Monitoring of Azathioprine Metabolite Concentrations and Cytokine Levels in Neuromyelitis Optica Spectrum Disorder
Status:
Completed
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Background: The pathogenesis of NMOSD has been linked to the cytokines interleukins (IL) -6,
NOD-, LRR-and pyrin domain-containing 3 (NLRP3) and IL-18 that contribute to development of
inflammatory reactionsmay. Although azathioprine (AZA) is efficacious in preventing NMOSD
recurrence, it may have adverse effects (AEs) maybe related to the plasma concentrations.
Objective: We would monitor the blood concentrations of AZA in NMOSD, and their relationship
with cytokines, severity, efficacy, and safety range of the drug.
Methods: A total of 53 NMOSD patients were included in the study, which included 20 patients
who had received AZA treatment within 1 month, and 16 patients who had received AZA treatment
within 6 months, as well as 17 patients who had received AZA treatment at least 12 months.
The patient's immunotherapy regimen was low-dose hormone combined with AZA. AZA was started
at small doses and added every two weeks after no AEs, namely 50 mg qd for two weeks, 50mg
bid for two weeks, and maintained at 50mg tid. The following clinical data were collected:
gender, age, clinical symptoms, EDSS score, number of recurrences and AEs, etc. Healthy
controls (HC) comprised 10 individuals. AZA metabolite concentrations
6-thioguaninenucleotides (6-TGN) and 6-methylmercaptopurine nucleotides (6-MMPN) were
measured by High-performance liquid chromatography (HPLC). Levels of IL-6, NLRP3 and IL-18
were measured by Enzyme-linked immunosorbent assay (ELISA).
Phase:
Phase 4
Details
Lead Sponsor:
First Affiliated Hospital of Guangxi Medical University