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Clinical and Immunologic Assessment of Patients With Psoriasis in a Randomized, Double-blind, Placebo-Controlled Trial Using Recombinant Human Interleukin 10
Alexa B. Kimball, MD, MPH;
Tatsuyoshi Kawamura, MD, PhD;
Krupali Tejura;
Carol Boss;
Ana R. Hancox, RN;
Jonathan C. Vogel, MD;
Seth M. Steinberg, PhD;
Maria L. Turner, MD;
Andrew Blauvelt, MD
Arch Dermatol. 2002;138:1341-1346.
Background In several open-label studies, recombinant human interleukin 10 (rhIL-10),
a type 2 anti-inflammatory cytokine, has been reported to improve psoriasis,
a disease characterized by type 1 cytokine inflammation.
Objective To evaluate the safety, efficacy, and immunologic parameters in individuals
with psoriasis treated with rhIL-10.
Design and Intervention Patients received rhIL-10 (20 µg/kg) or placebo subcutaneously
3 times weekly for 12 weeks in a randomized, double-blind manner.
Setting and Patients National Institutes of Health Clinical Center in Bethesda. Twenty-eight
patients with moderate-to-severe psoriasis as defined by a Psoriasis Area
Severity Index (PASI) score of 10 or higher.
Main Outcome Measure The primary clinical end point was the mean percentage change in the
PASI score comparing baseline and week 12 scores. Intracellular cytokine production
by peripheral blood mononuclear cells (PBMCs) was measured by flow cytometry.
Results There was no significant difference in the mean percentage change in
the PASI score from baseline to week 12 between the rhIL-10–treated
group and control patients (17% vs 13% improvement, respectively; P = .69), although a modest trend toward improvement in patients receiving
rhIL-10 was documented at both the 6- and 8-week points. Interestingly, proinflammatory
and type 1 cytokine production by PBMCs progressively declined in the rhIL-10–treated
patients during the entire 12-week study period.
Conclusions Treatment with rhIL-10 resulted in only temporary clinical improvement
in psoriasis, despite sustained systemic decreases in proinflammatory and
type 1 cytokine production. These data suggest that immunotherapy that decreases
the ratio of systemic type 1 and type 2 cytokine production does not necessarily
lead to improvement of type 1 cytokine–mediated disease.
From the Dermatology Branch (Drs Kimball, Kawamura, Vogel, Turner,
and Blauvelt and Mss Tejura, Boss, and Hancox) and the Biostatistics and Data
Management Section (Dr Steinberg), National Cancer Institute, Bethesda, Md.
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