Title |
Efficacy and safety of ixekizumab in a randomized, double‐blinded, placebo‐controlled phase IIIb study of patients with moderate‐to‐severe genital psoriasis
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Published in |
British Journal of Dermatology, July 2018
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DOI | 10.1111/bjd.16736 |
Pubmed ID | |
Authors |
C. Ryan, A. Menter, L. Guenther, A. Blauvelt, R. Bissonnette, K. Meeuwis, J. Sullivan, J.C. Cather, G. Yosipovitch, A.B. Gottlieb, J.F. Merola, K. Callis Duffin, S. Fretzin, O.O. Osuntokun, R. Burge, A.N. Naegeli, F.E. Yang, C.‐Y. Lin, K. Todd, A. Potts Bleakman, the IXORA‐Q Study Group |
Abstract |
Genital psoriasis (GenPs) is a common, debilitating, and difficult to treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. To determine the efficacy of ixekizumab versus placebo in patients with moderate-to-severe GenPs with BSA≥1%. Subjects with moderate-to-severe GenPs (defined as a baseline static Physician's Global Assessment of Genitalia [sPGA-G] score of ≥3) with BSA≥1% were randomized 1:1 to receive placebo (N=74) or the recommended dosing of ixekizumab (N=75). Major outcomes included the percentage of patients achieving 0 or 1 scores on the sPGA-G (primary endpoint), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and a ≥3-point improvement from baseline on the GenPs itch numeric rating scale. At week 12, ixekizumab was superior to placebo on the sPGA-G 0/1 (73.3% versus 8.1%, p<0.001), overall sPGA 0/1 (73.3% versus 2.7%, p<0.001), GenPs-SFQ item 2 0/1 (78.4% versus 21.4%, p<0.001), and genital itch (59.7% versus 8.3%, p<0.001). No candidiasis was reported, no deaths occurred, and one (1.4%) serious adverse event was reported in a patient receiving placebo. Ixekizumab was superior to placebo for the treatment of moderate-to-severe GenPs with BSA≥1%. The safety profile of ixekizumab was consistent with previous studies in moderate-to-severe plaque psoriasis. This article is protected by copyright. All rights reserved. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United Kingdom | 1 | 25% |
Unknown | 3 | 75% |
Demographic breakdown
Type | Count | As % |
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Science communicators (journalists, bloggers, editors) | 2 | 50% |
Members of the public | 2 | 50% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 87 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 10 | 11% |
Student > Master | 8 | 9% |
Student > Doctoral Student | 8 | 9% |
Unspecified | 7 | 8% |
Student > Ph. D. Student | 6 | 7% |
Other | 16 | 18% |
Unknown | 32 | 37% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 27 | 31% |
Unspecified | 7 | 8% |
Nursing and Health Professions | 4 | 5% |
Pharmacology, Toxicology and Pharmaceutical Science | 4 | 5% |
Psychology | 3 | 3% |
Other | 7 | 8% |
Unknown | 35 | 40% |