Table 2.
Immune Response Parameters (Ab3, HAMA) at Week 10, Week 22, and Final Study Visit in Overall ITT Population
| Parameter | Abagovomab (n = 593) |
Placebo (n = 295) |
Total (N = 888) |
|||
|---|---|---|---|---|---|---|
| Actual Value | Change From Baseline | Actual Value | Change From Baseline | Actual Value | Change From Baseline | |
| Ab3, ng/mL | ||||||
| Baseline | ||||||
| No. | 576 | 288 | 864 | |||
| Mean | 893.5 | 985.0 | 924.0 | |||
| SD | 7,585.82 | 5,613.77 | 6,987.36 | |||
| Median | 0.0 | 0.0 | 0.0 | |||
| Q1 to Q3 | 0 to 0 | 0 to 0 | 0 to 0 | |||
| Week 10 | ||||||
| No. | 538 | 532 | 269 | 263 | 807 | 795 |
| Mean | 89,952.1 | 89,230.7 | 1,128.9 | 500.4 | 60,344.4 | 59,877.1 |
| SD | 91,321.64 | 92,190.47 | 6,588.91 | 4,141.14 | 85,592.98 | 86,224.51 |
| Median | 63,550.0 | 63,150.0 | 0.0 | 0.0 | 31,400.0 | 30,700.0 |
| Q1 to Q3 | 31,400.0 to 115,500.0 | 30,100.0 to 115,500.0 | 0 to 0 | 0 to 0 | 0 to 88,000.0 | 0 to 88,000.0 |
| Week 22 | ||||||
| No. | 472 | 460 | 234 | 228 | 706 | 688 |
| Mean | 404,625.5 | 407,134.7 | 1,245.3 | 533.3 | 270,927.2 | 272,388.9 |
| SD | 271,569.40 | 273,703.11 | 6,433.85 | 4,396.22 | 292,219.18 | 294,520.64 |
| Median | 335,500.0 | 339,000.0 | 0.0 | 0.0 | 225,500.0 | 227,000.0 |
| Q1 to Q3 | 224,000.0 to 536,500.0 | 225,500.0 to 540,000.0 | 0 to 0 | 0 to 0 | 0 to 455,000.0 | 0 to 457,500.0 |
| Final study visit | ||||||
| No. | 449 | 441 | 230 | 224 | 679 | 665 |
| Mean | 595,209.8 | 596,580.7 | 3,950.5 | 2,936.4 | 394,930.5 | 396,616.3 |
| SD | 469,647.94 | 470,366.17 | 33,697.04 | 33,040.60 | 473,866.07 | 475,199.78 |
| Median | 493,000.0 | 493,000.0 | 0.0 | 0.0 | 256,000.0 | 258,000.0 |
| Q1 to Q3 | 258,000.0 to 794,000.0 | 258,000.0 to 798,000.0 | 0.0 | 0.0 | 0 to 627,000.0 | 0 to 625,400.0 |
| HAMA, ng/mL | ||||||
| Baseline | ||||||
| No. | 576 | 288 | 864 | |||
| Mean | 13.730 | 4.712 | 10.724 | |||
| SD | 117.7044 | 28.4410 | 97.5600 | |||
| Median | 0.000 | 0.000 | 0.000 | |||
| Q1 to Q3 | 0 to 0 | 0 to 0 | 0 to 0 | |||
| Week 10 | ||||||
| No. | 538 | 532 | 269 | 263 | 807 | 795 |
| Mean | 832.904 | 822.022 | 6.800 | 1.602 | 557.536 | 550.613 |
| SD | 1,523.2716 | 1,522.1293 | 35.2562 | 38.6689 | 1,303.1505 | 1,303.5092 |
| Median | 326.000 | 322.500 | 0.000 | 0.000 | 110.000 | 106.000 |
| Q1 to Q3 | 101.0 to 824.0 | 95.9 to 818.0 | 0 to 0 | 0 to 0 | 0 to 548.0 | 0 to 537.0 |
| Week 22 | ||||||
| No. | 472 | 460 | 234 | 228 | 706 | 688 |
| Mean | 9,844.807 | 9,833.055 | 13.795 | 8.922 | 6,586.370 | 6,577.383 |
| SD | 13,721.0703 | 13,779.9604 | 95.4973 | 100.9670 | 12,133.7797 | 12,177.3228 |
| Median | 6,380.000 | 6,415.000 | 0.000 | 0.000 | 2,795.000 | 2,760.000 |
| Q1 to Q3 | 2,760.0 to 11,850.0 | 2,745.0 to 11,850.0 | 0 to 0 | 0 to 0 | 0 to 8,370.0 | 0 to 8,465.0 |
| Final study visit | ||||||
| No. | 449 | 441 | 230 | 224 | 679 | 665 |
| Mean | 21,990.183 | 22,028.887 | 633.039 | 645.449 | 14,755.804 | 14,826.045 |
| SD | 40,079.0892 | 40,272.9965 | 7,038.0481 | 7,131.7401 | 34,357.8623 | 34,556.3083 |
| Median | 11,300.000 | 11,300.000 | 0.000 | 0.000 | 2,840.000 | 2,950.000 |
| Q1 to Q3 | 295.0 to 26,100.0 | 295.0 to 26,100.0 | 0 to 0 | 0 to 0 | 0 to 16,500.0 | 0 to 16,600.0 |
NOTE. Baseline value is defined as last measurement taken before first administration of study drug. Values specified as below limit of quantification were set to 0 in summary tables.
Abbreviations: Ab3, anti–anti-idiotypic antibody; HAMA, human antimouse antibody; Q, quartile; SD, standard deviation.