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Background <p>This study evaluated the efficacy of hydroxyzine and bepotastine, first- and second-generation H1 receptor antagonists (H1RA), as pretreatments to prevent infusion-related reactions (IRRs) during the initial rituximab infusion in patients with non-Hodgkin lymphoma.</p> Methods <p>In this double-blind, multicenter, randomized phase II study, 40 patients received hydroxyzine or bepotastine with acetaminophen 30&#xa0;min before rituximab infusion. Primary endpoint was incidence of ≥ grade 2 IRRs based on the National Cancer Institute Common Terminology Criteria for Adverse Events. Secondary endpoints included IRRs severity, time to IRR onset, and H1RA-induced drowsiness.</p> Results <p>Incidence of ≥ grade 2 IRRs was 52.4% and 31.6% for the hydroxyzine (n = 21) and bepotastine (n = 19) groups, respectively (<i>P</i> = 0.184). Distribution of initial and maximum IRR grades in the two groups was not statistically significant (<i>P</i> = 0.846 and 0.555). Median time (range) to IRR onset in the two groups was 67 (12–112) and 62 (10–119) min, respectively (<i>P</i> = 0.981). Median visual analog scale score (range and 75th percentile) for drowsiness was 37 (0–100, 46) and 12 (0–100, 29) mm in the two groups, respectively (<i>P</i> = 0.138). Incidence of ≥ grade 2 IRRs in the absence of bone marrow infiltration was&#xa0;43.8% and 14.3% in the two groups, respectively (<i>P</i> = 0.118), and no group differences were observed with bone marrow infiltration.</p> Conclusions <p>Bepotastine did not show significant superiority over hydroxyzine in preventing rituximab-induced IRRs due to the small sample size. Nevertheless, this exploratory study provides insight for further confirmatory studies.</p> Trial registration number and date of registration <p>jRCTs051220169; February 14, 2023.</p>

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Efficacy of bepotastine compared with hydroxyzine in preventing rituximab-induced infusion-related reactions in non-hodgkin lymphoma patients: a phase II, double-blind, multicenter, and randomized trial

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  • 发表日期：

    2026年4月16日

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  • Yumi Kitahiro,
  • Hironobu Minami,
  • Kazuhiro Yamamoto,
  • Kimikazu Yakushijin,
  • Keiji Kurata,
  • Rina Sakai,
  • Miki Saeki,
  • Yuri Okazoe-Hirakawa,
  • Kotaro Iida,
  • Natsuko Murase,
  • Isamu Harima,
  • Naoko Kitamura,
  • Kotaro Itohara,
  • Tomohiro Omura,
  • Takeshi Sugimoto,
  • Hidetomo Takakura,
  • Akihito Kitao,
  • Masako Takahashi,
  • Manabu Shimoyama,
  • Mamoru Okuno,
  • Ikuko Yano

摘要

Background

This study evaluated the efficacy of hydroxyzine and bepotastine, first- and second-generation H1 receptor antagonists (H1RA), as pretreatments to prevent infusion-related reactions (IRRs) during the initial rituximab infusion in patients with non-Hodgkin lymphoma.

Methods

In this double-blind, multicenter, randomized phase II study, 40 patients received hydroxyzine or bepotastine with acetaminophen 30 min before rituximab infusion. Primary endpoint was incidence of ≥ grade 2 IRRs based on the National Cancer Institute Common Terminology Criteria for Adverse Events. Secondary endpoints included IRRs severity, time to IRR onset, and H1RA-induced drowsiness.

Results

Incidence of ≥ grade 2 IRRs was 52.4% and 31.6% for the hydroxyzine (n = 21) and bepotastine (n = 19) groups, respectively (P = 0.184). Distribution of initial and maximum IRR grades in the two groups was not statistically significant (P = 0.846 and 0.555). Median time (range) to IRR onset in the two groups was 67 (12–112) and 62 (10–119) min, respectively (P = 0.981). Median visual analog scale score (range and 75th percentile) for drowsiness was 37 (0–100, 46) and 12 (0–100, 29) mm in the two groups, respectively (P = 0.138). Incidence of ≥ grade 2 IRRs in the absence of bone marrow infiltration was 43.8% and 14.3% in the two groups, respectively (P = 0.118), and no group differences were observed with bone marrow infiltration.

Conclusions

Bepotastine did not show significant superiority over hydroxyzine in preventing rituximab-induced IRRs due to the small sample size. Nevertheless, this exploratory study provides insight for further confirmatory studies.

Trial registration number and date of registration

jRCTs051220169; February 14, 2023.