A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD
Status:
Completed
Trial end date:
2018-05-15
Target enrollment:
Participant gender:
Summary
Neuromyelitis Optica Spectrum Disorder (NMOSD) is a severe inflammatory disease of the
central nervous system characterized by relapsing optic neuritis and longitudinal extensive
transverse myelitis. The specific autoantibody against aquaporin 4 (AQP4-ab) has been
suggested to contribute to the pathogenesis of the disease. Peripheral blood plasma cells are
a major source of AQP4-ab. Previous studies have observed increased IL-6 levels in serum and
cerebrospinal fluid of patients with NMOSD, particularly during relapses. Exogenous
interleukin (IL)-6 promotes the survival of plasma cells and their production of AQP4-ab in
vitro. And blockade of IL-6 receptor signaling by an anti-IL-6 receptor antibody reduces the
survival of plasma cells in vitro. Tocilizumab (ACTEMRA®), a humanized monoclonal antibody
against the IL-6 receptor, has shown beneficial clinical effects in some patients with NMOSD
when concomitant immunosuppressive medications were administered. However, the long-lasting
biological effects of preceding immunotherapies such as rituximab might overlap with the
subsequent tocilizumab therapy. To reduce the side effects of concomitant treatments to large
extent and verify the beneficial effects of tocilizumab, we evaluate the safety and efficacy
of tocilizumab as monotherapy in patients with NMOSD.