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Clinical Results of a Phase 2 Trial

Khusru Asadullah, MD; Wolf-Dietrich Döcke, MD; Merle Ebeling; Markus Friedrich, MD; Gudrun Belbe; Heike Audring, MD; Hans-Dieter Volk, MD; Wolfram Sterry, MD

Arch Dermatol. 1999;135:187-192.

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.

From the Department of Dermatology (Drs Asadullah, Friedrich, Audring, and Sterry, and Ms Ebeling) and Institute of Medical Immunology (Drs Döcke and Volk, and Ms Belbe), University Hospital Charité, Berlin Humboldt University, Berlin, Germany.

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