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Sutimlimab is generally well tolerated, and the frequency and nature of treatment-emergent adverse events are consistent with those observed in elderly, medically complex patients, according to an analysis of data from two phase 3 studies.

Cold agglutinin disease (CAD) is characterized by autoimmune hemolytic anemia mediated by the classical complement pathway. Sutimlimab, a monoclonal humanized antibody, works by selectively inhibiting C1s, which prevents the activation and resultant hemolysis by the complement pathway. 

This study is a post-hoc analysis of safety data from parts A and B of the phase 3 CARDINAL and CADENZA studies on the use of sutimlimab in CAD. The study found that sutimlimab was generally well tolerated, and treatment-emergent adverse effects (TEAEs) were consistent with the age and medical comorbidities of the study participants. This study was presented as a poster at the 65th American Society of Hematology Annual Meeting and Exposition

Study Protocol

The two clinical studies included in this post-hoc analysis were the phase 3 CARDINAL and CADENZA studies. In part A of CARDINAL, the participants were administered sutimlimab on days 0 and 7, followed by biweekly administration of the drug until part B of the study ended. 

In part A of the CADENZA study, the participants were administered sutimlimab on days 0 and 7, followed by biweekly administration of the drug. Part B involved the biweekly administration of the drug or a switch to sutimlimab from placebo on days 0 and 7, then biweekly. The data from the CARDINAL and CADENZA studies was combined to formulate the safety analysis set.

Baseline Characteristics

There were a total of 66 study participants with CAD in the safety analysis set. The median age of the participants was 69.5 (46–88) years. A total of 72.7% of the participants were female, and the median duration since the disease diagnosis was 5.7 (0–33) years. The median duration of follow-up of the study participants was 129.1 (5–175) weeks. 

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Treatment-Emergent Adverse Events 

Of the total patients, 64 experienced ≥ 1 TEAE. Of the total TEAEs, 86 of those determined to be associated with sutimlimab treatment occurred in 30 of the patients, and 53 treatment-emergent serious adverse events (TESAEs) were reported in 22 of the total patients, of which 3 patients experienced one TESAE associated with sutimlimab treatment. 

Treatment Discontinuation and Mortality Events

Four patients in the CARDINAL study and three patients in the CADENZA study discontinued treatment due to ≥ 1 TEAE. Four deaths were reported during the studies: one in the CADENZA study, which was associated with a TESAE of lung squamous cell carcinoma, and three in the CARDINAL study, which occurred due to fatal infection, hepatic cancer, and exacerbation of CAD during the washout period, respectively. No deaths were considered by the investigator to be related to sutimlimab.

Treatment-Emergent Adverse Events of Special Interest in Sutimlimab Treatment

There were 14 instances of severe infection that occurred in 9 patients, 31 occurrences of hypertension in 17 patients, 28 events associated with acrocyanosis and/or Raynaud’s phenomenon occurred in 13 patients, and 4 thromboembolic events occurred in 4 patients. There were no documented TEAEs associated with severe hypersensitivity reactions, anaphylaxis, meningococcal infection, or the onset of systemic lupus erythematosus.


Broome, C. (2023, December 11). Combined safety data for sutimlimab in cold agglutinin Disease: A Post-Hoc analysis of the Phase 3 Cardinal and Cadenza studies. https://ash.confex.com/ash/2023/webprogram/Paper188686.html