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Volumn 103, Issue 3, 2012, Pages 213-222

Pharmacokinetics and safety of roledumab, a novel human recombinant monoclonal anti-RhD antibody with an optimized Fc for improved engagement of FCγRIII, in healthy volunteers

Author keywords

Antibody function; Clinical trial; Immunoglobulins; Recombinant proteins

Indexed keywords

FC RECEPTOR; RHESUS D ANTIBODY; ROLEDUMAB;

EID: 84866436795     PISSN: 00429007     EISSN: 14230410     Source Type: Journal    
DOI: 10.1111/j.1423-0410.2012.01603.x     Document Type: Article
Times cited : (18)

References (31)
  • 1
    • 84942947912 scopus 로고
    • Isoimmunization in pregnancy: its possible bearing on the etiology of erythroblastosis fetalis
    • Levine P, Katzin EM, Burnham L: Isoimmunization in pregnancy: its possible bearing on the etiology of erythroblastosis fetalis. JAMA 1941; 116:825-827
    • (1941) JAMA , vol.116 , pp. 825-827
    • Levine, P.1    Katzin, E.M.2    Burnham, L.3
  • 2
    • 0010386602 scopus 로고
    • Anaemia from bleeding of the fetus into the mother's circulation
    • Chown B: Anaemia from bleeding of the fetus into the mother's circulation. Lancet 1954; 266:1213-1215
    • (1954) Lancet , vol.266 , pp. 1213-1215
    • Chown, B.1
  • 3
    • 0034651012 scopus 로고    scopus 로고
    • The Rh blood group system: a review
    • Avent ND, Reid ME: The Rh blood group system: a review. Blood 2000; 95:375-387
    • (2000) Blood , vol.95 , pp. 375-387
    • Avent, N.D.1    Reid, M.E.2
  • 4
    • 0014290063 scopus 로고
    • Results of clinical trials of RhoGAM in women
    • Pollack W, Gorman JG, Freda VJ, et al.: Results of clinical trials of RhoGAM in women. Transfusion 1968; 8:151-153
    • (1968) Transfusion , vol.8 , pp. 151-153
    • Pollack, W.1    Gorman, J.G.2    Freda, V.J.3
  • 5
    • 0034007375 scopus 로고    scopus 로고
    • RhD haemolytic disease of the fetus and the newborn
    • Urbaniak SJ, Greiss MA: RhD haemolytic disease of the fetus and the newborn. Blood Rev 2000; 14:44-61
    • (2000) Blood Rev , vol.14 , pp. 44-61
    • Urbaniak, S.J.1    Greiss, M.A.2
  • 6
    • 0037281752 scopus 로고    scopus 로고
    • A review of the clinical effectiveness and cost-effectiveness of routine anti-D prophylaxis for pregnant women who are rhesus-negative
    • Chilcott J, Lloyd Jones M, Wight J, et al.: A review of the clinical effectiveness and cost-effectiveness of routine anti-D prophylaxis for pregnant women who are rhesus-negative. Health Technol Assess 2003; 7:iii-62
    • (2003) Health Technol Assess , vol.7
    • Chilcott, J.1    Lloyd Jones, M.2    Wight, J.3
  • 9
    • 33646535304 scopus 로고    scopus 로고
    • Monoclonal anti-D antibodies to prevent alloimmunization: lessons from clinical trials
    • Beliard R: Monoclonal anti-D antibodies to prevent alloimmunization: lessons from clinical trials. Transfus Clin Biol 2006; 13:58-64
    • (2006) Transfus Clin Biol , vol.13 , pp. 58-64
    • Beliard, R.1
  • 10
    • 2542461209 scopus 로고    scopus 로고
    • 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
    • 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; 103:4028-4035
    • (2004) Blood , vol.103 , pp. 4028-4035
    • Miescher, S.1    Spycher, M.O.2    Amstutz, H.3
  • 11
    • 0028476637 scopus 로고
    • [Monoclonal anti-D immunoglobulin for prevention of hemolytic disease of the newborn]
    • Olovnikova NI, Belkina EV, Berkovskii AL, et al.: [Monoclonal anti-D immunoglobulin for prevention of hemolytic disease of the newborn]. Gematol Transfuziol 1994; 39:3-6
    • (1994) Gematol Transfuziol , vol.39 , pp. 3-6
    • Olovnikova, N.I.1    Belkina, E.V.2    Berkovskii, A.L.3
  • 12
    • 0036177942 scopus 로고    scopus 로고
    • In vivo studies of monoclonal anti-D and the mechanism of immune suppression
    • Kumpel BM: In vivo studies of monoclonal anti-D and the mechanism of immune suppression. Transfus Clin Biol 2002; 9:9-14
    • (2002) Transfus Clin Biol , vol.9 , pp. 9-14
    • Kumpel, B.M.1
  • 13
    • 70349140027 scopus 로고    scopus 로고
    • Effect of producer cell line on functional activity of anti-D monoclonal antibodies destined for prevention of rhesus sensitization
    • Olovnikova NI, Ershler MA, Belkina EV, et al.: Effect of producer cell line on functional activity of anti-D monoclonal antibodies destined for prevention of rhesus sensitization. Bull Exp Biol Med 2009; 147:448-452
    • (2009) Bull Exp Biol Med , vol.147 , pp. 448-452
    • Olovnikova, N.I.1    Ershler, M.A.2    Belkina, E.V.3
  • 14
    • 34547725185 scopus 로고    scopus 로고
    • Efficacy of RhD monoclonal antibodies in clinical trials as replacement therapy for prophylactic anti-D immunoglobulin: more questions than answers
    • Kumpel BM: Efficacy of RhD monoclonal antibodies in clinical trials as replacement therapy for prophylactic anti-D immunoglobulin: more questions than answers. Vox Sang 2007; 93:99-111
    • (2007) Vox Sang , vol.93 , pp. 99-111
    • Kumpel, B.M.1
  • 15
    • 77951886324 scopus 로고    scopus 로고
    • Impact of glycosylation on effector functions of therapeutic IgG
    • Abès R, Teillaud JL: Impact of glycosylation on effector functions of therapeutic IgG. Pharmaceuticals 2010; 3:146-157
    • (2010) Pharmaceuticals , vol.3 , pp. 146-157
    • Abès, R.1    Teillaud, J.L.2
  • 16
    • 39749086517 scopus 로고    scopus 로고
    • Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16
    • De Romeuf C, Dutertre CA, Le Garff-Tavernier M, et al.: Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16. Br J Haematol 2008; 140:635-643
    • (2008) Br J Haematol , vol.140 , pp. 635-643
    • De Romeuf, C.1    Dutertre, C.A.2    Le Garff-Tavernier, M.3
  • 17
    • 40449102205 scopus 로고    scopus 로고
    • A human anti-D monoclonal antibody selected for enhanced FcgammaRIII engagement clears RhD+ autologous red cells in human volunteers as efficiently as polyclonal anti-D antibodies
    • Beliard R, Waegemans T, Notelet D, et al.: A human anti-D monoclonal antibody selected for enhanced FcgammaRIII engagement clears RhD+ autologous red cells in human volunteers as efficiently as polyclonal anti-D antibodies. Br J Haematol 2008; 141:109-119
    • (2008) Br J Haematol , vol.141 , pp. 109-119
    • Beliard, R.1    Waegemans, T.2    Notelet, D.3
  • 18
    • 32044447251 scopus 로고    scopus 로고
    • Selection of a human anti-RhD monoclonal antibody for therapeutic use: impact of IgG glycosylation on activating and inhibitory Fc gamma R functions
    • Siberil S, de Romeuf C, Bihoreau N, et al.: Selection of a human anti-RhD monoclonal antibody for therapeutic use: impact of IgG glycosylation on activating and inhibitory Fc gamma R functions. Clin Immunol 2006; 118:170-179
    • (2006) Clin Immunol , vol.118 , pp. 170-179
    • Siberil, S.1    de Romeuf, C.2    Bihoreau, N.3
  • 19
    • 0014036440 scopus 로고
    • Clearance of Rh-positive red cells by low concentrations of Rh antibody
    • Mollison PL, Hughes-Jones NC: Clearance of Rh-positive red cells by low concentrations of Rh antibody. Immunology 1967; 12:63-73
    • (1967) Immunology , vol.12 , pp. 63-73
    • Mollison, P.L.1    Hughes-Jones, N.C.2
  • 20
    • 0036177943 scopus 로고    scopus 로고
    • Section 1A: Rh serology. Coordinator's report
    • Scott M: Section 1A: Rh serology. Coordinator's report. Transfus Clin Biol 2002; 9:23-29
    • (2002) Transfus Clin Biol , vol.9 , pp. 23-29
    • Scott, M.1
  • 21
    • 0038317906 scopus 로고    scopus 로고
    • Competitive enzyme-linked immunoassay of monoclonal immunoglobulin G anti-D preparations
    • Thorpe SJ, Fox B, Turner C, et al.: Competitive enzyme-linked immunoassay of monoclonal immunoglobulin G anti-D preparations. Transfus Med 2003; 13:153-159
    • (2003) Transfus Med , vol.13 , pp. 153-159
    • Thorpe, S.J.1    Fox, B.2    Turner, C.3
  • 22
    • 79960471593 scopus 로고    scopus 로고
    • Consistent manufacturing and quality control of a highly complex recombinant polyclonal antibody product for human therapeutic use
    • 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; 108:2171-2181
    • (2011) Biotechnol Bioeng , vol.108 , pp. 2171-2181
    • Frandsen, T.P.1    Naested, H.2    Rasmussen, S.K.3
  • 24
    • 3142534409 scopus 로고    scopus 로고
    • Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
    • Mire-Sluis AR, Barrett YC, Devanarayan V, et al.: Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 2004; 289:1-16
    • (2004) J Immunol Methods , vol.289 , pp. 1-16
    • Mire-Sluis, A.R.1    Barrett, Y.C.2    Devanarayan, V.3
  • 26
    • 0034852176 scopus 로고    scopus 로고
    • Workshop on bioanalytical methods validation for macromolecules: summary report
    • Miller KJ, Bowsher RR, Celniker A, et al.: Workshop on bioanalytical methods validation for macromolecules: summary report. Pharm Res 2001; 18:1373-1383
    • (2001) Pharm Res , vol.18 , pp. 1373-1383
    • Miller, K.J.1    Bowsher, R.R.2    Celniker, A.3
  • 27
    • 0003484310 scopus 로고    scopus 로고
    • Food and Drugs Administration: Rockville, USA, U.S. Department of Health and Human Services
    • Food and Drugs Administration: Guidance for Industry, Bioanalytical Method Validation. Rockville, USA, U.S. Department of Health and Human Services, 2001
    • (2001) Guidance for Industry, Bioanalytical Method Validation
  • 28
    • 33748416499 scopus 로고    scopus 로고
    • Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412
    • Suntharalingam G, Perry MR, Ward S, et al.: Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med 2006; 355:1018-1028
    • (2006) N Engl J Med , vol.355 , pp. 1018-1028
    • Suntharalingam, G.1    Perry, M.R.2    Ward, S.3
  • 29
    • 24944483671 scopus 로고    scopus 로고
    • Pharmacokinetics (PK) of S/D treated anti-D immunoglobulin after intramuscular injection in healthy volunteers: gender differences in PK
    • Jilma-Stohlawetz P, Reiter RA, Panzer S, et al.: Pharmacokinetics (PK) of S/D treated anti-D immunoglobulin after intramuscular injection in healthy volunteers: gender differences in PK. Transfus Apher Sci 2005; 33:135-140
    • (2005) Transfus Apher Sci , vol.33 , pp. 135-140
    • Jilma-Stohlawetz, P.1    Reiter, R.A.2    Panzer, S.3
  • 30
    • 0242432634 scopus 로고    scopus 로고
    • Pharmacokinetics of anti-D IgG in pregnant RhD-negative women
    • Bichler J, Schondorfer G, Pabst G, et al.: Pharmacokinetics of anti-D IgG in pregnant RhD-negative women. BJOG 2003; 110:39-45
    • (2003) BJOG , vol.110 , pp. 39-45
    • Bichler, J.1    Schondorfer, G.2    Pabst, G.3
  • 31
    • 2442450676 scopus 로고    scopus 로고
    • Pharmacokinetics and safety of recombinant anti-RhD in healthy RhD-negative male volunteers
    • Bichler J, Spycher MO, Amstutz HP, et al.: Pharmacokinetics and safety of recombinant anti-RhD in healthy RhD-negative male volunteers. Transfus Med 2004; 14:165-171
    • (2004) Transfus Med , vol.14 , pp. 165-171
    • Bichler, J.1    Spycher, M.O.2    Amstutz, H.P.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.