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Multiple measurements during allergen immunotherapy sometimes unnecessary

Repeated measurements of standard clinical chemistry and hematology parameters during allergen immunotherapy might not be necessary, according to recent study results.

Researchers in Germany evaluated 13 hematological laboratory parameters and eight clinical chemistry and hematology parameters that measured before and after treatment in three double blind, multicenter phase 3 studies. Studies included sublingual immunotherapy of high-dose grass pollen preparation (n=185 patients; mean age, 33.2 years; 63% male), subcutaneous immunotherapy using aluminum hydroxide-adsorbed recombinant hypoallergenic variant of the major birch pollen allergen (rBeta v1-FV; n=211; mean age, 38.2 years; 47% male) and a preseasonal subcutaneous immunotherapy with a 6-grass pollen allergoid (n=154; mean age, 34.4 years; 42% male).

In 21 analyzed parameters, allergen specific immunotherapy with administration forms and formulations showed no influence.

“Few patients had a change in laboratory parameters from within normal range at baseline to either below or above at end-of-treatment,” the researchers reported. “No differences between active and placebo were seen with respect to the number of patients with such a change.”

“The Guidelines from [European Medicines Agency] on safety pharmacology studies conclude that the basic pharmacology core battery for investigation of vital functions based on scientific rationale can in some situations be saved,” the researchers wrote. “We confirm such a scientific rationale and conclude that the evaluation of these parameters is relevant for inclusion of patients during the screening process. This study … indicates that the value of repeated measurements of standard clinical chemistry and hematology parameters during allergen immunotherapy should be discussed further.”

Disclosure: The researchers are employees of Allergopharma GmbH & Co. KG.