Rozrolimupab, amixture 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 Álvarez-Román, Isidro Jarque, Javier Loscertales, Gloria Pérez Rus, Andrzej Hellmann, Wiesław Wiktor Jêdrzejczak, Kazimierz Kuliczkowski, Lana M. Golubovic, Dusica Celeketic, Andrei Cucuianu, Emanuil Gheorghita, Mihaela Lazaroiu, Ofer ShpilbergDina 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

Research output: Contribution to journalArticle

33 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)3670-3676
Number of pages7
JournalBlood
Volume120
Issue number18
DOIs
Publication statusPublished - 01-11-2012

Fingerprint

Monoclonal antibodies
Idiopathic Thrombocytopenic Purpura
Platelets
Monoclonal Antibodies
Blood Platelets
Platelet Count
Therapeutics
Headache
rozrolimupab
Hemoglobins
Fever
Plasmas
Antibodies

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Robak, T., Windyga, J., Trelinski, J., Prondzinski, M. V. D., Giagounidis, A., Doyen, C., ... Petersen, J. (2012). Rozrolimupab, amixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia. Blood, 120(18), 3670-3676. https://doi.org/10.1182/blood-2012-06-438804
Robak, Tadeusz ; Windyga, Jerzy ; Trelinski, Jacek ; Prondzinski, Mario Von Depka ; 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. / Rozrolimupab, amixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia. In: Blood. 2012 ; Vol. 120, No. 18. pp. 3670-3676.
@article{dc3476807f3c4186b70763aed0d7da81,
title = "Rozrolimupab, amixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia",
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.",
author = "Tadeusz Robak and Jerzy Windyga and Jacek Trelinski and Prondzinski, {Mario Von Depka} and Aristoteles Giagounidis and Chantal Doyen and Ann Janssens and {\'A}lvarez-Rom{\'a}n, {Mar{\'i}a Teresa} and Isidro Jarque and Javier Loscertales and Rus, {Gloria P{\'e}rez} and Andrzej Hellmann and J{\^e}drzejczak, {Wiesław Wiktor} and Kazimierz Kuliczkowski and Golubovic, {Lana M.} and Dusica Celeketic and Andrei Cucuianu and Emanuil Gheorghita and Mihaela Lazaroiu and Ofer Shpilberg and Dina Attias and Elena Karyagina and Kalinina Svetlana and Kateryna Vilchevska and Nichola Cooper and Kate Talks and Mukhyaprana Prabhu and Prasad Sripada and Bharadwaj, {T. P.R.} and Henrik N{\ae}sted and Skartved, {Niels J.{\O}.} and Frandsen, {Torben P.} and Flensburg, {Mimi F.} and Andersen, {Peter S.} and J{\o}rgen Petersen",
year = "2012",
month = "11",
day = "1",
doi = "10.1182/blood-2012-06-438804",
language = "English",
volume = "120",
pages = "3670--3676",
journal = "Blood",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "18",

}

Robak, T, Windyga, J, Trelinski, J, Prondzinski, MVD, Giagounidis, A, Doyen, C, Janssens, A, Álvarez-Román, MT, Jarque, I, Loscertales, J, Rus, GP, Hellmann, A, Jêdrzejczak, WW, Kuliczkowski, K, Golubovic, LM, Celeketic, D, Cucuianu, A, Gheorghita, E, Lazaroiu, M, Shpilberg, O, Attias, D, Karyagina, E, Svetlana, K, Vilchevska, K, Cooper, N, Talks, K, Prabhu, M, Sripada, P, Bharadwaj, TPR, Næsted, H, Skartved, NJØ, Frandsen, TP, Flensburg, MF, Andersen, PS & Petersen, J 2012, 'Rozrolimupab, amixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia', Blood, vol. 120, no. 18, pp. 3670-3676. https://doi.org/10.1182/blood-2012-06-438804

Rozrolimupab, amixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia. / Robak, Tadeusz; Windyga, Jerzy; Trelinski, Jacek; Prondzinski, Mario Von Depka; 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.

In: Blood, Vol. 120, No. 18, 01.11.2012, p. 3670-3676.

Research output: Contribution to journalArticle

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 × 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.

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 × 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.

UR - http://www.scopus.com/inward/record.url?scp=84868570501&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84868570501&partnerID=8YFLogxK

U2 - 10.1182/blood-2012-06-438804

DO - 10.1182/blood-2012-06-438804

M3 - Article

C2 - 22915649

AN - SCOPUS:84868570501

VL - 120

SP - 3670

EP - 3676

JO - Blood

JF - Blood

SN - 0006-4971

IS - 18

ER -