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Varying allergen-specific immunotherapies did not influence metabolic processes

Hematological laboratory and clinical chemical parameters determined that different allergen-specific immunotherapies did not lead to abnormal changes in basic immunological and metabolic processes, according to study results.

Researchers in Germany evaluated 13 hematological laboratory parameters and eight clinical chemistry parameters from three double blind, placebo-controlled randomized phase 3 trials.

The first study included 185 patients (mean age, 33.2 years; 63% male) performed with sublingual immunotherapy of a high-dose grass pollen preparation. The second study evaluated 211 patients (mean age, 38.2 years; 47% male) using subcutaneous immunotherapy (SCIT) with an aluminum hydroxide-adsorbed recombinant hypoallergenic variant of major birch pollen allergen. The third study included 154 patients (mean age, 34.4 years; 42% male) and measured preseasonal SCIT of a grass pollen allergoid. All patients included had moderate to severe allergic symptoms to grass or birch pollen.

In all analyzed parameters, allergen-specific immunotherapy with both administration forms and formulations did not display any influence.

“Few patients had a change in laboratory parameters from within normal range at baseline to either below or above at the 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 [the European Medical 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 concluded. “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.