Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR)

Ana-Maria Orbai, Alexis Ogdie, Laure Gossec, William Tillett, Ying Ying Leung, Jingjing Gao, Mona Trivedi, Chantal Tasset, Luc Meuleners, Robin Besuyen, Thijs Hendrikx, Laura C Coates

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Abstract

To examine the effects of filgotinib, an oral, selective Janus kinase 1 inhibitor, on health-related quality of life (HRQoL) using the Psoriatic Arthritis Impact of Disease (PsAID)9 questionnaire in active PsA. Methods: Patients were randomized 1: 1 to filgotinib 200 mg or placebo once daily for 16 weeks in EQUATOR, a multicentre, double-blind, phase 2 randomized controlled trial. HRQoL was assessed with PsAID9 at Weeks 4 and 16. Change from baseline in total and individual domain scores, plus the proportions of patients achieving minimal clinically important improvement (MCII; ≥3 points) and patient-accepted symptom status (PASS; score <4), were evaluated. Correlation with the 36-item short-form health survey (SF-36) was investigated. Results: One hundred and thirty-one patients were randomized to filgotinib or placebo. Filgotinib effects on PsAID9 were observed from Week 4. At Week 16, mean (s.d.) change from baseline in PsAID9 was -2.3 (1.8) and -0.8 (2.2) for filgotinib and placebo, respectively (least-squares mean of group difference -1.48 [95% CI -2.12, -0.84], P < 0.0001), with significant improvements in all domains vs placebo. Significantly more patients on filgotinib achieved MCII (group difference 25.4% [95% CI 8.92, 39.99], P = 0.0022) and PASS (group difference 29.6% [95% CI 10.65, 45.60], P = 0.0018) at Week 16 vs placebo. Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36. Conclusion: Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9. To our knowledge, EQUATOR is the first randomized controlled trial to evaluate PsAID9. Trial registration: ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show, NCT03101670.

Original languageEnglish
Article numberkez408
Pages (from-to)1495–1504
Number of pages10
JournalRheumatology
Volume59
Issue number7
Early online date18 Oct 2019
DOIs
Publication statusPublished - 1 Jul 2020

Keywords

  • DMARDs
  • clinical trials and methods
  • outcome measures
  • psoriatic arthritis
  • quality of life

ASJC Scopus subject areas

  • Rheumatology
  • Pharmacology (medical)

Cite this

Orbai, A-M., Ogdie, A., Gossec, L., Tillett, W., Leung, Y. Y., Gao, J., Trivedi, M., Tasset, C., Meuleners, L., Besuyen, R., Hendrikx, T., & Coates, L. C. (2020). Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR). Rheumatology, 59(7), 1495–1504. [kez408]. https://doi.org/10.1093/rheumatology/kez408