Table 1.
Patients’ characteristics
| Characteristic | GB-0998 group (n = 12) | Placebo group (n = 14) | Total (n = 26) |
|---|---|---|---|
| Gender, n (%) | |||
| Male | 1 (8.3) | 5 (35.7) | 6 (23.1) |
| Female | 11 (91.7) | 9 (64.3) | 20 (76.9) |
| Age (years) | |||
| Mean | 50.6 | 48.1 | 49.3 |
| Standard deviation | 13.1 | 12.1 | 12.4 |
| Minimum value | 27 | 30 | 27 |
| Median | 49.0 | 50.5 | 49.0 |
| Maximum value | 69 | 68 | 69 |
| Diagnosis, cases (%) | |||
| Polymyositis | 6 (50.0) | 10 (71.4) | 16 (61.5) |
| Dermatomyositis | 6 (50.0) | 4 (28.6) | 10 (38.5) |
| Disease period, cases (%) | |||
| <6 months | 5 (41.7) | 3 (21.4) | 8 (30.8) |
| ≥6 months and <1 year | 0 (0.0) | 4 (28.6) | 4 (15.4) |
| ≥1 year | 7 (58.3) | 7 (50.0) | 14 (53.8) |
| Interstitial pulmonary disease, cases (%) | |||
| Absence | 6 (50.0) | 11 (78.6) | 17 (65.4) |
| Presence | 6 (50.0) | 3 (21.4) | 9 (34.6) |
| Daily dose of corticosteroid at formal registration (mg) | |||
| Mean | 34.79 | 40.71 | 37.98 |
| Standard deviation | 14.56 | 14.69 | 14.65 |
| Minimum value | 10 | 7.5 | 7.5 |
| Median | 35.00 | 47.50 | 42.50 |
| Maximum value | 60 | 55 | 60 |
| Therapeutic history with immunosuppressant, cases (%) | |||
| Absence | 5 (41.7) | 7 (50.0) | 12 (46.2) |
| Presence | 7 (58.3) | 7 (50.0) | 14 (53.8) |
| Manual muscle test score at formal registration (points) | |||
| 0–50 | 2 | 1 | 3 |
| 51–60 | 4 | 3 | 7 |
| 61–70 | 4 | 8 | 12 |
| 71–80 | 2 | 2 | 4 |
| Mean ± SD | 61.8 ± 10.6 | 64.7 ± 9.0 | – |
| Minimum value | 42 | 43 | 42 |
| Maximum value | 77 | 77 | 77 |
| Activities of daily living score at formal registration (points) | |||
| 0–15 | 3 | 2 | 5 |
| 16–20 | 3 | 1 | 4 |
| 21–25 | 0 | 1 | 1 |
| 26–30 | 2 | 0 | 2 |
| 31–35 | 2 | 5 | 7 |
| 36–40 | 2 | 3 | 5 |
| 41–45 | 0 | 2 | 2 |
| Not done | 0 | 0 | 0 |
| Mean ± SD (points) | 23.8 ± 11.1 | 30.2 ± 10.3 | – |
| Minimum value | 4 | 11 | 4 |
| Maximum value | 40 | 45 | 45 |