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 roz...

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Published in:Blood 2012-11, Vol.120 (18), p.3670-3676
Main Authors: Robak, Tadeusz, Windyga, Jerzy, Trelinski, Jacek, von Depka Prondzinski, Mario, Giagounidis, Aristoteles, Doyen, Chantal, Janssens, Ann, Álvarez-Román, María Teresa, Jarque, Isidro, Loscertales, Javier, Rus, Gloria Pérez, Hellmann, Andrzej, Jêdrzejczak, Wiesław Wiktor, Kuliczkowski, Kazimierz, Golubovic, Lana M., Celeketic, Dusica, Cucuianu, Andrei, Gheorghita, Emanuil, Lazaroiu, Mihaela, Shpilberg, Ofer, Attias, Dina, Karyagina, Elena, Svetlana, Kalinina, Vilchevska, Kateryna, Cooper, Nichola, Talks, Kate, Prabhu, Mukhyaprana, Sripada, Prasad, Bharadwaj, T.P.R., Næsted, Henrik, Skartved, Niels J.Ø., Frandsen, Torben P., Flensburg, Mimi F., Andersen, Peter S., Petersen, Jørgen
Format: Article
Language:eng ; rus
Subjects:
Adult
Aged
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - pharmacokinetics
Dose-Response Relationship, Drug
Female
Humans
Immunoglobulin G - administration & dosage
Immunoglobulin G - adverse effects
Male
Middle Aged
Purpura, Thrombocytopenic, Idiopathic - drug therapy
Recombinant Proteins - administration & dosage
Recombinant Proteins - adverse effects
Recombinant Proteins - pharmacokinetics
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Summary: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 × 109/L and an increase in platelet count by > 20 × 109/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.
ISSN:0006-4971
1528-0020
1528-0020
DOI:10.1182/blood-2012-06-438804