메뉴 건너뛰기




Volumn 36, Issue 25, 2011, Pages 2158-2167

Blood serum antibody analysis and long-term follow-up of patients treated with recombinant human bone morphogenetic protein-2 in the lumbar spine

Author keywords

antibody formation; BMP 2; bone morphogenetic protein; degenerative disc disease; INFUSE Bone Graft; lumbar fusion; lumbar spine; spinal arthrodesis

Indexed keywords

COLLAGEN SPONGE; NEUTRALIZING ANTIBODY; RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

EID: 81855163368     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/BRS.0b013e3182059a8c     Document Type: Article
Times cited : (17)

References (43)
  • 2
    • 0033574147 scopus 로고    scopus 로고
    • Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial
    • Moreland LW, Schiff MH, Baumgartner SW, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 1999;130:478-86.
    • (1999) Ann Intern Med , vol.130 , pp. 478-486
    • Moreland, L.W.1    Schiff, M.H.2    Baumgartner, S.W.3
  • 3
    • 0038384735 scopus 로고    scopus 로고
    • A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate
    • discussion 1225
    • Baskin DS, Ryan P, Sonntag V, et al. A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate. Spine 2003;28:1219-24; discussion 1225.
    • (2003) Spine , vol.28 , pp. 1219-1224
    • Baskin, D.S.1    Ryan, P.2    Sonntag, V.3
  • 4
    • 0037382906 scopus 로고    scopus 로고
    • Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device
    • Burkus JK, Heim SE, Gornet MF, et al. Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device. J Spinal Disord Tech 2003;16:113-22.
    • (2003) J Spinal Disord Tech , vol.16 , pp. 113-122
    • Burkus, J.K.1    Heim, S.E.2    Gornet, M.F.3
  • 5
    • 19944417622 scopus 로고    scopus 로고
    • Use of rhBMP-2 in combination with structural corticalallografts: Clinicaland radiographic outcomes in anterior lumbar spinal surgery
    • Burkus JK, Sandhu HS, Gornet MF, et al. Use of rhBMP-2 in combination with structural corticalallografts: Clinicaland radiographic outcomes in anterior lumbar spinal surgery. J Bone Joint Surg Am 2005;87:1205-12.
    • (2005) J Bone Joint Surg Am , vol.87 , pp. 1205-1212
    • Burkus, J.K.1    Sandhu, H.S.2    Gornet, M.F.3
  • 6
    • 0036843201 scopus 로고    scopus 로고
    • Clinicaland radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2
    • Burkus JK, Transfeldt EE, Kitchel SH, et al. Clinicaland radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2. Spine 2002;27:2396-408.
    • (2002) Spine , vol.27 , pp. 2396-2408
    • Burkus, J.K.1    Transfeldt, E.E.2    Kitchel, S.H.3
  • 7
    • 67649870799 scopus 로고    scopus 로고
    • Clinicaland radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral spine arthrodesis
    • Dimar JR, Glassman SD, Burkus JK, et al. Clinicaland radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral spine arthrodesis. J Bone Joint Surg Am 2009;91:1377-86.
    • (2009) J Bone Joint Surg Am , vol.91 , pp. 1377-1386
    • Dimar, J.R.1    Glassman, S.D.2    Burkus, J.K.3
  • 8
    • 0035222452 scopus 로고    scopus 로고
    • Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions
    • (Pt 2)
    • Friedlander GE, Perry CR, Cole JD, et al. Osteogenic protein-1 (bone morphogenetic protein-7) in the treatment of tibial nonunions. J Bone Joint Surg Am 2001;83(suppl 1)(Pt 2):S151-8.
    • (2001) J Bone Joint Surg Am , vol.83 , Issue.SUPPL.
    • Friedlander, G.E.1    Perry, C.R.2    Cole, J.D.3
  • 9
    • 0036899744 scopus 로고    scopus 로고
    • BMP-2 evaluation in surgery for tibial trauma. Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: A prospective, controlled, randomized study of four hundred and fifty patients
    • Govender S, Csimma C, Genant HK, et al. BMP-2 evaluation in surgery for tibial trauma. Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: A prospective, controlled, randomized study of four hundred and fifty patients. J Bone Joint Surg Am 2002;84:2123-34.
    • (2002) J Bone Joint Surg Am , vol.84 , pp. 2123-2134
    • Govender, S.1    Csimma, C.2    Genant, H.K.3
  • 10
    • 33745713060 scopus 로고    scopus 로고
    • Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial
    • Jones AL, Bucholz RW, Bosse MJ, et al. Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial. J Bone Joint Surg Am 2006;88:1431-41.
    • (2006) J Bone Joint Surg Am , vol.88 , pp. 1431-1441
    • Jones, A.L.1    Bucholz, R.W.2    Bosse, M.J.3
  • 11
    • 4444296471 scopus 로고    scopus 로고
    • A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis
    • Vaccaro AR, Patel T, Fischgrund J, et al. A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis. Spine 2004;29:1885-92.
    • (2004) Spine , vol.29 , pp. 1885-1892
    • Vaccaro, A.R.1    Patel, T.2    Fischgrund, J.3
  • 12
    • 26844503270 scopus 로고    scopus 로고
    • Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer
    • Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-72.
    • (2005) N Engl J Med , vol.353 , pp. 1659-1672
    • Piccart-Gebhart, M.J.1    Procter, M.2    Leyland-Jones, B.3
  • 13
    • 26844536978 scopus 로고    scopus 로고
    • Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer
    • Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-84.
    • (2005) N Engl J Med , vol.353 , pp. 1673-1684
    • Romond, E.H.1    Perez, E.A.2    Bryant, J.3
  • 14
    • 2542561964 scopus 로고    scopus 로고
    • Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer
    • Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350:2335-42.
    • (2004) N Engl J Med , vol.350 , pp. 2335-2342
    • Hurwitz, H.1    Fehrenbacher, L.2    Novotny, W.3
  • 15
    • 44949221309 scopus 로고    scopus 로고
    • Recombinant human insulinlike growth factor I (rhIGF-I) for amyotrophic lateral sclerosis/motor neuron disease
    • Mitchell JD, Wokke JH, Borasio GD. Recombinant human insulinlike growth factor I (rhIGF-I) for amyotrophic lateral sclerosis/motor neuron disease. Cochrane Database Syst Rev 2007;(4):CD002064.
    • (2007) Cochrane Database Syst Rev , vol.4
    • Mitchell, J.D.1    Wokke, J.H.2    Borasio, G.D.3
  • 17
    • 33744984209 scopus 로고    scopus 로고
    • Proteins in a DNA world: Expression systems for their study
    • Reyes-Ruiz JM, Barrera-Saldana HA. Proteins in a DNA world: Expression systems for their study. Rev Invest Clin 2006;58:47-55.
    • (2006) Rev Invest Clin , vol.58 , pp. 47-55
    • Reyes-Ruiz, J.M.1    Barrera-Saldana, H.A.2
  • 18
    • 37749004225 scopus 로고    scopus 로고
    • Protein therapeutics: A summary and pharmacological classification
    • Leader B, Baca QJ, Golan DE. Protein therapeutics: A summary and pharmacological classification. Nat Rev Drug Discov 2008;7:21-39.
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 21-39
    • Leader, B.1    Baca, Q.J.2    Golan, D.E.3
  • 20
    • 81855188463 scopus 로고    scopus 로고
    • OP-1 Putty [package insert]. Hopkinton, MA: Stryker Biotech LLC; 2004
    • OP-1 Putty [package insert]. Hopkinton, MA: Stryker Biotech LLC; 2004.
  • 21
    • 81855214899 scopus 로고    scopus 로고
    • Enbrel [package insert]. Thousand Oaks, CA, and Collegeville, PA: Amgen and Wyeth Pharmaceuticals; 2006
    • Enbrel [package insert]. Thousand Oaks, CA, and Collegeville, PA: Amgen and Wyeth Pharmaceuticals; 2006.
  • 22
    • 81855226858 scopus 로고    scopus 로고
    • Humatrope [package insert]. Indianapolis, IN: Eli Lilly & Co; 2006
    • Humatrope [package insert]. Indianapolis, IN: Eli Lilly & Co; 2006.
  • 23
    • 33947397632 scopus 로고    scopus 로고
    • Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
    • Gupta S, Indelicato SR, Jethwa V, et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods 2007;321:1-18.
    • (2007) J Immunol Methods , vol.321 , pp. 1-18
    • Gupta, S.1    Indelicato, S.R.2    Jethwa, V.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
  • 25
    • 66449124629 scopus 로고    scopus 로고
    • The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: A long-term (4 years) pivotal study
    • Vaccaro AR, Lawrence JP, Patel T, et al. The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: A long-term (4 years) pivotal study. Spine 2008;33:2850-62.
    • (2008) Spine , vol.33 , pp. 2850-2862
    • Vaccaro, A.R.1    Lawrence, J.P.2    Patel, T.3
  • 26
    • 78649463943 scopus 로고    scopus 로고
    • Maverick™ total disc replacement versus anterior lumbar interbody fusion with the INFUSE® Bone Graft /LT-CAGE® device: A prospective, randomized, controlled, multicenter IDE trial
    • [Abstract]. In: Proceedings of the 22nd Annual Meeting of the North American Spine Society
    • Gornet MF, Burkus JK, Mathews HH, et al. Maverick™ total disc replacement versus anterior lumbar interbody fusion with the INFUSE® Bone Graft /LT-CAGE® device: A prospective, randomized, controlled, multicenter IDE trial. [Abstract]. In: Proceedings of the 22nd Annual Meeting of the North American Spine Society. Spine J 2007;7:1S.
    • (2007) Spine J , vol.7
    • Gornet, M.F.1    Burkus, J.K.2    Mathews, H.H.3
  • 27
    • 0027947566 scopus 로고
    • Responsiveness of clonal limb bud cell lines to bone morphogenetic protein 2 reveals a sequential relationship between cartilage and bone cell phenotypes
    • Rosen V, Nove J, Song JJ, et al. Responsiveness of clonal limb bud cell lines to bone morphogenetic protein 2 reveals a sequential relationship between cartilage and bone cell phenotypes. J Bone Miner Res 1994;9:1759-68.
    • (1994) J Bone Miner Res , vol.9 , pp. 1759-1768
    • Rosen, V.1    Nove, J.2    Song, J.J.3
  • 28
    • 33846004405 scopus 로고    scopus 로고
    • Bone morphogenetic proteins and their antagonists
    • Gazzerro E, Canalis E. Bone morphogenetic proteins and their antagonists. Rev Endocr Metab Disord 2006;7:51-65.
    • (2006) Rev Endocr Metab Disord , vol.7 , pp. 51-65
    • Gazzerro, E.1    Canalis, E.2
  • 29
    • 0035158301 scopus 로고    scopus 로고
    • Human immune response to recombinant human proteins
    • Porter S: Human immune response to recombinant human proteins. J Pharm Sci 2001;90:1-11.
    • (2001) J Pharm Sci , vol.90 , pp. 1-11
    • Porter, S.1
  • 30
    • 0036861899 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins: Clinical implications and future prospects
    • Schellekens H: Immunogenicity of therapeutic proteins: Clinical implications and future prospects. Clin Ther 2002;24:1720-40.
    • (2002) Clin Ther , vol.24 , pp. 1720-1740
    • Schellekens, H.1
  • 31
    • 33744950980 scopus 로고    scopus 로고
    • Scientific and regulatory considerations on the immunogenicity of biologics
    • Shankar G, Shores E, Wagner C, et al. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol 2006;24:274-80.
    • (2006) Trends Biotechnol , vol.24 , pp. 274-280
    • Shankar, G.1    Shores, E.2    Wagner, C.3
  • 32
    • 27744601830 scopus 로고    scopus 로고
    • De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation
    • Boyne PJ, Lilly LC, Marx RE, et al. De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation. J Oral Maxillofac Surg 2005;63:1693-707.
    • (2005) J Oral Maxillofac Surg , vol.63 , pp. 1693-1707
    • Boyne, P.J.1    Lilly, L.C.2    Marx, R.E.3
  • 33
    • 19044369324 scopus 로고    scopus 로고
    • Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation
    • Fiorellini JP, Howell TH, Cochran D, et al. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol 2005;76:605-13.
    • (2005) J Periodontol , vol.76 , pp. 605-613
    • Fiorellini, J.P.1    Howell, T.H.2    Cochran, D.3
  • 34
    • 18844362943 scopus 로고    scopus 로고
    • Lower dose of rhBMP-2 achieves spine fusion when combined with an osteoconductive bulking agent in non-human primates
    • Barnes B, Boden SD, Louis-Ugbo J, et al. Lower dose of rhBMP-2 achieves spine fusion when combined with an osteoconductive bulking agent in non-human primates. Spine 2005;30:1127-33.
    • (2005) Spine , vol.30 , pp. 1127-1133
    • Barnes, B.1    Boden, S.D.2    Louis-Ugbo, J.3
  • 35
    • 23244467021 scopus 로고    scopus 로고
    • Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion
    • Glassman SD, Dimar JR, Carreon LY, et al. Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion. Spine 2005;30:1694-8.
    • (2005) Spine , vol.30 , pp. 1694-1698
    • Glassman, S.D.1    Dimar, J.R.2    Carreon, L.Y.3
  • 36
    • 0036025219 scopus 로고    scopus 로고
    • Retention of 125I-labeled recombinant human bone morphogenetic protein-2 by biphasic calcium phosphate or a composite sponge in a rabbit posterolateral spine arthrodesis model
    • Louis-Ugbo J, Kim HS, Boden SD, et al. Retention of 125I-labeled recombinant human bone morphogenetic protein-2 by biphasic calcium phosphate or a composite sponge in a rabbit posterolateral spine arthrodesis model. J Orthop Res 2002;20:1050-9.
    • (2002) J Orthop Res , vol.20 , pp. 1050-1059
    • Louis-Ugbo, J.1    Kim, H.S.2    Boden, S.D.3
  • 38
    • 81855188460 scopus 로고    scopus 로고
    • INFUSE Bone Graft [package insert]. Memphis, IN: Medtronic Spinal Biologics; 2002
    • INFUSE Bone Graft [package insert]. Memphis, IN: Medtronic Spinal Biologics; 2002.
  • 39
    • 0036861899 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins: Clinical implications and future prospects
    • discussion 1719
    • Schellekens H. Immunogenicity of therapeutic proteins: Clinical implications and future prospects. Clin Ther 2002;24:1720-40; discussion 1719.
    • (2002) Clin Ther , vol.24 , pp. 1720-1740
    • Schellekens, H.1
  • 40
    • 84859761601 scopus 로고    scopus 로고
    • American Pregnancy Association. Available at, Accessed August 21
    • American Pregnancy Association. Available at: Http://www. americanpregnancy. org. Accessed August 21, 2008.
    • (2008)
  • 41
    • 79551560904 scopus 로고    scopus 로고
    • Repeat use of human recombinant bone morphogenetic protei n-2 for second level lumbar arthrodesis
    • Singh K, Dumonski M, Stanley T, et al. Repeat use of human recombinant bone morphogenetic protei n-2 for second level lumbar arthrodesis. Spine 2001;36:192-6.
    • (2001) Spine , vol.36 , pp. 192-196
    • Singh, K.1    Dumonski, M.2    Stanley, T.3
  • 42
    • 39649098243 scopus 로고    scopus 로고
    • Adverse events in patients re-exposed to bone morphogenetic protein for spine surgery
    • Carreon LY, Glassman SD, Brock DC, et al. Adverse events in patients re-exposed to bone morphogenetic protein for spine surgery. Spine 2008;33:391-3.
    • (2008) Spine , vol.33 , pp. 391-393
    • Carreon, L.Y.1    Glassman, S.D.2    Brock, D.C.3
  • 43
    • 79551538006 scopus 로고    scopus 로고
    • Is there a clinically detectable response to repeat use of rhBMP-2 in the spine?
    • Presented at, October 24-27, Austin, TX
    • Kuklo T, Bridwell K, Cillo Y. Is there a clinically detectable response to repeat use of rhBMP-2 in the spine? Presented at: 22nd Annual Meeting of the North American Spine Society; October 24-27, 2007; Austin, TX.
    • (2007) 22nd Annual Meeting of the North American Spine Society
    • Kuklo, T.1    Bridwell, K.2    Cillo, Y.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.