Table 1.
Baseline clinical features of ALS patients for group A and group B
| Clinical features | All patients (50)–T0 | Analyzed patients (43)–T0 | All patients (39)–T1 | Analyzed patients (27)–T1 | All patients (31)–T2 | Analyzed patients (20)–T2 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Group A | Group B | Group A | Group B | Group A | Group B | Group A | Group B | Group A | Group B | Group A | Group B | |
| Number (sex, male) | 25 (M 15) | 22 (M 14) | 22 (M 12) | 21 (M 12) | 19 (M 10) | 20 (M 12) | 13 (M 7) | 14 (M 8) | 15 (M 9) | 16 (M 10) | 10 (M 7) | 10 (M 6) |
| Age (SD) | 60.36 (10.86) | 59.64 (8.12) | 59.64 (8.12) | 59.71 (10.03) | 62.0 (11.15) | 57.95 (11.25) | 59.77 (10.05) | 60.71 (10.09) | 61.2 (11.47) | 57.56 (11.58) | 58.9 (10.88) | 62.4 (11.80) |
| BMI (SD) | 24.82 (3.95) | 24.84 (3.97) | 24.84 (3.97) | 22.84 (4.01) | 24.70 (4.03) | 23.28 (4.18) | 25.65 (4.39) | 23.19 (4.44) | 24.21 (3.86) | 23.09 (3.96) | 24.64 (4.19) | 23.17 (4.53) |
| Spinal onset (n, %) | 20 (80%) | 18 (82%) | 18 (82%) | 17 (81%) | 16 (84%) | 17 (85%) | 12 (92%) | 12 (86%) | 12 (80%) | 14 (88%) | 9 (90%) | 10 (100%) |
| Disease duration (SD) | 20.91 (10.89) | 19.85 (10.71) | 21.54 (10.90) | 19.14 (10.70) | 22.47 (9.70) | 23.65 (9.98) | 24.23 (9.16) | 22.71 (9.60) | 27.07 (9.65) | 27.56 (10.14) | 29.9 (9.26) | 25.50 (9.28) |
| FVC% (SD) | 81.48 (18.28) | 83.90 (18.46) | 83.90 (18.46) | 85.52 (18.79) | 72.26 (22.0) | 74.22 (21.35) | 80.0 (19.27) | 78.67 (17.78) | 64.71 (24.9) | 74.57 (23.99) | 68.67 (22.38) | 81.0 (22.39) |
| ALSFRS-R (SD) | 36.56 (5.82) | 36.77 (5.88) | 36.77 (5.88) | 36.05 (5.86) | 36.26 (7.55) | 31.77 (7.26) | 36.85 (7.55) | 31.28 (7.02) | 33.64 (9.24) | 31.0 (9.10) | 33.22 (7.99) | 31.11 (8.33) |
| Bulbar ALSFRS-R (SD) | 11.26 (1.53) | 11.35 (1.52) | 10.47 (1.49) | 10.29 (1.52) | 11.2 (1.73) | 11.36 (1.23) | 10.33 (1.54) | 10.15 (1.72) | 9.6 (2.42) | 10.43 (1.98) | 9.92 (2.36) | 9.87 (1.97) |
| Delta ALSFRS-R (SD) | – | – | – | – | 0.63 (1.36) | 1.08 (1.43) | 0.77 (1.38) | 1.45 (1.55) | 0.93 (1.05) | 0.8 (0.99) | 1.0 (0.88) | 0.63 (0.77) |
The values are expressed as mean (SD). BMI body mass index, FVC forced vital capacity, ALSFRS-R ALS Functional Rating Scale–Revised. P value: not statistically significant for each analysis (> 0.05). T0: baseline, T1: 3 months since treatment start, T2: 6 months since treatment start. The value of disease duration is in months. Delta ALSFRS-R is calculated as monthly progression