Lancet Neurology: The safety and importance of the treatment of highly reococculptive optic neurospinal myelitis spectrum disorder (TANGO) with toad monoantin and thiopental: an open, multi-center, randomized, Phase 2 trial

Optic neurospinalitis (NMOSD) is a serious inflammatory autoimmune disease of the central nervous system, often accompanied by a pathological body fluid immune response of water channel protein-4 (AQP-4).
most common characteristics of the disease are recurrent optic neuritis and longitudinal transverse spinal corditis.
frequent relapses lead to a gradual build-up of neurological dysfunction.
, prevention of recurrence is important to reduce the risk of systemic disability over time.
thiopental, mycophenolate and lytoxidone are the most commonly used treatments in NMOSD patients.
Based on retrospective and open studies, thiopental, a carbide-like compound that blocks DNA synthesis, has been recommended as a first-line treatment to reduce recurrence rates and improve neurological disorders in patients with NMOSD.
, however, a large number of patients relapse and long-term use of thiopentine can have side effects.
addition, the efficacy of thiopental as a monotherapy remains unclear, as thiopental is often used in combination with corticosteroids.
Tozhu monoantigen is the first humanized monoclonal antibody against lecierin-6, which has been widely used in patients with rheumatoid arthritis and early-onset idiopathic arthritis and has been approved for the treatment of several autoimmune diseases, including cytomegastitis.
In previous case series, toad monoantigen was found to reduce relapse and disability rates in NMOSD patients, including patients who did not respond to several immunosuppressants or B-cell expendable antibody vitoxidant therapy.
study was an open, multi-center, randomized Phase 2 trial that recruited adult patients (age ≥18) who were diagnosed with high recurrence of NMOSD according to the 2015 International Group diagnostic criteria for optic neurospinalitis. Patients had an extended disability scale (EDSS) score of 7.5 or lower and had at least two clinical recurrences in the previous 12 months, or three relapses in the previous 24 months, and at least one recurrence in the previous 12 months.
randomly assigned (1:1) to intravenous toad monoants (8mg/kg every 4 weeks) or oral thiopental (2-3mg/kg per day).
was 60 weeks after random grouping.
result is the time of recurrence in the first set of complete analytical data, including all randomly assigned patients who received at least one dose of the study drug.
a total of 108 subjects were included in the programme analysis (56 subjects in the toad monoantin group and 52 in the thiopental group).
in the full analysis data set, the medium time of the first recurrence of the to-bead mono-resistance group was longer than that of the thiopental group (78.9 weeks (IQR 58.3-90.6) vs 56.7 (32.9-81.7) weeks; p.0026).
, in patients with NMOSD, the risk of recurrence was significantly reduced compared with thiopental.
, however, the long-term efficacy of toad monoantion in patients with NMOSD is worth further study.
Zhang, Chao et al. Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial. The Lancet Neurology, Volume 19, Issue 5, 391 - 401MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Originals" are owned by Mets Medical and are not authorized to reproduce by any media, website or individual.
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