Preventive Effects of Non-sedating and Sedating Histamine H₁ Receptor Antagonists Premedication for Subcutaneous Daratumumab-Associated Infusion-Related Reactions: A Prospective Observational Study
Abstract
antagonists (nsAHs) for preventing infusion-related reactions (IRRs) during daratumumab subcutaneous (DARA-SC) therapy remains unclear. Here, we aimed to compare the efficacy and safety of nsAH and sAH as premedication for DARA-SC therapy. Patients with multiple myeloma or light-chain amyloidosis who received DARA-SC therapy at eight hospitals were enrolled in this prospective, multicenter, observational study. Patients were categorized into nsAH and sAH groups based on their premedication. IRRs and drowsiness were assessed using patient-reported questionnaires, including the Stanford Sleepiness Scale (SSS) and the Japanese Epworth Sleepiness Scale (JESS), at baseline, post-administration (Q2), and before bedtime (Q3). Overall, 104 patients (nsAH, n = 49; sAH, n = 55) were analyzed. No significant differences were observed in the IRR incidence between the nsAH and sAH groups at Q2 (8.2 vs. 9.1%) or Q3 (13 vs. 17%). Conversely, the incidence of new-onset drowsiness at Q2 was significantly lower in the nsAH group (13%) than in the sAH group (32%, p < 0.05). Additionally, the increase in SSS from baseline to Q2 was significantly lower in the nsAH group than in the sAH group (p < 0.05). No significant differences were observed in JESS scores. Thus, nsAH was associated with reduced early post-administration drowsiness and there were no statistically significant differences in IRR preventive effects compared to that for sAH, suggesting that nsAH may reduce sedation without a significant increase in the incidence of IRRs; however, these hypothesis-generating findings warrant verification through future prospective comparative trials.
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BibTeX
@article{yakumarusuzukawa2026preventive,
title = {{Preventive Effects of Non-sedating and Sedating Histamine H₁ Receptor Antagonists Premedication for Subcutaneous Daratumumab-Associated Infusion-Related Reactions: A Prospective Observational Study}},
author = {Mayu Yakumaru-Suzukawa and Tohru Aomori and Norifumi Suzuki and Koichi Ohata and Maiko Abumiya and Yukiyoshi Fujita and Tomoe Yoshizawa and Kaori Matsumoto and Akira Kudo and Naoya Suehiro and Shiori Hishida-Sadaka and Haruka Igarashi and Chinami Inoue and Tomoko Yamazaki and Junichiro Wakatsuki and Hiroomi Sakurai and Serika Banno-Matsuoka and Yayoi Fukushi and Hirotoshi Iihara and Masafumi Kikuchi and Hitoshi Kawazoe and Hisakazu Ohtani},
journal = {Biological and Pharmaceutical Bulletin},
year = {2026},
month = jul,
doi = {10.1248/bpb.b26-00011},
url = {https://www.jstage.jst.go.jp/article/bpb/49/7/49_b26-00011/_article},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Preventive Effects of Non-sedating and Sedating Histamine H₁ Receptor Antagonists Premedication for Subcutaneous Daratumumab-Associated Infusion-Related Reactions: A Prospective Observational Study
AU - Mayu Yakumaru-Suzukawa
AU - Tohru Aomori
AU - Norifumi Suzuki
AU - Koichi Ohata
AU - Maiko Abumiya
AU - Yukiyoshi Fujita
AU - Tomoe Yoshizawa
AU - Kaori Matsumoto
AU - Akira Kudo
AU - Naoya Suehiro
AU - Shiori Hishida-Sadaka
AU - Haruka Igarashi
AU - Chinami Inoue
AU - Tomoko Yamazaki
AU - Junichiro Wakatsuki
AU - Hiroomi Sakurai
AU - Serika Banno-Matsuoka
AU - Yayoi Fukushi
AU - Hirotoshi Iihara
AU - Masafumi Kikuchi
AU - Hitoshi Kawazoe
AU - Hisakazu Ohtani
PY - 2026
DA - 2026/07/24
JO - Biological and Pharmaceutical Bulletin
DO - 10.1248/bpb.b26-00011
UR - https://www.jstage.jst.go.jp/article/bpb/49/7/49_b26-00011/_article
AB - antagonists (nsAHs) for preventing infusion-related reactions (IRRs) during daratumumab subcutaneous (DARA-SC) therapy remains unclear. Here, we aimed to compare the efficacy and safety of nsAH and sAH as premedication for DARA-SC therapy. Patients with multiple myeloma or light-chain amyloidosis who received DARA-SC therapy at eight hospitals were enrolled in this prospective, multicenter, observational study. Patients were categorized into nsAH and sAH groups based on their premedication. IRRs and drowsiness were assessed using patient-reported questionnaires, including the Stanford Sleepiness Scale (SSS) and the Japanese Epworth Sleepiness Scale (JESS), at baseline, post-administration (Q2), and before bedtime (Q3). Overall, 104 patients (nsAH, n = 49; sAH, n = 55) were analyzed. No significant differences were observed in the IRR incidence between the nsAH and sAH groups at Q2 (8.2 vs. 9.1%) or Q3 (13 vs. 17%). Conversely, the incidence of new-onset drowsiness at Q2 was significantly lower in the nsAH group (13%) than in the sAH group (32%, p < 0.05). Additionally, the increase in SSS from baseline to Q2 was significantly lower in the nsAH group than in the sAH group (p < 0.05). No significant differences were observed in JESS scores. Thus, nsAH was associated with reduced early post-administration drowsiness and there were no statistically significant differences in IRR preventive effects compared to that for sAH, suggesting that nsAH may reduce sedation without a significant increase in the incidence of IRRs; however, these hypothesis-generating findings warrant verification through future prospective comparative trials.
SN - 1347-5215
SN - 0918-6158
ER -