Journal: American journal of hematology
This multicenter international cohort study evaluated real‑world use of sutimlimab in 57 patients with cold agglutinin disease, median age 73.5 years, most with moderate–severe anemia (median Hb 8.9 g/dL), active hemolysis, and substantial transfusion needs after a median of two prior therapies (commonly corticosteroids and rituximab).
Key findings:
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Hematologic efficacy:
- • Median hemoglobin increased by ~2 g/dL within 2 weeks and reached ~12 g/dL by 4 weeks.
- • Hemoglobin levels remained stable for up to 24 months of follow‑up.
- • Markers of hemolysis normalized early and remained controlled.
- • Objective responses occurred in most patients by week 2.
- • Complete responses were seen in ~50% by week 4 and 55–60% with longer follow‑up.
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Symptom control and predictors of response:
- • Peripheral cold‑induced symptoms (e.g., acrocyanosis/Raynaud‑like features) generally did not improve.
- • Presence of these cold‑induced symptoms correlated with lower response rates.
- • Inadequate reticulocytosis predicted poorer response, suggesting a role for combining sutimlimab with erythropoiesis‑stimulating agents in selected patients.
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Safety:
- • Sutimlimab was overall well tolerated.
- • Infections were the most common adverse events (23%); severe infections occurred mainly in those previously treated with rituximab.
- • Hemolytic exacerbations occurred in 16%, most often triggered by infections.
- • Thrombotic events were rare.
Overall, in a heavily pretreated, older CAD population, sutimlimab produced rapid, durable hemoglobin improvement with sustained control of hemolysis and an acceptable safety profile, while leaving cold‑induced circulatory symptoms largely unchanged.