New Rheumatoid Arthritis Risk Stratification Criteria Released

Trial Rigor

Dr. Kulveer Mankia

In 2021, a EULAR task force formulated key points to consider when designing research trials investigating patients at risk for RA. Led by Kulveer Mankia, MD, a professor of clinical and translational rheumatology at the University of Leeds, U.K., the task force came to consensus on many helpful considerations when designing trials in individuals at risk for RA, including different at-risk populations that could be studied and the outcome measures that could be used. However, slightly different predictive tools had been used by individual centers.^8,9

“We lacked validation of the different individual predictive tools,” explains Dr. van der Helm-van Mil. “We didn’t have consensus on what variables should be tested.”

Several groups have already developed their own non-validated risk stratification tools, using prospective studies to identify factors that best predict the development of inflammatory arthritis and RA. However, these efforts have been limited due to sample size and the different biomarkers included by the different centers.¹⁰

To address these issues, EULAR formed an expert committee to develop an accurate and validated algorithm for risk stratification, which soon became a collaborative effort with the ACR. Importantly, the idea was to develop rigorous risk stratification criteria rather than true disease classification criteria (e.g., such as those used to promote patient homogeneity in studies of defined diseases).

“This is the first consensus on risk stratification criteria, combining data sets of different at-risk individuals from different countries and validating those previous efforts, providing a more robust risk stratification tool than we’ve previously had,” shares Dr. Mankia.

Dr. van der Helm-van Mil points out that although the field has initially focused on agents already approved for RA, the agents most helpful during an at-risk stage may be different from the ones that are already used to treat full-blown RA. Agents with early pathophysiological targets may be needed, requiring more drug development stages. Additionally, given the challenges of acquiring adequate individuals who are at-risk for future RA in studies, it’s essential that research in this area be of the highest quality possible.

“The risk stratification criteria will help harmonize efforts going forward in trials in this area,” says Dr. Mankia. “The key aim is an increased confidence of what the risk factors are, then taking that into trials by selecting the right individuals based on their risk status. Then we’re more likely to get valid results.”