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EFFICACY OF CORTICOSTEROID THERAPY FOR HTLV-1-ASSOCIATED MYELOPATHY: A RANDOMIZED CONTROLLED TRIAL (HAMLET-P)
Yamauchi, Junji et al. | Date Issued: 2022
Author
Yamauchi, Junji
Tanabe, Kenichiro
Sato, Tomoo
Nakagawa, Masanori
Matsuura, Eiji
Tsuboi, Yoshio
Tamaki, Keiko
Sakima, Hirokuni
Ishihara, Satoshi
Ohta, Yuki
Matsumoto, Naoki
Kono, Kenichi
Yagishita, Naoko
Araya, Natsumi
Takahashi, Katsunori
Kunitomo, Yasuo
Nagasaka, Misako
Reilly, Ariella Coler
Hasegawa, Yasuhiro
Araujo, Abelardo
Jacobson, Steven
Grassi, Maria Fernanda Rios
Castro, Bernardo Galvão
Bland, Martin
Taylor, Graham P.
Martin, Fabiola
Yamano, Yoshihisa
Affilliation
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan / Division of Neurology. Department of Internal Medicine. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Frontier Medicine. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan / Division of Neurology. Department of Internal Medicine. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Neurology. Kyoto Prefectural University of Medicine Graduate School of Medical Science. Kyoto, Japan.
Department of Neurology and Geriatrics. Kagoshima University Graduate School of Medical and Dental Sciences. Kagoshima, Japan.
Department of Neurology. Fukuoka University. Fukuoka, Japan.
Department of Neurology. Fukuoka University. Fukuoka, Japan.
Department of Cardiovascular Medicine. Nephrology and Neurology, Graduate School of Medicine. University of the Ryukyus. Okinawa, Japan.
Department of Cardiovascular Medicine. Nephrology and Neurology, Graduate School of Medicine. University of the Ryukyus. Okinawa, Japan.
Department of Pharmacology. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Pharmacology. St. Marianna University School of Medicine. Kawasaki, Japan.
Translational Research Center for Medical Innovation. Foundation for Biomedical Research and Innovation at Kobe. Kobe, Japan.
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan.
Department of Advanced Medical Innovation. St. Marianna University Graduate School of Medicine. Kawasaki, Japan / Division of Hematology and Oncology. Department of Medicine. University of California Irvine School of Medicine. Irvine, CA, USA.
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan / Department of Internal Medicine. Division of Bone and Mineral Diseases. Washington University School of Medicine. St. Louis, MO, USA.
Division of Neurology. Department of Internal Medicine. St. Marianna University School of Medicine. Kawasaki, Japan / Division of Neurology. Department of Internal Medicine. SHIN-YURIGAOKA General Hospital. Kanagawa, Japan.
Oswaldo Cruz Foundation. Evandro Chagas National Institute of Infectious Diseases. Laboratory for Clinical Research in Neuroinfections. Rio de Janeiro, RJ, Brazil.
Viral immunology Section. Neuroimmunology Branch. National Institute of Neurological Disorders and Stroke. National Institutes of Health. Bethesda, MD, USA.
Escola Bahiana de Medicina e Saúde Pública. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Salvador, BA, Brazil.
Escola Bahiana de Medicina e Saúde Pública. Salvador, BA, Brazil / Oswaldo Cruz Foundation. Gonçalo Moniz Institute. Salvador, BA, Brazil.
Department of Health Sciences. Seebohm Rowntree Building. University of York. York, UK.
Section of Virology. Department of Infectious Disease. Imperial College London. London, UK.
School of Public Health. Faculty of Medicine. University of Queensland. Herston, Australia.
Department of Rare Diseases Research. Institute of Medical Science. St. Marianna University School of Medicine. Kawasaki, Japan / Division of Neurology. Department of Internal Medicine. St. Marianna University School of Medicine. Kawasaki, Japan.
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 < 0.001) and −6.0% (95% CI: −12.8–1.3; 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.
Keywords in Portuguese
Vírus Linfotrópico T Tipo 1 Humano
Prednisolona
Metilprednisolona
Ensaio Clínico Controlado Aleatório
 
Keywords
Human T-lymphotropic virus 1
Prednisolone
Methylprednisolone
Randomized Controlled Trial
 
Keywords in Spanish
Virus Linfotrópico T Tipo 1 Humano
Prednisolona
Metilprednisolona
Ensayo Clínico Controlado Aleatorio
 
Publisher
MDPI
Citation
Yamauchi, Junji et al. Efficacy of corticosteroid therapy for htlv-1-associated myelopathy: a randomized controlled trial (HAMLET-P). Viruses, v. 14, n. 136, p. 1-17, Jan. 2022.
DOI
10.3390/v14010136
ISSN
1999-4915