MS Speaks

SUMMARY AND COMMENT | NEUROLOGYJune 12, 2018

Does “No Evidence of Disease Activity” at 2 Years Predict 16-Year MS Outcomes?


Robert T. Naismith, MD reviewing Goodin DS et al. Mult Scler 2018 May 1.

Radiologic activity did not predict disease progression.

Setting treatment goals in multiple sclerosis (MS) and defining thresholds for suboptimal response have been hot topics. The formulation ‘no evidence of disease activity' (NEDA) encompasses clinical findings (freedom from relapses, disability progression) as well as radiologic ones (new lesions on MRI).

The interferon-beta 1b studies from the mid-1990s recruited 376 patients with active MS and randomized them to treatment or placebo. Investigators evaluated patients who had NEDA at 2 years for negative disability outcomes (NDOs) at 16 years. (Negative outcomes included death, need for wheelchair, and transitioning to secondary progressive disease.)

At 16 years, 245 of the 376 trial participants were assessed. An NDO was present in 129 patients (53%). For patients who had achieved clinical NEDA at 2 years (18%), the likelihood of experiencing an NDO was decreased by 84%. However, adding MRI outcomes to clinical evidence of NEDA did not increase predictive accuracy for NDOs.


COMMENT


A limitation of this study is that patients were not treatment-escalated by a protocol in response to not achieving NEDA. The current data support the idea that three to five new T2 lesions and one or two new gadolinium lesions are associated with an increased risk for worsening future disability. Early disability progression and one or two early relapses should signal a concern for increased risk of long-term disability.