Novel Studies Aim to Prevent Rheumatoid Arthritis in High-risk Populations
Researchers in the Division of Rheumatology, Immunology, and Allergy at Brigham and Women’s Hospital (BWH) are leading studies designed to prevent the development of rheumatoid arthritis (RA) in patients at high risk for the disease and are participating in the first primary prevention trial for RA in the United States.
“Over decades of research, we have identified many significant risk factors for RA,” said Elizabeth W. Karlson, MD, Director of the Rheumatic Disease Epidemiology Research Program at BWH. “Our goal in these studies is to see if we can prevent RA in patients with specific risk factors by intervening at an earlier phase in the disease timeline, prior to the onset of symptoms and joint damage.”
RA Risk Education and Behavior Modification
Dr. Karlson is the national Principal Investigator of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study. Collaborating with BWH rheumatologist Jeffrey A. Sparks, MD, MMSc, she is evaluating the impact of RA risk education in first-degree relatives of people with RA. The PRE-RA Family Study Personalized Risk Estimator for RA is an online risk calculator developed by BWH researchers based on demographics, family history, biomarkers and behaviors related to RA. Modifiable environmental risk factors targeted in the study include smoking, obesity, oral health, and fish intake.
Supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a research institute of the NIH, the PRE-RA Family Study includes a total of 240 participants between 18 and 70 years-of-age with a first-degree blood relative with RA. The participants were randomized to one of three study arms. Those in the first arm (comparison group) have received general education about RA. In the second arm (PRE-RA), participants received their personalized risk as calculated by the Personalized Risk Estimator for RA. In the third arm (PRE-RA Plus), participants received their personalized risk from the Personalized Risk Estimator for RA online tool in addition to one-on-one counseling by a health educator. All participants will be followed for one year and were surveyed before and after RA education about their knowledge and attitudes about RA risk; their decisional balance related to behaviors; and their stage of behavior change concerning lifestyle risks.
“The PRE-RA Family Study provides us with an exciting opportunity to assess the impact of the reduction of environmental risks in preventing the development of RA,” said Dr. Karlson. “Our hypothesis is that participants who receive personalized RA risk will be most willing to change important behaviors.”
Pre-clinical Pharmacologic Intervention
Dr. Sparks is the BWH Site Principal Investigator for the Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis (StopRA) trial, the first primary prevention trial for RA in the United States. Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), the StopRA trial is a multicenter national study evaluating whether hydroxychloroquine (HCQ) is safe and effective for the prevention of future onset of RA in individuals who have elevations of anti-cyclic citrullinated peptide (anti-CCP). The trial is expected to enroll 200 participants and will open in the first half of 2016. Participants will be randomized to receive HCQ or placebo for one year and will be followed for an additional two years for a total of 10 visits over three years.
The StopRA study will include adults with:
Elevated anti-CCP of >40 units;
No history of or examination evidence of inflammatory arthritis (IA) of any type and/or rheumatic disease and immunologic disease that may be associated with IA;
No evidence of significant retinal disease.
(For more information on the StopRA trial or to refer a patient, contact Dr. Sparks at (617) 525-1038 or firstname.lastname@example.org)
“We have a great understanding of the pathogenesis of RA and have made many advances in the treatment of RA,” said Dr. Sparks. “The next important step is to prevent this disease in high-risk populations.”
Elizabeth W. Karlson, MD Director, Rheumatic Disease Epidemiology Research Program
Jeffrey A. Sparks, MD, MMSc Rheumatologist, Division of Rheumatology, Immunology, and Allergy