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Title: Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia
Authors: Robak, Tadeusz ×
Windyga, Jerzy
Trelinski, Jacek
von Depka Prondzinski, Mario
Giagounidis, Aristoteles
Doyen, Chantal
Janssens, Ann
Alvarez-Román, María Teresa
Jarque, Isidro
Loscertales, Javier
Rus, Gloria Pérez
Hellmann, Andrzej
Jêdrzejczak, Wieslaw 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 #
Issue Date: Nov-2012
Publisher: W.B. Saunders
Series Title: Blood vol:120 issue:18 pages:3670-6
Article number: 10.1182/blood-2012-06-438804
Abstract: 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.
URI: 
ISSN: 0006-4971
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Cell and Gene Therapy Applications (-)
Department of Development and Regeneration - miscellaneous (+)
× corresponding author
# (joint) last author

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