- In the phase 3 RA-BEGIN trial:
- At 24 weeks, 81 percent of patients receiving baricitinib monotherapy and 79 percent of patients receiving baricitinib plus methotrexate had clinically meaningful improvement in physical function compared with 70 percent among those receiving methotrexate alone (p < 0.05). Clinically meaningful improvement was defined as an improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score of ≥0.22.
- At 52 weeks, 68 percent of patients on baricitinib monotherapy and 72 percent of patients on baricitinib in combination with methotrexate saw clinically meaningful improvements in physical function compared to 57 percent of those treated with methotrexate alone (p < 0.05).
- At 24 and 52 weeks, baricitinib (as monotherapy or in combination with methotrexate) was also associated with significant improvement in pain, and clinically meaningful improvement in fatigue and the physical health components of the quality of life assessment compared with methotrexate alone.
- In the phase 3 RA-BEAM trial, where all patients received background methotrexate therapy:
- At 12 weeks, 75 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 71 percent of patients on adalimumab (p=0.302). Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22.
- At 24 weeks, 73 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 64 percent of patients on adalimumab (p < 0.05).
- At 52 weeks, 68 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 58 percent of patients on adalimumab (p < 0.01).
- At 52 weeks, baricitinib was also associated with significant improvement in pain, and clinically meaningful improvement in fatigue and the physical health components of quality of life compared with adalimumab.
- An analysis of the phase 3 trials found that in each study, patients taking baricitinib have less impairment in work productivity and daily activities compared to patients taking the comparator.
