How clinically meaningful are the differences in the primary outcome between treatment and placebo groups in the CENTAUR trial?
Will these results change your practice?
Answer from: at Academic Institution
Defining the term "clinically meaningful" proves challenging. Patients involved in the three positive and approved drug trials are unable to detect a slowdown in the progression rate. Attempts were made to gauge ALS providers' opinions regarding a meaningful change in the ALSFRS-R scale, suggesting ...
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Answer from: at Community Practice
In the CENTAUR trial, AMX0035 (now called Relyvrio) produced a 25% slowing in the rate of decline in a measure of disability called the Revised ALS Functional Rating Scale (ALSFRS-R). Most patients I have cared for in the past 22 years would find this meaningful (indeed, many patients testified to t...
Answer from: at Community Practice
The differences seen in the CENTAUR trial include a 25% reduction in disease progression rates and prolongation of survival (by about 5 months). These results are clinically meaningful in the context of a rapidly progressive and uniformly fatal disease like ALS.
Answer from: at Community Practice
My concern with the current "3 Rs" is that if each slows the disease's progression by 25-35%, then shouldn't the combined effect result in a 75% slowdown if one takes all three? I don't think so. Realistically, some might respond (whatever that means) to each treatment but not the others. However, o...
Answer from: at Academic Institution
A 25% reduction in disease progression is definitely worth the treatment. A 5-month prolongation of survival would be welcomed by most ALS patients, although not by all. I would certainly recommend it!