Details

Autor(en) / Beteiligte

• Ryan, C.
• Menter, A.
• Guenther, L.
• Blauvelt, A.
• Bissonnette, R.
• Meeuwis, K.
• Sullivan, J.
• Cather, J.C.
• Yosipovitch, G.
• Gottlieb, A.B.
• Merola, J.F.
• Callis Duffin, K.
• Fretzin, S.
• Osuntokun, O.O.
• Burge, R.
• Naegeli, A.N.
• Yang, F.E.
• Lin, C.‐Y.
• Todd, K.
• Potts Bleakman, A.

Titel

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

Ist Teil von

• British journal of dermatology (1951), 2018-10, Vol.179 (4), p.844-852

Ort / Verlag

England: Oxford University Press

Erscheinungsjahr

2018

Quelle

MEDLINE

Beschreibungen/Notizen

• Summary 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. What's already known about this topic? Genital psoriasis is a common and burdensome form of plaque psoriasis, but there are few controlled studies of effective therapies. What does this study add? Ixekizumab significantly improved the severity of genital psoriasis and associated disease characteristics. Ixekizumab may be appropriate for treatment of moderate‐to‐severe genital psoriasis, even in patients with limited body surface involvement. Linked Editorial: Becher and Burden. Br J Dermatol 2018; 179:811–812. Plain language summary available online