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Blood, 15 August 2004, Vol. 104, No. 4, pp. 948-955.
Prepublished online as a Blood First Edition Paper on April 15, 2004; DOI 10.1182/blood-2004-02-0593.
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Submitted February 17, 2004
Accepted April 4, 2004
Blood concentrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or subcutaneous routes of administration
Geoff Hale*, Peppy Rebello, Lee Brettman, Chris Fegan, Ben Kennedy, Eva Kimby, Mike Leach, Jeanette Lundin, Hakan Mellstedt, Paul Moreton, Andy Rawstron, Herman Waldmann, Anders Osterborg, and Peter Hillmen
Sir William Dunn School of Pathology, Oxford University, Oxford, United Kingdom
Millennium Pharmaceuticals Inc, Cambridge, MA, USA
Department of Haematology, Heartlands Hospital, Birmingham, United Kingdom
Department of Haematology, Leeds General Infirmary, Leeds, United Kingdom
Department of Hematology, Huddinge Hospital, Huddinge, Sweden
Department of Haematology, Stobhill Hospital, Glasgow, United Kingdom
Departments of Hematology and Oncology, Karolinska Hospital, Stockholm, Sweden
* Corresponding author; email: geoff.hale{at}path.ox.ac.uk.
Alemtuzumab is a humanised anti-CD52 antibody licensed for refractory B-CLL, when given intravenously (IV) at 30 mg thrice weekly. However the IV route is associated with infusion-related reactions and is inconvenient. We measured blood concentrations in 30 relapsed patients treated with IV alemtuzumab and in 20 patients from a previously untreated group who received similar doses SC. Highest trough samples in the IV group were < 0.5 to 18.3 µg/mL (mean 5.4 µg/mL). The cumulative dose required to reach 1.0 µg/mL was 13 to 316 mg (mean 90 mg). Higher blood concentrations correlated with better clinical responses and minimal residual disease. The highest measured concentrations in the SC group were very similar (0.6 to 24.8 µg/mL, mean 5.4 µg/mL). However, the cumulative dose to reach 1.0 µg/mL was higher: 146 to 1106 mg (mean 551 mg). No antiglobulin responses were detected in 30 patients given IV alemtuzumab whereas 2 of 32 SC patients made substantial anti-idiotype responses. Thus SC alemtuzumab achieves similar blood levels as IV, although with slightly higher cumulative doses. It is more convenient and better tolerated but may be associated with occasional patients forming anti-alemtuzumab antibodies, particularly in previously untreated patients.
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