Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.
The investigators primarily aim to observe the number of relapses from initiation of baricitinib treatment. The secondary outcomes are to determine: The safety profile of baricitinib in participants with NMO and whether baricitinib improves Expanded Disability Status Scale (EDSS), et al.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
11
Baricitinib will be taken orally with a dose of 4mg once daily until the disease relapses or week 96.
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The number of relapses
A relapse was defined as new-onset neurological symptoms or worsening of existing neurological function (vision loss, limb weakness or sensory symptoms, or bladder or bowel dysfunction) lasting more than 24 h, not attributable to an identifiable cause such as intercurrent infection, and preceded by at least 30 days of clinical stability.
Time frame: From baseline to 96 weeks
Changes in EDSS scores
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10.
Time frame: Changes in EDSS from baseline to 96 weeks
Changes in the number of new and/or enlarging lesions on T2-weighted imaging (T2WI) and gadolinium-enhancing lesions on T1-weighted imaging (T1WI).
The total number of new and/or enlarging lesions on T2-weighted imaging (T2WI) and gadolinium-enhancing lesions on T1-weighted imaging (T1WI) for all participants was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96
Time frame: From baseline to 96 weeks
Changes in the number of peripheral blood B cell subsets
Compare peripheral blood plasma cells before and two year after initial intervention
Time frame: From baseline to 96 weeks
Changes in serum AQP4-IgG titer
Compare serum AQP4-IgG titers before and two year after initial intervention
Time frame: From baseline to 96 weeks
Incidence of treatment-emergent adverse events [safety and tolerability]
Adverse events related to baricitinib are recorded
Time frame: From baseline to 96 weeks
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