORCID,Masaki Katsunori1ORCID,Kamata Hirofumi1,Ishii Makoto1,Kaneko Yuko4,Hasegawa Naoki2ORCID,Ueda Soichiro5,Sasaki Mamoru5,Izumo Takehiro6,Inomata Minoru6,Miyazawa Naoki7,Kimura Yasuhiro7,Suzuki Yusuke8,Harada Norihiro9,Ichikawa Masako9,Takata Tohru10,Ishikura Hiroyasu11,Yoshiyama Takashi12,Kokuto Hiroyuki12,Murakami Koji13,Sano Hirohito13,Ueda Tetsuya14,Kuwahara Naota15,Fujiwara Akiko15,Ogura Takashi16,Inoue Takashi17,Asami Takahiro17ORCID,Mutoh Yoshikazu18,Nakachi Ichiro19,Baba Rie18,Nishi Koichi20,Tani Mayuko20,Kagyo Junko21,Hashiguchi Mizuha21,Oguma Tsuyoshi22,Asano Koichiro22,Nishikawa Masanori23,Watanabe Hiroki23,Okada Yukinori242526,Koike Ryuji27,Kitagawa Yuko28,Kimura Akinori29,Imoto Seiya30,Miyano Satoru31,Ogawa Seishi32,Kanai Takanori33,Fukunaga Koichi1

Affiliation:

1. Division of Pulmonary Medicine, Department of Internal Medicine, Keio University School of Medicine , Tokyo , Japan

2. Department of Infectious Diseases, Keio University School of Medicine , Tokyo , Japan

3. Department of Preventive Medicine and Public Health, Keio University School of Medicine , Tokyo , Japan

4. Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine , Tokyo , Japan

5. JCHO (Japan Community Health Care Organization) Saitama Medical Center, Internal Medicine , Saitama , Japan

6. Japanese Red Cross Medical Center , Tokyo , Japan

7. Department of Respiratory Medicine, Saiseikai Yokohamashi Nanbu Hospital , Yokohama , Japan

8. Department of Respiratory Medicine, Kitasato University Kitasato Institute Hospital , Tokyo , Japan

9. Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine , Tokyo , Japan

10. Department of Infection Control, Fukuoka University Hospital , Fukuoka , Japan

11. Department of Emergency and Critical Care Medicine, Fukuoka University Faculty of Medicine , Fukuoka , Japan

12. Fukujuji Hospital , Kiyose , Japan

13. Department of Respiratory Medicine, Tohoku University Graduate School of Medicine , Sendai , Japan

14. Department of Respiratory Medicine, Osaka Saiseikai Nakatsu Hospital , Osaka , Japan

15. Internal Medicine, Internal Medicine Center, Showa University Koto Toyosu Hospital , Tokyo , Japan

16. Kanagawa Cardiovascular and Respiratory Center , Yokohama , Japan

17. Internal Medicine, Sano Kosei General Hospital , Sano , Japan

18. Department of Infectious Diseases, Tosei General Hospital , Seto , Japan

19. Saiseikai Utsunomiya Hospital , Utsunomiya , Japan

20. Ishikawa Prefectural Central Hospital , Kanazawa , Japan

21. Keiyu Hospital , Yokohama , Japan

22. Division of Pulmonary Medicine, Department of Medicine, Tokai University School of Medicine , Isehara , Japan

23. Department of Respiratory Medicine, Fujisawa City Hospital , Fujisawa , Japan

24. Department of Statistical Genetics, Osaka University Graduate School of Medicine , Suita , Japan

25. Department of Genome Informatics, Graduate School of Medicine, the University of Tokyo , Tokyo , Japan

26. Laboratory for Systems Genetics, RIKEN Center for Integrative Medical Sciences , Kanagawa , Japan

27. Medical Innovation Promotion Center, Tokyo Medical and Dental University , Tokyo , Japan

28. Department of Surgery, Keio University School of Medicine , Tokyo , Japan

29. Institute of Research, Tokyo Medical and Dental University , Tokyo , Japan

30. Division of Health Medical Intelligence, Human Genome Center, the Institute of Medical Science, the University of Tokyo , Tokyo , Japan

31. M&D Data Science Center, Tokyo Medical and Dental University , Tokyo , Japan

32. Department of Pathology and Tumor Biology, Kyoto University , Kyoto , Japan

33. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine , Tokyo , Japan

Abstract

Abstract Background To determine the effectiveness of baricitinib in patients with coronavirus disease 2019 (COVID-19), investigate whether baricitinib prevents the need for invasive mechanical ventilation and identify patient subgroups that would benefit from baricitinib. Methods This observational matched-cohort study was conducted by the Japan COVID-19 Task Force, a nationwide multicenter consortium. Patients with COVID-19 aged ≥18 years were identified from 70 hospitals in Japan. Among patients with confirmed COVID-19 from February 2020 to September 2021, those receiving baricitinib were propensity-score matched with controls. Results Among 3309 patients, 144 propensity score-matched pairs were identified. Thirteen (9.0%) patients in the baricitinib group and 27 (18.8%) in the control group required invasive mechanical ventilation during the disease course (odds ratio, 0.43). Although the baricitinib group had more severe disease, there were no significant differences in the intensive care unit admission rates (odds ratio, 1.16) and mortality rates (odds ratio, 0.74) between groups. In subgroup analyses, baricitinib was associated with a significant reduction in the need for invasive mechanical ventilation in patients requiring oxygen support (odds ratio, 0.28), with rapid shadow spread on chest radiography (odds ratio, 0.11), or treated with remdesivir (odds ratio, 0.27), systemic corticosteroids (odds ratio, 0.31), or anticoagulants (odds ratio, 0.17). Conclusions Baricitinib is effective at preventing the need for invasive mechanical ventilation in patients with COVID-19.

Funder

Japan Agency for Medical Research and Development

Japan Science and Technology Agency

Ministry of Health, Labour and Welfare of Japan

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Oncology

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