Table 1.

Patient baseline demographics (ITT population)

CharacteristicCAD cohort (N = 13)wAIHA cohort (N = 11)
Age, mean (SD), y 72.0 (8.50) 56.3 (19.32) 
Sex, n (%)   
Female 9 (69.2) 6 (54.5) 
Male 4 (30.8) 5 (45.5) 
Body weight, median (IQR), kg 80.6 (68.6-82.0) 77.0 (71.2-100.1) 
Body mass index, mean (SD), kg/m2 28.6 (4.80) 29.3 (5.38) 
Race, n (%)   
Black or African American 1 (7.7) 
White 12 (92.3) 11 (100.0) 
Ethnicity, n (%)   
Hispanic or Latino 2 (15.4) 6 (54.5) 
Not Hispanic or Latino 11 (84.6) 5 (45.5) 
Time since diagnosis of CAD or wAIHA, mean (SD), y 4.8 (5.83) 3.0 (1.61) 
Hb levels, median (IQR), g/dL 9.20 (8.10-9.80) 9.00 (8.00-10.10) 
Reticulocyte count, median (IQR), 109/L 148.1 (103.40-157.28) 228.2 (106.86-255.00) 
Cold agglutinin titers, n (%) n = 8 n = 2 
<1:32 0 (0.0) 2 (100.0) 
1:128 1 (12.5) 0 (0.0) 
1:256 1 (12.5) 0 (0.0) 
1:512 1 (12.5) 0 (0.0) 
>1:512 5 (62.5) 0 (0.0) 
Prior treatments   
Number of transfusions per month in the 12 mo before first dose, median (IQR) 0.08 (0.0-0.2) 0.00 (0.0-0.2) 
Number of patients not needing a transfusion in the 12 mo before first dose, n (%) 6 (46.2) 6 (54.5) 
Splenectomy 4 (36.4) 
Rituximab (alone or in combination) 10 (76.9) 8 (72.7) 
Immunosuppressant 1 (9.1) 
Prior medications used by patients in both cohorts, n (%)   
Bacterial vaccines 11 (84.6) 11 (100.0) 
Systemic corticosteroids 7 (53.8) 11 (100.0) 
β-Blocking agents 5 (38.5) 6 (54.5) 
Other antineoplastic agents 7 (53.8) 6 (54.5) 
Drugs for peptic ulcer and gastroesophageal reflux disease 6 (46.2) 6 (54.5) 
Other analgesics and antipyretics 7 (53.8) 1 (9.1) 
Vitamin B12 and folic acid 10 (76.9) 5 (45.5) 
Concomitant medications, n (%)   
Systemic corticosteroids 6 (42.6) 9 (81.8) 
Erythropoiesis-stimulating agents 1 (7.7) 
CharacteristicCAD cohort (N = 13)wAIHA cohort (N = 11)
Age, mean (SD), y 72.0 (8.50) 56.3 (19.32) 
Sex, n (%)   
Female 9 (69.2) 6 (54.5) 
Male 4 (30.8) 5 (45.5) 
Body weight, median (IQR), kg 80.6 (68.6-82.0) 77.0 (71.2-100.1) 
Body mass index, mean (SD), kg/m2 28.6 (4.80) 29.3 (5.38) 
Race, n (%)   
Black or African American 1 (7.7) 
White 12 (92.3) 11 (100.0) 
Ethnicity, n (%)   
Hispanic or Latino 2 (15.4) 6 (54.5) 
Not Hispanic or Latino 11 (84.6) 5 (45.5) 
Time since diagnosis of CAD or wAIHA, mean (SD), y 4.8 (5.83) 3.0 (1.61) 
Hb levels, median (IQR), g/dL 9.20 (8.10-9.80) 9.00 (8.00-10.10) 
Reticulocyte count, median (IQR), 109/L 148.1 (103.40-157.28) 228.2 (106.86-255.00) 
Cold agglutinin titers, n (%) n = 8 n = 2 
<1:32 0 (0.0) 2 (100.0) 
1:128 1 (12.5) 0 (0.0) 
1:256 1 (12.5) 0 (0.0) 
1:512 1 (12.5) 0 (0.0) 
>1:512 5 (62.5) 0 (0.0) 
Prior treatments   
Number of transfusions per month in the 12 mo before first dose, median (IQR) 0.08 (0.0-0.2) 0.00 (0.0-0.2) 
Number of patients not needing a transfusion in the 12 mo before first dose, n (%) 6 (46.2) 6 (54.5) 
Splenectomy 4 (36.4) 
Rituximab (alone or in combination) 10 (76.9) 8 (72.7) 
Immunosuppressant 1 (9.1) 
Prior medications used by patients in both cohorts, n (%)   
Bacterial vaccines 11 (84.6) 11 (100.0) 
Systemic corticosteroids 7 (53.8) 11 (100.0) 
β-Blocking agents 5 (38.5) 6 (54.5) 
Other antineoplastic agents 7 (53.8) 6 (54.5) 
Drugs for peptic ulcer and gastroesophageal reflux disease 6 (46.2) 6 (54.5) 
Other analgesics and antipyretics 7 (53.8) 1 (9.1) 
Vitamin B12 and folic acid 10 (76.9) 5 (45.5) 
Concomitant medications, n (%)   
Systemic corticosteroids 6 (42.6) 9 (81.8) 
Erythropoiesis-stimulating agents 1 (7.7) 

IQR, interquartile range; SD, standard deviation.

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