Abstract Details

Title Phase 3 Clinical Study of IVIG for Efficacy and Safety in Patients with Autoimmune Encephalitis

Topic Autoimmune Neurology

Presentation(s) P8 - Poster Session 8 (11:45 AM-12:45 PM)

Poster/Presentation
Number 1-006

Objective This study aimed to investigate the efficacy and safety of intravenous immunoglobulin (IVIG) in patients with autoimmune encephalitis (AE) refractory to steroid pulse therapy.

Background The efficacy of IVIG for AE has not been clearly established in controlled clinical studies.

Design/Methods In this randomized, double-blind, active-controlled, parallel-group study (NCT05177939), patients who showed insufficient improvement after steroid pulse therapy were enrolled. Patients were randomly assigned in a 1:1 ratio to receive either IVIG or control (steroid pulse therapy). The primary endpoint was the proportion of responders where response was defined as ≥40% improvement in the Clinical Assessment Scale in Autoimmune Encephalitis at Week4. Other scales including modified Rankin Scale (mRS) were examined for secondary efficacy endpoints.

Results A total of 40 patients were randomized. The primary analysis population included patients with cell-surface antigen antibodies (n=7 in the IVIG group and 3 in the control group). The proportion of responders was 57.1% (95% CI: 18.405, 90.101) in the IVIG group and 0% (95% CI: 0.000, 70.706) in the control group. Secondary analysis in the full analysis set (n=20 per group) showed response rates of 50.0% (95% CI: 27.196, 72.804) and 25.0% (95% CI: 8.657, 49.105). Secondary endpoints, including mRS, supported the primary results. The incidence of adverse events was similar between groups, mostly mild or moderate.

Conclusions In patients with AE refractory to steroid pulse therapy, IVIG provided benefits with no safety concerns.

Authors/Disclosures
Ko Sakamoto PRESENTER	Mr. Sakamoto has received personal compensation for serving as an employee of Takeda Pharmaceutical Company Limited. Mr. Sakamoto has or had stock in Takeda Pharmaceutical Company Limited.
Satoshi Kamei, MD, PhD	Dr. Kamei has nothing to disclose.
Keiko Tanaka, MD, PhD	Prof. Tanaka has nothing to disclose.
Osamu Watanabe, MD (Kagoshima City Hospital)	No disclosure on file
Makoto Hara, MD (Nihon University School of Medicine)	Dr. Hara has nothing to disclose.
Joseph S. Takahashi, PhD	Dr. Takahashi has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Synchronicity Pharma, Inc..
Keizo Yasui, MD, PhD	Dr. Yasui has nothing to disclose.
Shigeru Nogawa, MD, PhD (Tokai University)	Dr. Nogawa has nothing to disclose.
Keiko Tokunaga, MD, PhD	Dr. Tokunaga has nothing to disclose.
Emma Sasaki	Ms. Sasaki has received personal compensation for serving as an employee of Takeda Pharmaceutical Co. Ltd..
Atsushi Kuga, MD, PhD	Dr. Kuga has nothing to disclose.
Hakan AY, MD (Takeda)	Dr. AY has received personal compensation for serving as an employee of Takeda.
Takashi Kanda, MD (Dept. of Neurology, Medical and Dental University)	Dr. Kanda has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Igaku-shoin Ltd..

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