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Clinical Trial
. 2021 Nov-Dec;44(6):315-322.
doi: 10.1097/NAN.0000000000000444.

Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study

Jarrod P Holmes  1   2   3   4   5   6   7   8 , Julio A Peguero  1   2   3   4   5   6   7   8 , R Campbell Garland  1   2   3   4   5   6   7   8 , Janine North  1   2   3   4   5   6   7   8 , Stacia Young  1   2   3   4   5   6   7   8 , Lonnie D Brent  1   2   3   4   5   6   7   8 , Nancy Joseph-Ridge  1   2   3   4   5   6   7   8
Affiliations
Clinical Trial

Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study

Jarrod P Holmes et al. J Infus Nurs. 2021 Nov-Dec.

Abstract

Pretreatment with antihistamines for the prevention of hypersensitivity infusion reactions is recommended for certain biologics and chemotherapies. Cetirizine is the first injectable second-generation antihistamine recently approved for acute urticaria. A randomized, exploratory phase 2 study evaluated intravenous (IV) cetirizine 10 mg versus IV diphenhydramine 50 mg as pretreatment in patients receiving an anti-CD20 agent or paclitaxel. In the overall population (N = 34) and an elderly subgroup (n = 21), IV cetirizine was as effective as IV diphenhydramine in preventing infusion reactions (primary outcome) and associated with less sedation at all time points, a shorter infusion center stay, and fewer treatment-related adverse events.

Trial registration: ClinicalTrials.gov NCT04189588.

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Conflict of interest statement

Drs Holmes, Peguero, and Garland are principal investigators for this study. Drs Holmes and Peguero have been paid consultants for TerSera Therapeutics. Ms North and Drs Young, Brent, and Joseph-Ridge are employed by TerSera Therapeutics, which provided funding for this research. Dr Garland has no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Participant flow chart. aIncluded only patients with a baseline sedation score of 0 who received at least 1 dose of study medication. Abbreviations: FAS, full analysis set; IV, intravenous; PP, per-protocol analysis set; SAS, safety analysis set.
Figure 2
Figure 2
Patient-rated sedation scores by visit: overall population. SAS population. Results were similar with health care provider-related sedation scores. Abbreviations: IV, intravenous; SAS, safety analysis set; SD, standard deviation.
Figure 3
Figure 3
Patient-rated sedation scores by visit: elderly subgroup (aged ≥65 years). SAS population. Results were similar with health care provider-related sedation scores. Abbreviations: IV, intravenous; SAS, safety analysis set; SD, standard deviation.
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