Table. Demographic and Baseline Characteristics of the Intent-to-Treat Population.
| 100 μg of Sprifermin | 30 μg of Sprifermin | Placebo Every 6 mo (n = 108) |
|||
|---|---|---|---|---|---|
| Every 6 mo (n = 110) |
Every 12 mo (n = 110) |
Every 6 mo (n = 111) |
Every 12 mo (n = 110) |
||
| Age, median (range), y | 66.0 (44-84) | 65.0 (40-80) | 65.0 (41-80) | 66.5 (41-80) | 64.5 (41-83) |
| Sex, No. (%) | |||||
| Female | 73 (66.4) | 77 (70.0) | 80 (72.1) | 73 (66.4) | 76 (70.4) |
| Male | 37 (33.6) | 33 (30.0) | 31 (27.9) | 37 (33.6) | 32 (29.6) |
| Body mass index, median (Q1-Q3)a | 29.4 (25.46-33.32) | 27.9 (24.84- 32.14) | 28.2 (25.03-31.99) | 28.8 (25.87-32.58) | 29.2 (25.30-33.64) |
| Kellgren-Lawrence grade for radiographic severity, No. (%)b,c | |||||
| 2 | 78 (70.9) | 77 (70.0) | 77 (69.4) | 73 (66.4) | 74 (68.5) |
| 3 | 32 (29.1) | 33 (30.0) | 34 (30.6) | 37 (33.6) | 34 (31.5) |
| Time since diagnosis, median (Q1-Q3), yb | 6.0 (4.0-11.0) | 7.0 (3.0-11.0) | 7.0 (4.0-12.0) | 6.0 (4.0-10.0) | 7.0 (4.0-12.0) |
| Medial minimum joint space width, mean (SD), mmb | 4.2 (1.1) | 4.3 (1.2) | 4.2 (1.3) | 4.1 (1.1) | 4.2 (1.3) |
| Total femorotibial joint cartilage thickness, mean (SD), mmb,d | 1.81 (0.26) | 1.81 (0.27) | 1.84 (0.29) | 1.78 (0.22) | 1.81 (0.27) |
| Response to WOMAC question 1, mean (SD)e | 5.8 (1.4) | 5.5 (1.2) | 5.6 (1.4) | 5.6 (1.4) | 5.6 (1.4) |
| Laterality, No./total No. (%)f | |||||
| Predominately medial | 64/84 (76.2) | 64/88 (72.7) | 61/83 (73.5) | 62/86 (72.1) | 53/78 (67.9) |
| Predominantly lateral | 16/84 (19.0) | 18/88 (20.5) | 19/83 (22.9) | 20/86 (23.3) | 19/78 (24.4) |
| Medial and lateral | 4/84 (4.8) | 6/88 (6.8) | 3/83 (3.6) | 4/86 (4.7) | 6/78 (7.7) |
Abbreviation: WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.
Calculated as weight in kilograms divided by height in meters squared.
In the more symptomatic knee.
Grading system progresses from grade 0 to 4. Grade 2 indicates the presence of osteophytes and possible joint space narrowing on radiographic analysis; grade 3, multiple osteophytes, definite joint space narrowing, sclerosis, and possible bony deformity.
Calculated as the total volume divided by the total surface area (ie, average cartilage thickness) in the primary analysis population.
The question asked was “How much pain have you had [in the more symptomatic knee, over the past 48 hours] when walking on a flat surface?” The WOMAC is a self-administered questionnaire with questions scored on a scale of 0 to 10 (0, no pain; 10, extreme pain).
Subset of participants with available readings.