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Rapid and sustained improvements in patient-reported signs and symptoms with ixekizumab in biologic-naive and TNF-inadequate responder patients with psoriatic arthritis

1, 2, 3, 4, 5, 6, 7


  1. Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  2. University of Toronto, Toronto, ON, Canada.
  3. Osaka City General Hospital, Osaka, Japan.
  4. Eli Lilly and Company, Indianapolis, IN, USA.
  5. Eli Lilly and Company, Indianapolis, IN, USA.
  6. Eli Lilly and Company, Indianapolis, IN, USA.
  7. Diakonhjemmet Hospital, Oslo, Norway.

2021 Vol.39, N°2
PI 0329, PF 0336
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PMID: 32573426 [PubMed]

Received: 20/12/2019
Accepted : 20/04/2020
In Press: 19/06/2020
Published: 09/04/2021


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.
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.
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.
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.

Rheumatology Article