Table 2.
Week 24 | Adjusted mean change from baseline (SE)* |
Chi-square† | LS mean difference | p-value | |
---|---|---|---|---|---|
Tacrolimus | Placebo | ||||
Osserman’s classification score | 2.85 | 0.092 | |||
MG-ADL score | −3.7 (0.4) | −2.8 (0.4) | −0.9 (–2.0–0.2) | 0.099 | |
MMT score | |||||
Manual muscle test | −12.4 (1.2) | −9.3 (1.3) | −3.0 (–6.7–0.6) | 0.097 | |
Cranial nerves muscle force | −4.9 (0.5) | −3.9 (0.6) | −1.0 (–2.5–0.5) | 0.201 | |
Human body muscle force | −7.5 (0.9) | −5.4 (1.0) | −2.1 (–4.9–0.7) | 0.137 | |
GC dose change (mg/day) | −16.4 (2.5) | −15.3 (2.7) | −1.1 (–8.5–6.3) | 0.767 | |
Patients who completed the trial (%) | 86.4 | 89.5 | − | − | 0.745‡ |
A generalized linear model, using the observed cases to compare the difference in the change of MG-ADL, MMT and GC dose from baseline. The response variable was the difference in indication at baseline and at the end of the trial. Baseline score was the covariate and treatment group was the fixed effect; † A non-parametric Mann–Whitney U test was used to compare the Osserman’s classification change from baseline between the treatment groups. ‡ Fisher’s exact test was used to compare the number of patients who completed the trial between treatment groups.
FAS, full analysis set; GC, glucocorticoid; LS, least squares; MG-ADL, myasthenia gravis-related activities of daily living; MMT, manual muscle test; SE, standard error.