Summary of incidence and titres of anti-alemtuzumab antibody and inhibitory antibody (pooled Phase III studies)
ADA incidence and titres . | Baseline . | Month 1 . | Month 3 . | Month 12 . | Month 13 . | Month 15 . | Month 24 . | ||
---|---|---|---|---|---|---|---|---|---|
ADA | 12 mg | % patients positive | 0·9% | 62·4% | 66·7% | 29·3% | 83·2% | 83·4% | 75·4% |
Titre, median | 30 | 400 | 400 | 200 | 204800 | 51200 | 1600 | ||
Titre, range | 30, 800 | 30, 10 2400 | 30, 102 400 | 30, 102 400 | 306 55 3 600 | 30, 6 553 600 | 30, 204 800 | ||
24 mg | % patients positive | 0 | 48·7% | 55·4% | 28·7% | 73·6% | 72·4% | 67·1% | |
Titre, median | na | 400 | 400 | 200 | 204800 | 51200 | 2400 | ||
Titre, range | na | 30, 51200 | 30, 12800 | 30, 12800 | 30, 13107200 | 30, 1638400 | 30, 102400 | ||
Inhibitory ADA | 12 mg | % patients positive1 | 0 | 86·8% | 45·60% | 2·2% | 94·3% | 88·1% | 41·5% |
Titre, median | na | 40 | 20 | 20 | 640 | 160 | 20 | ||
Titre, range | na | 20, 640 | 20, 640 | 20, 640 | 20, 81920 | 20, 2560 | 20, 640 | ||
24 mg | % patients positivea | 0 | 89·3% | 57·5% | 8·9% | 95·1% | 90·9% | 41·2% | |
Titre, median | na | 80 | 20 | 40 | 1280 | 320 | 40 | ||
Titre, range | na | 20, 1280 | 20, 320 | 20, 40 | 20, 10240 | 20, 2560 | 20, 320 |
ADA incidence and titres . | Baseline . | Month 1 . | Month 3 . | Month 12 . | Month 13 . | Month 15 . | Month 24 . | ||
---|---|---|---|---|---|---|---|---|---|
ADA | 12 mg | % patients positive | 0·9% | 62·4% | 66·7% | 29·3% | 83·2% | 83·4% | 75·4% |
Titre, median | 30 | 400 | 400 | 200 | 204800 | 51200 | 1600 | ||
Titre, range | 30, 800 | 30, 10 2400 | 30, 102 400 | 30, 102 400 | 306 55 3 600 | 30, 6 553 600 | 30, 204 800 | ||
24 mg | % patients positive | 0 | 48·7% | 55·4% | 28·7% | 73·6% | 72·4% | 67·1% | |
Titre, median | na | 400 | 400 | 200 | 204800 | 51200 | 2400 | ||
Titre, range | na | 30, 51200 | 30, 12800 | 30, 12800 | 30, 13107200 | 30, 1638400 | 30, 102400 | ||
Inhibitory ADA | 12 mg | % patients positive1 | 0 | 86·8% | 45·60% | 2·2% | 94·3% | 88·1% | 41·5% |
Titre, median | na | 40 | 20 | 20 | 640 | 160 | 20 | ||
Titre, range | na | 20, 640 | 20, 640 | 20, 640 | 20, 81920 | 20, 2560 | 20, 640 | ||
24 mg | % patients positivea | 0 | 89·3% | 57·5% | 8·9% | 95·1% | 90·9% | 41·2% | |
Titre, median | na | 80 | 20 | 40 | 1280 | 320 | 40 | ||
Titre, range | na | 20, 1280 | 20, 320 | 20, 40 | 20, 10240 | 20, 2560 | 20, 320 |
Percentage of the total patients who tested positive in anti-alemtuzumab antibodies (ADA).
Summary of incidence and titres of anti-alemtuzumab antibody and inhibitory antibody (pooled Phase III studies)
ADA incidence and titres . | Baseline . | Month 1 . | Month 3 . | Month 12 . | Month 13 . | Month 15 . | Month 24 . | ||
---|---|---|---|---|---|---|---|---|---|
ADA | 12 mg | % patients positive | 0·9% | 62·4% | 66·7% | 29·3% | 83·2% | 83·4% | 75·4% |
Titre, median | 30 | 400 | 400 | 200 | 204800 | 51200 | 1600 | ||
Titre, range | 30, 800 | 30, 10 2400 | 30, 102 400 | 30, 102 400 | 306 55 3 600 | 30, 6 553 600 | 30, 204 800 | ||
24 mg | % patients positive | 0 | 48·7% | 55·4% | 28·7% | 73·6% | 72·4% | 67·1% | |
Titre, median | na | 400 | 400 | 200 | 204800 | 51200 | 2400 | ||
Titre, range | na | 30, 51200 | 30, 12800 | 30, 12800 | 30, 13107200 | 30, 1638400 | 30, 102400 | ||
Inhibitory ADA | 12 mg | % patients positive1 | 0 | 86·8% | 45·60% | 2·2% | 94·3% | 88·1% | 41·5% |
Titre, median | na | 40 | 20 | 20 | 640 | 160 | 20 | ||
Titre, range | na | 20, 640 | 20, 640 | 20, 640 | 20, 81920 | 20, 2560 | 20, 640 | ||
24 mg | % patients positivea | 0 | 89·3% | 57·5% | 8·9% | 95·1% | 90·9% | 41·2% | |
Titre, median | na | 80 | 20 | 40 | 1280 | 320 | 40 | ||
Titre, range | na | 20, 1280 | 20, 320 | 20, 40 | 20, 10240 | 20, 2560 | 20, 320 |
ADA incidence and titres . | Baseline . | Month 1 . | Month 3 . | Month 12 . | Month 13 . | Month 15 . | Month 24 . | ||
---|---|---|---|---|---|---|---|---|---|
ADA | 12 mg | % patients positive | 0·9% | 62·4% | 66·7% | 29·3% | 83·2% | 83·4% | 75·4% |
Titre, median | 30 | 400 | 400 | 200 | 204800 | 51200 | 1600 | ||
Titre, range | 30, 800 | 30, 10 2400 | 30, 102 400 | 30, 102 400 | 306 55 3 600 | 30, 6 553 600 | 30, 204 800 | ||
24 mg | % patients positive | 0 | 48·7% | 55·4% | 28·7% | 73·6% | 72·4% | 67·1% | |
Titre, median | na | 400 | 400 | 200 | 204800 | 51200 | 2400 | ||
Titre, range | na | 30, 51200 | 30, 12800 | 30, 12800 | 30, 13107200 | 30, 1638400 | 30, 102400 | ||
Inhibitory ADA | 12 mg | % patients positive1 | 0 | 86·8% | 45·60% | 2·2% | 94·3% | 88·1% | 41·5% |
Titre, median | na | 40 | 20 | 20 | 640 | 160 | 20 | ||
Titre, range | na | 20, 640 | 20, 640 | 20, 640 | 20, 81920 | 20, 2560 | 20, 640 | ||
24 mg | % patients positivea | 0 | 89·3% | 57·5% | 8·9% | 95·1% | 90·9% | 41·2% | |
Titre, median | na | 80 | 20 | 40 | 1280 | 320 | 40 | ||
Titre, range | na | 20, 1280 | 20, 320 | 20, 40 | 20, 10240 | 20, 2560 | 20, 320 |
Percentage of the total patients who tested positive in anti-alemtuzumab antibodies (ADA).
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