For patients with multiple sclerosis (MS), having no evidence of disease activity (NEDA) at two years has a positive predictive value of 78.3% for absence of progression at seven years, according to research published in the February issue of JAMA Neurology.
Although 46% of patients in the study had achieved NEDA at one year, 7.9% of patients maintained NEDA after seven years. These findings result from a longitudinal study of 215 patients with clinically isolated syndrome or relapsing-remitting MS.
Dalia L. Rotstein, MD, Assistant Professor of Neurology at the University of Toronto, and her colleagues analyzed data for members of the Comprehensive Longitudinal Investigation of MS at Brigham and Women’s Hospital (CLIMB) cohort who had a minimum of seven years of prospective MRI and clinical follow-up data.
The concept of NEDA is common in the treatment of diseases such as cancer and rheumatoid arthritis, but is considered a secondary outcome measure in MS. NEDA is defined as the absence of new or enlarging T2 lesions or T1 gadolinium-enhancing lesions on MRI and the absence of sustained Expanded Disability Status Scale score progression or clinical relapse.
During the study period, clinical and MRI indicators of disease progress were dissociated, said the investigators. The percentage of patients who had no evidence of disease progression on one measure but not on another ranged from 42.9% at year 2 to 30.6% at year 7. No MRI disease activity occurred in 23.5% of patients at year 1 and in 14.8% of patients at year 7, but the percentage of participants who had NEDA was about 15% at both time points.
“Although NEDA has the potential to become not only a key outcome measure of disease-modifying therapy, but also a treat-to-target goal, it will require a comprehensive approach that integrates advances in MRI technology, linkage of blood and CSF biomarkers, and a high degree of cooperation among investigators,” said the authors.
The study did not explore the effects of different treatment approaches, but NEDA is a necessary, albeit ambitious, benchmark that likely will become an important goal in MS care, said Jaime Imitola, MD, Assistant Professor of Neurology and Neuroscience, and Michael K. Racke, MD, Professor and Chair of the Department of Neurology, both at Ohio State University in Columbus, in an accompanying editorial.
Although the study suggests that NEDA is difficult to maintain over the long term, the outcome has prognostic value at two years. “Neurologists must start discussing the goal of disease-activity-free status with their patients to take NEDA from the uniform environment of clinical trials to actual clinical practice,” said Drs. Imitola and Racke.