A trial designed for patients still in need1,3
BEACON (Study IV) was one of four phase 3 clinical trials evaluating the efficacy of Olumiant across the RA treatment algorithm
Olumiant was evaluated in a 24-week, randomized, double-blind, placebo-controlled trial in 527 patients with moderately to severely active RA who had an inadequate response or intolerance to at least 1 TNF inhibitor. Patients received Olumiant 2 mg (n=174) or baricitinib 4 mg (n=177) once daily or placebo (n=176), added to stable background cDMARD treatment. From week 16, non-responding patients could be rescued to a higher dose (baricitinib 4 mg/day). Baricitinib 4 mg is not an approved dose. The primary endpoint was the proportion of patients achieving ACR20 response at week 12.
cDMARD=conventional disease-modifying antirheumatic drug; RA=rheumatoid arthritis; TNF=tumor necrosis factor; ACR20=American College of Rheumatology 20% improvement criteria.
Olumiant demonstrated significantly greater ACR20, ACR50, and ACR70 response rates vs placebo at weeks 12 and 241,3,4
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
ACR20 is defined as achieving a 20% improvement in tender and swollen joint counts and 20% improvement in at least 3 of the 5 remaining ACR components.5
From week 16, non-responding patients could be rescued to a higher dose which is not approved. Patients who were rescued or discontinued treatment were considered non-responders in the analysis.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12.
ACR20/50/70=American College of Rheumatology 20%/50%/70% improvement criteria; ACR=American College of Rheumatology; cDMARD=conventional disease modifying antirheumatic drug; ACR20=American College of Rheumatology 20% improvement criteria.
Olumiant demonstrated significant improvement in physical function vs placebo at week 243
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
HAQ-DI is a patient-reported questionnaire that measures the degree of difficulty experienced in completing activities of daily living such as dressing and grooming, arising, eating, walking, hygiene, reaching and gripping.6
From week 16, non-responding patients could be rescued to a higher dose which is not approved.
Missing data were reported as modified last observation carried forward (mLOCF) except for week 12, which was reported as modified baseline observation carried forward (mBOCF).
Primary endpoint was the proportion of patients achieving ACR20 response at week 12.
Mean baseline HAQ-DI was 1.71 for Olumiant 2 mg + cDMARDs and 1.78 for placebo + cDMARDs.
HAQ-DI=Health Assessment Questionnaire-Disability Index; LS=least squares; cDMARDs=conventional disease-modifying antirheumatic drugs.
Olumiant is a once-daily oral therapy
Olumiant is available as a tablet, with a recommended dose of 2 mg once daily
Study IV (BEACON) clinical trial
Learn more about the Study IV (BEACON) clinical trial, including ACR response, onset of ACR20 response, HAQ-DI, and DAS28.
Olumiant mechanism of action
Olumiant is a JAK inhibitor for the treatment of moderately to severely active RA for adult patients with an inadequate response to TNFis.
ACR=American College of Rheumatology; ACR20=American College of Rheumatology 20% improvement criteria; HAQ-DI=Health Assessment Questionnaire-Disability Index; DAS28=Disease Activity Score 28.