1st NMOSD Patient Enrolls in SPHERES Observational Study
The SPHERES registry, an observational study to better understand the underlying mechanisms and clinical course of neuromyelitis optica spectrum disorder (NMOSD), as well as effects of current treatments, has enrolled its first patient.
SPHERES, which stands for Synergy of Prospective Health & Experimental Research for Emerging Solutions in NMOSD, is the result of a collaboration between CorEvitas, a sponsor of several registries in autoimmune and inflammatory diseases, and the Guthy-Jackson Charitable Foundation (GJCF).
The registry aims to enroll up to 800 NMOSD patients, and CorEvitas and GJCF are currently inviting sites and patients eligible to join.
“First patient enrollment is a milestone achievement in the SPHERES study to understand and improve clinical outcomes in the new era of approved NMOSD therapeutics,” Michael Yeaman, PhD, a professor of medicine at the University of California, Los Angeles, and GJCF’s chair medical adviser, said in a press release.
“SPHERES will also facilitate quantum leaps in the field, including the GJCF Relapse Navigator to standardize relapse adjudication and severity,” Yeaman said, adding that these advances “will create new opportunities to discover and apply clinical, therapeutic and laboratory correlates in NMOSD to promote remission and improve patient lives.”
NMOSD is a rare and potentially life-threatening autoimmune disease in which the immune system wrongly produces antibodies against proteins at the surface of nervous system-supporting cells. This causes damaging inflammation, mainly in the optic nerve and spinal cord.
The disease is estimated to affect about 15,000 people in the U.S. and hundreds of thousands around the world.
While NMOSD has been associated with significant physical and emotional disability, recent advances in diagnosis and biomarkers, as well as the approval of new treatments, offer ways to lessen or prevent patients’ disability and improve their quality of life.
SPHERES will evaluate the real-world safety and effectiveness of these therapies, treatment patterns and access, and therapy impact on life quality and patient-reported outcomes. It will also analyze potential cellular and molecular biomarkers of NMOSD.
In addition to detailed background information, clinical data and biological samples will be collected from each participant every two years.
Understanding gained with this registry is expected to help improve patient care.
CorEvitas scientists will manage and analyze the study’s data, while GJCF’s advisers will be part of the scientific steering committee and promote research, building on the insights generated by the GJCF-led CIRCLES registry.
The largest multicenter NMOSD study in the world, CIRCLES enrolled 1,100 people living with NMOSD, patients with other autoimmune or central nervous system diseases, and healthy volunteers across North America.
SPHERES is currently supported by Genentech (a Roche’s subsidiary) and by Horizon Therapeutics; other industry partners are welcomed to join the collaboration.
“We are grateful for the expertise and partnership of the GJCF in achieving this meaningful milestone and are deeply committed to advancing the understanding of neurologic diseases through real-world evidence generation,” said Jeff Greenberg, MD, CorEvitas’ chief medical officer.
To learn more about the SPHERES registry, contact CorEvitas.