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 attacks 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
12
Baricitinib will be taken orally with a dose of 4mg once daily until the disease relapses or week 48, with a final evaluation at week 52.
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe number of attacks
An acute attack was defined as a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack
Time frame: From baseline to one year after
Changes in EDSS
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 52 weeks
Changes in the number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Optic nerve,brain and spinal cord Magnetic Resonance Imaging (MRI)
The total number of new and/or enlarging T2 lesions for all participants was calculated as the sum of the individual number of lesions at Weeks 12, 24, and 52
Time frame: From baseline to 52 weeks
Changes in peripheral blood B cell subsets
Compare peripheral blood plasma cells before and one year after initial intervention
Time frame: From baseline to 52 weeks
Changes in serum AQP4 antibodies
Compare serum AQP4-ab titers before and one year after initial intervention
Time frame: From baseline to 52 weeks
Incidence of treatment-emergent adverse events [safety and tolerability]
Adverse events related to belimumab are recorded
Time frame: From baseline to 52 weeks
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