Subgroup Analyses by European Country-Specific Reimbursement Requirements Confirm Efficacy for Ixekizumab in Psoriasis
June 2022 | Volume 21 | Issue 6 | 659 | Copyright © June 2022
Published online May 27, 2022
Elisabeth Riedl MDa, Ulrich Mrowietz MDb, Julie Hill B. Pharm MBAc, Christophe Sapin PhDd, Richard B. Warren MDe
aEli Lilly Regional Operations GmbH, Vienna, Austria
bPsoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany
cEli Lilly and Company, Basingstoke, Hampshire, UK
dLilly France, Neuilly sur Seine, France
eDermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, UK
Abstract
Background: Biologic drugs are generally recommended for treating moderate-to-severe psoriasis. While eligibility criteria are primarily defined by clinical treatment guidelines, access to these therapies varies between European countries and is regulated by country-specific reimbursement criteria. This post-hoc subgroup analysis of integrated data from two phase III trials (UNCOVER-2 and -3) reports the efficacy of ixekizumab relative to that of etanercept in patients with moderate-to-severe plaque psoriasis selected into groups defined by original reimbursement criteria from eight European countries.
Methods: This analysis included baseline and 12-week data from the ixekizumab- and etanercept-treated study populations from UNCOVER-2 and -3. Patients were classified as meeting/not meeting each country-specific biologic eligibility criterion. Efficacy was defined by Psoriasis Area and Severity Index (PASI) 75, 90, and 100 response rates and by Dermatology Life Quality Index (DLQI) (0,1) response rates. Treatment responses across subgroups were analysed using logistic regression models.
Results: PASI 75/90/100 response rates were significantly higher for ixekizumab-treated patients than for etanercept-treated patients at week 12 (P<0.05), irrespective of whether predefined reimbursement criteria were met, for all countries, with the exception of PASI 100 response in those meeting reimbursement criteria in Belgium, where sample size was very small. Clinical efficacy outcomes were corroborated by proportions of patients achieving DLQI (0,1) responses.
Conclusions: The overall high efficacy of ixekizumab, and the consistency of the higher treatment effect compared with etanercept, in patients with moderate-to-severe psoriasis across a range of European biologic treatment reimbursement eligibility criteria provides new insights to inform treatment decisions in clinical practice.
J Drugs Dermatol. 2022;21(6):659-667. doi:10.36849/JDD.6620
INTRODUCTION
Psoriasis is a common chronic inflammatory disease affecting 2-4% of the adult population worldwide, with one-third of patients having moderate-to-severe psoriasis.1-4 The development of targeted and highly effective biological systemic therapies (biologic drugs [biologics]) has transformed outcomes for patients affected by moderate-to-severe plaque psoriasis. This has been paralleled by an enhanced understanding of the impact of the disease on patients’ quality of life and the association of psoriasis with comorbidities including psoriatic arthritis, depression, metabolic syndrome and cardiovascular disease, and has led to redefined treatment goals.5-10 Still, biologics are persistently underused in the treatment of moderate-to-severe psoriasis.11 Barriers include cost, concerns regarding their long-term safety and difficulties surrounding reimbursement.11,12 In fact, access to biologics varies from country to country across Europe because of differences in country-specific rules and reimbursement criteria.13,14
Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, has proven to have a positive benefit/risk profile in several placebo-controlled and head-to-head studies compared with different biologics,15,16 including the tumour necrosis factor inhibitor etanercept at week 12.17,18 This post-hoc subgroup analysis of integrated data from two of the phase III trials, UNCOVER-2 and -3 (NCT01597245 and NCT01646177),
