Summary

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• Enjaymo (sutimlimab-jome) is indicated to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• Sutimlimab demonstrated a rapid and sustained increase in hemoglobin levels from 8.6 g/dL at baseline to 12.2 g/dL over a median of 144 weeks, with a corresponding decrease in bilirubin levels from 52.1 μmol/L to 16.5 μmol/L in patients with CAD and a recent history of transfusion (Cardinal Study Part B).
• In patients with CAD without a recent history of transfusion, sutimlimab significantly increased hemoglobin levels and improved fatigue scores, with a least-squares mean change in FACIT-Fatigue score of 10.8 points versus 1.9 points for placebo (p < 0.001), and 73% of patients met the composite primary endpoint compared to 15% on placebo (Cadenza Study).
• Sutimlimab normalized bilirubin levels by week 1 and significantly improved patient-reported outcomes, including SF-12 and PGIC scores, compared to placebo in CAD patients without recent transfusion (Cadenza Study).
• In the Cardinal Study Part B, all 22 patients experienced at least one treatment-emergent adverse event (TEAE), with 54.5% experiencing at least one serious TEAE, and 31.8% experiencing at least one serious infection. Three patients discontinued treatment due to a TEAE, with no cases of systemic lupus erythematosus or meningococcal infections reported.
• In the Cadenza Study, 96% of patients treated with sutimlimab and 100% of placebo patients experienced at least one TEAE. Headache, hypertension, rhinitis, Raynaud phenomenon, and acrocyanosis occurred more frequently in the sutimlimab group compared to placebo, with three patients discontinuing treatment due to adverse events, while no placebo patients discontinued.
• The studies demonstrated significant clinical benefits of sutimlimab in patients with CAD, both in those with a recent history of transfusion and in those without, including rapid improvements in hemolysis, hemoglobin levels, and fatigue, as well as sustained improvements in anemia and quality of life, with specific subgroup findings indicating these benefits across varying baseline conditions such as hemoglobin levels, bilirubin levels, and CAD symptoms.