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. 2024 Apr;14(4):1007-1018.
doi: 10.1007/s13555-024-01147-7. Epub 2024 Apr 22.

Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60

Alexander Egeberg  1   2 , Jason E Hawkes  3 , Najwa Somani  4 , Russel Burge  4   5 , Kyoungah See  4 , Gaia Gallo  4 , Missy McKean-Matthews  6 , Melinda Gooderham  7 , George Han  8 , April Armstrong  9
Affiliations

Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60

Alexander Egeberg et al. Dermatol Ther (Heidelb). 2024 Apr.

Abstract

Introduction: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for the treatment of moderate-to-severe plaque psoriasis. Since scalp psoriasis can be burdensome and challenging to treat with non-systemic therapies, this post hoc analysis focused on scalp psoriasis in patients with moderate-to-severe plaque psoriasis and baseline scalp involvement. The analysis considered a holistic concept of clearance through 5 years of ixekizumab treatment.

Methods: Ixekizumab-treated patients with baseline scalp involvement were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials (integrated UNCOVER-1/2 and UNCOVER-3). Analyses were performed on a subpopulation of patients who achieved complete resolution of scalp psoriasis at Week 60 (i.e., Week 60 Psoriasis Scalp Severity Index [PSSI-0] responders) and on the overall patient population (i.e., Week 60 PSSI-0 responders and non-responders), which was used as a reference. Clinical outcomes (PSSI), patient-reported outcomes (Itch Numeric Rating Scale [NRS] score, Skin Pain Visual Analogue Scale [VAS]), quality of life (Dermatology Life Quality Index [DLQI]), and concurrent outcomes were assessed from baseline through 5 years. Descriptive statistics of observed data were reported.

Results: After 60 weeks of ixekizumab treatment, 88.4% (UNCOVER-1/2) and 75.9% (UNCOVER-3) of patients with baseline scalp involvement achieved complete clearance (PSSI-0) of scalp psoriasis. Substantial improvements in the clinical outcomes (PSSI), patient-reported outcomes (Itch NRS, Skin Pain VAS), and quality of life (DLQI) were achieved by Week 60 and sustained through Week 264 in the Week 60 PSSI-0 responders and in the overall patient population. Additionally, a significant proportion of Week 60 PSSI-0 responders achieved concurrent complete scalp and skin clearance and quality of life improvement through 5 years.

Conclusions: Continued treatment with ixekizumab provided long-term sustained scalp clearance over 5 years to patients with moderate-to-severe plaque psoriasis and baseline scalp involvement, and holistic improvements occurred across clinical outcomes, patient-reported outcomes, and quality of life.

Clinical trial numbers: NCT01474512 (UNCOVER-1), NCT01597245 (UNCOVER-2), and NCT01646177 (UNCOVER-3).

Keywords: Clinical outcomes; Ixekizumab; Long-term; Patient-reported outcomes; Psoriasis; Quality of life; Scalp clearance.

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Conflict of interest statement

Alexander Egeberg is now an employee of LEO Pharma, has received research funding from Pfizer, Eli Lilly and Company, Novartis, Bristol-Myers Squibb, AbbVie, Janssen Pharmaceuticals, Boehringer Ingelheim, the Danish National Psoriasis Foundation, the Simon Spies Foundation, and the Kgl Hofbundtmager Aage Bang Foundation, and honoraria as consultant and/or speaker from AbbVie, Almirall, LEO Pharma, Zuellig Pharma Ltd., Galápagos NV, Sun Pharma, Samsung Bioepis Co., Ltd., Pfizer, Eli Lilly and Company, Novartis, Union Therapeutics, Galderma, Dermavant, UCB, Mylan, Bristol-Myers Squibb, McNeil Consumer Healthcare, Horizon Therapeutics, Boehringer Ingelheim, and Janssen Pharmaceuticals. Jason E. Hawkes currently serves on the medical board and scientific advisory committee of the National Psoriasis Foundation and as a consultant for AbbVie, Arcutis, Boehringer Ingelheim, Bristol-Myers Squibb, Janssen, LEO Pharma, Eli Lilly and Company, Novartis, Pfizer, Regeneron-Sanofi, Sun Pharma, and UCB. Najwa Somani, Russel Burge, Kyoungah See, and Gaia Gallo are employees and stockholders of Eli Lilly and Company. Missy McKean-Matthews reports working for Eli Lilly and Company through Syneos Health. Melinda Gooderham has received honoraria, grants, and/or research funding as a speaker, investigator, advisory board member, data safety monitoring board member, and/or consultant for AbbVie, Amgen, Arcutis, AnaptysBio, Aristea, Bausch Health, Boehringer Ingelheim, Celgene, Dermira, Dermavant, Eli Lilly and Company, Galderma, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Merck Sharp & Dohme, Meiji, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, Tarsus, UCB Pharma, and Ventyx. George Han is or has been an investigator, consultant/advisor, or speaker for AbbVie, Arcutis, Athenex, Boehringer Ingelheim, Bond Avillion, Bristol-Myers Squibb, Celgene Corporation, Dermavant, Eli Lilly and Company, Incyte, Janssen, LEO Pharma, MC2, Novartis, Ortho Dermatologics, PellePharm, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. April Armstrong has served as a research investigator and/or scientific advisor to AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, BI, Bristol-Myers Squibb, EPI, Incyte, LEO Pharma, UCB, Janssen, Eli Lilly and Company, Nimbus, Novartis, Ortho Dermatologics, Sun Pharma, Dermavant, Dermira, Sanofi, Regeneron, and Pfizer.

Figures

Fig. 1
Fig. 1
Flow chart of the analyzed patient population from UNCOVER-1/2 and UNCOVER-3 trials
Fig. 2
Fig. 2
Proportion of patients with Psoriasis Scalp Severity Index (PSSI-0) among week 60 PSSI-0 responders and overall patient population (i.e., responders and non-responders) from UNCOVER-1/2 and UNCOVER-3 trials. Observed data with 95% confidence interval (CI) are presented
Fig. 3
Fig. 3
Mean percent improvement in A Psoriasis Scalp Severity Index (PSSI) score, B Dermatology Life Quality Index (DLQI) total score, C Itch Numeric Rating Scale (NRS) score, and D skin pain visual analogue scale (VAS) score among Week 60 PSSI-0 responders and overall patient population (i.e., responders and non-responders) from UNCOVER-1/2 and UNCOVER-3 trials. Mean observed data with standard error (SE) are presented. The timepoints for which SEs are < 2 may not be visible on figures
Fig. 4
Fig. 4
Proportion of patients with A concurrent Psoriasis Scalp Severity Index (PSSI-0) and Psoriasis Area and Severity Index (PASI100) and B concurrent Psoriasis Area and Severity Index (PASI100) and Dermatology Life Quality Index (DLQI-0,1) among week 60 PSSI-0 responders from UNCOVER-1/2 and UNCOVER-3 trials. Observed data with 95% confidence interval (CI) are presented
See this image and copyright information in PMC

References

    1. Armstrong AW, Mehta MD, Schupp CW, Gondo GC, Bell SJ, Griffiths CEM. Psoriasis prevalence in adults in the United States. JAMA Dermatol. 2021;157(8):940–946. doi: 10.1001/jamadermatol.2021.2007. - DOI - PMC - PubMed
    1. Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590. doi: 10.1136/bmj.m1590. - DOI - PMC - PubMed
    1. Papp K, Berth-Jones J, Kragballe K, Wozel G, de la Brassinne M. Scalp psoriasis: a review of current topical treatment options. J Eur Acad Dermatol Venereol. 2007;21(9):1151–1160. doi: 10.1111/j.1468-3083.2007.02424.x. - DOI - PubMed
    1. Callis Duffin K, Mason MA, Gordon K, et al. Characterization of patients with psoriasis in challenging-to-treat body areas in the Corrona Psoriasis Registry. Dermatology. 2021;237(1):46–55. doi: 10.1159/000504841. - DOI - PMC - PubMed
    1. Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003;49(2 Suppl):S57–61. doi: 10.1016/S0190-9622(03)01136-8. - DOI - PubMed

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