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Safety of Subcutaneous Daratumumab in Anti-CD38 Monoclonal Antibody-Naïve Patients with Plasma Cell Disorders: A Multicenter Real-Life Experience

BACKGROUND: Daratumumab, an anti-CD38 monoclonal antibody, is used for treatment of multiple myeloma (MM) and light chain amyloidosis at an intravenous dosage of 16 mg/kg or at a subcutaneous fixed dose of 1800 mg. However, the subcutaneous formulation has only recently been approved in Europe, and...

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Detalles Bibliográficos
Autores principales: De Novellis, Danilo, Fontana, Raffaele, Palmieri, Salvatore, Della Pepa, Roberta, Di Perna, Maria, Cetani, Giusy, Esposito, Daniela, Amendola, Angela, Delle Cave, Giuseppe, Serio, Bianca, Morini, Denise, Rizzo, Michela, Mettivier, Laura, Trastulli, Fabio, Rocco, Stefano, Pagano, Anastasia, Barbato, Serafina, Leone, Aldo, La Magna, Martina, Bianco, Rosario, Rascato, Gabriella, Carobene, Angela, Cuffa, Bianca, Iannalfo, Marialuigia, Giudice, Valentina, Svanera, Gino, Annunziata, Mario, Pizzuti, Michele, Frigeri, Ferdinando, Califano, Catello, Ferrara, Felicetto, Pane, Fabrizio, Selleri, Carmine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10663178/
https://www.ncbi.nlm.nih.gov/pubmed/37747623
http://dx.doi.org/10.1007/s11523-023-01001-4
Descripción
Sumario:BACKGROUND: Daratumumab, an anti-CD38 monoclonal antibody, is used for treatment of multiple myeloma (MM) and light chain amyloidosis at an intravenous dosage of 16 mg/kg or at a subcutaneous fixed dose of 1800 mg. However, the subcutaneous formulation has only recently been approved in Europe, and real-life data on its safety are still few. OBJECTIVE: In this multicenter retrospective real-life experience, we provided evidence for the safety of subcutaneous daratumumab in plasma cell disorders. PATIENTS AND METHODS: A total of 189 patients diagnosed with MM or light chain amyloidosis were included in this retrospective study, and all subjects were daratumumab-naïve. Primary endpoint was safety of subcutaneous daratumumab, especially for infusion-related reaction (IRR) incidence and severity. All patients received premedication with dexamethasone, paracetamol, and antihistamine, with montelukast usage in 85% of cases. RESULTS: Eight patients (4%) experienced IRRs, mainly of grade I–II, and other frequent toxicities were: hematological (thrombocytopenia, 4%; neutropenia, 5%; lymphopenia, 6%) and non-hematological (pneumonia, 4%; diarrhea, 2%; and cytomegalovirus reactivation, 0.5%). In our multicenter retrospective real-life experience, subcutaneous daratumumab was well-tolerated with an excellent safety profile with a very low (4%) IRR incidence, even in frailer MM patients with severe renal impairment or increased body weight. CONCLUSIONS: Subcutaneous daratumumab was safe in a real-life setting including patients with severe renal failure and advanced disease. However, further studies on larger and prospective cohorts are required to confirm our real-life observations.