Summary

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• This summary is based on the review of four randomized controlled trial(s). ^[1-4]
• In the CADENZA trial, 73% of sutimlimab-treated patients achieved the composite primary endpoint (hemoglobin increase ≥1.5 g/dL, avoidance of transfusion, and avoidance of CAD therapy) compared to 15% in the placebo group. Sutimlimab also significantly improved fatigue, with an LS mean change in FACIT-Fatigue score of 10.8 points versus 1.9 points in the placebo group.
• In the CARDINAL study, the least-squares mean increase in hemoglobin level was 2.6 g/dL, with mean hemoglobin levels >11 g/dL maintained from week 3 through the study. Additionally, 71% of patients did not require a transfusion from week 5 through week 26.
• Both trials demonstrated rapid normalization of bilirubin levels and inhibition of the classical complement pathway, with normalization achieved by week 1 in the CADENZA trial and by week 3 in the CARDINAL study.
• In the CADENZA trial, 96% of sutimlimab patients and 100% of placebo patients experienced at least one treatment-emergent adverse event (AEs). Common AEs in the sutimlimab group included headache, hypertension, rhinitis, Raynaud phenomenon, and acrocyanosis, with three sutimlimab patients discontinuing due to adverse events, while no placebo patients discontinued.
• In the CARDINAL study, 92% of patients experienced at least one AE, and 29% had at least one serious adverse event (SAE), though none were determined to be related to sutimlimab. No meningococcal infections were reported.
• There is no population types or subgroups information available in the reviewed documents.