Denosumab and osteonecrosis of the jaw. A systematic analysis of events reported in clinical trials

doi:10.1111/clr.12556

★ Alto impactoQ1 · DentistryImpact Factor · 3.681

AutoresAna Boquete‐Castro, Gerardo Gómez Moreno, José Luis Calvo‐Guirado, Antonio Aguilar‐Salvatierra, Rafael Delgado-Ruíz

Por qué importa

Este análisis sistemático y metaanálisis examina la relación entre el tratamiento con denosumab y la incidencia de osteonecrosis de la mandíbula (ONJ) en pacientes oncológicos. Se revisaron siete ensayos controlados aleatorizados que incluyeron casi 9000 pacientes, evaluando la frecuencia de ONJ y comparándola con bisfosfonatos o placebo. Los resultados indican un riesgo incrementado de ONJ con el uso de denosumab, especialmente en comparación con placebo y en ciertos subgrupos como pacientes con cáncer de próstata. La presencia de factores de riesgo adicionales, como extracciones dentales, mala higiene oral, uso de prótesis removibles o quimioterapia, parece potenciar el desarrollo de esta complicación. La información obtenida es relevante para la práctica clínica al alertar sobre este potencial efecto adverso y la importancia de la evaluación y manejo de factores de riesgo en pacientes tratados con denosumab.

Abstract original

OBJECTIVES: The aims of this meta-analysis were (i) to perform a systematic review of the relation between treatment with denosumab and the incidence of osteonecrosis of the jaw (ONJ) and (ii) to obtain information on dosage, first event apparition, and treatment approaches for patients with ONJ related to denosumab. MATERIALS AND METHODS: A systematic review and meta-analysis of relevant literature was performed in the PubMed, MEDLINE, Embase, and Cochrane databases, identifying randomized clinical trials that evaluate the adverse effects of denosumab. The overall incidence rates and 95% confidence intervals (CI) for ONJ were calculated employing fixed- and random-effects models, according to the heterogeneity of the studies included. RESULTS: A total of 8963 patients with a variety of solid tumors reported in seven randomized controlled trials (RCTs) were included in the systematic analysis. The overall incidence of ONJ in patients with cancer receiving denosumab was 1.7% [95% CI: 0.9-3.1%]. The use of denosumab was associated with a significantly increased risk of ONJ in comparison with bisphosphonates (BPs)/placebo treatment (RR 1.61, 95% CI: 1.05-2.48, P = 0.029). Subgroup analysis based on controlled therapies demonstrated an increased risk of ONJ in denosumab therapy, when compared with BPs (RR 1.48, 95% CI: 0.96-2.29, P = 0.078) or placebo (RR 16.28, 95% CI: 1.68-158.05, P = 0.017). Similar results were observed for prostate cancer (RR 3.358, 95% CI: 1.573-7.166, P = 0.002). CONCLUSIONS: Denosumab combined with risk factors such as dental extraction, poor oral hygiene, use of removable apparatus, and chemotherapy may favor the development of ONJ.

Leer texto completo ↗DOI · 10.1111/clr.12556

Autor Doctor&Cols

Ana Boquete Castro
Cirugía Oral e Implantología

Cómo citar

Boquete‐Castro A, Moreno GG, Calvo‐Guirado JL, Aguilar‐Salvatierra A, Delgado-Ruíz R. Denosumab and osteonecrosis of the jaw. A systematic analysis of events reported in clinical trials. Clinical Oral Implants Research. 2015. doi:10.1111/clr.12556