This is from the ann on the 25th of May food for thought as it includes the placebo
"3. Study 280: A Phase 3 randomized placebo-controlled trial in 260 patients, including 28 children,
across 72 centers in seven countries where RYONCIL or placebo were added to second line therapy in
patients with steroid-refractory acute GVHD who failed to respond to steroid treatment.
o Among high-risk children and adults who had the most severe disease stages, day 28 OR was
significantly greater in the RYONCIL treated group (58% versus 37%; P = 0.03) compared to
placebo. Among the standard risk patients there was no significant benefit of RYONCIL
treatment. Within the pediatric patients in this study (n=28) day 28 OR was significantly
greater in the RYONCIL group compared with the placebo group (64% vs 36%, respectively,
P=0.05).
o These Phase 3 results provide prospective, randomized controlled data which are supportive
for the use of RYONCIL in children and high-risk adults with steroid-refractory acute GVHD."
As we all know it really only seems to have benefit to the worse of the worse, which is why after learning this the ARDS trial may do very well.
They may have to redo AGVHD though.
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