The effect on a range of biologic responses of interferon-beta serine (IFN-βser), administered by either the sc or the iv route, was examined in 16 patients. Despite the absence of IFN in the serum of 13 of 16 patients after sc administration, biologic changes associated with IFN administration occurred. Significant increases in peripheral mononu-clear cell surface proteins were evident. Monocyte human leukocyte antigen-DR (HLA-DR) showed a 23% increase in mean fluorescent intensity (P =.04) and a 9% increase in percentage of positive cells (P =.02); lymphocyte OKT10 had an 11% increase in percentage of positive cells (P <.0001) and a 26% increase in mean fluorescent intensity (P =.002). Natural killer cell activity against the Chang target increased by 125% (P=.004). Intracellular activity of 2‘, 5’-oligoadenylate synthetase increased 297% at 24 hours and 226% at 48 hours (P <.0001). Significant increases in serum concentrations of β2 microglobulin (24% at 24 hr and 27% at 48 hr, P <.0001) and neopterin (85%, P =.0001 and 165%, P =.00001) were observed. These alterations after sc administration were similar quantitatively to those resulting from the same dose of IFN-βser. given iv. Thus, serum IFN concentrations did not have to be measurable for IFN-βser to exert biologic activity. The different effects of two dose levels, 45 × 106 IU and 180 × 106 IU, also were compared independent of route. The higher dose resulted in greater increases over baseline of 2′, 5′-oligoadenylate synthetase activity (344% vs. 145% at 24 hr; 231% vs. 83% at 48 hr) and serum neopterin concentrations (185% vs. 99% at 24 hr; 271% vs. 153% at 48 hr). For all the other parameters, there was no significant difference between the two doses. [J Natl Cancer Inst 81: 1061–1068, 1989]

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