OP0117 REAL-WORLD EFFECTIVENESS OF TNFI VERSUS NON-TNFI BIOLOGICS ON DISEASE ACTIVITY IN PATIENTS WITH RHEUMATOID ARTHRITIS: DATA FROM THE ACR’S RISE REGISTRY
Authors: M. Gianfrancesco, J. LI, M. Evans, M. Petersen, G. Schmajuk, J. Yazdany
Journal: Annals of the Rheumatic Diseases (2021)

Background: Our understanding of how medications such as biologic disease modifying anti-rheumatic drugs and targeted small molecules (b/tsDMARDs) influence disease activity in RA is based largely on randomized controlled trials (RCTs). However, most U.S. trials in RA are limited by small sample sizes and have often excluded patients who are older, male, and from racial/ethnic minorities. Whether effectiveness of b/tsDMARDs varies in these populations has largely been unexplored. Objectives: We aimed to examine differences in longitudinal RA disease activity by demographic and clinical characteristics using a novel electronic health record data source of rheumatology providers across the U.S. We simulated various treatment assignments of b/tsDMARDs that have been examined in RCTs: namely, TNF-inhibitors (TNFi) and non-TNFi. Methods: We included 16,448 individuals from the ACR’s RISE registry with ≥ 2 RA diagnoses (ICD-9: 714.0) ≥ 30 days apart, who had at least 2 recorded clinical disease activity index (CDAI) scores and no historical b/tsDMARD use documented in RISE. b/tsDMARD use and CDAI scores were assessed at each quarter; covariates included sex, race (white, Black, Asian, other), ethnicity (Hispanic/non-Hispanic), age, smoking, obesity, area deprivation index, other DMARD use, RF status, anti-CCP status, and practice type. Longitudinal targeted maximum likelihood estimation estimated the average treatment effect (ATE) of cumulative TNFi vs. non-TNFi use over a 12-month period on CDAI score among the entire population and across various subgroups based on demographic and clinical characteristics, accounting for censoring and time-varying confounding. Results: Approximately 75% of patients were female with a mean age of 65.1 (+/- 13.7) years. Sixty percent of patients were white, 8% black, 2% Asian, and 30% other/mixed or unknown race; 6% were Hispanic. The mean CDAI score at baseline was 11.3 (+/- 10.7). For the overall population, there was no significant difference in disease activity between TNFi and non-TNFi at 12 months (ATE= 0.85, 95% CI -0.26, 1.96; Table 1). Stratified analyses found higher disease activity for TNFi compared to non-TNFi among patients of Black and Asian race, non-Hispanic ethnicity, and female sex. Among Black race patients, TNFi use was associated with a 6.08 point higher CDAI score compared to non-TNFi use (95% CI 1.99, 10.17). In contrast, in Hispanic/Latino ethnicity patients, TNFi use was associated with a lower CDAI score compared to non-TNFi use (ATE= -2.64, 95% CI -3.99, -1.30). Table 1. Average treatment effect (ATE) of cumulative TNFi vs. non-TNFi use at 12-months on CDAI score in patients with RA TNFi Non-TNFi ATE (95% CI) Overall (n=16,448) 8.84 7.99 0.85 (-0.26, 1.96) Race White (n=9,814) 8.24 6.81 1.42 (0.03, 2.81)* Black (n=1,358) 13.91 7.83 6.08 (1.99, 10.17)* Asian (n=301) 6.54 2.74 3.80 (2.93, 4.67)* Ethnicity Non-Hispanic (n=14,216) 8.92 7.63 1.29 (0.08, 2.51)* Hispanic (n=938) 5.69 8.33 -2.64 (-3.99, -1.30)* Sex Female (n=12,527) 8.98 7.47 1.51 (0.31, 2.72)* Male (n=3,921) 8.57 9.49 -0.92 (-3.42, 1.58) * P &lt;0.05 Conclusion: Results from this RCT simulation study suggest that non-TNFi may have an important role as first-line agents in the treatment of Black and Asian patients, but not Hispanic patients. These novel findings fill gaps where RCTs have not been conducted, highlight the need for inclusion of diverse populations in future trials, and have the potential to lead to a more personalized approach to rheumatologic care. References: Disclosure of Interests: Milena Gianfrancesco: None declared, Jing Li: None declared, Michael Evans: None declared, Maya Petersen: None declared, Gabriela Schmajuk: None declared, Jinoos Yazdany Consultant of: Eli Lilly and Astra Zeneca, unrelated to this project., Grant/research support from: Gilead, unrelated to this project.