PT - JOURNAL ARTICLE AU - Richard S. Bedlack AU - Timothy Vaughan AU - Paul Wicks AU - Jamie Heywood AU - Ervin Sinani AU - Roger Selsov AU - Eric A. Macklin AU - David Schoenfeld AU - Merit Cudkowicz AU - Alex Sherman TI - How common are ALS plateaus and reversals? AID - 10.1212/WNL.0000000000002251 DP - 2016 Mar 01 TA - Neurology PG - 808--812 VI - 86 IP - 9 4099 - http://n.neurology.org/content/86/9/808.short 4100 - http://n.neurology.org/content/86/9/808.full SO - Neurology2016 Mar 01; 86 AB - Objective: To determine the frequency of amyotrophic lateral sclerosis (ALS) plateaus and reversals in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.Methods: We 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.Results: Over 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.Conclusion: ALS 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.ALS=amyotrophic lateral sclerosis; ALSFRS=Amyotrophic Lateral Sclerosis Functional Rating Score; ALSFRS-R=Amyotrophic Lateral Sclerosis Functional Rating Score–revised; PRO-ACT=Pooled Resource Open-Access ALS Clinical Trials