C Ryan1, A Menter2, L Guenther3, A Blauvelt4, R Bissonnette5, K Meeuwis6, J Sullivan7, J C Cather8, G Yosipovitch9, A B Gottlieb10, J F Merola11, K Callis Duffin12, S Fretzin13, O O Osuntokun14, R Burge14, A N Naegeli14, F E Yang14, C-Y Lin14, K Todd14, A Potts Bleakman14. 1. Department of Dermatology, Blackrock Clinic, Dublin, Ireland. 2. Department of Dermatology, Baylor University Medical Center, Dallas, TX, U.S.A. 3. Guenther Dermatology Research Centre, London, ON, Canada. 4. Oregon Medical Research Center, Portland, OR, U.S.A. 5. Innovaderm Research, Montreal, QC, Canada. 6. Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands. 7. Kingsway Dermatology, Miranda, NSW, Australia. 8. Modern Research Associates, Dallas, TX, U.S.A. 9. Department of Dermatology and Itch Center, University of Miami School of Medicine, Miami, FL, U.S.A. 10. Department of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY, U.S.A. 11. Department of Dermatology and Medicine, Division of Rheumatology, Harvard Medical School Brigham and Women's Hospital, Boston, MA, U.S.A. 12. Department of Dermatology, University of Utah School of Medicine, Salt Lake City, UT, U.S.A. 13. Dawes Fretzin Dermatology Group, Indianapolis, IN, U.S.A. 14. Eli Lilly and Company, Indianapolis, IN, U.S.A.
Abstract
BACKGROUND: Genital psoriasis (GenPs) is a common, debilitating and difficult-to-treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. OBJECTIVES: To determine the efficacy of ixekizumab vs. placebo in patients with moderate-to-severe GenPs with ≥ 1% involved body surface area (BSA). METHODS:Patients 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 receiveplacebo (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 end point), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and ≥ 3-point improvement from baseline on the GenPs itch numerical rating scale. RESULTS: At week 12, ixekizumab was superior to placebo for sPGA-G 0/1 (73% vs. 8%, P < 0·001), overall sPGA 0/1 (73% vs. 3%, P < 0·001), GenPs-SFQ item 2 score of 0 or 1 (78% vs. 21%, P < 0·001) and genital itch (60% vs. 8%, P < 0·001). No candidiasis was reported, no deaths occurred and one (1%) serious adverse event was reported in a patient receiving placebo. CONCLUSIONS: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.
RCT Entities:
BACKGROUND:Genital psoriasis (GenPs) is a common, debilitating and difficult-to-treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. OBJECTIVES: To determine the efficacy of ixekizumab vs. placebo in patients with moderate-to-severe GenPs with ≥ 1% involved body surface area (BSA). METHODS:Patients 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 end point), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and ≥ 3-point improvement from baseline on the GenPs itch numerical rating scale. RESULTS: At week 12, ixekizumab was superior to placebo for sPGA-G 0/1 (73% vs. 8%, P < 0·001), overall sPGA 0/1 (73% vs. 3%, P < 0·001), GenPs-SFQ item 2 score of 0 or 1 (78% vs. 21%, P < 0·001) and genital itch (60% vs. 8%, P < 0·001). No candidiasis was reported, no deaths occurred and one (1%) serious adverse event was reported in a patient receiving placebo. CONCLUSIONS: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.
Authors: Di Yan; Andrew Blauvelt; Amit K Dey; Rachel S Golpanian; Samuel T Hwang; Nehal N Mehta; Bridget Myers; Zhen-Rui Shi; Gil Yosipovitch; Stacie Bell; Wilson Liao Journal: J Invest Dermatol Date: 2021-04-19 Impact factor: 7.590
Authors: C Ryan; L Guenther; P Foley; J Weisman; R T Burge; G Gallo; K See; M McKean-Matthews; C C Bertram; J F Merola Journal: J Eur Acad Dermatol Venereol Date: 2021-12-04 Impact factor: 9.228
Authors: J F Merola; P-D Ghislain; J N Dauendorffer; A Potts Bleakman; A J M Brnabic; R Burge; E Riedl Journal: J Eur Acad Dermatol Venereol Date: 2020-02-05 Impact factor: 6.166