Natural history and clinical outcomes in adults with NAFLD – lessons from cohort studies and placebo arms of trials

It was found that the natural history of NAFLD is variable. Whilst 31% of patients with NAFLD develop NASH, 29% of patients have been found to resolve it. The fibrosis progression rate in clinical trials stands at ~20%. The rate of improvement for fibrosis patients stands at ~22% and results are driven by factors such as regression to the mean, sampling variability and observer variability. The placebo response was also determined by the same variables mentioned above. Advanced fibrosis (F3 and F4) act as drivers for clinical outcomes. 10% IR was also found in the new decompensation in advanced NASH.

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