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
Wakiro Sato1, Eiichiro Amano2, Tomoko Okamoto3, Youwei Lin3, Atsuko Katsumoto3, Reiko Saika3, Yuji Takahashi3, Hideki Oi1, Norimitsu Inoue4, Sami Fam5, Takashi Yamamura6
1Translational Medical Center, 2Department of Immunology, National Institute of Neuroscience, 3Department of Neurology, National Center Hospital, National Center of Neurology and Psychiatry, 4Wakayama Medical University, 5Alexion AstraZeneca Rare Disease, 6National Institute of Neuroscience, National Center of Neurology and Psychiatry
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.
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