Table 3.
Mean changes in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative MG (QMG) total scores from eculizumab starta to open-label extension (OLE) last assessment by immunosuppressive therapy (IST) and nature of dose change during the OLE.
| IST | Nature of dose change during the OLE | MG-ADL total score | QMG total score | ||
|---|---|---|---|---|---|
| Eculizumab baselinea, mean (SD) | Change to OLE last assessment, mean (SD) | Eculizumab baselinea, mean (SD) | Change to OLE last assessment, mean (SD) | ||
| Total | All patients, N = 117 | 8.9 (3.60) | −3.6 (4.14) | 15.9 (5.69) | −4.1 (5.81) |
| PREDb | Patients who decreased and/or stopped, n = 45 | 8.6 (3.57) | −4.7 (3.92) | 16.0 (5.49) | −5.6 (5.15) |
| Patients with no change, n = 36 | 8.9 (3.59) | −2.3 (4.11) | 15.4 (5.49) | −1.5 (4.98) | |
| Patients who increased and/or started, n = 10 | 8.7 (3.16) | −0.7 (4.16) | 14.9 (5.65) | 0.2 (4.92) | |
| AZAb | Patients who decreased and/or stopped, n = 16 | 7.6 (3.08) | −3.4 (4.00) | 15.3 (4.61) | −3.8 (6.76) |
| Patients with no change, n = 20 | 9.0 (4.15) | −4.7 (3.77) | 16.0 (6.35) | −5.1 (5.26) | |
| Patients who increased and/or started, n = 3 | 7.7 (6.66) | 0.3 (2.31) | 13.3 (8.02) | −2.7 (4.93) | |
| MMFb | Patients who decreased and/or stopped, n = 13 | 8.5 (2.57) | −5.1 (3.64) | 14.1 (2.36) | −4.9 (3.52) |
| Patients with no change, n = 14 | 9.0 (2.75) | −2.5 (3.37) | 16.1 (4.92) | −1.6 (4.01) | |
| Patients who increased and/or started, n = 7 | 12.6 (2.23) | −5.3 (3.55) | 20.0 (6.81) | −7.9 (5.24) | |
a
Eculizumab baseline is REGAIN baseline for the eculizumab/eculizumab group and OLE baseline for the placebo/eculizumab group.
b
PRED, AZA, and MMF could be used as monotherapies, in combination with each other, or with other ISTs.
AZA, azathioprine; MMF, mycophenolate mofetil; PRED, prednisone and related corticosteroids; SD, standard deviation.