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February 1999

Interleukin 10 Treatment of PsoriasisClinical Results of a Phase 2 Trial

Author Affiliations

Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999

Arch Dermatol. 1999;135(2):187-192. doi:10.1001/archderm.135.2.187

Objective  To determine the safety and clinical effects of interleukin 10 (IL-10) treatment of psoriasis.

Design and Methods  In an open-label phase 2 trial, 10 patients with psoriasis subcutaneously received recombinant human IL-10 over a 7-week period in a dosage of 8 µg/kg daily (n=5) or 20 µg/kg 3 times per week (n=5). Patients were followed up for an additional 5 weeks.

Results  The treatment was well tolerated. Antipsoriatic effects were found in all but 1 patient. A significant decrease of the psoriasis area and severity index by 55.3% ± 11.5% (mean ± SEM) was observed (P<.02). The antipsoriatic efficiency was confirmed by histological examination. Heterogeneity in the effectiveness was found among the patients, but seems to be independent of the dosage regimen. However, a tendency to a better response was found in the patients who received 20-µg/kg IL-10 3 times per week. Decreasing response in the delayed-type hypersensitivity reaction against recall antigens indicated immunosuppressive effects. Moderate effects on hematopoietic cells were observed.

Conclusions  Our data suggest that IL-10 therapy for psoriasis is safe and possibly clinically effective. Consequently, its value in psoriasis and similar immune diseases should be further determined. Dose-finding, placebo-controlled, double-blind trials are necessary now.