SPHERES, real-world data registry for NMOSD, enrolls 200 patients

Goal is to more fully understand disease course over time and effects of treatment

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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SPHERES, a real-world registry designed to better understand neuromyelitis optica spectrum disorder (NMOSD) — its underlying mechanisms, clinical course, and treatment effects — has reached a milestone of 200 enrolled patients.

Standing for Synergy of Prospective Health & Experimental Research for Emerging Solutions in NMOSD, the SPHERES registry launched in 2021 as a collaboration between CorEvitas, a company sponsoring several registries in autoimmune and inflammatory diseases, and the Guthy-Jackson Charitable Foundation (GJCF).

SPHERES “is systematically capturing extensive longitudinal [over time] data to better understand the impact of therapeutics used in NMOSD on disease course and biomarker signatures, among other advances,” Michael Yeaman, PhD, GJCF’s chair medical adviser, said in a joint press release.

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“These data will support new insights into the safety and effectiveness of current treatment options and their benefit to [the] patient experience,” added Yeaman, who is also a professor of medicine at the University of California, Los Angeles’s David Geffen School of Medicine.

NMOSD, a rare autoimmune disease, is due to immune system attacks on cells that support the nervous system, causing inflammation in the spinal cord and the optic nerve, which relays information between the eyes and the brain. This leads to motor disability and vision problems that can affect a person’s quality of life considerably.

Advances in diagnosis and biomarkers, as well as in disease treatments, offer patients a chance to lessen or prevent disability.

From the first NMOSD patient enrolled in July 2021, current registry participants have been recruited at 23 clinical sites across North America, with the support of 72 physicians. An announced goal is to enroll 800 patients.

SPHERES is evaluating the real-world safety and effectiveness of approved therapies, changes in treatment patterns and access, as well as the disease’s impact on life quality and patient-reported outcomes. Data collected also will support research into potential cellular and molecular biomarkers of NMOSD.

In addition to detailed background information, complied data address a patient’s treatment history, adverse events, and disease characteristics. To understand the disease and treatment effects, fatigue is assessed using the Modified Fatigue Impact Scale, and pain due to nerve damage with the PainDETECT Questionnaire.

Patients’ quality of life is self-assessed using the EuroQoL Visual Analogue Scale and vision via the Visual Function Questionnaire-utility index.

CorEvitas scientists will manage and analyze SPHERES’s data, while GJCF’s advisers are part of its scientific steering committee, using insights learned from the GJCF-led CIRCLES registry, reported to be the largest multicenter NMOSD study in the world.

More information about SPHERES is available by calling CorEvitas at (508) 408-5435 or sending an email to [email protected].