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Ixekizumab improves patient-reported outcomes in patients with active psoriatic arthritis and inadequate response to tumour necrosis factor inhibitors: SPIRIT-P2 results to 52 weeks
A. Kavanaugh1, H. Marzo-Ortega2, R. Vender3, C.-C. Wei4, J. Birt5, D.H. Adams6, O. Benichou7, C.-Y. Lin8, P. Nash9
- Division of Rheumatology, Allergy, and Immunology, University of California, San Diego (UCSD) School of Medicine, San Diego, CA, USA. akavanaugh@ucsd.edu
- NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and LIRMM, University of Leeds, UK.
- Dermatrials Research, Inc, Hamilton, Ontario, Canada.
- Institute of Medicine, Chung Shan Medical University; Chung Shan Medical University Hospital; Graduate Institute of Integrated Medicine, Division of Allergy, Immunology and Rheumatology, China Medical University, Taichung, Taiwan.
- Eli Lilly and Company, Global Patient Outcomes and Real World Evidence, Indianapolis, IN, USA.
- Eli Lilly and Company, Global Medical, Indianapolis, IN, USA.
- Eli Lilly and Company, Global Medical, Indianapolis, IN, USA.
- Eli Lilly and Company, Real-world Analytics-Immunology, Global Statistical Science, Indianapolis, IN, USA.
- Department of Medicine, Rheumatology Research Unit, University of Queensland, Sunshine Coast, QLD, Australia.
CER11366
2019 Vol.37, N°4
PI 0566, PF 0574
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PMID: 30557128 [PubMed]
Received: 30/04/2018
Accepted : 27/08/2018
In Press: 19/11/2018
Published: 27/06/2019
Abstract
OBJECTIVES:
To report patient-reported outcomes (PROs) of ixekizumab-treated patients with psoriatic arthritis (PsA) and an inadequate response (IR) or intolerance to tumour necrosis factor inhibitors (TNFi) to 52 weeks.
METHODS:
In SPIRIT-P2, patients with active PsA and an IR or intolerance to TNFi were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W; N=122) or every 2 weeks (IXEQ2W; N=123), or placebo (PBO; N=118) during the initial 24-week double-blind treatment period. At Week 16, background therapy was modified for IRs; additionally, IRs in the placebo group were re-randomised (1:1) to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at Week 24 received the same dose during the study remainder. Patients completed several PROs for PsA disease activity, skin, health-related quality of life (HRQOL, and work through Week 52.
RESULTS:
Ixekizumab-treated patients reported significant improvements versus PBO in 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions visual analogue scale, Bath Ankylosing Spondylitis Disease Activity Index (total score and question 2), and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem (3 of 4 domains) through Week 24. At Week 24, 9% (PBO), 52% (IXEQ4W), and 50% (IXEQ2W) of patients reported Dermatology Life Quality Index scores of 0 or 1; 0% (PBO) and 24% (IXEQ4W and IXEQ2W) reported Itch Numeric Rating Scale score of 0. Where data were collected, improvements persisted through Week 52.
CONCLUSIONS:
In patients with PsA and an IR or intolerance to TNFi, ixekizumab significantly improved disease activity, skin symptoms, HRQOL, and work productivity to 52 weeks.
