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A new study finds that autoimmune disease patients with higher baseline B-cell counts and IL-6 levels are significantly more likely to develop cytokine release syndrome (CRS) after CAR T-cell therapy. Across 108 patients, 80% developed CRS — though most cases were mild. Researchers say these biomarkers could help identify high-risk patients before treatment begins.
CAR T-cell therapy is showing real promise for autoimmune diseases, but it comes with risks — and a new study published in The Lancet Rheumatology may help clinicians get ahead of them. Researchers analyzed 108 patients with refractory autoimmune diseases (mostly lupus) who received CAR T-cell therapy across seven centers in Germany and China, finding that 80% developed cytokine release syndrome (CRS) afterward. The good news: the vast majority of cases were mild (grade 1 or 2).
The key finding is that two baseline biomarkers — B-cell counts and interleukin-6 (IL-6) concentrations — were strongly and independently associated with CRS risk. Patients who developed CRS had notably higher pre-treatment B-cell counts and IL-6 levels compared to those who didn't. Researchers also identified specific cutoff values that could stratify patients into higher- and lower-risk groups before infusion.
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Why it matters: As CAR T-cell therapy expands beyond cancer into autoimmune disease, identifying who's most at risk for serious side effects is critical. These biomarkers could enable personalized monitoring strategies and preventive interventions — potentially making this powerful therapy safer and more accessible.