Viruses (Jan 2022)
Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P)
- Junji Yamauchi,
- Kenichiro Tanabe,
- Tomoo Sato,
- Masanori Nakagawa,
- Eiji Matsuura,
- Yoshio Tsuboi,
- Keiko Tamaki,
- Hirokuni Sakima,
- Satoshi Ishihara,
- Yuki Ohta,
- Naoki Matsumoto,
- Kenichi Kono,
- Naoko Yagishita,
- Natsumi Araya,
- Katsunori Takahashi,
- Yasuo Kunitomo,
- Misako Nagasaka,
- Ariella Coler-Reilly,
- Yasuhiro Hasegawa,
- Abelardo Araujo,
- Steven Jacobson,
- Maria Fernanda Rios Grassi,
- Bernardo Galvão-Castro,
- Martin Bland,
- Graham P. Taylor,
- Fabiola Martin,
- Yoshihisa Yamano
Affiliations
- Junji Yamauchi
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- Kenichiro Tanabe
- Department of Frontier Medicine, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan
- Tomoo Sato
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- Masanori Nakagawa
- Department of Neurology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto 602-8566, Japan
- Eiji Matsuura
- Department of Neurology and Geriatrics, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima 890-8544, Japan
- Yoshio Tsuboi
- Department of Neurology, Fukuoka University, Fukuoka 814-0180, Japan
- Keiko Tamaki
- Department of Neurology, Fukuoka University, Fukuoka 814-0180, Japan
- Hirokuni Sakima
- Department of Cardiovascular Medicine, Nephrology and Neurology, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, Japan
- Satoshi Ishihara
- Department of Cardiovascular Medicine, Nephrology and Neurology, Graduate School of Medicine, University of the Ryukyus, Okinawa 903-0215, Japan
- Yuki Ohta
- Department of Pharmacology, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan
- Naoki Matsumoto
- Department of Pharmacology, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan
- Kenichi Kono
- Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe 650-0047, Japan
- Naoko Yagishita
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- Natsumi Araya
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- Katsunori Takahashi
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- Yasuo Kunitomo
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- Misako Nagasaka
- Department of Advanced Medical Innovation, St. Marianna University Graduate School of Medicine, Kawasaki 216-8511, Japan
- Ariella Coler-Reilly
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- Yasuhiro Hasegawa
- Division of Neurology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki 216-8511, Japan
- Abelardo Araujo
- Laboratory for Clinical Research in Neuroinfections, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro 21040-900, Brazil
- Steven Jacobson
- Viral immunology Section, Neuroimmunology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD 20892, USA
- Maria Fernanda Rios Grassi
- Escola Bahiana de Medicina e Saúde Pública, Salvador 40290-000, BA, Brazil
- Bernardo Galvão-Castro
- Escola Bahiana de Medicina e Saúde Pública, Salvador 40290-000, BA, Brazil
- Martin Bland
- Department of Health Sciences, Seebohm Rowntree Building, University of York, York YO10 5DD, UK
- Graham P. Taylor
- Section of Virology, Department of Infectious Disease, Imperial College London, London W2 1PG, UK
- Fabiola Martin
- School of Public Health, Faculty of Medicine, University of Queensland, 266 Herston Road, Herston, QLD 4006, Australia
- Yoshihisa Yamano
- Department of Rare Diseases Research, Institute of Medical Science, St. Marianna University School of Medicine, Kawasaki 216-8512, Japan
- DOI
- https://doi.org/10.3390/v14010136
- Journal volume & issue
-
Vol. 14,
no. 1
p. 136
Abstract
Corticosteroids are most commonly used to treat HTLV-1-associated myelopathy (HAM); however, their clinical efficacy has not been tested in randomized clinical trials. This randomized controlled trial included 8 and 30 HAM patients with rapidly and slowly progressing walking disabilities, respectively. Rapid progressors were assigned (1:1) to receive or not receive a 3-day course of intravenous methylprednisolone in addition to oral prednisolone therapy. Meanwhile, slow progressors were assigned (1:1) to receive oral prednisolone or placebo. The primary outcomes were a composite of ≥1-grade improvement in the Osame Motor Disability Score or ≥30% improvement in the 10 m walking time (10 mWT) at week 2 for rapid progressors and changes from baseline in 10 mWT at week 24 for slow progressors. In the rapid progressor trial, all four patients with but only one of four without intravenous methylprednisolone achieved the primary outcome (p = 0.14). In the slow progressor trial, the median changes in 10 mWT were −13.8% (95% CI: −20.1–−7.1; p p = 0.10) with prednisolone and placebo, respectively (p for between-group difference = 0.12). Whereas statistical significance was not reached for the primary endpoints, the overall data indicated the benefit of corticosteroid therapy. (Registration number: UMIN000023798, UMIN000024085)
Keywords
- human T-lymphotropic virus type 1
- HTLV-1-associated myelopathy
- prednisolone
- methylprednisolone
- randomized controlled trial