Nature Communications (Jun 2021)
Phase 1 double-blind randomized safety trial of the Janus kinase inhibitor tofacitinib in systemic lupus erythematosus
- Sarfaraz A. Hasni,
- Sarthak Gupta,
- Michael Davis,
- Elaine Poncio,
- Yenealem Temesgen-Oyelakin,
- Philip M. Carlucci,
- Xinghao Wang,
- Mohammad Naqi,
- Martin P. Playford,
- Rishi R. Goel,
- Xiaobai Li,
- Ann J. Biehl,
- Isabel Ochoa-Navas,
- Zerai Manna,
- Yinghui Shi,
- Donald Thomas,
- Jinguo Chen,
- Angélique Biancotto,
- Richard Apps,
- Foo Cheung,
- Yuri Kotliarov,
- Ashley L. Babyak,
- Huizhi Zhou,
- Rongye Shi,
- Katie Stagliano,
- Wanxia Li Tsai,
- Laura Vian,
- Nathalia Gazaniga,
- Valentina Giudice,
- Shajia Lu,
- Stephen R. Brooks,
- Meggan MacKay,
- Peter Gregersen,
- Nehal N. Mehta,
- Alan T. Remaley,
- Betty Diamond,
- John J. O’ Shea,
- Massimo Gadina,
- Mariana J. Kaplan
Affiliations
- Sarfaraz A. Hasni
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Sarthak Gupta
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Michael Davis
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Elaine Poncio
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Yenealem Temesgen-Oyelakin
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Philip M. Carlucci
- Systemic Autoimmunity Branch, NIAMS, NIH
- Xinghao Wang
- Systemic Autoimmunity Branch, NIAMS, NIH
- Mohammad Naqi
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Martin P. Playford
- Section of Inflammation and Cardiometabolic Diseases, National Heart Lung and Blood Institute (NHLBI), NIH
- Rishi R. Goel
- Systemic Autoimmunity Branch, NIAMS, NIH
- Xiaobai Li
- NIH Clinical Center Biostatistics and Clinical Epidemiology Service
- Ann J. Biehl
- Office of the Clinical Director, NIAMS, NIH
- Isabel Ochoa-Navas
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Zerai Manna
- Lupus Clinical Trials Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)
- Yinghui Shi
- Translational Immunology Section, NIAMS, NIH
- Donald Thomas
- Arthritis and Pain Associates of PG County
- Jinguo Chen
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Angélique Biancotto
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Richard Apps
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Foo Cheung
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Yuri Kotliarov
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Ashley L. Babyak
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Huizhi Zhou
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Rongye Shi
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Katie Stagliano
- Trans-NIH Center for Human Immunology, Autoimmunity and Inflammation, NIH
- Wanxia Li Tsai
- Translational Immunology Section, NIAMS, NIH
- Laura Vian
- Translational Immunology Section, NIAMS, NIH
- Nathalia Gazaniga
- Translational Immunology Section, NIAMS, NIH
- Valentina Giudice
- Hematology Branch, NHLBI, NIH
- Shajia Lu
- Translational Immunology Section, NIAMS, NIH
- Stephen R. Brooks
- Biodata Mining and Discovery Section, NIAMS, NIH
- Meggan MacKay
- Feinstein Institute for Medical Research
- Peter Gregersen
- Feinstein Institute for Medical Research
- Nehal N. Mehta
- Section of Inflammation and Cardiometabolic Diseases, National Heart Lung and Blood Institute (NHLBI), NIH
- Alan T. Remaley
- Translational Vascular Medicine Branch, NHLBI, NIH
- Betty Diamond
- Feinstein Institute for Medical Research
- John J. O’ Shea
- Molecular Immunology and Inflammation Branch, NIAMS, NIH
- Massimo Gadina
- Translational Immunology Section, NIAMS, NIH
- Mariana J. Kaplan
- Systemic Autoimmunity Branch, NIAMS, NIH
- DOI
- https://doi.org/10.1038/s41467-021-23361-z
- Journal volume & issue
-
Vol. 12,
no. 1
pp. 1 – 11
Abstract
Increased risk of premature cardiovascular disease in systemic lupus erythematosus (SLE) is not well understood, but in animal models, the Janus kinase inhibitor tofacitinib improves related phenotypes. Here the authors report a Phase 1 double-blind randomized trial that shows tofacitinib is safe and well tolerated in in patients with SLE.
