New Concept in MS: NEDA

Demyelination in multiple sclerosis. (Courtesy Wikipedia.)

No evidence of disease activity (NEDA) may become a key outcome measure of disease-modifying therapy for patients with multiple sclerosis (MS), as well as a potential treat-to-target goal, according to a new study.

“NEDA is a new concept developing in MS. New MS treatments are available. For the first time, the field is beginning to ask how well are these treatments doing and can we ultimately shut down the disease,” said senior author Howard L. Weiner, MD, of Partners Multiple Sclerosis Center, Brigham & Women’s Hospital, in Boston, MA.  

To investigate what proportion of MS patients can be expected to maintain NEDA over time, the researchers measured NEDA by relapses, disability progression, and yearly MRI. Patients were selected from the 2,200-patient Comprehensive Longitudinal Investigation of Multiple Sclerosis cohort study at Brigham and Women’s Hospital. The study included 219 patients who had a minimum of 7 years of prospective follow-up that included yearly brain MRI and biannual clinical visits.

NEDA was defined as a composite that consisted of absence of relapses, no sustained Expanded Disability Status Scale score progression, and no new or enlarging T2 or T1 gadolinium-enhancing lesions on annual MRI.

The patients were classified as having early (recent-onset) MS if they were 5 years or less from their first MS symptom at enrollment or otherwise considered to have established MS (more than 5 years from onset).

At 1 year, nearly half (46%) of the patients had NEDA for clinical and MRI measures and at 2 years more than one-quarter (27.5%) maintained NEDA. But only 7.9% of patients maintained NEDA status after 7 years. No differences were found in NEDA status between patients with early versus established MS.

NEDA at 2 years had a positive predictive value of 78.3% for no progression at 7 years. Only minor improvement was found in the positive predictive values with additional follow-up of 1 to 3 years.

The researchers conclude that “NEDA is difficult to sustain long-term even with treatment. NEDA status at 2 years may be optimal in terms of prognostic value in the longer term. Our results provide a basis for investigating NEDA as an outcome measure and treatment goal and for evaluating the effect of new MS drugs on NEDA.”

The researchers plan to look at subcategories of MS patients to see whether some patients achieve NEDA easier than others.

An editorial writer, Michael Racke, MD, of the Comprehensive Multiple Sclerosis Center, The Ohio State University Wexner Medical Center, Columbus, OH, said: “NEDA is a goal that we all would like to achieve. As we put patients on treatments, they continue to have some degree of disease activity. Does this mean that everyone switches to the most aggressive treatment, or is there some level of disease activity we might accept?”

The important concept from NEDA, he said, is “if you look at a cohort of patients with no disease activity in the short-term, they are likely to do better in the long-term.”

The researchers published their results online on December 22, 2014 in JAMA Neurology.