Sutimlimab shows promising results in long-term relief for rare autoimmune hemolytic anemia

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The Phase 3 study of sutimlimab, a C1s inhibitor, for the treatment of Cold Agglutinin Disease (CAD) showed promising results in improving patient quality of life. The study’s long-term evaluation demonstrated sustained alleviation of CAD disease burden over 2 years of treatment with sutimlimab.

Patients experienced significant relief from fatigue, improvement in physical and mental well-being, and a reduction in perceived disease burden.

The study, known as CARDINAL (NCT03347396), consisted of 2 parts and was conducted as an open-label, single-arm, multicenter trial. Part A, the pivotal study phase, aimed to assess the efficacy of sutimlimab in managing CAD, while Part B focused on the extension phase, evaluating the long-term safety and durability of response, with a particular emphasis on patient-reported outcomes. During the study, 22 patients successfully transitioned from Part A to Part B.

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale score significantly exceeded the pre-defined clinically important change of ≥5 points versus baseline. The mean change was measured at 11.7 (standard error [SE] of 3.7) points by Week 135, indicating substantial relief from fatigue.

The study evaluated the 12-Item Short Form Health Survey to assess patients’ physical and mental component scores. Both scores remained above baseline levels, with the mean change at Week 123 surpassing clinically important changes of 3.9 for physical and 2.8 for mental component scores. The improvements were 4.7 (SE 2.8) and 3.8 (SE 5.7) points, respectively.

The EuroQol Visual Analogue Scale, used to measure self-rated health, also showed favorable outcomes, remaining above baseline with a notable change of 17.1 (SE 5.6) points at Week 135.

Röth A, Broome CM, Barcellini W, et al. Long-term sutimlimab improves quality of life for patients with cold agglutinin disease: CARDINAL 2-year follow-up. Blood Adv. 2023;bloodadvances.2022009318. doi: 10.1182/bloodadvances.2022009318. Epub ahead of print. PMID: 37459203.