Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1-2 study

Bertrand Coiffier, Nedjad Losic, Birgitte Biilmann Rønn, Stéphane Lepretre, Lars Møller Pedersen, Ole Gadeberg, Henrik Frederiksen, Marinus H J van Oers, James Wooldridge, Janusz Kloczko, Jerzy Holowiecki, Andrzej Hellmann, Jan Walewski, Tadeusz Robak, Jørgen Petersen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

The purpose of this phase 1-2 study was to investigate the association between the pharmacokinetic properties of ofatumumab, a human monoclonal CD20 antibody, and outcomes in 33 patients with relapsed/refractory chronic lymphocytic leukaemia receiving 4 weekly infusions of ofatumumab. The ofatumumab concentration profiles were fitted well by a two-compartment model with different elimination rate constant at first infusion compared to the remaining infusions in line with the observed rapid and sustained B-cell depletion. Exposure to ofatumumab was linked to clinical outcomes: high exposure was associated with higher probability of overall clinical response and longer progression-free survival. This association still remained statistically significant even when adjusting for relevant baseline covariates including tumour burden.
OriginalsprogEngelsk
TidsskriftBritish Journal of Haematology
Vol/bind150
Udgave nummer1
Sider (fra-til)58-71
Antal sider14
ISSN0007-1048
DOI
StatusUdgivet - 1. jul. 2010

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