Effects of Abatacept on Myocarditis in Rheumatoid Arthritis
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This study aims to evaluate the effects of abatacept, a CTLA4-Ig fusion protein that binds
CD80/86 (B7-1/B7-2), on subclinical myocarditis in rheumatoid arthritis (RA) through its
effect on T cell subpopulations. RA patients without clinical CVD, biologic naïve, and with
inadequate response to methotrexate (MTX), will undergo cardiac FDG PET/CT imaging to assess
myocardial inflammation. Studies that investigate the impact of treatment on subclinical
myocarditis in RA, a possible contributor to heart failure, while exploring potential
underlying mechanisms (i.e., different T cell subpopulations), are needed for a better
understanding of their relevance in the pathogenesis of heart failure in RA and survival
improvement in these patients with excess risk for cardiovascular death. If the investigator
hypothesis is confirmed and treatment with abatacept decreases and/or suppresses or prevents
myocardial inflammation in RA, this will have multidisciplinary implications that could lead
to changes in the current management of RA patients at high risk for cardiovascular events.
Similarly, identification of T cell subpopulations in RA patients with myocardial FDG uptake
will shed light into the underlying cellular mechanisms of myocardial injury and serve to
guide the use of therapies that prevent their pathogenicity. The objectives of this study are
to compare the change in myocardial FDG uptake in RA patients treated with abatacept vs
adalimumab, and identify T cell subpopulations associated with myocardial FDG uptake in each
treatment arm. RA patients will be randomized in an unblinded, 1:1 ratio to treatment with
abatacept vs adalimumab. A cardiac FDG PET/CT will be performed at baseline and 16 weeks
post-biologic treatment. T cell subpopulations associated with myocardial FDG uptake will be
evaluated at both points in time with their transcriptional phenotype outlined by RNAseq.