Ustekinumab for the treatment of plaque psoriasis

Recent advances in the understanding of disease pathways in psoriasis indicate an important role of IL-23. Ustekinumab is a first-in-class, fully human IgG1 κ monoclonal antibody that binds with high specificity to the p40 subunit of IL-12 and IL-23. It is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who failed, are contraindicated to, or intolerant to other systemic therapies. In Phase III studies, ustekinumab significantly improved symptoms of plaque psoriasis by week 12 (psoriasis area and severity index 75 response 66–76%) versus placebo (3–4%; p < 0.0001 for all comparisons versus placebo), and showed continued efficacy through week 76 with every 12-week dosing. Ustekinumab was well tolerated: the incidence of adverse events leading to withdrawal of study medication was less than or equal to 2% across treatment groups. Extended exposure was not found to be associated with lymphocyte depletion or cumulative toxicity.