TY - JOUR
T1 - Effect of filgotinib on health-related quality of life in active psoriatic arthritis
T2 - A randomized phase 2 trial (EQUATOR)
AU - Orbai, Ana Maria
AU - Ogdie, Alexis
AU - Gossec, Laure
AU - Tillett, William
AU - Leung, Ying Ying
AU - Gao, Jingjing
AU - Trivedi, Mona
AU - Tasset, Chantal
AU - Meuleners, Luc
AU - Besuyen, Robin
AU - Hendrikx, Thijs
AU - Coates, Laura C.
N1 - Funding Information:
We wish to thank the participants of EQUATOR and all study investigators. Medical writing support (including development of drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking and referencing) was provided by Alice Wareham PhD, CMPP at Aspire Scientific Limited (Bollington, UK), and funded by Galapagos NV (Mechelen, Belgium). These data were presented at the European Congress of Rheumatology (EULAR) 2019 on 12 15 June in Madrid, Spain. C.T. and L.M. designed the study. J.G., C.T., L.M., R.B., T.H. and L.C.C. analysed the data. A.-M.O., A.O., L.G., W.T., Y.Y.L., M.T., C.T., L.M., R.B., T.H. and L.C.C. interpreted the data. All authors reviewed and revised drafts of the manuscript and approved the final version to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Data sharing with regard to this study is being managed by Gilead Sciences, Inc. The clinical study report synopsis and de-identified patient-level data from clinical trial analysis datasets will be made available from six months after approval of the study compound by the US Food and Drug Administration and European Medicines Agency until an indefinite date. Proposals should be submitted to Gilead. Access to these data will be provided in a secured analysis environment to qualified external researchers approved by Gilead, depending on the nature of the request, the merit of the research proposed, availability of the data and the intended use of the data. To gain access, approved requestors will need to sign a data sharing agreement.
Funding Information:
Funding: This work was supported by Galapagos NV (Mechelen, Belgium).
Publisher Copyright:
© 2019 The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - 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.
AB - 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.
KW - DMARDs
KW - clinical trials and methods
KW - outcome measures
KW - psoriatic arthritis
KW - quality of life
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U2 - 10.1093/rheumatology/kez408
DO - 10.1093/rheumatology/kez408
M3 - Article
C2 - 31624837
AN - SCOPUS:85088694845
SN - 1462-0324
VL - 59
SP - 1495
EP - 1504
JO - Rheumatology and Rehabilitation
JF - Rheumatology and Rehabilitation
IS - 7
ER -