Denosumab - Where are we?

Estero Serrano de la Cruz, B.; Laguillo Cadenas, J.L.; Ruano Santiago, M.; Echevarría Moreno, M.

doi:10.1016/j.redare.2022.11.001

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"tieneTextoCompleto" => true "saludo" => "To the Editor:" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "366" "paginaFinal" => "367" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "B. Estero Serrano de la Cruz, J.L. Laguillo Cadenas, M. Ruano Santiago, M. Echevarría Moreno" "autores" => array:4 [ 0 => array:4 [ "nombre" => "B." "apellidos" => "Estero Serrano de la Cruz" "email" => array:1 [ 0 => "belen.estero07@gmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "J.L." "apellidos" => "Laguillo Cadenas" ] 2 => array:2 [ "nombre" => "M." "apellidos" => "Ruano Santiago" ] 3 => array:2 [ "nombre" => "M." "apellidos" => "Echevarría Moreno" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Hospital Universitario de Valme, Sevilla, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Denosumab. ¿Dónde estamos?" ] ] "textoCompleto" => "Ten years after it was first introduced, denosumab is in the news again because it is currently under investigation by the Spanish Public Prosecution Ministry due to adverse effects.Although this biological drug was approved in 2011 in the European Union, its use in patients undergoing surgery has never been addressed in clinical practice guidelines. In addition, its 6-monthly dosing interval raises some problems in terms of perioperative management. What will happen if denosumab is maintained in the postoperative period? And what are the implications for the patient if it is suspended?Denosumab is a fully human monoclonal antibody that inhibits osteoclastic-mediated bone resorption. It is administered subcutaneously every 6 months, and is currently indicated as a treatment for osteoporosis in postmenopausal women and in men at high risk of bone fracture, as it has been shown to reduce the risk of vertebral and hip fractures.It is also indicated in men receiving hormone suppression therapy for prostate cancer and in bone loss associated with long-term systemic glucocorticoid therapy. Some of the most important side effects of denosumab are an increased risk of infection due to weakening of the immune system, and more recently, the risk of multiple vertebral fractures following withdrawal of the drug.<a class="elsevierStyleCrossRef" href="#bib0005">1</a>The constant influx of new biological agents makes it difficult to maintain recommendations current. Most are not based on evidence from clinical trials, but rather on expert opinion, clinical cases, or extrapolation of experiences obtained with similar drugs.The Spanish Society of Rheumatology (SER, in its Spanish acronym) published an updated consensus statement in 2019 that includes denosumab, teriparatide and rh-PTH 1-84, which have a very different mechanisms of action and safety profile from other biologicals.<a class="elsevierStyleCrossRef" href="#bib0010">2</a> This document, however, only discusses temporary withdrawal of denosumab in patients undergoing extensive oral surgery with associated risk factors (diabetes, periodontal disease, immunodeficiencies, smoking), and recommends that prolonging suspension unnecessarily should be avoided.In the United States, we only found one clinical practice guideline on perioperative medication from the University of Wisconsin,<a class="elsevierStyleCrossRef" href="#bib0015">3</a> which makes the following recommendation: “Coordinate calcitonin and denosumab perioperative plans with the surgeon and prescribing provider. (UW Health strong recommendation, low quality of evidence).”The aim of this letter is to draw attention to the difficulty in locating clinical practice guidelines on the management of denosumab in non-dental elective surgery, since there are no clear recommendations. This is particularly relevant in light of recent meta-analyses on infections<a class="elsevierStyleCrossRef" href="#bib0020">4</a> and the health alert<a class="elsevierStyleCrossRef" href="#bib0025">5</a> issued regarding the risk of multiple vertebral fractures<a class="elsevierStyleCrossRef" href="#bib0005">1</a> after withdrawal of denosumab, which are described below.In the literature, several meta-analyses have found that denosumab-treated patients may have a higher overall incidence of serious adverse events, mainly respiratory and gastrointestinal infections.<a class="elsevierStyleCrossRef" href="#bib0020">4</a> None of the evidence in this meta-analysis derives from patients during the perioperative period, when surgical stress could increase susceptibility to infection.Suspension of denosumab or delayed dosing is also associated with adverse events, insofar as withdrawal appears to be associated with an increased risk of multiple vertebral fractures,<a class="elsevierStyleCrossRef" href="#bib0005">1</a> which is why the drug is currently under judicial investigation. In 2019, the Spanish Agency of Medicines and Medical Devices published an alert<a class="elsevierStyleCrossRef" href="#bib0025">5</a> regarding this rebound effect and recommended using denosumab only in patients at high risk of fractures, and in the context of its authorised indications.Because of the dearth of information on this drug, suspending administration in the context of a pre-anaesthetic evaluation due to ignorance of its complications or lack of information on its perioperative management can lead to important complications." 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Castañeda" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.reuma.2018.09.004" "Revista" => array:5 [ "tituloSerie" => "Reumatol Clín (English Edition)" "fecha" => "2019" "volumen" => "15" "paginaInicial" => "188" "paginaFinal" => "210" ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "University of Wisconsin Hospitals and Clinics Authority. Perioperative medication management -adult/pediatric -inpatient/ambulatory clinical practice guideline. Uwhealth.org. 2020 Nov. Available from: <a target="_blank" href="https://www.uwhealth.org/cckm/cpg/medications/Perioperative-Medication-Management-Clinical-Pratice-Guideline---August-2022.pdf">https://www.uwhealth.org/cckm/cpg/medications/Perioperative-Medication-Management-Clinical-Pratice-Guideline---August-2022.pdf</a>." ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Is denosumab associated with an increased risk for infection in patients with low bone mineral density? A systematic review and meta- analysis of randomized controlled trials" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "B. Catton" 1 => "S. Surangiwala" 2 => "T. Towheed" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1111/1756-185X.14101" "Revista" => array:6 [ "tituloSerie" => "Int J Rheum Dis" "fecha" => "2021 Jul" "volumen" => "24" "paginaInicial" => "869" "paginaFinal" => "879" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/33793076" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Prolia® (denosumab): posible riesgo de fracturas vertebrales múltiples tras la suspensión del tratamiento; 2019. Available from: <a target="_blank" href="https://www.aemps.gob.es/informa/notasinformativas/medicamentosusohumano-3/seguridad-1/prolia-denosumab-posible-riesgo-de-fracturas-vertebrales-multiples-tras-la-suspension-del-tratamiento/">https://www.aemps.gob.es/informa/notasinformativas/medicamentosusohumano-3/seguridad-1/prolia-denosumab-posible-riesgo-de-fracturas-vertebrales-multiples-tras-la-suspension-del-tratamiento/</a>." ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/23411929/0000007000000006/v3_202310300659/S2341192923001002/v3_202310300659/en/main.assets" "Apartado" => array:4 [ "identificador" => "66474" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letter to the Director" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/23411929/0000007000000006/v3_202310300659/S2341192923001002/v3_202310300659/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2341192923001002?idApp=UINPBA00004N"]

ISSN: 2341-1929

Revista Española de Anestesiología y Reanimación (REDAR) -the Spanish Journal of Anesthesiology and Resuscitation- is the scientific body of the Spanish Society of Anesthesiology, Resuscitation and Pain Therapy. This is a monthly journal (10 issues) that publishes scientific articles of all areas within its specialty: clinical anesthesia, resuscitation-intensive medicine and critical care, diagnosis and treatment of acute and chronic pain, urgent care and emergencies and studies on basic science and related fields. The journal accepts work in both Spanish and English.

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362

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