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Studies on safety problem by skin tests using human beta interferon preparation.

M Muranaka, S Suzuki

Journal of Interferon Research

|January 1, 1984

Summary

Skin reactions to human fibroblast-derived interferon (HuIFN-beta) were studied. A concentration below 2 X 10(5) IU/ml is recommended for skin testing to predict hypersensitivity, alongside tests for bovine proteins.

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Area of Science:

Immunology
Dermatology
Pharmacology

Background:

Interferons, such as human fibroblast-derived interferon (HuIFN-beta), are used therapeutically.
Assessing hypersensitivity to biological preparations is crucial for patient safety.

Purpose of the Study:

To establish a reliable skin testing method for detecting hypersensitivity to HuIFN-beta preparations.
To differentiate specific hypersensitivity from nonspecific reactions to HuIFN-beta.

Main Methods:

Intracutaneous injections of varying HuIFN-beta concentrations (up to 3 X 10(6) IU/ml) were administered to 20 healthy subjects.
Cutaneous reactions (wheal-and-erythema) were observed and measured at different time points.
Tests included solutions with bovine proteins, potential contaminants.

Main Results:

High concentrations (3 X 10(6) IU/ml) of HuIFN-beta induced immediate wheal-and-erythema reactions, similar to IgE-mediated responses.
Lower concentrations (< 2 X 10(5) IU/ml) and bovine protein solutions elicited minimal reactions.
The immediate reaction to high-dose HuIFN-beta appears nonspecific.

Conclusions:

A skin test concentration of HuIFN-beta below 2 X 10(5) IU/ml may predict IgE-mediated hypersensitivity.
Testing for bovine protein contaminants is also recommended.
This approach aids in distinguishing specific allergic reactions from nonspecific responses to HuIFN-beta.

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