Table 6

Summary of incidence and titres of anti-alemtuzumab antibody and inhibitory antibody (pooled Phase III studies)

ADA incidence and titresBaselineMonth 1Month 3Month 12Month 13Month 15Month 24
ADA12 mg% patients positive0·9%62·4%66·7%29·3%83·2%83·4%75·4%
  Titre, median30400400200204800512001600
  Titre, range30, 80030, 10 240030, 102 40030, 102 400306 55 3 60030, 6 553 60030, 204 800
 24 mg% patients positive048·7%55·4%28·7%73·6%72·4%67·1%
  Titre, medianna400400200204800512002400
  Titre, rangena30, 5120030, 1280030, 1280030, 1310720030, 163840030, 102400
Inhibitory ADA12 mg% patients positive1086·8%45·60%2·2%94·3%88·1%41·5%
  Titre, medianna40202064016020
  Titre, rangena20, 64020, 64020, 64020, 8192020, 256020, 640
 24 mg% patients positivea089·3%57·5%8·9%95·1%90·9%41·2%
  Titre, medianna802040128032040
  Titre, rangena20, 128020, 32020, 4020, 1024020, 256020, 320
ADA incidence and titresBaselineMonth 1Month 3Month 12Month 13Month 15Month 24
ADA12 mg% patients positive0·9%62·4%66·7%29·3%83·2%83·4%75·4%
  Titre, median30400400200204800512001600
  Titre, range30, 80030, 10 240030, 102 40030, 102 400306 55 3 60030, 6 553 60030, 204 800
 24 mg% patients positive048·7%55·4%28·7%73·6%72·4%67·1%
  Titre, medianna400400200204800512002400
  Titre, rangena30, 5120030, 1280030, 1280030, 1310720030, 163840030, 102400
Inhibitory ADA12 mg% patients positive1086·8%45·60%2·2%94·3%88·1%41·5%
  Titre, medianna40202064016020
  Titre, rangena20, 64020, 64020, 64020, 8192020, 256020, 640
 24 mg% patients positivea089·3%57·5%8·9%95·1%90·9%41·2%
  Titre, medianna802040128032040
  Titre, rangena20, 128020, 32020, 4020, 1024020, 256020, 320
a

Percentage of the total patients who tested positive in anti-alemtuzumab antibodies (ADA).

Table 6

Summary of incidence and titres of anti-alemtuzumab antibody and inhibitory antibody (pooled Phase III studies)

ADA incidence and titresBaselineMonth 1Month 3Month 12Month 13Month 15Month 24
ADA12 mg% patients positive0·9%62·4%66·7%29·3%83·2%83·4%75·4%
  Titre, median30400400200204800512001600
  Titre, range30, 80030, 10 240030, 102 40030, 102 400306 55 3 60030, 6 553 60030, 204 800
 24 mg% patients positive048·7%55·4%28·7%73·6%72·4%67·1%
  Titre, medianna400400200204800512002400
  Titre, rangena30, 5120030, 1280030, 1280030, 1310720030, 163840030, 102400
Inhibitory ADA12 mg% patients positive1086·8%45·60%2·2%94·3%88·1%41·5%
  Titre, medianna40202064016020
  Titre, rangena20, 64020, 64020, 64020, 8192020, 256020, 640
 24 mg% patients positivea089·3%57·5%8·9%95·1%90·9%41·2%
  Titre, medianna802040128032040
  Titre, rangena20, 128020, 32020, 4020, 1024020, 256020, 320
ADA incidence and titresBaselineMonth 1Month 3Month 12Month 13Month 15Month 24
ADA12 mg% patients positive0·9%62·4%66·7%29·3%83·2%83·4%75·4%
  Titre, median30400400200204800512001600
  Titre, range30, 80030, 10 240030, 102 40030, 102 400306 55 3 60030, 6 553 60030, 204 800
 24 mg% patients positive048·7%55·4%28·7%73·6%72·4%67·1%
  Titre, medianna400400200204800512002400
  Titre, rangena30, 5120030, 1280030, 1280030, 1310720030, 163840030, 102400
Inhibitory ADA12 mg% patients positive1086·8%45·60%2·2%94·3%88·1%41·5%
  Titre, medianna40202064016020
  Titre, rangena20, 64020, 64020, 64020, 8192020, 256020, 640
 24 mg% patients positivea089·3%57·5%8·9%95·1%90·9%41·2%
  Titre, medianna802040128032040
  Titre, rangena20, 128020, 32020, 4020, 1024020, 256020, 320
a

Percentage of the total patients who tested positive in anti-alemtuzumab antibodies (ADA).

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