Table 2.
Primary and Subgroup Analyses of the Primary Outcomes.*
Outcome | Prednisone Alone | Thymectomy plus Prednisone | Estimated Difference (95% CI)† | P Value‡ | ||
---|---|---|---|---|---|---|
value | no. of patients | value | no. of patients | |||
Primary analyses | ||||||
| ||||||
Time-weighted average QMG score over 3-yr period | 8.99±4.93 | 56 | 6.15±4.09 | 62 | 2.85 (0.47 to 5.22) | <0.001 |
| ||||||
Time-weighted average alternate-day prednisone dose over 3-yr period (mg) | 60±27 | 56 | 44±21 | 61 | 16 (7 to 25) | <0.001 |
| ||||||
Subgroup analyses | ||||||
| ||||||
Time-weighted average QMG score | ||||||
| ||||||
Prednisone use at enrollment | 0.86 | |||||
| ||||||
Yes | 9.10±5.06 | 46 | 6.30±3.89 | 47 | 2.80 (0.11 to 5.49) | 0.004 |
| ||||||
No | 8.84±4.60 | 9 | 5.66±4.79 | 15 | 3.18 (−3.03 to 9.39) | 0.12 |
| ||||||
Sex | 0.57 | |||||
| ||||||
Female | 9.73±5.16 | 38 | 6.47±4.13 | 46 | 3.26 (0.34 to 6.18) | 0.002 |
| ||||||
Male | 7.45±4.11 | 18 | 5.23±3.95 | 16 | 2.22 (−1.96 to 6.40) | 0.12 |
| ||||||
Age at disease onset | 0.74 | |||||
| ||||||
<40 yr | 9.60±5.32 | 34 | 6.50±4.41 | 42 | 3.10 (−0.13 to 6.33) | 0.007 |
| ||||||
≥40 yr | 7.85±3.50 | 18 | 5.33±2.79 | 18 | 2.52 (−0.65 to 5.69) | 0.02 |
| ||||||
Time-weighted average alternate-day prednisone dose (mg) | ||||||
| ||||||
Prednisone use at enrollment | 0.37 | |||||
| ||||||
Yes | 61±28 | 46 | 44±22 | 46 | 17 (7 to 28) | 0.002 |
| ||||||
No | 48±19 | 9 | 42±20 | 15 | 7 (−10 to 24) | 0.40 |
| ||||||
Sex | 0.32 | |||||
| ||||||
Female | 59±25 | 37 | 46±23 | 45 | 13 (3 to 24) | 0.01 |
| ||||||
Male | 61±32 | 19 | 38±15 | 16 | 23 (6 to 40) | 0.009 |
| ||||||
Age at disease onset | 0.94 | |||||
| ||||||
<40 yr | 61±27 | 33 | 45±22 | 41 | 16 (4 to 27) | 0.007 |
| ||||||
≥40 yr | 56±28 | 19 | 41±21 | 18 | 15 (−1 to 32) | 0.07 |
CI denotes confidence interval.
We used 95% confidence intervals in all analyses except for analyses involving the QMG score, for which we used 99.5% confidence intervals, per protocol.
P values for between-group comparisons are based on two independent sample Student’s t-tests. P values for interaction with treatment were based on fitting a general linear model separately for each variable.