The condition that will be studied is Rheumatoid Arthritis (RA), and in particular, RA patients with moderate to highly active disease who were prescribed Abatacept (Orencia®) (ABA) by their physician during their setting of care at Hospital for Special Surgery (HSS). This investigator-initiated, prospective, comparative, 3-arm observational study will examine changes in lymphocytes in RA patients starting abatacept compared to RA patients starting TNF inhibitors and to healthy controls. This will help investigators to learn more about the processes that cause joints to swell and hurt. This may also offer clues that might predict which patients will have a good or poor response to these treatments.
None
Have severe complications of RA that might require imminent escalation of therapy, e.g. pericarditis, active vasculitis of a major organ system.
Have an autoimmune disease or systemic inflammatory rheumatic disease (e.g., lupus erythematosus) that could confound T and B cell subset results
Have a concurrent serious medical disease (e.g., terminal malignancy)
Have a BMI indicating poor health (<18 or > 40)
The study population is patients with RA who are starting ABA. Data from the study population will be compared with RA controls being treated with standard of care therapy, i.e., MTX with or without either other conventional synthetic (cs)DMARDs and/or a TNF inhibitor (etanercept, adalimumab, golimumab, infliximab, certolizumab pegol). RA patients who enter the study must meet inclusion criteria.
Cohort
Prospective
Not listed
Change in clonotype diversity of T cell and B cell repertoires
Investigators will compare the change in clonotype diversity of T cell and B cell repertoires in patients over 6 months by analyzing clonotype diversity of T cell and B cell repertoires at BL (pre-treatment), 3 months, and 6 months post treatment for each individual in each of the three groups (RA starting ABA; RA on stable MTX +/- TNFi.
CTLA4 gene expression in peripheral blood at 3 times points
Investigators will assess changes in CTLA4 gene expression in peripheral blood at BL, and at 3 and 6 months post-treatment.
Changes in the proportions of T and B cell subtypes
Changes in the proportions of T and B cell subtypes well as NK cells associated with ABA treatment. Flow cytometry analysis will be used to quantify the frequency of T and B cell subtypes and NK cells at each timepoint in each subject in each Arm.
Expression levels in peripheral blood of genes key to the immune response.
Changes in expression levels in peripheral blood of 150 genes key to the immune response.
T cell and B cell repertoire changes and CDAI
Association between T cell and B cell repertoire changes and clinically meaningful improvements in CDAI.
T cell and B cell repertoire changes and SDAI.
Association between T cell and B cell repertoire changes and clinically meaningful improvements in SDAI.
T cell and B cell repertoire changes and DAS23-ESR.
Association between T cell and B cell repertoire changes and clinically meaningful improvements in DAS23-ESR.
T cell and B cell repertoire changes and DAS-28-CRP.
Association between T cell and B cell repertoire changes and clinically meaningful improvements in DAS28-CRP.
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