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DOI 10.1136/rmdopen-2022-002939

Медицинская библиотека · RMD open · 2023

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.

Coates Laura C, Mease Philip J, Gladman Dafna D, Navarra Sandra, Bao Weibin, Gaillez Corine

Рандомизированное исследованиеКлиническое исследование III фазыСтатьяПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

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.

Для цитирования: Coates Laura C, Mease Philip J, Gladman Dafna D, Navarra Sandra, Bao Weibin, Gaillez Corine. 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. 2023. DOI: 10.1136/rmdopen-2022-002939.

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