Effectiveness of Newly Initiated Tofacitinib and Biologic DMARDs in Patients with Rheumatoid Arthritis.
TL;DR
There were no statistically significant differences in CDAI remission and LDA rates between treatments at 6 and 12 months and potential HTE was observed among subgroups of age ≥ 50 years, obesity, prior b/tsDMARD use, corticosteroid use, and Sjӧgren's disease.
Abstract
INTRODUCTION This new-user, active comparator study of patients with rheumatoid arthritis (RA) evaluated the real-world effectiveness of tofacitinib versus biologic disease-modifying antirheumatic drugs (bDMARDs) using data from the US OM1 PremiOM™ RA dataset.
Methods
This analysis included patients with RA aged ≥ 18 years initiating tofacitinib or bDMARDs (tumor necrosis factor inhibitors, TNFi; abatacept; interleukin-6 inhibitors, IL-6i) from January 1, 2013-March 13, 2024, with > 1 Clinical Disease Activity Index (CDAI) score in the 45 days prior to and including the index date. Propensity score weighting adjusted for differences in baseline characteristics between treatment groups. Crude incidence rates were calculated to estimate the first record of CDAI remission (CDAI ≤ 2.8) and low disease activity (LDA; CDAI ≤ 10.0) at 6 and 12 months. Cox regression was used to estimate weighted hazard ratios. Subgroup analyses assessed heterogeneity of treatment effects (HTE).
Results
The final sample size across cohorts was 3681 (tofacitinib), 11,667 (TNFi), 3528 (abatacept), and 2464 (IL-6i). At baseline, the proportion of patients with observed RA disease duration ≥ 2 years was 48.7-70.0% across cohorts; use of 2/3/≥ 4 prior biologic/targeted synthetic (b/ts) DMARDs was 21.4%/10.2%/5.0% (tofacitinib), versus 8.1%/3.0%/2.4% (TNFi), 19.2%/8.3%/3.7% (abatacept), and 25.4%/13.7%/10.5% (IL-6i). In the overall and TNFi-experienced population, there were no statistically significant differences in CDAI remission and LDA rates between treatments at 6 and 12 months. Potential HTE was observed among subgroups of age ≥ 50 years, obesity, prior b/tsDMARD use, corticosteroid use, and Sjӧgren's disease.
Conclusion
At 6 and 12 months, there were no significant differences in achieving or maintaining CDAI remission and LDA for tofacitinib versus TNFi, abatacept, and IL-6i among the overall and TNFi-experienced RA population in US clinical practice. Subgroup analyses suggest some potential HTE; however, interpretation is limited by the small number of outcome events. CLINICALTRIALS GOV ID NCT06418529.