Effect of Ixekizumab on Patient Reported Outcomes and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis: 5-Year Results from the UNCOVER-1 and -2 Studies

April 2021 | Volume 20 | Issue 4 | Original Article | 394 | Copyright © April 2021


Published online March 22, 2021

Melinda J. Gooderham MDa, Boni Elewski MD MPHb, Matthias Augustin MDc, Lars Iversen MDd, Hideshi Torii MDe, Russel Burge PhDf,g, Kyoungah See PhDh, Gaia Gallo MDi, William J. Eastman MDj, Missy McKean-Matthews MSk, Peter Foley MDl

aDepartment of Medicine, Queens University and SKiN Centre for Dermatology, Peterborough, Ontario, Canada
bDepartment of Dermatology, University of Alabama at Birmingham, Birmingham, AL
cInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf, Hamburg, Germany
dDepartment of Dermatology, Aarhus University Hospital, Aarhus, Denmark
eDivision of Dermatology, Tokyo Yamate Medical Center, Tokyo, Japan
fGlobal Patient Outcomes and Real World Evidence, Eli Lilly and Company, Indianapolis, IN
gDivision of Pharmaceutical Sciences, University of Cincinnati, Cincinnati, OH
hDepartment of Statistical Science, Eli Lilly and Company, Indianapolis, IN
iGlobal Medical Affairs, Eli Lilly and Company, Indianapolis, IN
jUS Medical Affairs, Eli Lilly and Company, Indianapolis, IN
kBiostatistics Department, Syneos Health, Morrisville, NC
lDepartment of Medicine, The University of Melbourne, St. Vincent’s Hospital Melbourne and Probity Medical Research, Skin Health Institute, Melbourne, VIC, Australia

Abstract
Objective: We describe patient-reported outcomes and quality of life through 5 years of treatment in patients with moderate-to-severe plaque psoriasis in the UNCOVER-1 and -2 studies.
Methods: This analysis included patients who were randomized to ixekizumab every 2 weeks then received ixekizumab every 4 weeks during the maintenance period, and who achieved static physician global assessment (0,1) at week 12, completed week 60, and entered the long-term extension period (weeks 60–264). Outcomes measures included responses in itch numeric rating scale (NRS), skin pain visual analog scale (VAS), and dermatology life quality index (DLQI) (0,1), and mean change from baseline in short form health survey (SF-36) mental (MCS) and physical component summaries (PCS), psoriasis skin appearance bothersomeness (PSAB), and work productivity activity impairment (WPAI).
Results: At week 264 in UNCOVER-1 and -2, the observed itch NRS ≥4 responses were 82.4% and 93.1%, respectively, the itch NRS=0 responses were 51.7% and 58.5%, respectively, the skin pain VAS=0 responses were 59.3% and 63.1%, respectively, and the DLQI (0,1) responses were 75.0% and 88.1%, respectively. The observed mean changes from baseline at week 264 in UNCOVER-1 and UNCOVER-2 were 3.4 and 6.5, respectively, for SF-36 MCS, 4.4 and 4.8, respectively, for SF-36 PCS, and -21.3 and -22.0, respectively, for PSAB. WPAI psoriasis item scores improved from baseline in both UNCOVER-1 and -2.
Conclusion: Ixekizumab provided clinically meaningful and sustained improvements in itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI through 5 years of treatment in patients with moderate-to-severe plaque psoriasis.

J Drugs Dermatol. 20(4):394-401. doi:10.36849/JDD.5821

Visit the JDD Psoriasis Resource Center for more.

INTRODUCTION

Psoriasis is a chronic, systemic, immune-mediated disease recognized by its cutaneous manifestation of well-demarcated, erythematous, scaly plaques. These skin lesions, often associated with significant pruritus, stinging, and burning, cause substantial psychosocial impairment and overall decreased quality of life (QoL).1

Patient-reported outcome (PRO) measures provide patients and clinicians with a tool to assess physical and psychological functioning, facilitate treatment decision making, and identify coping strategies. When used effectively, individual and aggregated PRO data can inform and evaluate treatment, aid the holistic management of patients, and improve communication between patients and clinicians.2,3 The motivation to completely