At week 12, participants who received placebo were reassigned to upadacitinib daily.The benefit of upadacitinib was measured by comparing the proportion of participants treated with upadacitinib who achieved an American College of Rheumatology 20 (ACR20) response at week 12 or week 14 to the proportion of participants treated with MTX or placebo who achieved an ACR20 response. ACR20 is a 20% improvement in signs and symptoms of RA.Upadacitinib was approved for medical use in the European Union in December 2019. Research
Upadacitinib has also demonstrated success in treating moderate to severe atopic dermatitis and has been found to have superior efficacy compared with placebo and dupilumab. References
External links
"Upadacitinib". Drug Information Portal. U.S. National Library of Medicine.
BALANCE I
In the first study, 276 rheumatoid arthritis patients were recruited who had previously experienced inadequate response to anti–tumor necrosis factor (TNF) therapy and were currently on a stable dose of methotrexate. Patients were randomized to receive 3, 6, 12, or 18 mg twice daily or placebo. The primary endpoint was a 20% improvement in symptoms according to the American College of Rheumatology improvement criteria (ACR20). At the completion of the study it was found that response rates were significantly higher in those receiving upadacitinib versus in those receiving placebo alone (36–42% and 22– 26%, respectively). Adverse events included headache, nausea, and infection but no infections were serious. BALANCE II
In the second phase IIb study, 300 rheumatoid arthritis patients were recruited who have had an inadequate response to methotrexate. Patients were randomized to receive 3, 6, 12, or 18 mg twice daily or placebo. The primary endpoint was a 20% improvement in symptoms according to the American College of Rheumatology improvement criteria (ACR20). At the completion of the study it was found that response rates were significantly higher in those receiving upadacitinib versus in those receiving placebo alone. (62%, 68%, 80%, 64%, and 76% for the 3, 6, 12, 18, and 24 mg doses, respectively) than with placebo (46%). Improvement in symptoms was rapid, with significant changes in disease scores by week 2. Adverse events were mild with infection being the most serious. One case of community-acquired pneumonia occurred at 12 mg.

CELEST
In this 16-week study, 220 patients were recruited with moderately to severely active Crohns disease.