Document Detail

Immunogenicity of osteogenic protein 1: results from a prospective, randomized, controlled, multicenter pivotal study of uninstrumented lumbar posterolateral fusion.
MedLine Citation:
PMID:  20887146     Owner:  NLM     Status:  MEDLINE    
OBJECT: The aim in this study was to detect and quantify antibody responses against recombinant human osteogenic protein 1 (OP-1) and to compare these responses to patient clinical outcomes and safety information. METHODS: A controlled, open-label, randomized, prospective, multicenter pivotal study was performed in which patients with single-level Grade I or II degenerative lumbar spondylolisthesis (Meyerding classification) and spinal stenosis underwent decompression and uninstrumented posterolateral spinal arthrodesis. Three hundred thirty-six patients were randomized in a 2:1 fashion to receive either OP-1 Putty or autogenous iliac crest bone graft. Patients were evaluated at regular postoperative intervals for radiographic results, clinical outcomes, and safety parameters for more than 36 months. Serum samples were collected over this period and evaluated for the presence of anti–OP-1 antibodies and neutralizing activity by using a battery of in vitro binding assays (including enzyme-linked immunosorbent assay [ELISA]) and cell-based bioassays, respectively. RESULTS: Antibodies were predominantly seen in the OP-1–treated patients, although some responses were recorded preoperatively and in patients receiving autograft alone. Antibody production peaked in the 6-week to 3-month postoperative time frame and diminished thereafter. Neutralizing antibodies (Nabs) were detected at 1 time point at least in 25.6% of the patients treated with OP-1 Putty, but were not found in any patient following the 24-month postoperative time period. A single autograft patient (1.2%) also presented with OP-1 Nabs. An anti–OP-1 antibody status did not correlate with any measure of patient outcomes or adverse events. CONCLUSIONS: Recombinant human OP-1 (bone morphogenetic protein 7), like many recombinant human proteins, induces an immune response following its use as a bone graft alternative. This response was transient and diminished over time, and there was no statistical evidence to suggest an association between Nab status and any of the efficacy or safety criteria that were examined.
Chang Ju Hwang; Alexander R Vaccaro; Joseph Hong; James P Lawrence; Jeffrey S Fischgrund; Moulay Hicham Alaoui-Ismaili; Dean Falb
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of neurosurgery. Spine     Volume:  13     ISSN:  1547-5646     ISO Abbreviation:  J Neurosurg Spine     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-04     Completed Date:  2010-10-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101223545     Medline TA:  J Neurosurg Spine     Country:  United States    
Other Details:
Languages:  eng     Pagination:  484-93     Citation Subset:  IM    
Department of Orthopaedic Surgery, Asan Medical Center, Seoul, Korea.
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MeSH Terms
Aged, 80 and over
Antibodies / blood
Antibodies, Neutralizing / blood
Bone Morphogenetic Protein 7 / immunology*
Bone Transplantation
Decompression, Surgical
Enzyme-Linked Immunosorbent Assay
Lumbar Vertebrae*
Middle Aged
Recombinant Proteins / immunology
Spinal Fusion
Spinal Stenosis / complications,  surgery*
Spondylolisthesis / complications,  surgery*
Time Factors
Transplantation, Autologous
Treatment Outcome
Reg. No./Substance:
0/Antibodies; 0/Antibodies, Neutralizing; 0/BMP7 protein, human; 0/Bone Morphogenetic Protein 7; 0/Recombinant Proteins

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