Sustained High Efficacy and Favorable Safety Over Five Years in Patients With Burdensome Psoriasis (UNCOVER-1/UNCOVER-2)

August 2021 | Volume 20 | Issue 8 | Original Article | 880 | Copyright © August 2021


Published online August 1, 2021

doi:10.36849/JDD.6101THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Kim A. Papp MD PhD FRCPC,a Sascha Gerdes MD,b Craig L. Leonardi MD,c Hany Elmaraghy MD,d Kyoungah See MS,d Missy McKean-Matthews MS,d Bruce W. Konicek MS,d Heidi M. Crane MD,d William Eastman MDd

aProbity Medical Research and K. Papp Clinical Research, Waterloo, Ontario, Canada
bPsoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany
cCentral Dermatology, St Louis, MO DEli Lilly and Company, Indianapolis, IN
dEli Lily and Company, Indianapolis, IN

Abstract
Background: Long-term efficacy, safety, and quality of life with ixekizumab (IXE) through 5 years in UNCOVER-1 and UNCOVER-2 patients with baseline scalp, nail, or palmoplantar psoriasis were assessed.
Methods: Patients included in this intent-to-treat subanalysis had baseline involvement in at least one of the three anatomic areas (scalp, fingernail, or palmoplantar locations) and 1) received IXE through week 60, with a 160-mg starting dose 80 mg Q2W through week 12 and Q4W thereafter, 2) achieved a static Physician’s Global Assessment score of 0 or 1 at week 12, and 3) completed week 60 and continued treatment with IXE Q4W or were escalated to Q2W during the long-term extension. Efficacy outcomes (e.g., percent improvement in Psoriasis Scalp Severity Index [PSSI], Nail Psoriasis Severity Index [NAPSI], Palmoplantar Psoriasis Area and Severity [PPASI], and Dermatology Life Quality Index [DLQI]) were summarized by descriptive statistics through week 264.
Results: Patients rapidly achieved and sustained improvements in scalp, nail, and palmoplantar psoriasis for up to 5 years with IXE. Patients achieved complete clearance at year 5: observed (scalp, 82%; nail, 73%; palmoplantar, 96%) and mNRI (scalp, 77%; nail, 67%; palmoplantar, 85%). Up to 80% of patients reported DLQI 0,1 responses at week 12, which were sustained through week 264. No increases in the number of annual treatment-emergent adverse events were observed from years 1–5.
Conclusion: Patients receiving IXE for 5 years sustained high rates of improvement in scalp, nail, and palmoplantar psoriasis, with a long-term quality of life benefit with no unexpected safety signals.

J Drugs Dermatol. 2021;20(8):880-887. doi:10.36849/JDD.6101

THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

INTRODUCTION

Scalp, nail, and palmoplantar psoriasis are highly prevalent among psoriasis patients and often lead to greater impairment of patients’ quality of life (QoL).1 Up to half of patients with psoriasis have burdensome psoriasis affecting the scalp (50%), nail (50%), and palmoplantar areas (17%).2-4 With non-biologic treatment options, complete clearance is infrequent, efficacy decreases with time, and systemic side effects limit their use.5 Currently, the joint American Academy of Dermatology (AAD)-National Psoriasis Foundation (NPF) guidelines recommend prescribing anti-psoriatic biologic therapies for adults with scalp, nail, and palmoplantar psoriasis.6

Interleukin (IL)-17A inhibitors have demonstrated significant improvements in patients with burdensome psoriasis up to 60 weeks and up to 80 weeks for ixekizumab (IXE)3,7,8 and secukinumab,9-12 respectively. While longer-term sustained response through 5 years in UNCOVER-3 has been reported,13 here we present longer-term data from UNCOVER-1 and UNCOVER-2. Additionally, improvements in health-related QoL up to 12 weeks have been reported with IXE in patients with burdensome psoriasis.14 In this integrated analysis, the long-term efficacy and safety, as well as the impact of IXE on QoL, through 5 years in patients with baseline scalp, nail, or palmoplantar psoriasis were assessed.

MATERIALS AND METHODS

Study Design
Data from patients with baseline burdensome psoriasis from UNCOVER-1 (NCT01474512, N=1296) and UNCOVER-2 (NCT01597245, N=1224) trials were assessed. The study designs for these trials have been reported previously).15
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