Clinical and Immunologic Assessment of Patients With Psoriasis in a Randomized, Double-blind, Placebo-Controlled Trial Using Recombinant Human Interleukin 10

摘要: Background In several open-label studies, recombinant human interleukin 10 (rhIL-10), a type 2 anti-inflammatory cytokine, has been reported to improve psoriasis, disease characterized by 1 cytokine inflammation. Objective To evaluate the safety, efficacy, and immunologic parameters in individuals with psoriasis treated rhIL-10. Design Intervention Patients received rhIL-10 (20 µg/kg) or placebo subcutaneously 3 times weekly for 12 weeks randomized, double-blind manner. Setting National Institutes of Health Clinical Center Bethesda. Twenty-eight patients moderate-to-severe as defined Psoriasis Area Severity Index (PASI) score higher. Main Outcome Measure The primary clinical end point was mean percentage change PASI comparing baseline week scores. Intracellular production peripheral blood mononuclear cells (PBMCs) measured flow cytometry. Results There no significant difference from between rhIL-10–treated group control (17% vs 13% improvement, respectively;P= .69), although modest trend toward improvement receiving documented at both 6- 8-week points. Interestingly, proinflammatory PBMCs progressively declined during entire 12-week study period. Conclusions Treatment resulted only temporary despite sustained systemic decreases production. These data suggest that immunotherapy ratio does not necessarily lead cytokine–mediated disease.