The SPHERES Registry of Patients with NMOSD Reaches Enrollment Milestone of 200 Patients

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Apr 12, 2023, 10:30 ET

WALTHAM, Mass. and BEVERLY HILLS, Calif., April 12, 2023 /PRNewswire/ -- CorEvitas, the leading sponsor of registries in autoimmune and inflammatory diseases, and The Guthy-Jackson Charitable Foundation (GJCF) are pleased to announce that the SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions in NMOSD) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD) has reached an enrollment milestone of 200 patients.

Launched in early 2021, the SPHERES Registry serves as the first regulatory-grade and real-world study to advance the understanding of NMOSD. The goals of the study focus on the safety and effectiveness of newly approved medications, evolving treatment patterns and access, and evaluating patient experience over time. This study also supports expanded research on cellular and molecular biomarkers through collection of biospecimens, standardized adjudication of relapses, and extensive patient-reported outcomes (PROs).

To date, the SPHERES Registry has recruited 200 patients, across 23 sites in North America, supported by 72 physicians. Key variables being captured include demographics, treatment history, adverse events (AEs) and severe AEs, disease characteristics, and key patient burden and quality of life measures, including the Modified Fatigue Impact Scale (MFIS), the PainDETECT Questionnaire (PD-Q), EuroQol Visual Analogue Scale (EQ-VAS), and the Visual Function Questionnaire (VFQ-UI).

"The SPHERES Registry is systematically capturing extensive longitudinal data to better understand the impact of therapeutics used in NMOSD on disease course and biomarker signatures, among other advances. These data will support new insights into the safety and effectiveness of current treatment options and their benefit to patient experience." said Dr. Michael Yeaman, Professor of Medicine at the David Geffen School of Medicine at UCLA and Chair Medical Advisor to the Guthy-Jackson Charitable Foundation.

NMOSD includes rare, neuroinflammatory autoimmune diseases (NMO and myelin oligodendrocyte glycoprotein antibody-associated disease [MOGAD]) of the central nervous system, primarily targeting the optic nerves, spinal cord, and brain. These diseases are currently estimated to afflict at least 15,000 people in the U.S. and hundreds of thousands worldwide. Historically, these conditions have imposed significant physical and emotional disability and life-threatening outcomes. Today, advances in diagnosis, biomarkers, and newly FDA-approved treatment options offer patients with NMOSD the promise to lessen or prevent disability and enhance quality of life.

About The Guthy-Jackson Charitable Foundation (GJCF)
Since 2008, The Guthy-Jackson Charitable Foundation has dedicated more than $65 million to funding clinical and basic science research aimed at understanding and solving NMOSD. As part of its field-transforming blueprint, GJCF designed and led the CIRCLES Registry, created the International Clinical Consortium for NMOSD including more than 100 world experts from 32 countries, formed the NMOSD Industry Council, organized the International Panel on NMOSD Diagnosis, engaged FDA in support of new therapies, and published a body of high-impact papers in leading journals, among other high-impact initiatives. As a result, the first-ever approved NMOSD therapies — along with quantum leaps in patient quality of life, improved diagnostics, biomarker identification, advances in epidemiology, and pioneering tolerization clinical trials—are now realities. The GJCF passionately supports programs that elevate public awareness of NMOSD through education and advocacy for patients, caregivers and healthcare providers. Together with its partners, these breakthroughs exemplify the GJCF mission to minimize the burden of NMOSD through prevention, rapid diagnosis, safe and effective treatments, and ultimately cures for this disease. Learn more at guthyjacksonfoundation.org.

About CorEvitas

CorEvitas is a science-led, real-world data intelligence company. Using syndicated registry data and analytic services to understand the real-world safety, effectiveness, and patient experience of therapeutics, CorEvitas provides the life sciences industry with the objective data and clinical insights to demonstrate the value of their products to clinicians, patients, payers, and regulators. The company operates nine major autoimmune and inflammatory registries across the U.S., Canada, and Japan, collecting data from over 400 participating investigator sites, including the collection of biosamples linked to deep clinical data. CorEvitas recently expanded its services to include Pregnancy Registries through the acquisition of Pregistry, LLC. CorEvitas also conducts client-sponsored registries through its Patient Powered Registries business, employing a transformative patient-focused registry model to support research needs for patient-centered outcomes across all therapeutic areas. The company's regulatory-grade registry data is complemented by its Patient Experience business, supporting evidence-based patient engagement initiatives across the product lifecycle, as well as its Specialty EMR Data business and retinal data set. CorEvitas is headquartered in Waltham, MA and is a portfolio company of Audax Private Equity. www.corevitas.com

CONTACT INFORMATION:
CorEvitas, LLC
Erem Latif
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SOURCE CorEvitas, LLC