Figures & data
Table 1. Characteristics of CAD-associated lymphoproliferative disease compared to lymphoplasmacytic lymphoma and secondary bone marrow infiltration by marginal zone lymphoma [Citation7].
Figure 1. The role of the complement pathway in CAD and mechanism of action of sutimlimab [Citation3,Citation10,Citation18–21].
C, complement protein; Ig, immunoglobulin; MAC, membrane attack complex; MBL, mannose-binding lectin; RBC, red blood cell
![Figure 1. The role of the complement pathway in CAD and mechanism of action of sutimlimab [Citation3,Citation10,Citation18–21].C, complement protein; Ig, immunoglobulin; MAC, membrane attack complex; MBL, mannose-binding lectin; RBC, red blood cell](/cms/asset/9a473e06-61ad-4ce5-94cc-a88eb9bc350b/ierr_a_2218611_f0001_oc.jpg)
Figure 2. An overview of the clinical trial program for sutimlimab in CAD [Citation19,Citation20,Citation46–51].
![Figure 2. An overview of the clinical trial program for sutimlimab in CAD [Citation19,Citation20,Citation46–51].](/cms/asset/22a00ede-5416-440e-a138-94475df5e081/ierr_a_2218611_f0002_oc.jpg)
Table 2. Summary of the Phase 3 CARDINAL and CADENZA studies [Citation46,Citation49–51].
Table 3. Summary of the key patient demographics and baseline characteristics [Citation46,Citation51–53].
Table 4. Summary of the key efficacy results of the phase 3 CARDINAL and CADENZA studies at week 26 [Citation46,Citation51,Citation54].
Figure 3. Effect of sutimlimab on A. hemoglobin levels and B. bilirubin levels from baseline to week 26 [Citation46,Citation51].
Figure adapted from Röth A, Barcellini W, D’Sa S, et al. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 8 April 2021;384(14):1323–1334 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society; and reprinted from Röth A, Berentsen S, Barcellini W, et al. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 1 September 2022;140(9):980–991 with permission from Elsevier.
![Figure 3. Effect of sutimlimab on A. hemoglobin levels and B. bilirubin levels from baseline to week 26 [Citation46,Citation51].Figure adapted from Röth A, Barcellini W, D’Sa S, et al. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 8 April 2021;384(14):1323–1334 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society; and reprinted from Röth A, Berentsen S, Barcellini W, et al. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 1 September 2022;140(9):980–991 with permission from Elsevier.](/cms/asset/c0eee57f-89bc-49f8-89bc-83ec0229857b/ierr_a_2218611_f0003_oc.jpg)
Table 5. Summary of the change in patient-reported outcomes in the Phase 3 CARDINAL and CADENZA studiesa at week 26 [Citation52,Citation53,Citation57].
Table 6. Summary of the safety data for sutimlimab from the phase 3 CARDINAL and CADENZA studies [Citation46,Citation51,Citation56,Citation59].
Table 7. Comparison of sutimlimab versus other unapproved therapies used for treatment of CAD including study design, efficacy, time to response, duration of response, and toxicity [Citation13,Citation40,Citation41,Citation43,Citation46,Citation51,Citation65–68,Citation69].