Safety and efficacy of combined B-cell depleting therapy and daratumumab in patients with autoimmune encephalitis (RADIA): study protocol for a multicenter, randomized trial - Summary - MDSpire
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Safety and efficacy of combined B-cell depleting therapy and daratumumab in patients with autoimmune encephalitis (RADIA): study protocol for a multicenter, randomized trial
To describe the study protocol for the RADIA study, which aims to address significant treatment gaps by evaluating the efficacy and safety of B-cell depleting agents followed by daratumumab in patients with severe autoimmune encephalitis, particularly NMDA receptor encephalitis.
Key Findings:
The primary endpoint is the proportion of patients with an mRS score ≤ 2 at 16 weeks after treatment initiation.
Secondary outcomes include neurocognitive function, antibody status, ICU stay, and hospitalization duration up to 48 weeks.
Adverse events will be monitored continuously, with specific protocols in place to ensure comprehensive reporting.
Interpretation:
This trial aims to provide robust data on the efficacy of B-cell depleting agents followed by daratumumab in patients with severe autoimmune encephalitis, focusing on the NMDARE subgroup, which may significantly influence future treatment strategies.
Limitations:
The study is limited to patients in tertiary hospitals in China, which may affect generalizability.
The open-label design may introduce bias in outcome assessment, potentially impacting the perceived efficacy of the treatments.
Conclusion:
This trial may provide a new treatment option for NMDARE by evaluating the combined regimen of B-cell depleting agents and daratumumab.
