Table 1.
Baseline characteristics (FAS).
| Parameter | Tacrolimus (n = 44) |
Placebo (n = 38) |
p-value |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 41.0 (12.8) | 44.0 (12.1) | 0.284 |
| Median (range) | 40.0 (20–68) | 43.0 (24–68) | |
| Sex, n (%) | |||
| Male | 16 (36.4) | 20 (52.6) | 0.182 |
| Female | 28 (63.6) | 18 (47.4) | |
| Ethnicity, n (%) | |||
| Han | 42 (95.5) | 38 (100.0) | 0.497 |
| Others | 2 (4.5) | 0 (0.0) | |
| BMI (kg/m2) | |||
| Mean (SD) | 22.9 (2.9) | 23.8 (3.1) | 0.179 |
| Median (range) | 22.6 (17.8–28.3) | 24.0 (16.6–31.2) | |
| Duration of MG (months*) | |||
| Mean (SD) | 27.9 (37.8) | 63.5 (90.2) | 0.028 |
| Median (range) | 13.3 (0.0–196.7) | 33.00 (1.9–455.7) | |
| Concomitant conditions, n (%) | |||
| Diabetes mellitus | 4 (9.1) | 1 (2.6) | 0.369 |
| Hypertension | 4 (9.1) | 7 (18.4) | 0.330 |
| Hyperlipidaemia | 2 (4.5) | 4 (10.5) | 0.405 |
| Baseline daily GC dose (mg) | |||
| Mean (SD) | 42.1 (13.5) | 40.8 (10.9) | NA |
| Median (range) | 40.0 (30.0–50.0) | 40 (20.0–80.0) | NA |
| QMG score | |||
| Mean (SD) | 14.3 (4.3) | 13.6 (3.7) | 0.432 |
| Median (range) | 14.0 (7–24) | 14.0 (7–21) | |
| Osserman’s scale grading | |||
| 1 | 0 (0) | 0 (0) | 0.606* |
| 2 | 16 (36.4) | 15 (39.5) | |
| 3 | 21 (47.7) | 19 (50.0) | |
| 4 | 7 (15.9) | 4 (10.5) | |
| 5 | 0 (0) | 0 (0) | |
| Activities of daily living scale† | |||
| Mean (SD) | 6.2 (3.3) | 5.6 (3.1) | 0.383 |
| Median (range) | 5.5 (1–14) | 6.0 (0–12) | |
| Manual muscle test | |||
| Mean (SD) | 21.3 (14.0) | 21.2 (15.4) | 0.986 |
| Median (range) | 20.0 (3–62) | 17.0 (2–72) |
*
A significant difference in duration of MG between groups (p = 0.028). There were no other statistically significant differences in other demographic variables; †Total score.
BMI, body mass index; FAS, full analysis set; GC, glucocorticoid; MG, myasthenia gravis; SD, standard deviation; QMG, quantitative MG.