Improvement in general touch avoidance in patients with moderate‐to‐severe genital psoriasis treated with ixekizumab during a 52‐week, randomized, phase 3 clinical trial (IXORA‐Q)

Author:

Soung Jennifer1,Cather Jennifer C.23,Gooderham Melinda456,Ryan Caitriona78ORCID,Somani Najwa9,Feely Meghan910,See Kyoungah9,Burge Russel9,Elrayes Mohamed9,Gallo Gaia9,Armstrong April W.11

Affiliation:

1. Southern California Dermatology Santa Ana California USA

2. Mindful Dermatology Dallas Texas USA

3. Modern Research Associates Dallas Texas USA

4. SKiN Centre for Dermatology Peterborough Ontario Canada

5. Department of medicine Queen's University Kingston Ontario Canada

6. Probity Medical Research Peterborough Ontario Canada

7. Institute of Dermatologists Ireland Dublin Ireland

8. Charles Institute of Dermatology University College Dublin Dublin Ireland

9. Eli Lilly and Company Indianapolis Indiana USA

10. Department of Dermatology Mount Sinai New York New York USA

11. Department of Dermatology Keck School of Medicine University of Southern California Los Angeles California USA

Abstract

AbstractBackgroundPeople with genital psoriasis may avoid close social interactions (hugs, handshakes, kisses, touching others, or being touched), which can have a significant impact on quality of life. Ixekizumab, an interleukin 17A antagonist, demonstrated rapid and persistent improvement in moderate‐to‐severe genital psoriasis through 52 weeks in a phase 3 trial (IXORA‐Q).ObjectivesTo evaluate general touch avoidance (TA) in patients with moderate‐to‐severe genital psoriasis treated with ixekizumab through 52 weeks in the IXORA‐Q trial.MethodsIn IXORA‐Q (NCT02718898), adult patients received 80 mg ixekizumab every 2 weeks (IXE Q2W, N = 75) or placebo (PBO, N = 74) for 12 weeks. At Week 12, all patients received open‐label 80 mg ixekizumab every 4 weeks (IXE Q4W) through Week 52, with an opportunity to escalate dosing to Q2W at Weeks 24, 28, or 40. Patients used a numeric rating scale (NRS) to self‐report the degree of TA experienced over the past 2 weeks (score of 0 [not at all] to 10 [very much]). Outcomes included TA NRS score change from baseline and the proportion of patients achieving a TA NRS score of 0 through Week 52. Correlations between TA NRS scores and psoriasis outcomes were also examined.ResultsMean (standard deviation) baseline TA NRS score was 2.7 (3.3) for IXE Q2W and 3.0 (3.5) for PBO. Among patients with a baseline TA NRS score >0, mean (standard deviation) change from baseline at Week 52 (where a lower score indicates greater improvement) and the proportion of patients who achieved a TA NRS score of 0 at Week 52 were −4.4 (3.2) [78.0%] for patients treated continuously with ixekizumab (Q2W then Q4W, N = 41) and −4.1 (3.6) [62.5%] for PBO/IXE Q4W (N = 40). TA NRS score improved in parallel with the majority of psoriasis outcomes examined, with the strongest positive association between the TA NRS score and Dermatology Life Quality Index total score.ConclusionsAmong patients with moderate‐to‐severe genital psoriasis, ixekizumab treatment achieves continued sustained improvement in general TA to 52 weeks.

Funder

Eli Lilly and Company

Publisher

Wiley

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