Journal Article

Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P)

Araya, Natsumi, Kunitomo, Yasuo, Galvão-Castro, Bernardo, Tanabe, Kenichiro, Sato, Tomoo, Ohta, Yuki, Kono, Kenichi, Jacobson, Steven, Coler-Reilly, Ariella, Nakagawa, Masanori, Matsuura, Eiji, Ishihara, Satoshi, Matsumoto, Naoki, Yagishita, Naoko, Nagasaka, Misako, Tsuboi, Yoshio, Yamano, Yoshihisa, Hasegawa, Yasuhiro, Takahashi, Katsunori, Sakima, Hirokuni, Grassi, Maria Fernanda Rios, Martin, Fabiola, Taylor, Graham P., Bland, Martin, Yamauchi, Junji, Tamaki, Keiko, Araujo, Abelardo

2022

Overview

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. (Registration number: UMIN000023798, UMIN000024085)

• Publisher: MDPI AG,MDPI
• Subject: adrenal cortex hormones / Adrenal Cortex Hormones - therapeutic use / Aged / Arthritis / Central nervous system diseases / Clinical trials / Corticosteroids / Disabled Persons / Drug dosages / Female / Hospitals / HTLV-1-associated myelopathy / Human T-lymphotropic virus 1 / human T-lymphotropic virus type 1 / Humans / Intravenous administration / intravenous injection / Male / Methylprednisolone / Methylprednisolone - therapeutic use / Middle Aged / Motor Disorders - drug therapy / Orthopedic apparatus / Paraparesis, Tropical Spastic - cerebrospinal fluid / Paraparesis, Tropical Spastic - drug therapy / Patients / Placebos / Prednisolone / Prednisolone - therapeutic use / Prospective Studies / Quality of life / Questionnaires / randomized clinical trials / randomized controlled trial / Registration / Review boards / Spasticity / Spinal cord / Steroids / Treatment Outcome / Walking