TY - JOUR
T1 - 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
AU - Coiffier, Bertrand
AU - Losic, Nedjad
AU - Rønn, Birgitte Biilmann
AU - Lepretre, Stéphane
AU - Pedersen, Lars Møller
AU - Gadeberg, Ole
AU - Frederiksen, Henrik
AU - van Oers, Marinus H. J.
AU - Wooldridge, James
AU - Kloczko, Janusz
AU - Holowiecki, Jerzy
AU - Hellmann, Andrzej
AU - Walewski, Jan
AU - Robak, Tadeusz
AU - Petersen, Jørgen
PY - 2010
Y1 - 2010
N2 - 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
AB - 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
U2 - https://doi.org/10.1111/j.1365-2141.2010.08193.x
DO - https://doi.org/10.1111/j.1365-2141.2010.08193.x
M3 - Article
C2 - 20408846
SN - 0007-1048
VL - 150
SP - 58
EP - 71
JO - British journal of haematology
JF - British journal of haematology
IS - 1
ER -