Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia.
Rozrolimupab, a recombinant mixture of 25 fully human RhD-specific monoclonal antibodies, represents a new class of recombinant human antibody mixtures. In a phase 1 or 2 dose escalation study, RhD(+) patients (61 subjects) with primary immune thrombocytopenia received a single intravenous dose of rozrolimupab ranging from 75 to 300 μg/kg. The primary outcome was the occurrence of adverse events. The principal secondary outcome was the effect on platelet levels 7 days after the treatment. The most common adverse events were headache and pyrexia, mostly mild, and reported in 20% and 13% of the patients, respectively, without dose relationship. Rozrolimupab caused an expected transient reduction of hemoglobin concentration in the majority of the patients. At the dose of 300 μg/kg platelet responses, defined as platelet count ≥ 30 × 10(9)/L and an increase in platelet count by > 20 × 10(9)/L from baseline were observed after 72 hours and persisted for at least 7 days in 8 of 13 patients (62%). Platelet responses were observed within 24 hours in 23% of patients and lasted for a median of 14 days. Rozrolimupab was well tolerated and elicited rapid platelet responses in patients with immune thrombocytopenia and may be a useful alternative to plasma-derived products. This trial is registered at www.clinicaltrials.gov as #NCT00718692.
Department of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland. robaktad@csk.umed.lodz.pl
Tadeusz
T
Robak
Jerzy
J
Windyga
Jacek
J
Trelinski
Mario
M
von Depka Prondzinski
Aristoteles
A
Giagounidis
Chantal
C
Doyen
Ann
A
Janssens
María Teresa
MT
Alvarez-Román
Isidro
I
Jarque
Javier
J
Loscertales
Gloria Pérez
GP
Rus
Andrzej
A
Hellmann
Wieslaw Wiktor
WW
Jêdrzejczak
Kazimierz
K
Kuliczkowski
Lana M
LM
Golubovic
Dusica
D
Celeketic
Andrei
A
Cucuianu
Emanuil
E
Gheorghita
Mihaela
M
Lazaroiu
Ofer
O
Shpilberg
Dina
D
Attias
Elena
E
Karyagina
Kalinina
K
Svetlana
Kateryna
K
Vilchevska
Nichola
N
Cooper
Kate
K
Talks
Mukhyaprana
M
Prabhu
Prasad
P
Sripada
T P R
TP
Bharadwaj
Henrik
H
Næsted
Niels J Ø
NJ
Skartved
Torben P
TP
Frandsen
Mimi F
MF
Flensburg
Peter S
PS
Andersen
Jørgen
J
Petersen
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics
D000911:Antibodies, Monoclonal; D007074:Immunoglobulin G; D011994:Recombinant Proteins; C558236:rozrolimupab