Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis

the IXORA-Q Study Group

Research output: Contribution to journalArticle

16 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)844-852
Number of pages9
JournalBritish Journal of Dermatology
Volume179
Issue number4
DOIs
StatePublished - Oct 1 2018

Fingerprint

LY2439821
Psoriasis
Placebos
Safety
Genitalia
Body Surface Area
Physicians
Candidiasis

ASJC Scopus subject areas

  • Dermatology

Cite this

Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis. / the IXORA-Q Study Group.

In: British Journal of Dermatology, Vol. 179, No. 4, 01.10.2018, p. 844-852.

Research output: Contribution to journalArticle

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title = "Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis",
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 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.",
author = "{the IXORA-Q Study Group} and C. Ryan and A. Menter and L. Guenther and A. Blauvelt and R. Bissonnette and K. Meeuwis and J. Sullivan and Cather, {J. C.} and Gil Yosipovitch and Gottlieb, {A. B.} and Merola, {J. F.} and {Callis Duffin}, K. and S. Fretzin and Osuntokun, {O. O.} and R. Burge and Naegeli, {A. N.} and Yang, {F. E.} and Lin, {C. Y.} and K. Todd and {Potts Bleakman}, A.",
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T1 - Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis

AU - the IXORA-Q Study Group

AU - Ryan, C.

AU - Menter, A.

AU - Guenther, L.

AU - Blauvelt, A.

AU - Bissonnette, R.

AU - Meeuwis, K.

AU - Sullivan, J.

AU - Cather, J. C.

AU - Yosipovitch, Gil

AU - Gottlieb, A. B.

AU - Merola, J. F.

AU - Callis Duffin, K.

AU - Fretzin, S.

AU - Osuntokun, O. O.

AU - Burge, R.

AU - Naegeli, A. N.

AU - Yang, F. E.

AU - Lin, C. Y.

AU - Todd, K.

AU - Potts Bleakman, A.

PY - 2018/10/1

Y1 - 2018/10/1

N2 - 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.

AB - 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.

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