An analysis of patient-reported data from the CARDINAL Part A trial has revealed substantial improvements in fatigue symptoms and quality of life (QOL) in patients with cold agglutinin disease (CAD) receiving sutimlimab (Enjaymo™).

“Sutimlimab rapidly inhibits classical [complement pathway (CP)] activity and subsequent hemolysis, which coincides with rapid, sustained improvements in fatigue symptoms and overall health-related QOL, further supporting the effectiveness of targeting upstream CP components in the management of patients with CAD,” the study authors wrote in the Annals of Hematology.

After a 26-week treatment period with sutimlimab, patients with CAD reported improvements in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, 12-Item Short Form Health Survey (SF-12), EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L), visual analogue scale (VAS), Patient Global Impression of Change (PGIC), and Patient Global Impression of (fatigue) Severity (PGIS) scores.

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Moreover, symptomatic patients with CAD reported improvements in the incidence of hemoglobinuria, disabling circulatory symptoms, and anemia symptoms, including fatigue, weakness, shortness of breath, palpitations, and chest pain. On the other hand, the incidence of acrocyanosis and Raynaud’s syndrome at week 26 were similar to those at baseline.

Sutimlimab May Decrease Hemolysis, Anemia, and Fatigue in Patients With CAD

Most patients (≥75%) achieved an increase of 3 or more points in FACIT-Fatigue score. Improvements were noted as soon as week 1 of treatment and were sustained through week 26.

Hematologic nonresponders (n=3) showed either a minimal increase (<1 point, n=2) or decrease (n=1) in FACIT-Fatigue score. Moreover, 1 patient who missed a sutimlimab infusion experienced a 44% decline in FACIT-Fatigue score, which was associated with a 68% increase in CP activity and a decrease in C4 levels.

Improvements in mean SF-12 score were also sustained through week 26. The increase in SF-12 score was associated with a decrease in classical CP activity and an increase in total C4. These, in turn, co-occurred with an increase in hemoglobin and normalization of bilirubin levels.

Most patients (94%) who completed the PGIC mentioned that the treatment improved their disease, and none felt that it had worsened. In addition, most (89%) patients who completed the PGIS reported mild to moderate fatigue at week 26 and none reported severe fatigue, while 67% classified their fatigue as moderate to severe at baseline.

The CARDINAL study is a pivotal, phase 3, single-arm, multicenter trial that enrolled CAD patients with a history of recent transfusion.


Röth A, Barcellini W, Tvedt THA, et al. Sutimlimab improves quality of life in patients with cold agglutinin disease: results of patient-reported outcomes from the CARDINAL study. Ann Hematol. 2022;101(10):2169-2177. doi:10.1007/s00277-022-04948-y