Generalization of the Effectiveness of Baricitinib 4MG Among bDMARD-IR Rheumatoid Arthritis Patients from a RCT to a Real-World Population in China
Author(s)
Jiang N1, Li M1, Wang Y2, Zhao J1, Tian X1, Zhu H3, Li J4, Xu J4, Zhang Y4, Zeng X1
1Chinese Academy of Medical Sciences & Peking Union Medical College, BEIJING, China, 2Chinese Academy of Medical Sciences and Peking Union Medical College, BEIJING, China, 3Eli Lilly China, Shanghai, China, Beijing, 11, China, 4Eli Lilly China, Shanghai, China, Shanghai, 31, China
Presentation Documents
OBJECTIVES: To generalize the effectiveness of baricitinib 4mg once daily in Chinese bDMARD-IR RA patients from the phase III RCT to a “real-world” population using the reweighting approach.
METHODS: Weights were calculated using individualized patient data from the RA-BEACON trial (phase III RCT, bDMARD-IR patients) and aggregated real-world data from CREDIT registry in China by generalized method of moments. bDMARD-IR is defined as patients with an inadequate response to or unacceptable side effects associated with one or more tumor necrosis factor inhibitors, other biologic DMARDs, or both. Demographic and clinical characteristics recorded from RA-BEACON and CREDIT were balanced to calculate the weights. Reweighted response rates of categorical efficacy measures (ACR20, ACR50 and ACR70), along with reweighted values of continuous efficacy measures (CDAI, SDAI, DAS28-ESR, DAS28-CRP and HAQ-DI scores) were analyzed in the baricitinib 4mg vs placebo at week 12. Logistic regression and covariance analysis with weights were used for generalizing efficacy results. Sandwich estimators or bootstrapping were utilized for evaluating p-values and 95% CIs in weighted analyses.
RESULTS: Higher response rates were observed in weighted ACR20 (47.61% vs 26.23%), ACR50 (24.53% vs 7.65%) and ACR70 (10.65% vs 2.12%) scores in patients from the baricitinib 4mg arm compared to the placebo arm at Week 12 (p ≤0.05 for all outcomes). Statistically significant improvements in weighted CDAI (-16.23 vs -9.19), SDAI (-16.92 vs -9.03), DAS28-CRP (-1.65 vs -0.73), DAS28-ESR (-1.61 vs -0.79) and HAQ-DI (-0.39 vs -0.23) were observed in patients from the baricitinib 4mg arm compared to the placebo arm (p ≤0.05 for all outcomes) at Week 12.
CONCLUSIONS: Comparable outcomes were observed between original and reweighted population, indicating the reproducibility of efficacy results from the RA-BEACON trial population to the real-world Chinese RA population. This study provided evidence for the effectiveness of baricitinib 4mg for the treatment of Chinese bDMARD-IR RA patients.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
RWD104
Topic
Real World Data & Information Systems
Topic Subcategory
Distributed Data & Research Networks, Reproducibility & Replicability
Disease
Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)