Multinational phase 3 study of ruxolitinib for glucocorticoid-refractory chronic graft-versus-host disease

The multinational phase 3 study REACH3 randomized patients with glucocorticoid-refractory or glucocorticoid-dependent chronic graft-versus-host disease to ruxolitinib or investigator’s choice from 10 commonly used options. Overall response at week 24 was seen in 49.7% of patients in the ruxolitinib group versus 25.6% of patients in the control group (OR 2.99; p<0.001). Median failure-free survival was longer than 18.6 months with ruxolitinib versus 5.7 months with control (HR 0.37; p<0.001). Symptom response was seen in 24.2% versus 11.0% (OR 2.62; p=0.001). Up to week 24 incidence of grade 3 or higher thrombocytopenia (15.2% versus 10.1%) and anemia (12.7% versus 7.6%) was higher with ruxolitinib compared to control.