Table 4 Relationship between initial antibody status and types of and reasons for therapy change for the scheduled antibody testing arm and the usual care arm
Outcome | Antibody status | |||||||
|---|---|---|---|---|---|---|---|---|
BAb(−) | BAb(+) | p-value | NAb(−) | NAb(+) | p-value | |||
Scheduled Ab testing arm, n | 387 | 266 | 148 | 118 | ||||
Patients who changed therapy, n (%)* | 62 (16.0) | 66 (24.8) | 0.0054 | 18 (12.2) | 48 (40.7) | <0.0001 | ||
Type of therapy change† | ||||||||
Start glatiramer acetate | 10 (2.6) | 37 (13.9) | <0.0001 | 6 (4.1) | 31 (26.3) | <0.0001 | ||
New/change in symptomatic therapy | 10 (2.6) | 10 (3.8) | 0.3917 | 2 (1.4) | 8 (6.8) | 0.0096 | ||
Closer vigilance | 13 (3.4) | 27 (10.2) | 0.0004 | 8 (5.4) | 19 (16.1) | <0.0001 | ||
Reason for change*,† | ||||||||
NAb result | 2 (0.5) | 43 (16.2) | <0.0001 | 1 (0.7) | 42 (35.6) | <0.0001 | ||
MS clinical worsening | 55 (14.2) | 56 (21.1) | 0.0222 | 26 (17.6) | 30 (25.4) | 0.0071 | ||
MRI changes | 11 (2.8) | 22 (8.3) | 0.0019 | 6 (4.1) | 16 (13.6) | <0.0001 | ||
Clinical composite‡ | 60 (15.5) | 66 (24.8) | 0.0031 | 27 (18.2) | 39 (33.1) | <0.0001 | ||
Usual care arm, n | 343 | 233 | 119 | 114 | ||||
Patients who changed therapy, n (%)* | 39 (11.4) | 42 (18.0) | 0.0241 | 24 (20.2) | 18 (15.8) | 0.5537 | ||
Type of therapy change† | ||||||||
Start glatiramer acetate | 4 (1.2) | 13 (5.6) | 0.0021 | 6 (5.0) | 7 (6.1) | 0.0247 | ||
New/change in symptomatic therapy | 8 (2.3) | 5 (2.2) | 0.8825 | 4 (3.4) | 1 (0.9) | 0.2681 | ||
Closer vigilance | 14 (4.1) | 11 (4.7) | 0.7117 | 5 (4.2) | 6 (5.3) | 0.5892 | ||
Reason for change*,† | ||||||||
NAb result | 1 (0.3) | 2 (0.9) | 0.5687 | 0 (0.0) | 2 (1.8) | 0.1015 | ||
MS clinical worsening | 32 (9.3) | 41 (17.6) | 0.0034 | 21 (17.6) | 20 (17.5) | 0.0809 | ||
MRI changes | 13 (3.8) | 10 (4.3) | 0.7628 | 6 (5.0) | 4 (3.5) | 0.7681 | ||
Clinical composite‡ | 36 (10.5) | 44 (18.9) | 0.0043 | 23 (19.3) | 21 (18.4) | 0.1182 | ||