Abstract Details

Title A Real-world Study of the Effectiveness and Safety of Ravulizumab in AQP4-Ab+ NMOSD Patients with Suboptimal Response to Satralizumab in Japan - Interim Analysis

Topic Autoimmune Neurology

Presentation(s) P3 - Poster Session 3 (5:00 PM-6:00 PM)

Poster/Presentation
Number 1-006

Objective To assess the efficacy and safety of ravulizumab and its effects on inflammatory biomarkers in NMOSD patients switched from satralizumab to ravulizumab.

Background Although prognosis of the patients with neuromyelitis optica spectrum disorders (NMOSD) has improved with the advent of several molecular-targeted drugs, there are cases of resistance to treatment and there is a lack of evidence on the use of biologic agents.

Design/Methods AQP4-Ab+ NMOSD patients aged 18 years or older who have been on satralizumab for at least 3 months, but have made insufficient clinical improvement and are willing to switch to ravulizumab are recruited for this study. The primary endpoint is the proportion of patients without relapse within 12 months of starting ravulizumab. Key secondary endpoints include steroid dose reduction, MRI imaging changes, EDSS changes, and changes in blood biomarkers.

Results An interim analysis of 11 patients who had been switched to ravulizumab for at least 6 months (10.9±1.4 months on average) was conducted. All patients received concomitant immunosuppressive drugs (IS) with a mean prednisolone dose of 7.2 mg/day. After the switch, 1 patient had a relapse at 2 months (myelitis with no new lesions in the spinal MRI) and discontinued ravulizumab, but 10 patients are relapse-free and continued. EDSS decreased in two cases. Prednisolone dose decreased (mean 3.8 mg/day at 6 months) and other IS drug dose also decreased. No serious adverse events occurred. Before switching, the frequency of CD19+CD27-IgD- Double negative B cells (%DNB) was significantly increased and that of unswitched memory B cells (%USM) was significantly decreased in patients compared with HCs. After the induction of ravulizumab, %DNB were significantly decreased (p<0.05) and %USMB were increased (p<0.01) at 2 months follow-up.

Conclusions

Findings from this interim analysis suggest that the switch from satralizumab to ravulizumab induces clinical stability accompanied by changes in B cell subsets.

Authors/Disclosures
Sami Fam PRESENTER	Sami Fam has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Sami Fam has or had stock in Astra Zeneca.
Wakiro Sato	Wakiro Sato has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Biogen. Wakiro Sato has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis Pharma. Wakiro Sato has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Mitsubishi Tanabe Pharma.
Eiichiro Amano, MD, PhD	Dr. Amano has nothing to disclose.
Tomoko Okamoto	Tomoko Okamoto has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Tomoko Okamoto has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion Pharma G.K.. Tomoko Okamoto has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Tomoko Okamoto has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Chugai Pharmaceutical Co., Ltd.. Tomoko Okamoto has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teijin Pharma Limited.. The institution of Tomoko Okamoto has received research support from Alexion Pharma G.K.. The institution of Tomoko Okamoto has received research support from Sanofi. The institution of Tomoko Okamoto has received research support from Novartis. The institution of Tomoko Okamoto has received research support from UCB Japan Co., Ltd. The institution of Tomoko Okamoto has received research support from Biogen Japan Ltd.. The institution of Tomoko Okamoto has received research support from Chugai Pharmaceutical Co., Ltd.. The institution of Tomoko Okamoto has received research support from Mitsubishi Tanabe Pharma Corporation. Tomoko Okamoto has received intellectual property interests from a discovery or technology relating to health care.
Youwei Lin	No disclosure on file
Atsuko Katsumoto, MD, PhD	Dr. Katsumoto has nothing to disclose.
Reiko Saika	Reiko Saika has nothing to disclose.
Yuji Takahashi, MD, PhD (National Center of Neurology and Psychiatry)	The institution of Dr. Takahashi has received research support from Nihon Medi-Physics Co. Limit.. The institution of Dr. Takahashi has received research support from Takeda Pharmaceutical Company Limited.
Hideki Oi (National Center of Neurology and Psychiatry)	No disclosure on file
Norimitsu Inoue, PhD	Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Prof. Inoue has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Swedish Orphan Biovitrum Japan. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CSL Behring. Prof. Inoue has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion Pharmaceuticals. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCBJapan. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Chugai Pharmaceutical. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis Japan. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanwa Kagaku Kenkyusyo . Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Swedish Orphan Biovitrum Japan. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kissei Pharmaceutical. Prof. Inoue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Asahi Kasei Pharma. The institution of Prof. Inoue has received research support from Japan Agency for Medical Research and Development. The institution of Prof. Inoue has received research support from Ministry of Health, Labour and Welfare. The institution of Prof. Inoue has received research support from National Center of Neurology and Psychiatry.
Takashi Yamamura, MD (National Inst of Neuroscience)	Dr. Yamamura has nothing to disclose.

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