DOI: 10.1097/bn9.0000000000000125 ISSN: 3066-8905

Efficacy and Safety of Dibotermin Alfa (rhBMP-2) in the Surgical Treatment of Adult Spinal Deformity: A Systematic Review and Meta-Analysis

Ian Harding, Jörg Franke, Andrew James Bowey, Thomas Blattert, Martina Di Giovangiulio, Lorenza M.D.S. Stefano, Adrian Williams
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Study Design:

A systematic literature review and meta-analysis following PRISMA guidelines and registered at PROSPERO (CRD42024575081).

Objective:

To evaluate the safety and efficacy of dibotermin alfa/absorbable collagen sponge (ACS) used in spinal fusion surgery for adult spinal deformity (ASD).

Summary of Background Data:

Dibotermin alfa, a recombinant human bone morphogenetic protein-2, is approved for single-level lumbar interbody fusion in degenerative disc disease, demonstrating higher fusion rates compared to iliac crest bone graft (ICBG). Despite historic safety concerns, published examples of off-label use in multilevel and posterolateral fusion are extensive.

Methods:

Medline, Embase, and PubMed databases were searched for studies involving ASD patients treated with dibotermin alfa/ACS in single- or multilevel fusion. Comparators included various autografts or no grafts. Primary outcomes were fusion rates, patient-reported outcomes, pseudarthrosis, and reoperation rates. Certainty of evidence was assessed according to the GRADE approach.

Results:

Seventeen studies met inclusion criteria; 5 reported outcomes at ≥12 months. Pooled fusion rate for dibotermin alfa was 90% (95% CI: 82–99%), with high heterogeneity ( I 2 =88.2%). Meta-regression found no significant associations between fusion and dose, sex ratio, or smoking. In a subanalysis of the 2 comparative studies, dibotermin alfa/ACS showed superior fusion rates versus ICBG at ≥12 months (OR: 6.61, 95% CI: 1.81–24.16). Dibotermin alfa significantly reduced pseudarthrosis risk for patients at ≥12 months (OR: 0.48, 95% CI: 0.31–0.74), with consistent findings after adjusting for publication bias. Reoperation rates were also lower (OR: 0.65, 95% CI: 0.42–1.02), implying a 35% reduction in odds compared to controls, although the result did not reach statistical significance. Reported rates of cancer (≈5% in high-dose cohorts), radiculopathy (∼1%), and seroma (∼0.6%) were consistently low and showed no dose pattern.

Conclusion:

Dibotermin alfa/ACS is associated with safe and effective outcomes in ASD surgery. Further high-quality studies are warranted to confirm these results and address evidence limitations.

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