Mogamulizumab for Treatment of Human T-lymphotropic Virus Type 1-Associated Myelopathy/Tropical Spastic Paraparesis: A Single-Center US-based Series.

BACKGROUND: Human T-lymphotropic virus type 1 (HTLV-1)-associated myelopathy/tropical spastic paraparesis (HAM/TSP) is a chronic neurological condition characterized by progressive myelopathic symptoms including spasticity, pain, weakness, and urinary symptoms, without proven treatments. Mogamulizumab (MOG) is a monoclonal antibody that binds CCR4 and leads to the clearance of HTLV-1-infected CCR4+ cells. A phase 1-2a study in Japan evaluated MOG for the treatment of HAM/TSP and reported decreases in HTLV-1 proviral load and neuroinflammatory markers, with clinical improvement in some participants. METHODS: We administered MOG 0.1 mg/kg every 8 weeks to individuals with HAM/TSP as a compassionate and palliative treatment. Patients who received MOG had (1) a positive peripheral HTLV-1 antibody, (2) progressive myelopathic symptoms, and (3) a diagnosis of HAM/TSP. RESULTS: Four female patients, ages 45-68, received MOG (range, 2-6 infusions) between 1 November 2019 and 30 November 2022. Two patients with <3 years of symptoms had milder disease, with Osame scores <4. The other 2, with >7 years of symptoms, had Osame scores >5. One patient, with 6 total treatments, received dose-reduced MOG after she developed a rash at the initial dose. The 2 patients with milder baseline disease reported symptomatic improvement and saw reductions in Osame and/or modified Ashworth scale scores during follow-up. The other 2 patients showed no improvement. All 4 developed rashes after receiving MOG-a treatment-limiting event in some cases. CONCLUSIONS: Clinical trials are needed including diverse patient populations to assess the potential role of MOG for HAM/TSP. Our findings may help inform the development of these trials.

Rapid sideline performance meets outpatient clinic: Results from a multidisciplinary concussion center registry.

OBJECTIVE: This study investigated the utility of sideline concussion tests, including components of the Sports Concussion Assessment Tool, 3rd Edition (SCAT3) and the King-Devick (K-D), a vision-based test of rapid number naming, in an outpatient, multidisciplinary concussion center treating patients with both sports-related and non-sports related concussions. The ability of these tests to predict clinical outcomes based on the scores at the initial visit was evaluated. METHODS: Scores for components of the SCAT3 and the K-D were fit into regression models accounting for age, gender, and sport/non-sport etiology in order to predict clinical outcome measures including total number of visits to the concussion center, whether the patient reached a SCAT3 symptom severity score≤7, and the total types of referrals each patient received over their course. Patient characteristics, differences between those with sport and non-sport etiologies, and correlations between the tests were also analyzed. RESULTS: Among 426 patients with concussion, SCAT3 total symptom score and symptom severity score at the initial visit predicted each of the clinical outcome variables. K-D score at the initial visit predicted the total number of visits and the total number of referrals. Those with sports-related concussions were younger, had less severely-affected test scores, had fewer visits and types of referrals, and were more likely to have clinical resolution of their concussion and to reach a symptom severity score≤7. CONCLUSIONS: This large-scale study of concussion patients supports the use of sideline concussion tests as part of outpatient concussion assessment, especially the total symptom and symptom severity score portions of the SCAT3 and the K-D. Women in this cohort had higher total symptom and symptom severity scores compared to men. Our data also suggest that those with non-sports-related concussions have longer lasting symptoms than those with sports-related concussions, and that these two groups should perhaps be regarded separately when assessing outcomes and needs in a multidisciplinary setting.