Summary

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• Rezurock (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• Viloxazine demonstrated a significantly higher proportion of ADHD-RS-5 responders compared to placebo (RR = 1.62; 95% CI = 1.36-1.93; P < .00001) and showed improvement on the CGI-I scale (RR = 1.53; 95% CI = 1.32-1.78; P < .00001) in pediatric patients aged 6-17 years with ADHD.
• Comparatively, other novel non-stimulant medications reviewed do not show better efficacy than stimulants but may offer comparable or better tolerability.
• No significant subgroup effectiveness outcomes were reported within the pediatric population (ages 6-17) for viloxazine ER.
• Adverse events (AEs) were consistent with those expected in patients with chronic graft-versus-host disease (cGVHD) receiving corticosteroids and other immunosuppressants; 12% of subjects discontinued belumosudil due to possible drug-related AEs.
• The study involved subjects with chronic graft-versus-host disease (cGVHD) who had received 2 to 5 prior lines of therapy; high response rates were observed across all subgroups, with complete responses in all affected organs, and symptom reduction in 59% (200 mg daily) and 62% (200 mg twice daily) of subjects.