Table 1.
Baseline demographic and disease characteristics of the patients with OA (full analysis set)a
| FX006 16 mg (n = 102) | FX006 32 mg (n = 104) | Saline placebo (n = 100) | Total (n = 306) | |
|---|---|---|---|---|
| Male, no. (%) | 40 (39.2) | 53 (51.0) | 39 (39.0) | 132 (43.1) |
| White, no. (%) | 81 (79.4) | 85 (81.7) | 82 (82.0) | 248 (81.0) |
| Age at consent, mean ± SD years | 58.2 ± 8.34 | 58.7 ± 8.06 | 59.7 ± 8.23 | 58.8 ± 8.20 |
| BMI, mean ± SD kg/m2 | 30.6 ± 4.86 | 31.0 ± 4.55 | 31.2 ± 5.11 | 30.9 ± 4.84 |
| Weight category, no. (%) | ||||
| Underweight (BMI <18.5) | 2 (2.0) | 0 (0.0) | 0 (0.0) | 2 (0.7) |
| Normal weight (BMI 18.5–24.9) | 12 (11.8) | 10 (9.6) | 10 (10.0) | 32 (10.5) |
| Overweight (BMI 25.0–29.9) | 32 (31.4) | 35 (33.7) | 33 (33.0) | 100 (32.7) |
| Obesity class I (BMI 30.0–34.9) | 37 (36.3) | 39 (37.5) | 29 (29.0) | 105 (34.3) |
| Obesity class II (BMI 35.0–39.9) | 19 (18.6) | 18 (17.3) | 27 (27.0) | 64 (20.9) |
| Morbid obesity (BMI ≥40.0) | 0 (0.0) | 2 (1.9) | 1 (1.0) | 3 (1.0) |
| Type of knee OA, no. (%) | ||||
| Unilateral | 45 (44.1) | 46 (44.2) | 38 (38.0) | 129 (42.2) |
| Bilateral | 57 (55.9) | 58 (55.8) | 62 (62.0) | 177 (57.8) |
| Years since diagnosis, mean ± SD | 6.7 ± 6.66 | 7.2 ± 7.27 | 6.4 ± 5.79 | 6.8 ± 6.60 |
| Kellgren/Lawrence grade, no. (%) | ||||
| 2 | 33 (32.4) | 28 (26.9) | 37 (37.0) | 98 (32.0) |
| 3 | 69 (67.6) | 76 (73.1) | 63 (63.0) | 208 (68.0) |
| Prior index knee surgeries/interventions, no. (%) | ||||
| Surgery or procedure | 20 (19.6) | 17 (16.3) | 15 (15.0) | 52 (17.0) |
| IA steroid injection | 32 (31.4) | 35 (33.7) | 24 (24.0) | 91 (29.7) |
| IA hyaluronic acid injection | 6 (5.9) | 11 (10.6) | 19 (19.0) | 36 (11.8) |
|
ADP intensity, mean ± SD (0–10 scale) |
6.6 ± 0.97 | 6.5 ± 1.01 | 6.7 ± 1.08 | 6.6 ± 1.02 |
|
WOMAC pain subscale, mean ± SD (0–4 scale) |
2.3 ± 0.62 | 2.1 ± 0.58 | 2.3 ± 0.65 | 2.2 ± 0.62 |
|
WOMAC stiffness subscale, mean ± SD (0–4 scale) |
2.5 ± 0.74 | 2.4 ± 0.71 | 2.4 ± 0.68 | 2.4 ± 0.71 |
|
WOMAC physical function subscale, mean ± SD (0–4 scale) |
2.3 ± 0.68 | 2.1 ± 0.57 | 2.3 ± 0.65 | 2.2 ± 0.63 |
a
The Patient Global Impression of Change (PGIC) is the patient's report of change since baseline; thus, there is no PGIC assessment at baseline. OA = osteoarthritis; BMI = body mass index; IA = intraarticular; ADP = average daily pain; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index.