Association Between Abatacept Exposure Levels and Infection Occurrence in Patients With Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study
Authors' conclusion
This exposure-response analysis of AVERT-2 showed no increase in the risk of first infection, regardless of ABA exposure level, in patients with RA treated with SC ABA.
Study context
- Population
- ACPA-positive adults with early rheumatoid arthritis (RA)
- Participants
- 693 vs 301
- Comparison
- Higher vs lower steady-state subcutaneous (SC) abatacept serum exposure and risk of first infection
- ABA + methotrexate (MTX)n = 693
- ABA placebo + MTXn = 301reference
- Primary endpoint
- Association between steady-state ABA exposure (time-averaged, trough, maximum serum concentration) and first infection
Methodological detailspopulation pharmacokinetic analysis, exposure-response analysis, Kaplan-Meier, Cox proportional hazards models
- Population pharmacokinetic analysis
- Exposure-response analysis
- Kaplan-Meier
- Cox proportional hazards models
Primary result
As reported in the abstract
Exposure-response for first infection
- No exposure relationship for an increased risk of first infection with concomitant MTX and glucocorticoids (GCs) during induction, baseline GC use, or higher-than-median body weight (> 70 kg) at baseline
- Post hoc
Further findings
Population pharmacokinetic (PPK) model of SC ABA
- Linear 2-compartment model with first-order absorption and elimination; higher body weight the only clinically relevant covariate
Safety
Infections
Serious infections
Original publication
Association Between Abatacept Exposure Levels and Infection Occurrence in Patients With Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study. J Rheumatol. Published 15 January 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →