Researchers reported that sutimlimab provides sustained improvements in patient-reported outcomes and quality of life in patients who have been diagnosed with cold agglutinin disease (CAD), according to a study published in Blood.

CAD is a rare autoimmune hemolytic anemia mediated by the classical complement pathway. The most commonly reported symptoms are fatigue and decreased quality of life.

Sutimlimab is a C1s complement inhibitor that works by halting hemolysis and increasing circulating levels of hemoglobin. The result is improved fatigue in patients with CAD, even among those with no recent history of transfusion. 

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A randomized, double-blind, placebo-controlled phase 3 trial investigated the merits of this drug compared to placebo in patients with CAD. In the open-label second portion of this trial, patients with CAD who had completed the first portion of the trial were eligible to receive biweekly doses of sutimlimab, at 6.5 g for patients who weighed less than 75 kg and 7.5 g for patients who weighed 75 kg or more. 

Read more about CAD etiology 

To assess the main complaint of CAD-related symptoms, namely fatigue, the research team used a number of fatigue scores to allow participants to assess the effects of sutimlimab. Five fatigue scores were used, including the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and 12-Item Short Form Health Survey (SF-12), among others. 

Thirty-nine participants who completed the first portion of the trial enrolled in the second portion, with 32 patients completing the trial. The results from the first portion of the trial indicate that sutimlimab improves fatigue-related scores in patients with CAD. 

The research team reported that the second portion of the study further clarified the sustained benefits that patients with CAD obtained from sutimlimab in terms of quality of life improvements beyond 36 weeks, as well as 1 year or more after drug initiation. 

“These findings demonstrate that continued inhibition of the classical complement pathway via treatment with sutimlimab results in meaningful long-term benefits to fatigue and patient-reported [quality of life], in addition to improving hematologic parameters in patients with CAD,” the authors of the study wrote.


Roeth A, Broome CM, Barcellini W, et al. Sutimlimab provides sustained improvements in patient-reported outcomes and quality of life in patients with cold agglutinin disease: open-label extension of the randomized, phase 3 Cadenza study. Blood. 2022;140(Suppl 1):70-72. doi:10.1182/blood-2022-159966