abstructs

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Field Value
Trial Name REACH3
DOI https://doi.org/10.1056/NEJMoa2033122
Diagnosis Chronic graft-versus-host disease, glucocorticoid-refractory or glucocorticoid-dependent
Drugs Ruxolitinib 10 mg twice daily
Line Of Therapy Second-line therapy
Regimen Ruxolitinib at a dose of 10 mg twice daily compared with investigator's choice of therapy
Primary End Point Overall response at week 24
Secondary End Point Failure-free survival and improved score on the modified Lee Symptom Scale at week 24
Competitor Arm Investigator's choice of therapy from a list of 10 commonly used options considered best available care
Efficacy Overall response at week 24 was greater in the ruxolitinib group than in the control group (49.7% vs. 25.6%)
Response Types Complete or partial response
Time To Response
Surveillance
Subsets Patients 12 years of age or older with moderate or severe glucocorticoid-refractory or -dependent chronic GVHD
Adverse Events Thrombocytopenia (15.2% in the ruxolitinib group and 10.1% in the control group) and anemia (12.7% and 7.6%, respectively)
Others REACH3 ClinicalTrials.gov number, NCT03112603
Conclusion Ruxolitinib led to significantly greater overall response, failure-free survival, and symptom response among patients with glucocorticoid-refractory or -dependent chronic GVHD.