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DOI 10.1136/rmdopen-2021-001600

Медицинская библиотека · RMD open · 2021

Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study.

Mease Philip J, Landewé Robert, Rahman Proton, Tahir Hasan, Singhal Atul, Boettcher Elke, Navarra Sandra, Readie Aimee, Mpofu Shephard, Delicha Eumorphia Maria, Pricop Luminita, van der Heijde Desirée

СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПеревод в очереди

Аннотация

OBJECTIVE

Secukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA) in the FUTURE 5 study. Here, we report 2-year (end-of-study) results from this study.

METHODS

Adults with active PsA were randomised 2:2:2:3 to receive subcutaneous secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load or placebo at baseline; weeks 1, 2, 3 and 4; and every 4 weeks thereafter. Secukinumab could be escalated from 150 mg to 300 mg starting at week 52, if active signs of disease were observed based on physician's assessment. Assessments at week 104 (2 years) included clinical end points and radiographic damage (mean change in van der Heijde-modified total Sharp score (vdH-mTSS)). Safety analysis included all patients who received ≥1 dose of study medication.

RESULTS

Of the 996 patients randomised, 783 patients (78.6%) completed 2 years of treatment. Improvement in clinical end points was sustained through 2 years. The vdH-mTSS (mean change (SD)) was 0.10 (1.74; 300 mg), 0.52 (2.66; 150 mg) and 0.41 (2.20; 150 mg no load) at 2 years. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS ≤0.5) at 2 years was 89.5% (300 mg), 82.3% (150 mg) and 81.1% (150 mg no load).

CONCLUSION

Secukinumab with and without loading regimen provided sustained clinical efficacy and low radiographic progression through 2 years in patients with PsA. No new safety findings were reported.

TRIAL REGISTRATION NUMBER: NCT02404350.

Для цитирования: Mease Philip J, Landewé Robert, Rahman Proton, Tahir Hasan, Singhal Atul, Boettcher Elke, Navarra Sandra, Readie Aimee, Mpofu Shephard, Delicha Eumorphia Maria, Pricop Luminita, van der Heijde Desirée. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study.. RMD open. 2021. DOI: 10.1136/rmdopen-2021-001600.

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