Mayako Uchida1, Takehiro Kawashiri2, Nami Maegawa3, Aoi Takano4, Keiko Hosohata4, Yoshihiro Uesawa5. 1. Osaka University of Pharmaceutical Sciences. 2. Department of Clinical Pharmacy and Pharmaceutical Care, Graduate School of Pharmaceutical Sciences, Kyushu University, Maidashi, Higashi-ku, Fukuoka, Japan. 3. Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences,Nasahara, Takatsuki, Japan. 4. Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences, Nasahara, Takatsuki, Japan. 5. Department of Medical Molecular Informatics, Meiji Pharmaceutical University, Noshio, Kiyose, Tokyo, Japan.
Abstract
PURPOSE: Bendamustine is used in hematologic malignancies such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, and multiple myeloma. This study evaluated the association of bendamustine-related skin disorders using the Japanese Adverse Drug Event Report (JADER) database. METHODS: We identified and analyzed reports of skin disorders between April 2004 and November 2019 from the JADER database and calculated the reported odds ratios (RORs) using disproportionality analysis. Additionally, we analyzed the relationship between skin disorders related to bendamustine use and patient information (age and sex). RESULTS: The symptoms, ranked in order of decreasing strength of association with skin disorders, were infusion-related reaction (ROR=5.708), herpes zoster (ROR=4.658), hypersensitivity (ROR=3.271), and rash (ROR=1.472). Additionally, analysis of the relationships between rash related to bendamustine and sex or age showed significant relationships for female sex and age younger than 70 years (ROR=2.247 and 2.176, respectively). Meanwhile, analysis of the relationship between herpes zoster and sex showed a significantly stronger association for male than female sex (ROR=2.887). CONCLUSION: Our analysis of skin disorders related to bendamustine use reported in the spontaneous reporting system databases showed that the association of rash with bendamustine use was affected by sex (female) and age (younger than 70 years). Additionally, the association of herpes zoster with bendamustine was affected by sex (male). Bendamustine is an outpatient chemotherapy regimen, and so we recommend close monitoring of female patients or those younger than 70 years who experience rash-like symptoms and male patients who experience herpes zoster-like symptoms.
PURPOSE:Bendamustine is used in hematologic malignancies such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, and multiple myeloma. This study evaluated the association of bendamustine-related skin disorders using the Japanese Adverse Drug Event Report (JADER) database. METHODS: We identified and analyzed reports of skin disorders between April 2004 and November 2019 from the JADER database and calculated the reported odds ratios (RORs) using disproportionality analysis. Additionally, we analyzed the relationship between skin disorders related to bendamustine use and patient information (age and sex). RESULTS: The symptoms, ranked in order of decreasing strength of association with skin disorders, were infusion-related reaction (ROR=5.708), herpes zoster (ROR=4.658), hypersensitivity (ROR=3.271), and rash (ROR=1.472). Additionally, analysis of the relationships between rash related to bendamustine and sex or age showed significant relationships for female sex and age younger than 70 years (ROR=2.247 and 2.176, respectively). Meanwhile, analysis of the relationship between herpes zoster and sex showed a significantly stronger association for male than female sex (ROR=2.887). CONCLUSION: Our analysis of skin disorders related to bendamustine use reported in the spontaneous reporting system databases showed that the association of rash with bendamustine use was affected by sex (female) and age (younger than 70 years). Additionally, the association of herpes zoster with bendamustine was affected by sex (male). Bendamustine is an outpatient chemotherapy regimen, and so we recommend close monitoring of female patients or those younger than 70 years who experience rash-like symptoms and male patients who experience herpes zoster-like symptoms.