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

Research output: Contribution to journalArticle

5 Downloads (Pure)

Abstract

OBJECTIVE: 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
JournalRheumatology
Early online date18 Oct 2019
DOIs
Publication statusE-pub ahead of print - 18 Oct 2019

Cite this

Effect of filgotinib on health-related quality of life in active psoriatic arthritis : a randomized phase 2 trial (EQUATOR). / Orbai, Ana-Maria; Ogdie, Alexis; Gossec, Laure; Tillett, William; Leung, Ying Ying; Gao, Jingjing; Trivedi, Mona; Tasset, Chantal; Meuleners, Luc; Besuyen, Robin; Hendrikx, Thijs; Coates, Laura C.

In: Rheumatology, 18.10.2019.

Research output: Contribution to journalArticle

Orbai, A-M, Ogdie, A, Gossec, L, Tillett, W, Leung, YY, Gao, J, Trivedi, M, Tasset, C, Meuleners, L, Besuyen, R, Hendrikx, T & Coates, LC 2019, 'Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR)', Rheumatology. https://doi.org/10.1093/rheumatology/kez408
Orbai, Ana-Maria ; Ogdie, Alexis ; Gossec, Laure ; Tillett, William ; Leung, Ying Ying ; Gao, Jingjing ; Trivedi, Mona ; Tasset, Chantal ; Meuleners, Luc ; Besuyen, Robin ; Hendrikx, Thijs ; Coates, Laura C. / Effect of filgotinib on health-related quality of life in active psoriatic arthritis : a randomized phase 2 trial (EQUATOR). In: Rheumatology. 2019.
@article{149743c144be43768050a985eedce041,
title = "Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR)",
abstract = "OBJECTIVE: 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.",
author = "Ana-Maria Orbai and Alexis Ogdie and Laure Gossec and William Tillett and Leung, {Ying Ying} and Jingjing Gao and Mona Trivedi and Chantal Tasset and Luc Meuleners and Robin Besuyen and Thijs Hendrikx and Coates, {Laura C}",
note = "{\circledC} The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology.",
year = "2019",
month = "10",
day = "18",
doi = "10.1093/rheumatology/kez408",
language = "English",
journal = "Rheumatology",
issn = "1462-0324",
publisher = "Oxford University Press",

}

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 - © The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology.

PY - 2019/10/18

Y1 - 2019/10/18

N2 - OBJECTIVE: 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 - OBJECTIVE: 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.

U2 - 10.1093/rheumatology/kez408

DO - 10.1093/rheumatology/kez408

M3 - Article

JO - Rheumatology

JF - Rheumatology

SN - 1462-0324

M1 - kez408

ER -