• Richard S Bedlack, Timothy Vaughan, Paul Wicks, Jamie Heywood, Ervin Sinani, Roger Selsov, Eric A Macklin, David Schoenfeld, Merit Cudkowicz, and Alex Sherman.
• From the Department of Neurology (R.S.B.), Duke University and Durham VA Medical Center, Durham, NC; PatientsLikeMe (T.V., P.W., J.H.), Cambridge, MA; Massachusetts General Hospital (E.S., R.S., E.A.M., D.S., M.C., A.S.), Boston; and Harvard Medical School (E.A.M.), Boston, MA. Bedla001@mc.duke.edu.
• Neurology. 2016 Mar 1; 86 (9): 808-12.

ObjectiveTo determine the frequency of amyotrophic lateral sclerosis (ALS) plateaus and reversals in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.MethodsWe analyzed Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) and ALSFRS-revised (ALSFRS-R) data from PRO-ACT participants. The frequencies of participants experiencing plateaus (periods where scores did not change) were calculated over 6-, 12-, and 18-month epochs. The percentage of participants ever experiencing reversals (periods where scores improved) of different lengths were also calculated and plotted.ResultsOver 6 months, 25% of 3,132 participants did not decline. Over 12 months, 16% of 2,105 participants did not decline. Over 18 months, 7% of 1,218 participants did not decline. Small ALS reversals were also common, especially over shorter follow-up intervals; 14% of 1,343 participants had a 180-day interval where their ALSFRS-R slope was greater than zero. Fewer than 1% of participants ever experienced improvements of 4 or more ALSFRS-R points lasting at least 12 months.ConclusionALS plateaus and small reversals are common, especially over brief intervals. In light of these data, stable disease, especially for a short period of time, should not be interpreted as an ALS treatment effect. Large sustained ALS reversals, on the other hand, are rare, potentially important, and warrant further study.© 2015 American Academy of Neurology.

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