Efficacy of corticosteroid therapy for HTLV-1-associated myelopathy: a randomized controlled trial (HAMLET-P)

dc.creatorYamauchi, Junji
dc.creatorTanabe, Kenichiro
dc.creatorSato, Tomoo
dc.creatorNakagawa, Masanori
dc.creatorMatsuura, Eiji
dc.creatorTsuboi, Yoshio
dc.creatorTamaki, Keiko
dc.creatorSakima, Hirokuni
dc.creatorIshihara, Satoshi
dc.creatorOhta, Yuki
dc.creatorMatsumoto, Naoki
dc.creatorKono, Kenichi
dc.creatorYagishita, Naoko
dc.creatorAraya, Natsumi
dc.creatorTakahashi, Katsunori
dc.creatorKunitomo, Yasuo
dc.creatorNagasaka, Misako
dc.creatorReilly, Ariella Coler
dc.creatorHasegawa, Yasuhiro
dc.creatorAraujo, Abelardo
dc.creatorJacobson, Steven
dc.creatorGrassi, Maria Fernanda Rios
dc.creatorCastro, Bernardo Galvão
dc.creatorBland, Martin
dc.creatorTaylor, Graham P
dc.creatorMartin, Fabiola
dc.creatorYamano, Yoshihisa
dc.date2022-03-07T19:44:43Z
dc.date2022-03-07T19:44:43Z
dc.date2022
dc.date.accessioned2023-09-26T20:52:54Z
dc.date.available2023-09-26T20:52:54Z
dc.identifierYamauchi, 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, 2022.
dc.identifier1999-4915
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/51603
dc.identifierdoi.org/10.3390/v14010136
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8865521
dc.descriptionDepartment 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. 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 / Division of Neurology. Department of Internal Medicine. 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 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 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 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. Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Neuroinfecções. Rio de Janeiro, RJ, Brasil. 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, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. Escola Bahiana de Medicina e Saúde Pública. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. 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. 266 Herston Road. 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.
dc.descriptionPractical Research Project for Rare/Intractable Diseases of the Japan Agency for Medical Research and Development. Ministry of Health, Labour and Welfare of Japan.
dc.descriptionCorticosteroids 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.
dc.formatapplication/pdf
dc.languageeng
dc.publisherMDPI
dc.rightsopen access
dc.subjectVírus Linfotrópico T Tipo 1 Humano
dc.subjectPrednisolona
dc.subjectMetilprednisolona
dc.subjectEnsaio Clínico Controlado Aleatório
dc.subjectHuman T-lymphotropic virus 1
dc.subjectPrednisolone
dc.subjectMethylprednisolone
dc.subjectRandomized Controlled Trial
dc.subjectVirus Linfotrópico T Tipo 1 Humano
dc.subjectPrednisolona
dc.subjectMetilprednisolona
dc.subjectEnsayo Clínico Controlado Aleatorio
dc.subjectVirus T-lymphotrope humain de type 1
dc.subjectPrednisolone
dc.subjectMéthylprednisolone
dc.subjectEssai contrôlé randomisé
dc.titleEfficacy of corticosteroid therapy for HTLV-1-associated myelopathy: a randomized controlled trial (HAMLET-P)
dc.typeArticle


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