Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study
Objective To investigate the impact of sustained low disease activity (LDA)/remission (REM) on physical function, quality of life (QoL) and structural outcomes in secukinumab-treated psoriatic arthritis (PsA) patients from the FUTURE 5 study.Methods FUTURE 5 was a randomised, double-blind, placebo-c...
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BMJ Publishing Group
2023-04-01
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Series: | RMD Open |
Online Access: | https://rmdopen.bmj.com/content/9/2/e002939.full |
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author | Philip J Mease Dafna D Gladman Laura C Coates Sandra Navarra Corine Gaillez Weibin Bao |
author_facet | Philip J Mease Dafna D Gladman Laura C Coates Sandra Navarra Corine Gaillez Weibin Bao |
author_sort | Philip J Mease |
collection | DOAJ |
description | Objective To investigate the impact of sustained low disease activity (LDA)/remission (REM) on physical function, quality of life (QoL) and structural outcomes in secukinumab-treated psoriatic arthritis (PsA) patients from the FUTURE 5 study.Methods FUTURE 5 was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 study in patients with active PsA. Patients were categorised according to LDA (Minimal Disease Activity, MDA/Disease Activity index for Psoriatic Arthritis, DAPSA LDA+REM) or REM (very LDA/DAPSA REM): not achieving LDA/REM, achieving it once or sustained LDA/REM ≥3 times up to week 104. Key outcomes were improvements in Health Assessment Questionnaire Disability Index and Short Form-36 Physical Component Summary Score, proportion of non-radiographic progressors and predictors of sustained LDA response.Results Patients were randomised (N=996) into the following treatment groups: secukinumab 300 mg (N=222), secukinumab 150 mg loading (N=220)/non-loading (N=222) and placebo (N=332). Baseline characteristics were comparable between patients with sustained DAPSA and MDA responses. By week 104, 48%–81% and 19%–36% of the secukinumab-treated patients achieved sustained LDA and REM, respectively. Numerically greater improvements in physical function and QoL were observed with sustained LDA/REM versus LDA/REM achieved once or not at all, although patients reached the established minimal clinically important difference for all composite indices. A high proportion of secukinumab-treated patients were non-structural progressors at 2 years irrespective of achieving sustained LDA/REM. Younger age, lower body mass index at baseline, reduced tender joint count and PsA pain at week 16 were key predictors of sustained LDA in secukinumab-treated patients.Conclusion Sustained LDA/REM was associated with improvements in physical function, QoL and inhibition of structural damage progression. |
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spelling | doaj.art-8c58257d0b9840c38bda997d59127a2d2023-07-25T22:05:07ZengBMJ Publishing GroupRMD Open2056-59332023-04-019210.1136/rmdopen-2022-002939Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 studyPhilip J Mease0Dafna D Gladman1Laura C Coates2Sandra Navarra3Corine Gaillez4Weibin Bao5Department of Rheumatology, Swedish Medical Centre/Providence St. Joseph Health and University of Washington, Seattle, Washington, USASchroeder Arthritis Institute and Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, CanadaNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UKDepartment of Rheumatology, University of Santo Tomas Hospital, Manila, PhilippinesGlobal Medical Affairs, Novartis Pharma AG, Basel, SwitzerlandGlobal Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USAObjective To investigate the impact of sustained low disease activity (LDA)/remission (REM) on physical function, quality of life (QoL) and structural outcomes in secukinumab-treated psoriatic arthritis (PsA) patients from the FUTURE 5 study.Methods FUTURE 5 was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 study in patients with active PsA. Patients were categorised according to LDA (Minimal Disease Activity, MDA/Disease Activity index for Psoriatic Arthritis, DAPSA LDA+REM) or REM (very LDA/DAPSA REM): not achieving LDA/REM, achieving it once or sustained LDA/REM ≥3 times up to week 104. Key outcomes were improvements in Health Assessment Questionnaire Disability Index and Short Form-36 Physical Component Summary Score, proportion of non-radiographic progressors and predictors of sustained LDA response.Results Patients were randomised (N=996) into the following treatment groups: secukinumab 300 mg (N=222), secukinumab 150 mg loading (N=220)/non-loading (N=222) and placebo (N=332). Baseline characteristics were comparable between patients with sustained DAPSA and MDA responses. By week 104, 48%–81% and 19%–36% of the secukinumab-treated patients achieved sustained LDA and REM, respectively. Numerically greater improvements in physical function and QoL were observed with sustained LDA/REM versus LDA/REM achieved once or not at all, although patients reached the established minimal clinically important difference for all composite indices. A high proportion of secukinumab-treated patients were non-structural progressors at 2 years irrespective of achieving sustained LDA/REM. Younger age, lower body mass index at baseline, reduced tender joint count and PsA pain at week 16 were key predictors of sustained LDA in secukinumab-treated patients.Conclusion Sustained LDA/REM was associated with improvements in physical function, QoL and inhibition of structural damage progression.https://rmdopen.bmj.com/content/9/2/e002939.full |
spellingShingle | Philip J Mease Dafna D Gladman Laura C Coates Sandra Navarra Corine Gaillez Weibin Bao Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study RMD Open |
title | Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study |
title_full | Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study |
title_fullStr | Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study |
title_full_unstemmed | Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study |
title_short | Secukinumab improves physical function and quality of life and inhibits structural damage in patients with PsA with sustained remission or low disease activity: results from the 2-year phase 3 FUTURE 5 study |
title_sort | secukinumab improves physical function and quality of life and inhibits structural damage in patients with psa with sustained remission or low disease activity results from the 2 year phase 3 future 5 study |
url | https://rmdopen.bmj.com/content/9/2/e002939.full |
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