The American Association of Immunologists (AAI) Clinical Immunology Committee recently hosted an illuminating webinar titled “Biomarker Selection and Analysis in Clinical Trials.” Moderated by Dr. Laura Donlin (Hospital for Special Surgery & Weill Cornell Medicine) and Dr. Bjoern Peters (La Jolla Institute for Immunology), the event featured expert presentations from Dr. Katherine Liao (Harvard Medical School/Brigham and Women’s Hospital) and Dr. Allan Kirk (Duke University).
Precision in Rheumatoid Arthritis
Dr. Katherine Liao spotlighted the pressing need for biomarkers that predict treatment response in rheumatoid arthritis (RA), noting that up to 50% of patients fail to respond to a given therapy. One standout example was the use of high-sensitivity cardiac troponin to detect elevated cardiovascular risk. According to Liao, patients with detectable troponin had a sevenfold increase in major cardiac events, compared with low-risk populations. Liao proposed a potential clinical trial design leveraging troponin levels to stratify RA patients into treatment pathways, aiming to better tailor therapy to individuals.
Dr. Liao also highlighted the Accelerating Medicines Partnership (AMP), which uses synovial tissue profiling and molecular clustering to uncover biomarkers that might guide personalized RA treatment.
“Where we struggle the most is really finding the right treatment for the right patient at the right time,” she noted.
Biomarkers in Transplantation
Shifting focus to transplantation, Dr. Allan Kirk distinguished between prognostic (predicting outcomes) and predictive biomarkers (indicating likely treatment response). Although modern transplant techniques have reduced rejection rates, this very success makes it harder to statistically power biomarker studies.
Among the biomarkers discussed, donor-specific antibodies (DSA) emerged as a powerful prognostic factor for long-term graft loss. Dr. Kirk celebrated the legacy of the cross-match test, calling it “probably the best biomarker of any disease ever” for its role in eliminating hyperacute rejection.
Dr. Kirk also introduced the promising iBox composite biomarker score—which integrates metrics like glomerular filtration rate, proteinuria, biopsy data, and DSA status as a potential surrogate endpoint in clinical trials.
Next Chapter of Precision Medicine
Biomarkers are poised to transform how clinicians select and evaluate therapies, but their full potential will only be realized through rigorous trials, practical implementation, and continued collaboration across fields. By bringing together experts from diverse fields, this webinar highlighted not only the scientific advances already underway, but also the shared challenges and opportunities that will define the next chapter of precision medicine.
If you missed the webinar live, you can still view the recorded video at the AAI Virtual portal.
