Patient demographics and disease characteristics at baseline
| . | Sutimlimab . | Placebo . |
|---|---|---|
| Patients, n | 22 | 20 |
| Age, y | ||
| Mean (SD) | 65.3 (10.9) | 68.2 (10.1) |
| Median (range) | 64.0 (46-88) | 69.0 (51-83) |
| Female, n (%) | 17 (77.3) | 16 (80.0) |
| Geographic location, n (%) | ||
| Europe | 15 (68.2) | 13 (65.0) |
| North America | 3 (13.6) | 3 (15.0) |
| Asia | 3 (13.6) | 2 (10.0) |
| Other* | 1 (4.5) | 2 (10.0) |
| Patients with transfusions, n (%) | ||
| In the prior 6 mo | NC | NC |
| In the prior year | 3 (13.6) | 0 (0) |
| Patients with disabling circulatory symptoms,† n (%) | 3 (13.6) | 0 (0) |
| Patients with acrocyanosis, n (%) | 9 (40.9) | 4 (20.0) |
| Patients with Raynaud phenomenon, n (%) | 5 (22.7) | 3 (15.0) |
| Patients with ≥1 prior CAD therapy within previous 5 y, n (%)‡ | 16 (72.7) | 15 (75.0) |
| Single-agent rituximab | 12 (54.5) | 9 (45.0) |
| Any previous rituximab | 12 (54.5) | 12 (60.0) |
| Patients with history of hospitalization related to CAD within previous 2 y, n (%) | 2 (9.1) | 3 (15.0) |
| Patients with history of ≥1 thromboembolic event within previous 1 y, n (%) | 0 (0) | 0 (0) |
| Baseline Hb, g/dL | ||
| Mean (SD) | 9.2 (1.1) | 9.3 (1.0) |
| Median (range) | 9.3 (6.5-11.1) | 9.3 (7.7-11.7) |
| Baseline total bilirubin, μmol/L§ | ||
| Mean (SD) | 41 (27) | 36 (12) |
| Median (range) | 35 (19-145) | 34 (17-59) |
| Baseline LDH, U/L | ||
| Mean (SD) | 422 (195) | 381 (243) |
| Median (range) | 359 (215-8 93) | 294 (169-1 239) |
| Baseline absolute reticulocytes, 109/L | ||
| Mean (SD) | 159 (70) | 145 (46) |
| Median (range) | 176 (4-274) | 151 (65-245) |
| Baseline haptoglobin, g/L | ||
| Mean (SD) | 0.2 (0.0) | 0.2 (0.0) |
| Median (range) | 0.2 (0.2-0.2) | 0.2 (0.2-0.3) |
| Baseline IgM, g/L | ||
| Mean (SD) | 5.7 (7.8) | 2.7 (2.0) |
| Median (range) | 2.9 (0.5-33.0) | 1.9 (0.4-8.7) |
| Cold agglutinin titer at 4°C | ||
| Median (range) | 2 560 (40-2 621 440) | 1 280 (40-1 310 720) |
| FACIT-Fatigue‖ | ||
| Mean (SD) | 31.7 (12.8) | 33.0 (10.9) |
| Median (range) | 32.6 (9.0-51.0) | 35.4 (14.0-51.0) |
| . | Sutimlimab . | Placebo . |
|---|---|---|
| Patients, n | 22 | 20 |
| Age, y | ||
| Mean (SD) | 65.3 (10.9) | 68.2 (10.1) |
| Median (range) | 64.0 (46-88) | 69.0 (51-83) |
| Female, n (%) | 17 (77.3) | 16 (80.0) |
| Geographic location, n (%) | ||
| Europe | 15 (68.2) | 13 (65.0) |
| North America | 3 (13.6) | 3 (15.0) |
| Asia | 3 (13.6) | 2 (10.0) |
| Other* | 1 (4.5) | 2 (10.0) |
| Patients with transfusions, n (%) | ||
| In the prior 6 mo | NC | NC |
| In the prior year | 3 (13.6) | 0 (0) |
| Patients with disabling circulatory symptoms,† n (%) | 3 (13.6) | 0 (0) |
| Patients with acrocyanosis, n (%) | 9 (40.9) | 4 (20.0) |
| Patients with Raynaud phenomenon, n (%) | 5 (22.7) | 3 (15.0) |
| Patients with ≥1 prior CAD therapy within previous 5 y, n (%)‡ | 16 (72.7) | 15 (75.0) |
| Single-agent rituximab | 12 (54.5) | 9 (45.0) |
| Any previous rituximab | 12 (54.5) | 12 (60.0) |
| Patients with history of hospitalization related to CAD within previous 2 y, n (%) | 2 (9.1) | 3 (15.0) |
| Patients with history of ≥1 thromboembolic event within previous 1 y, n (%) | 0 (0) | 0 (0) |
| Baseline Hb, g/dL | ||
| Mean (SD) | 9.2 (1.1) | 9.3 (1.0) |
| Median (range) | 9.3 (6.5-11.1) | 9.3 (7.7-11.7) |
| Baseline total bilirubin, μmol/L§ | ||
| Mean (SD) | 41 (27) | 36 (12) |
| Median (range) | 35 (19-145) | 34 (17-59) |
| Baseline LDH, U/L | ||
| Mean (SD) | 422 (195) | 381 (243) |
| Median (range) | 359 (215-8 93) | 294 (169-1 239) |
| Baseline absolute reticulocytes, 109/L | ||
| Mean (SD) | 159 (70) | 145 (46) |
| Median (range) | 176 (4-274) | 151 (65-245) |
| Baseline haptoglobin, g/L | ||
| Mean (SD) | 0.2 (0.0) | 0.2 (0.0) |
| Median (range) | 0.2 (0.2-0.2) | 0.2 (0.2-0.3) |
| Baseline IgM, g/L | ||
| Mean (SD) | 5.7 (7.8) | 2.7 (2.0) |
| Median (range) | 2.9 (0.5-33.0) | 1.9 (0.4-8.7) |
| Cold agglutinin titer at 4°C | ||
| Median (range) | 2 560 (40-2 621 440) | 1 280 (40-1 310 720) |
| FACIT-Fatigue‖ | ||
| Mean (SD) | 31.7 (12.8) | 33.0 (10.9) |
| Median (range) | 32.6 (9.0-51.0) | 35.4 (14.0-51.0) |
NC, not calculated.
Other includes Australia and Israel.
Reporting of disabling circulatory symptoms was based on the medical judgment of the investigators. The presence of disabling circulatory symptoms was collected at each visit in a dedicated questionnaire. If serious adverse event criteria were met (including severity grade 3), the event was additionally reported as a serious adverse event.
Including corticosteroids (n = 20; 47.6%), rituximab monotherapy (n = 21; 50.0%), combination regimens (n = 6; 14.3%), any previous rituximab (n = 24; 57.1%), and other chemotherapy (n = 6; 14%). Patients may be included in >1 category.
Excluding patients with positive or unknown Gilbert syndrome test result (sutimlimab, n = 20; placebo, n = 18).
Scores on the FACIT-Fatigue Scale range from 0 to 52, with higher scores indicating less fatigue.