Adverse reactions related to brentuximab vedotin use: A real-life retrospective study - 01/09/18

Doi : 10.1016/j.therap.2018.07.004

Béatrice Clarivet ^a, Laure Vincent ^b, Laurence Vergely ^c, Virginie Bres ^a, Kathleen Foglia ^a, Guillaume Cartron ^b, Dominique Hillaire-Buys ^a, Jean-Luc Faillie ^a,^d,^⁎
^a Department of medical pharmacology and toxicology, Montpellier university hospital, 34295 Montpellier, France
^b Department of hematology, Montpellier university hospital, 34295 Montpellier, France
^c Clinical oncology pharmacy unit, Montpellier university hospital, 34295 Montpellier, France
^d Laboratory of biostatistics, epidemiology and public health (EA 2415), faculty of medicine, university of Montpellier, 34295 Montpellier, France

^⁎Corresponding author. Laboratory of biostatistics, epidemiology and public health (EA 2415), faculty of medicine, university of Montpellier, 371, avenue du Doyen-Gaston-Giraud, 34295 Montpellier cedex, France.Laboratory of biostatistics, epidemiology and public health (EA 2415), faculty of medicine, university of Montpellier371, avenue du Doyen-Gaston-GiraudMontpellier cedex34295France

Sous presse. Épreuves corrigées par l'auteur. Disponible en ligne depuis le Saturday 01 September 2018
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Summary

Post-marketing data regarding brentuximab vedotin (BV) are sparse. The aim of this study was to assess the frequency and nature of significant adverse drug reactions (ADRs) in patients treated with BV in a real-world setting. We conducted a systematic retrospective study of patients treated with BV in a French university hospital. Significant ADRs were collected using the electronic patient records. Between January 2009 and December 2016, 39 patients received BV. Median age was 43.2 and 53.8% were males. Overall, 20 patients (51.3%) experienced at least one significant ADR and 24 reactions were reported in total. Twelve (50%) out of 24 ADRs were severe. The most frequently observed significant ADRs were peripheral sensory neuropathy and CMV reactivation. ADRs led to drug discontinuation for 4 patients and dose reduction for 6 patients. Only 29.2% of the events were spontaneously reported. Prospective monitoring is needed to better assess BV safety.

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Keywords : Brentuximab vedotin, Hodgkin lymphoma, Systemic anaplastic large cell lymphoma, Adverse drug reactions, Post-marketing surveillance