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. (Registration number: UMIN000023798, UMIN000024085)
Highlights
Human T-lymphotropic virus type 1 (HTLV-1) infects at least 5–10 million people globally
We evaluated the cerebrospinal fluid (CSF) concentrations of neopterin and CXCL10, as well as HTLV-1 proviral loads in the peripheral blood mononuclear cells (PBMCs) and CSF cells, as described in the Supplementary Materials [24]
Prednisolone significantly decreased CSF marker concentrations compared with placebo: the median changes in neopterin concentrations at week 24 from baseline were −28.3% in the prednisolone group and −3.6% in the placebo group (p for between-group difference = 0.030); the changes in CXCL10 levels were −43.0%
Summary
Human T-lymphotropic virus type 1 (HTLV-1) infects at least 5–10 million people globally. It causes rare but devastating diseases, including HTLV-1-associated myelopathy (HAM) and adult T-cell leukemia/lymphoma (ATL) in a small proportion of infected individuals [1,2,3]. HAM is characterized by chronic spinal cord inflammation, at the thoracic level, resulting in neurological disorders such as spastic paraparesis, sensory disturbance in the legs, and bladder and bowel dysfunction [4]. Interferon-α is the only drug that demonstrated clinical efficacy in a randomized controlled trial (RCT) [5]. This medication is seldom used because it is not highly efficient [6]. Corticosteroids are most commonly used to maintain motor function by suppressing inflammation [4,6,7]
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