Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia
Tadeusz Robak, Jerzy Windyga, Jacek Trelinski, Mario von Depka Prondzinski, Aristoteles Giagounidis, Chantal Doyen, Ann Janssens, María Teresa Alvarez-Román, Isidro Jarque, Javier Loscertales, Gloria Pérez Rus, Andrzej Hellmann, Wieslaw Wiktor Jêdrzejczak, Kazimierz Kuliczkowski, Lana M Golubovic, Dusica Celeketic, Andrei Cucuianu, Emanuil Gheorghita, Mihaela Lazaroiu, Ofer Shpilberg, Dina Attias, Elena Karyagina, Kalinina Svetlana, Kateryna Vilchevska, Nichola Cooper, Kate Talks, Mukhyaprana Prabhu, Prasad Sripada, T P R Bharadwaj, Henrik Næsted, Niels J Ø Skartved, Torben P Frandsen, Mimi F Flensburg, Peter S Andersen, Jørgen Petersen, Tadeusz Robak, Jerzy Windyga, Jacek Trelinski, Mario von Depka Prondzinski, Aristoteles Giagounidis, Chantal Doyen, Ann Janssens, María Teresa Alvarez-Román, Isidro Jarque, Javier Loscertales, Gloria Pérez Rus, Andrzej Hellmann, Wieslaw Wiktor Jêdrzejczak, Kazimierz Kuliczkowski, Lana M Golubovic, Dusica Celeketic, Andrei Cucuianu, Emanuil Gheorghita, Mihaela Lazaroiu, Ofer Shpilberg, Dina Attias, Elena Karyagina, Kalinina Svetlana, Kateryna Vilchevska, Nichola Cooper, Kate Talks, Mukhyaprana Prabhu, Prasad Sripada, T P R Bharadwaj, Henrik Næsted, Niels J Ø Skartved, Torben P Frandsen, Mimi F Flensburg, Peter S Andersen, Jørgen Petersen
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.
Source: PubMed