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Satralizumab Treatment in Adult Patients With AQP4-IgG–Seropositive Neuromyelitis Optica Spectrum Disorder Switching From Other Therapies: Case Series
Shervin Gholizadeh,1 Brian Steingo,2 Diana Vargas,3 Julie Patel,3,4 Nancy Nealon,5 Mary Alissa Willis,6 Dmitry Khaitov,7 Jose Avila Ornelas,8 Adnan Subei,9 Lisa Ferayorni,1 Xavier Laucirica,1 Hesham Abboud10
1 Genentech, Inc., South San Francisco, CA, USA;
2 Infinity Clinical Research, Sunrise, FL, USA;
3 Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA;
4 Department of Pharmacy, Emory University Hospital Midtown, Atlanta, GA, USA;
5 Department of Neurology, Weill Cornell Medicine, New York, NY, USA;
6 Department of Neurology, University of Mississippi Medical Center, Jackson, MS, USA;
7 Lehigh Valley Health Network, Allentown, PA, USA;
8 HIMA Caguas Multiple Sclerosis Center, Caguas, Puerto Rico;
9 Memorial Healthcare System, Hollywood, FL, USA;
10 University Hospitals Cleveland Medical Center, Cleveland, OH, USA
Purpose: Neuromyelitis optica spectrum disorder (NMOSD) is a rare autoimmune neuroinflammatory disease that primarily affects the optic nerves and spinal cord and can lead to sensory and motor impairment, vision loss and permanent neurological disability. Satralizumab was approved for use in adults with aquaporin 4 autoantibody–positive (AQP4-IgG+) NMOSD in 2020, but real-world data are limited. This case series describes patients with AQP4-IgG+ NMOSD who received satralizumab following treatment with biologics or conventional immunosuppressive therapies (ISTs).
Methods: Case information for patients with AQP4-IgG+ NMOSD who received satralizumab for ≥6 months was obtained from US healthcare providers; case collection is ongoing. Patient characteristics, examination findings, treatment response and reported satralizumab-related adverse events were recorded. Patients who received biologics or ISTs (other than corticosteroids) before satralizumab were included.
Results: To date, 10 patients aged 23 to 69 years are included; 5 self-identified as Black/African American, 3 as White and 2 as Hispanic. Nine patients are female; ~50% have autoimmune comorbidities. NMOSD disease duration ranged from 3 to 14 years; symptoms included optic neuritis and transverse myelitis. Seven patients received rituximab (2 with concomitant mycophenolate mofetil [MMF]), 2 MMF alone and 1 eculizumab as the last NMOSD treatment prior to satralizumab, with reasons for initiation of satralizumab including treatment intolerance and inadequate disease control. To date, patients received satralizumab for 14 to 21 months. Seven patients received satralizumab monotherapy, and 3 have received satralizumab in combination with MMF. Nine patients were relapse free with satralizumab, despite reports of confirmed or suspected relapses with previous treatments in some patients. Overall, patients maintained disease control, with few adverse events reported (leukopenia being the most common). No patients permanently discontinued satralizumab due to ineffectiveness or intolerance.
Conclusions: In this ongoing retrospective case series, patients with NMOSD receiving satralizumab in clinical practice had a beneficial response compared with previous treatments, and satralizumab was well tolerated. These outcomes align with the efficacy and safety outcomes with satralizumab in Phase III SAkura clinical trials.