How common are XXXX plateaus and reversals?

@entity1 @entity746
OBJECTIVE: To determine the frequency of @entity746 ( @entity746 ) plateaus and reversals in the Pooled Resource Open-Access @entity746 Clinical Trials (PRO-ACT) database. METHODS: We analyzed Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) and ALSFRS-revised (ALSFRS-R) data from PRO-ACT @entity1 . The frequencies of @entity1 experiencing plateaus (periods where scores did not change) were calculated over 6-, 12-, and 18-month epochs. The percentage of @entity1 ever experiencing reversals (periods where scores improved) of different lengths were also calculated and plotted. RESULTS: Over 6 months, 25% of 3,132 @entity1 did not decline. Over 12 months, 16% of 2,105 @entity1 did not decline. Over 18 months, 7% of 1,218 @entity1 did not decline. Small @entity746 reversals were also common, especially over shorter follow-up intervals; 14% of 1,343 @entity1 had a 180-day interval where their ALSFRS-R slope was greater than zero. Fewer than 1% of @entity1 ever experienced improvements of 4 or more ALSFRS-R points lasting at least 12 months. CONCLUSION: @entity746 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 @entity746 treatment effect. Large sustained @entity746 reversals, on the other hand, are rare, potentially important, and warrant further study.
