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

Abstract

Skin reactivities to human fibroblast-derived interferon (HuIFN-beta) preparation were studied in 20 healthy subjects in order to establish a method that detects hypersensitivity to the preparation. In response to intracutaneous injection of 0.02 ml of a 3 X 10(6) international reference units (IU)/ml of HuIFN-beta, the subjects developed immediate wheal-and-erythema type cutaneous reactions followed by erythemas maximum in diameter at 12 and 48 h. The immediate reactions were macroscopically similar to those observed in IgE-mediated cutaneous allergic reactions were macroscopically similar to those observed in IgE-mediated cutaneous allergic reactions elicited by intradermal injection of allergens. Little or no such reactions occurred with test solutions in concentration of less than 2 X 10(5) IU/ml and with solutions containing proteins of bovine origin, possible contaminants of the proteins in the preparation. These results suggest that the immediate cutaneous response to the solution of 3 X 10(6) IU/ml of HuIFN-beta is an essentially nonspecific reaction to HuIFN-beta or substances intimately associated with HuIFN-beta. For prediction of IgE-mediated hypersensitivity, a skin test with a solution containing HuIFN-beta in concentration of less than 2 X 10(5) IU/ml seems to be applicable. A test with a solution containing neonatal calf serum in concentration of 10-100 micrograms/ml may also be necessary as well as with the HuIFN-beta preparation.