“The drug is efficacious in resistant rheumatoid arthritis, and rheumatoid arthritis is a devastating disease. Organs are being destroyed, joints as well as organs, and it’s war. We need to make the patient aware that it’s war and then fight it like it is,” he said.
Many of the committee members mentioned that the efficacies of the 2-mg and 4-mg doses were not in question, primarily based on the data from four phase 3 clinical trials.
The studies RA-BEACON (JADW), RA-BUILD (JADX), RA-BEGIN (JADZ), and RA-BEAM (JADV) were all randomized phase 3 trials that evaluated the efficacy of baricitinib in patients with moderate to severe RA.
RA-BEACON and RA-BUILD both had similar designs and compared 2-mg and 4-mg doses of baricitinib with placebo; the trials primarily differed in their patient populations.