Interleukin 10 treatment of psoriasis: clinical results of a phase 2 trial.
OBJECTIVE
To determine the safety and clinical effects of interleukin 10 (IL-10) treatment of psoriasis.


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 microg/kg daily (n=5) or 20 microg/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-microg/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.
Department of Dermatology, University Hospital Charité, Berlin Humboldt University, Germany.
K
K
Asadullah
W D
WD
Döcke
M
M
Ebeling
M
M
Friedrich
G
G
Belbe
H
H
Audring
H D
HD
Volk
W
W
Sterry
D000328:Adult; D005260:Female; D006801:Humans; D016753:Interleukin-10 / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology
D016753:Interleukin-10