OMRF Discusses Autoimmune Disease Insights from the SMILE & StopRA Trials

Autoimmune diseases. Book, pills and stethoscope on the desk. TrialsiteN

The Oklahoma Medical Research Foundation (OMRF) has partnered with the University of Colorado and Benaroya Research Institute and others to participate in the SMILE and StopRA trials—these researchers are on a mission to identify autoimmune markers that help us one day avoid the diseases altogether. Results were recently published in EBioMedicine.

The SMILE Trial and StopRA Rheumatoid Arthritis Prevention Study

With the SMILE trial, OMRF sought to seek to identify individuals at high risk for developing lupus and treat them with immune-modifying medication before they ever transition into the disease. OMRF’s ongoing goal is to delay the onset of lupus, lessen its symptoms and potentially prevent it altogether. SMILE, sponsored by Penn State and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) includes several prominent research sites including OMRF. The published objective is to test whether treating patients who are at risk for the development of lupus with hydroxychloroquine can slow the accumulation of disease features. Effects on clinical progression of symptoms, patient-reported outcomes and changes in the immune markers of response will be measured and toxicity of the treatment will be assessed. The sponsors and participating research centers hope that this trial represents a first step in testing a prevention strategy for lupus.

StopRA is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and collaborator Autoimmunity Centers of Excellence and initiative within the NIH. The University of Colorado represents the Principal Investigative unit and involves OMRF’s Arthritis and Clinical Immunology Research Program and Judith James.

The purpose of the StopRA study is to determine if hydroxychloroquine (HCQ) is safe and effective for the prevention of the future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3).

Lead OMRF Investigator

Dr. Judith James, MD, Ph.D. reports that the quest is to understand “Where does autoimmunity start.” She reports that OMRF (and of course the other centers) are collecting and studying samples from large collections of lupus, rheumatoid arthritis and type 1 diabetes patients and their family members in the hopes of identifying some of the first signs of autoimmunity trouble. Dr. James notes “If you’re in a family with a person who has RA, do you have blood markers that only look like rheumatoid arthritis or could they also look like lupus or type 1 diabetes? “ She notes “It’s important to understand if individuals start with abnormal immune responses to many different factors which cross autoimmune diseases or if they just start with markers specific to one disease.”

Findings Thus Far

Findings recently show lupus family members are more likely to have antibodies seen in patients who go on to develop lupus, but some also had antibodies for RA and other autoimmune diseases present. Although the study is not complete OMRF is reporting that more than likely for those that have family members afflicted with autoimmune disease, individuals within that family may have a higher probability of having one such blood marker themselves.