Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• In the MOVE trial, palovarotene demonstrated a 60% lower mean annualized new heterotopic ossification (HO) volume compared to the natural history study (NHS), with a probability of reduction in new HO volume of 99.4% based on Bayesian compound Poisson model (BcPM) analysis without transformation, and 65.4% with transformation.
• The weighted linear mixed-effects (wLME) model results indicated a 54% reduction in new HO volume, achieving statistical significance with a nominal p-value of 0.039.
• In patients aged <14 years, 36.8% experienced premature physeal closure (PPC) or epiphyseal disorder, alongside evide 5. All patients treated with palovarotene reported at least one adverse event, with 97.0% experiencing at least one retinoid-associated adverse event and 29.3% reporting at least one serious adverse event. PPC or epiphyseal disorder was observed in 36.8% of patients aged <14 years.
• Post hoc analyses indicated decreased vertebral bone mineral density, content, and strength, along with an increased risk of vertebral fractures in palovarotene-treated patients.
• There is no population types or subgroups information available in the reviewed documents.