Journal of drugs in dermatology : JDD · 2016
Ixekizumab Is Effective in Subjects With Moderate to Severe Plaque Psoriasis With Significant Nail Involvement: Results From UNCOVER 3.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Dennehy Ellen B, Zhang Lu, Amato David, Goldblum Orin, Rich Phoebe
Аннотация
BACKGROUND: Ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, has been established as safe and effective in 3 Phase 3 trials for the treatment of moderate to severe plaque psoriasis. The lifetime incidence of psoriatic nail disease is 80%-90% of patients, and approximately 50% of patients with psoriasis have nail involvement.<BR />
MATERIALS AND METHODS: The design of UNCOVER-3, a Phase 3, multicenter, double-blind, placebo- and active-controlled trial that evaluated the efficacy and safety of ixekizumab for moderate to severe psoriasis, has been published previously. Patients were randomized to receive blinded placebo, etanercept (50 mg twice weekly) or 80 mg ixekizumab every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) for 12 weeks. At week 12, all patients were assigned to open-label ixekizumab 80 mg every 4 weeks through week 60. In this 60-week post hoc subset analysis, we evaluated only those patients with significant baseline nail involvement, defined as fingernail NAPSI ≥16 and at least 4 fingernails involved.<BR />
RESULTS: Ixekizumab Q2W or Q4W resulted in greater improvement in nail psoriasis than placebo or etanercept by week 12 of administration, as measured by percent NAPSI reduction (IXEQ2W 39% improvement, IXEQ4W 40%, etanercept 28%, placebo -4.7%). At week 24, significantly more patients receiving ixekizumab exhibited no signs of nail involvement (IXEQ2W/Q4W 34%, IXEQ4W/Q4W 30%). Similar gains were observed at 60 weeks in all treatment groups.<BR />
CONCLUSION: Ixekizumab led to improvement in fingernail psoriasis by week 12 compared with placebo. Continued improvement in fingernail psoriasis with ixekizumab was observed, with >50% of patients achieving complete fingernail psoriasis resolution (NAPSI=0) at week 60.<BR /><BR /> <em>J Drugs Dermatol</em>. 2016;15(8):958-961.
MATERIALS AND METHODS: The design of UNCOVER-3, a Phase 3, multicenter, double-blind, placebo- and active-controlled trial that evaluated the efficacy and safety of ixekizumab for moderate to severe psoriasis, has been published previously. Patients were randomized to receive blinded placebo, etanercept (50 mg twice weekly) or 80 mg ixekizumab every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) for 12 weeks. At week 12, all patients were assigned to open-label ixekizumab 80 mg every 4 weeks through week 60. In this 60-week post hoc subset analysis, we evaluated only those patients with significant baseline nail involvement, defined as fingernail NAPSI ≥16 and at least 4 fingernails involved.<BR />
RESULTS: Ixekizumab Q2W or Q4W resulted in greater improvement in nail psoriasis than placebo or etanercept by week 12 of administration, as measured by percent NAPSI reduction (IXEQ2W 39% improvement, IXEQ4W 40%, etanercept 28%, placebo -4.7%). At week 24, significantly more patients receiving ixekizumab exhibited no signs of nail involvement (IXEQ2W/Q4W 34%, IXEQ4W/Q4W 30%). Similar gains were observed at 60 weeks in all treatment groups.<BR />
CONCLUSION: Ixekizumab led to improvement in fingernail psoriasis by week 12 compared with placebo. Continued improvement in fingernail psoriasis with ixekizumab was observed, with >50% of patients achieving complete fingernail psoriasis resolution (NAPSI=0) at week 60.<BR /><BR /> <em>J Drugs Dermatol</em>. 2016;15(8):958-961.