TY - JOUR
T1 - Rozrolimupab, amixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia
AU - Robak, Tadeusz
AU - Windyga, Jerzy
AU - Trelinski, Jacek
AU - Prondzinski, Mario Von Depka
AU - Giagounidis, Aristoteles
AU - Doyen, Chantal
AU - Janssens, Ann
AU - Álvarez-Román, María Teresa
AU - Jarque, Isidro
AU - Loscertales, Javier
AU - Rus, Gloria Pérez
AU - Hellmann, Andrzej
AU - Jêdrzejczak, Wiesław Wiktor
AU - Kuliczkowski, Kazimierz
AU - Golubovic, Lana M.
AU - Celeketic, Dusica
AU - Cucuianu, Andrei
AU - Gheorghita, Emanuil
AU - Lazaroiu, Mihaela
AU - Shpilberg, Ofer
AU - Attias, Dina
AU - Karyagina, Elena
AU - Svetlana, Kalinina
AU - Vilchevska, Kateryna
AU - Cooper, Nichola
AU - Talks, Kate
AU - Prabhu, Mukhyaprana
AU - Sripada, Prasad
AU - Bharadwaj, T. P.R.
AU - Næsted, Henrik
AU - Skartved, Niels J.Ø.
AU - Frandsen, Torben P.
AU - Flensburg, Mimi F.
AU - Andersen, Peter S.
AU - Petersen, Jørgen
PY - 2012/11/1
Y1 - 2012/11/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84868570501&partnerID=8YFLogxK
U2 - 10.1182/blood-2012-06-438804
DO - 10.1182/blood-2012-06-438804
M3 - Article
AN - SCOPUS:84868570501
SN - 0006-4971
VL - 120
SP - 3670
EP - 3676
JO - Blood
JF - Blood
IS - 18
ER -