Rozrolimupab, amixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia

Blood

Volumn 120, Issue 18, 2012, Pages 3670-3676

  Robak, Tadeusz ^a   Windyga, Jerzy ^b   Trelinski, Jacek ^a   Prondzinski, Mario Von Depka ^c   Giagounidis, Aristoteles ^d   Doyen, Chantal ^e   Janssens, Ann ^f   Álvarez Román, María Teresa ^g   Jarque, Isidro ^h   Loscertales, Javier ⁱ   Rus, Gloria Pérez ^j   Hellmann, Andrzej ^k   Jêdrzejczak, Wiesław Wiktor ^l   Kuliczkowski, Kazimierz ^m   Golubovic, Lana M ⁿ   Celeketic, Dusica ^o   Cucuianu, Andrei ^p   Gheorghita, Emanuil ^q   Lazaroiu, Mihaela ^q   Shpilberg, Ofer ^r   Attias, Dina ^s   Karyagina, Elena ^t   Svetlana, Kalinina ^u   Vilchevska, Kateryna ^v   Cooper, Nichola ^w   Talks, Kate ^x   Prabhu, Mukhyaprana ^y   Sripada, Prasad ^z   Bharadwaj, T P R ^aa   Næsted, Henrik ^ab   Skartved, Niels J Ø ^ab   Frandsen, Torben P ^ab   Flensburg, Mimi F ^ab   Andersen, Peter S ^ab   Petersen, Jørgen ^ab   more..

^a MEDICAL UNIVERSITY OF LODZ   (Poland)

^b INSTITUTE OF HEMATOLOGY AND TRANSFUSION MEDICINE   (Poland)

^c Werlhof Institut   (Germany)

^d ST JOHANNES HOSPITAL   (Germany)

^e UNIVERSITY HOSPITAL OF MONT GODINNE   (Belgium)

^f UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^g HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^h HOSPITAL UNIVERSITARIO LA FE   (Spain)

ⁱ HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^j HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^k MEDICAL UNIVERSITY OF GDANSK   (Poland)

^l Onkologii i Chorob   (Poland)

^m WROCLAW MEDICAL UNIVERSITY   (Poland)

ⁿ Clinic for Haematology and Clinical Immunology   (Serbia)

^o Clinical Hospital Center Zemun   (Serbia)

^p THE ONCOLOGY INSTITUTE PROF DR ION CHIRICUTA   (Romania)

^q Romania Aleea L cr mioarelor   (Romania)

^r RABIN MEDICAL CENTER   (Israel)

^s BNAI ZION MEDICAL CENTER   (Israel)

^t Saint Petersburg State Budgetary Healthcare Institution Tuberculosis Dispensary No12   (Russian Federation)

^u Department of Blood Systems Diseases   (Ukraine)

^v Gusak Academy of AMS Ukraine   (Ukraine)

^w HAMMERSMITH HOSPITAL   (United Kingdom)

^x KASTURBA HOSPITAL   (India)

^y KASTURBA MEDICAL COLLEGE   (India)

^z Apollo Clinic   (India)

^aa Division of Clinical Research   (India)

^ab Symphogen AS   (Denmark)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PARACETAMOL; RHESUS D ANTIBODY; ROZROLIMUPAB; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ADULT; AGED; ARTICLE; AUTOIMMUNE THROMBOCYTOPENIA; BLOOD TRANSFUSION; CHILL; COOMBS TEST; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIMARY IMMUNE THROMBOCYTOPENIA; PRIORITY JOURNAL; RETICULOCYTE COUNT; RIGOR; SIDE EFFECT; SINGLE DRUG DOSE; THROMBOCYTE COUNT; CLINICAL TRIAL; DOSE RESPONSE; IDIOPATHIC THROMBOCYTOPENIC PURPURA; MIDDLE AGED; MULTICENTER STUDY;

ADULT; AGED; ANTIBODIES, MONOCLONAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; IMMUNOGLOBULIN G; MALE; MIDDLE AGED; PURPURA, THROMBOCYTOPENIC, IDIOPATHIC; RECOMBINANT PROTEINS;

EID: 84868570501     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2012-06-438804     Document Type: Article

References (30)

1. Stasi R, Evangelista ML, Stipa E, et al. Idiopathic thrombocytopenic purpura: current concepts in pathophysiology and management. Thromb Haemost. 2008;99(1):4-13.
2. Segal JB, Powe NR. Prevalence of immune thrombocytopenia: analysis of administrative data. J Thromb Haemost. 2006;4(11):2377-2383. (Pubitemid 44575432)
3. Provan D, Stasi R, Newland AC, et al. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010;115(2):168-186.
4. Coopamah MD, Freedman J, Semple JW. Anti-D initially stimulates an Fc-dependent leukocyte oxidative burst and subsequently suppresses erythrophagocytosis via interleukin-1 receptor antagonist. Blood. 2003;102(8):2862-2867. (Pubitemid 37248858)
5. Cooper N, Heddle NM, Haas M, et al. Intravenous (IV) anti-D and IV immunoglobulin achieve acute platelet increases by different mechanisms: modulation of cytokine and platelet responses to IV anti-D by FcgammaRIIa and FcgammaRIIIa polymorphisms. Br J Haematol. 2004;124(4):511-518. (Pubitemid 38230598)
6. Blanchette V, Imbach P, Andrew M, et al. Randomised trial of intravenous immunoglobulin G, intravenous anti-D, and oral prednisone in childhood acute immune thrombocytopenic purpura. Lancet. 1994;344(8924):703-707. (Pubitemid 24281420)
7. Tarantino MD, Young G, Bertolone SJ, et al. Single dose of anti-D immune globulin at 75 μg/kg is as effective as intravenous immune-globulin at rapidly raising the platelet count in newly diagnosed immune thrombocytopenic purpura in children. J Pediatr. 2006;148(4):489-494.
8. Aledort LM, Salama A, Kovaleva L, et al. Efficacy and safety of intravenous anti-D immunoglobulin (Rhophylac) in chronic immune thrombocytopenic purpura. Hematology. 2007;12(4):289-295. (Pubitemid 47180654)
9. Frandsen TP, Naested H, Rasmussen SK, et al. Consistent manufacturing and quality control of a highly complex recombinant polyclonal antibody product for human therapeutic use. Biotechnol Bioeng. 2011;108(9):2171-2181.
10. Andersen PS, Haahr-Hansen M, Coljee VW, et al. Extensive restrictions in the VH sequence usage of the human antibody response against the Rhesus D antigen. Mol Immunol. 2007;44(4):412-422. (Pubitemid 44308352)
11. Wiken M, Jensen AMV, Andersen PS, Flegel WA. D epitope evaluation of the 25 rhesus-D-specific IgG1 antibodies in rozrolimupab (Sym001), the first recombinant polyclonal antibody product. Haematologica. 2009;94(Suppl 2): Abstract 0178.
12. Persson P, Engström A, Rasmussen LK, et al. Development of mass spectrometry based techniques for the identification and determination of compositional variability in recombinant polyclonal antibody products. Anal Chem. 2010;82(17):7274-7282.
13. Wiken M, Jensen AMV, Andersen PS, Flegel WA. Binding of the recombinant polyclonal anti-D product rozrolimupab (Sym001) and plasma-derived anti-D to RhD variants. Haematologica. 2009;94(Suppl 2): Abstract 0188.
14. Neunert C, Lim W, Crowther M et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207.
15. Miescher S, Spycher MO, Amstutz H, et al. A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcgammaRIIA and FcgammaIIIA genes. Blood. 2004;103(11):4028-4035. (Pubitemid 38685340)
16. Shankar G, Devanarayan V, Amaravadi L, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Analysis. 2008;48(5):1267-1281.
17. Mullis KB, Faloona FA. Specific synthesis of DNA in vitro via a polymerase-catalyzed chain reaction. Methods Enzymol. 1987;155:335-350.
18. Sanger F, Niclen S, Coulsen AR. DNA sequencing with chain-terminating inhibitors. Proc Natl Acad Sci U S A. 1977;74(12):5463-5467.
19. Taylor FB Jr, Toh CH, Hoots WK, et al. Towards definition, clinical and laboratory criteria, and a scoring system for disseminated intravascular coagulation. Thromb Haemost. 2001;86(5):1327-1330.
20. Bussel JB, Graziano JN, Kimberly RP, Pahwa S, Aledort LM. Intravenous anti-D treatment of immune thrombocytopenic purpura: analysis of efficacy, toxicity, and mechanism of effect. Blood. 1991;77(9):1884-1893.
21. Newman GC, Novoa MV, Fodero EM, et al. A dose of 75 microg/kg/d of i.v. anti-D increases the platelet count more rapidly and for a longer period of time than 50 microg/kg/d in adults with immune thrombocytopenic purpura. Br J Haematol. 2001;112(4):1076-1078. (Pubitemid 32322940)
22. Salama A, Mueller-Eckhardt C, Kiefel V. Effect of intravenous immunoglobulin in immune thrombocytopenia. Lancet. 1983;2(8343):193-195.
23. Imbach P, Barundun S, Hirt A, Wagner HP. Intravenous immunoglobulin for idiopathic thrombocytopenic purpura (ITP) in childhood. Am J Pediatr Hematol Oncol. 1984;6(2):171-174. (Pubitemid 14029401)
24. Scaradavou A, Woo B, Woloski BMR, et al. Intravenous anti-D treatment of immune thrombocytopenic purpura: experience in 272 patients. Blood. 1997;89(8):2689-2700. (Pubitemid 27172553)
25. Varma M, Beautyman EJ, Grossboard M. Optimal response to 100 μg/kg anti-Rh(D) in two patients who had suboptimal responses to 75 mug/kg anti-Rh(D). Am J Hematol. 2009;84(2):124.
26. Gaines AR. Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rh(0)D immune globulin intravenous administration for immune thrombocytopenic purpura. Blood. 2005;106(5):1532- 1537. (Pubitemid 41208562)
27. Gaines AR, Lee-Stroka H, Byrne K, et al. Investigation of whether the acute hemolysis associated with Rh(o)(D) immune globulin intravenous (human administration for treatment of immune thrombocytopenia is consistent with acute hemolytic transfusion reaction model. Transfusion. 2009;49(6):1050-1058.
28. Tarantino MD, Bussel JB, Cines DB, et al. A closer look at intravascular hemolysis (IVH) following intravenous anti-D for immune thrombocytopenic purpura (ITP). Blood. 2007;109(12):5527. (Pubitemid 46890578)
29. Balkan C, Kavakli K, Kerapinar D. Coagulation parameters in children with acute immune thrombocytopenic purpura. Ege J Med. 2009;48:13-18.
30. Oner AF, Bay A, Kuru M, et al. Effects of high-dose methylprednisolone in coagulation factors in patients with acute immune thrombocytopenic purpura. Clin Appl Thromb Hemost. 2005;11(4):489-492. (Pubitemid 41546778)