Inebilizumab for Treatment of NMOSD in a Real-world Cohort: Analysis from the SPHERES Registry
Michael Levy1, Dustin Cavida2, Kristina Patterson2, Jenny Park2, Rajvi J. Wani2, Andrea Meyers3, Nicole Middaugh4, C. Jean Choi4, Marie Gurrola4, Jeffrey Bennett5
1Massachusetts General Hospital/Harvard Medical School, 2Amgen Inc., 3Amgen, Inc., 4Thermo Fisher Scientific, 5University of Colorado School of Medicine
Objective:
This study aimed to describe demographics, disease characteristics, and treatment patterns among patients receiving inebilizumab in a real-world setting. 
Background:
Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune disorder of the central nervous system that affects the optic nerves and spinal cord. Early initiation of maintenance therapy is recommended to reduce NMOSD relapses and prevent disability. Inebilizumab targets CD19+ B cells to reduce the risk of NMOSD relapses. 
Design/Methods:
Patients with NMOSD from the US-based SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry who enrolled from June 2, 2021, to February 28, 2025, and had ever received inebilizumab were included (adults age ≥18 years who were diagnosed with NMOSD according to the 2015 IPND consensus diagnostic criteria). The index visit was defined as the enrollment visit for patients with inebilizumab use prior to enrollment, or the registry visit coinciding with inebilizumab initiation for patients who initiated inebilizumab at or after enrollment. 
Results:
Of 68 patients treated with inebilizumab, 63 (93%) were aquaporin-4 antibody positive. The mean age was 50 years, 93% were female, 38% were White, and 46% were Black/African American. The mean time from diagnosis to index visit was 6 years, but 19% of users were newly diagnosed (within one year of the index visit). Prior to the index visit, 32%, 19%, and 49% of subjects had one, two, or three or more relapses, respectively; the mean number±SD of relapses was 3.2±2.6. Of patients on A-BIOs, inebilizumab was initiated as first-, second-, or third-line therapy in 34% (30/89), 31% (21/67), and 24% (9/37) patients, respectively. 
Conclusions:
This descriptive analysis of real-world NMOSD patients who newly initiated or used inebilizumab provides valuable insights into patient demographic, clinical characteristics, and treatment patterns. While patients were commonly switched to inebilizumab, further analysis is needed to understand long-term real-world outcomes.
10.1212/WNL.0000000000216902
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