Brigham and Women’s Hospital and Columbia University Medical Center have received a four-year, $8.56 million grant from the National Institutes of Health (NIH) /National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS) for a new, clinical trial examining Cardiovascular Disease (CVD) in patients with Rheumatoid Arthritis (RA).
CVD is the leading cause of death in patients with RA, a chronic inflammatory disease causing joint damage and disability. Most experts believe that enhanced vascular inflammation underpins accelerated atherosclerosis, hardening of the arteries, and cardiovascular events in patients with RA, but there is no direct proof of this hypothesis. With this grant, researchers will conduct one of the first randomized, clinical trials to explore whether existing RA therapies that reduce joint inflammation will also reduce inflammation in the blood vessels, thereby hopefully reducing CVD risk.
“This is the first trial of its kind in RA to compare two known arthritis treatment strategies’ effects on cardiovascular risk,” says Daniel Solomon, MD, rheumatologist at BWH and one of the principal investigators leading the trial.
Researchers from 40 sites across the country will enroll 200 RA patients to compare the impact of two different treatment regimens for RA on vascular inflammation using a PET-CT scan before patients begin the trial, and again at 24 weeks after starting treatment, to assess the difference in vascular inflammation, and determine whether one treatment is superior to the other.
Specifically, researchers will compare sulfasalazine (SSZ) plus hydroxychloroquine plus methotrexate (MTX), commonly referred to as triple therapy, to MTX in combination with a Tumor Necrosis Factor (TNF) inhibitor. Both regimens are recognized to suppress the inflammatory response.
“Another important feature of the trial is to understand whether reducing inflammation in the joints to a very low level is paralleled by a similar level of reduction in inflammation in the blood vessels, regardless of which treatment regimen the patients receive,” says Joan Bathon, MD, director of the Division of Rheumatology at NewYork-Presbyterian/Columbia University Medical Center, the other principal investigator leading the trial.
The trial, which is anticipated to begin in early 2016, will include a two year enrollment period. Once a participant has enrolled, researchers will conduct a 6 month follow up for each, accumulating enough data to analyze and review within the next 3 years. For more information, contact Alyssa Wohlfahrt at 617-525-8784.