Original articleA 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis
Section snippets
Study design and treatment
This was a multicenter, OLE study of a phase-II RCT designed to evaluate the long-term use of ixekizumab in patients with chronic (≥6 months) moderate to severe plaque psoriasis. Patients were administered ixekizumab (10, 25, 75, or 150 mg) or placebo subcutaneously at 0, 2, 4, 8, 12, and 16 weeks in the RCT, the results of which have been previously published.6 Patients who completed 20 weeks of the RCT and who had not experienced a treatment-related adverse event (AE) or a serious AE (SAE)
Patient disposition and baseline characteristics
Of the 129 patients who completed the RCT, 120 (93%) entered the OLE and received at least 1 dose of study drug and 103 (86%) completed at least 52 weeks of treatment (Fig 1). On average, patients were 47 years of age; 58% were men, 93% were Caucasian, and the majority (93%) had previously received treatment for psoriasis.
Before entering the OLE, 69 of 120 (58%) patients (10 mg, n = 5; 25 mg, n = 20; 75 mg, n = 21; 150 mg, n = 23) had achieved a PASI75 response at week 20 of the RCT and entered
Discussion
In this long-term OLE study of ixekizumab for the treatment of moderate to severe plaque psoriasis, a high rate of clinical response was observed in all patient groups. There was a low rate of discontinuation over 52 weeks, and 77% (92 of 120) of patients who entered the OLE achieved a PASI75 response. Patients who had taken subtherapeutic doses (10 mg or 25 mg) during the RCT achieved PASI75, PASI90, and PASI100 response rates that were similar to higher-dose groups by week 52. The majority of
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Supported by Eli Lilly and Company.
Disclosure: Dr Gordon is a consultant and/or investigator for AbbVie Inc, Amgen Inc, Centocor, Merck, Eli Lilly and Company, Novartis, and Pfizer. Dr Leonardi is a consultant and/or investigator for AbbVie Inc, Amgen Inc, Celgene Corp, Centocor, Eli Lilly and Company, Galderma, Genentech, Genzyme, GlaxoSmithKline, Incyte, Novartis, Novo Nordisk, Pfizer, Schering-Plough, Sirtris, Stiefel, Vascular Biogenics, and Wyeth, and is a speaker for AbbVie Inc. Dr Lebwohl has been a consultant and/or investigator for Inbios, Coronado Biosciences, AbbVie Inc, Valeant, Taro, Pfizer, UCB Pharma, Forward Pharma, DermiPsor, Galderma, Ranbaxy, Novartis, Dermira, Merz, Merck, LEO Pharma Inc, Janssen-Biotech, GlaxoSmithKline, Eli Lilly and Company, Celgene Corp, Can-Fite Biopharma Ltd, Anacor Pharmaceuticals Inc, and Amgen Inc. Dr Blauvelt is a consultant and/or investigator for AbbVie Inc, Amgen Inc, Boehringer Ingelheim, Celgene Corp, Janssen Biotech, Merck, Novartis, Pfizer, and Eli Lilly and Company. Drs Cameron, Braun, Erickson, and Heffernan are employees and shareholders of Eli Lilly and Company.