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MAGIC Composite Response: Integration of clinical and biomarker data to predict long-term aGvHD outcomes
Reduction in the severity of acute graft-versus-host disease (aGvHD) clinical symptoms at Day 28 is the gold standard for measuring treatment response in clinical trials, with limitations including modest prediction of non-relapse mortality. The Mount Sinai aGvHD Internal Consortium (MAGIC) has shown that integration of serum biomarkers with clinical symptoms on Day 28 (MAGIC Composite Score; MCS) at treatment onset more accurately predicts treatment response and 6-month non-relapse mortality compared with clinical symptoms alone. Akahoshi et al. conducted a prospective study to assess whether the MAGIC Composite Response (MCS 0 or MCS 1 at Day 28 as responses) can more accurately predict long-term outcomes than clinical response only in pediatric and adult patients receiving systemic treatment for aGvHD (N = 1,135; training cohort [n = 826] underwent transplant from 2014 to 2020, and validation cohort [n = 309] underwent transplant from 2021 to 2023). Results were published in Blood Advances. |
Key learnings |
MCR more accurately predicted 6-month NRM than CRO in the validation cohort (n = 309; AUC, 0.77 vs 0.69, p = 0.014) and demonstrated higher positive and negative predictive values. |
MCR reclassified both clinical non-responders and responders; 28/213 (13%) of clinical responders became non-responders with 5-fold higher NRM (34.3% vs 6.8%, p < 0.001) and 29/96 (30%) of clinical non-responders became responders with 6-fold lower NRM (7.6% vs 50.7%, p < 0.001). |
Inclusion of biomarkers at Day 28 significantly improved the ability of the response metric to predict long-term GvHD outcomes even in cases where biomarkers were unknown/unavailable at treatment onset. |
These findings support the use of MCR as a superior surrogate endpoint for long-term aGvHD outcomes in clinical trials. Future studies should investigate whether earlier composite assessments can predict long-term outcomes to reduce time on experimental therapies and allow earlier next-line therapy initiation. |
aGvHD, acute graft-versus-host disease; AUC, area under the curve; CRO, clinical response only; GvHD, graft-versus-host disease; MAGIC, Mount Sinai Acute GvHD International Consortium; MAP, MAGIC Algorithm Probability; MCR, MAGIC Composite Response; MCS, MAGIC Composite Score; NPV, negative predictive value; NRM, non-relapse mortality.
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