Patient baseline demographics (ITT population)
Characteristic . | CAD 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) | 0 |
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 | 0 | 4 (36.4) |
Rituximab (alone or in combination) | 10 (76.9) | 8 (72.7) |
Immunosuppressant | 0 | 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) | 0 |
Characteristic . | CAD 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) | 0 |
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 | 0 | 4 (36.4) |
Rituximab (alone or in combination) | 10 (76.9) | 8 (72.7) |
Immunosuppressant | 0 | 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) | 0 |
IQR, interquartile range; SD, standard deviation.