Table 1.
Demographics and baseline PRO values for patients who entered Part B (Full Analysis Set).
| Baselinea | Treatment in Part A |
All patients |
|
|---|---|---|---|
| Sutimlimab (n = 19) | Placebo (n = 20) | (N = 39) | |
| Mean (range) age, years | 66 (46–88) | 68 (51–83) | 67 (46–88) |
| Age ≥ 65 years, n (%) | 9 (47) | 14 (70) | 23 (59) |
| Female, n (%) | 15 (78.9) | 16 (80.0) | 31 (79.5) |
| Mean BMI (range), kg/m2 | 24.8 (19–30) | 24.0 (18–32) | 24.4 (18–32) |
| Geographic location, n (%)b | 19 | 20 | 39 |
| Europe | 12 (63.2) | 13 (65.0) | 25 (64.1) |
| North America | 3 (15.8) | 3 (15.0) | 6 (15.4) |
| Asia | 3 (15.8) | 2 (10.0) | 5 (12.8) |
| Other | 1 (5.3) | 2 (10.0) | 3 (7.7) |
| Mean (range) duration of CAD, years | 5.8 (0.2–19.0) | 6.3 (0.3–20.7) | 6.1 (0.2–20.7) |
| Patients with prior CAD therapy in the past 5 years, n (%) | 11 (57.9) | 10 (50.0) | 21 (53.9) |
| Mean (SD) FACIT-Fatigue | 33.0 (11.7) | 33.0 (10.9) | 33.0 (11.2) |
| Mean (SD) SF-12 PCS | 43.6 (6.3) | 39.0 (7.7) | 41.2 (7.4) |
| Mean (SD) SF-12 MCS | 44.8 (9.3) | 49.8 (10.0) | 47.4 (9.9) |
| Mean (SD) EQ VAS | 62.9 (18.5) | 66.0 (18.8) | 64.5 (18.4) |
| Solicited symptoms of anaemia, n (%) | |||
| At least one symptom | 15 (78.9) | 16 (80.0) | 31 (79.5) |
| Fatigue | 15 (78.9) | 15 (75.0) | 30 (76.9) |
| Weakness | 11 (57.9) | 10 (50.0) | 21 (53.8) |
| Shortness of breath | 8 (42.1) | 12 (60.0) | 20 (51.3) |
| Palpitations | 5 (26.3) | 4 (20.0) | 9 (23.1) |
| Light-headedness | 2 (10.5) | 2 (10.0) | 4 (10.3) |
| Chest pain | 3 (15.8) | 1 (5.0) | 4 (10.3) |
| PGIS Status, n (%) | n = 15 | n = 15 | n = 30 |
| None | 3 (20.0) | 2 (13.3) | 5 (16.7) |
| Mild | 5 (33.3) | 4 (26.7) | 9 (30.0) |
| Moderate | 6 (40.0) | 7 (46.7) | 13 (43.3) |
| Severe | 1 (6.7) | 2 (13.3) | 3 (10.0) |
| Very severe | 0 | 0 | 0 |
FACIT-Fatigue total score ranges from 0 to 52, the higher score the less fatigue. SF-12 PCS and MCS are scored on a T-score metric, which has a mean of 50 and standard deviation of 10, referenced to the US general population. A higher score represents improved QoL.
BMI, body mass index; EQ VAS, EuroQol visual analogue scale; FACIT, Functional Assessment of Chronic Illness Therapy; MCS, mental component score; PCS, physical component score; PGIS, Patient Global Impression of (Fatigue) Severity; PRO, patient-reported outcome; SD, standard deviation; SF-12, Short form 12-item survey.
Part A baseline values, for patients entering Part B.
Europe includes France, Germany, Italy, Norway, and the United Kingdom. North America includes the United States. Asia includes Japan. Other includes Australia and Israel.