Full Papers
Rapid and sustained improvements in patient-reported signs and symptoms with ixekizumab in biologic-naive and TNF-inadequate responder patients with psoriatic arthritis
A.-M. Orbai1, D.D. Gladman2, H. Goto3, J.A. Birt4, A.M. Gellett5, C.-Y. Lin6, T.K. Kvien7
- Johns Hopkins University School of Medicine, Baltimore, MD, USA. aorbai1@jhmi.edu
- University of Toronto, Toronto, ON, Canada.
- Osaka City General Hospital, Osaka, Japan.
- Eli Lilly and Company, Indianapolis, IN, USA.
- Eli Lilly and Company, Indianapolis, IN, USA.
- Eli Lilly and Company, Indianapolis, IN, USA.
- Diakonhjemmet Hospital, Oslo, Norway.
CER13036
2021 Vol.39, N°2
PI 0329, PF 0336
Full Papers
Free to view
(click on article PDF icon to read the article)
PMID: 32573426 [PubMed]
Received: 20/12/2019
Accepted : 20/04/2020
In Press: 19/06/2020
Published: 09/04/2021
Abstract
OBJECTIVES:
To analyse the onset and sustainability of patient-reported improvements in symptoms of psoriatic arthritis (PsA) following treatment with ixekizumab (IXE) up to Week 108.
METHODS:
In patients with active PsA, either naive to biological DMARDs (SPIRIT-P1) or having inadequate response or intolerance to 1 or 2 prior TNF-inhibitors (TNFi‑experienced; SPIRIT-P2), we analysed the change from baseline in joint pain visual analogue scale (VAS; 0–100 scale), patient global assessment (PatGA VAS; 0–100 scale), fatigue numerical rating scale (NRS; 0 [no fatigue] to 10 [worst imaginable]), and Health Assessment Questionnaire-Disability Index (HAQ-DI; 0–3), up to Week 108.
RESULTS:
IXE-treated patients compared to placebo reported rapid and statistically significant improvement in pain VAS, PatGA, and HAQ-DI as early as Week 1 and this benefit was sustained or increased through Week 108. Fatigue scores improved in IXE-treated patients compared to placebo in both studies; results were statistically significant at Week 24 only in SPIRIT-P2. Improvements in fatigue with IXE were sustained over 2 years. The improvements observed in these patient-reported outcomes (PROs) were consistent in biologic-naive or TNFi-experienced patients.
CONCLUSIONS:
Patients treated with IXE versus PBO achieved significantly greater improvements and showed faster onset of improvements in patient-reported outcomes measuring symptoms and impact of PsA. Responses were sustained over 2 years and were generally consistent regardless of prior TNFi experience.