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
ObjectiveSecukinumab 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.MethodsAdults with active PsA were randomised 2:2:2:3 to...
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Published in | Rheumatic & musculoskeletal diseases open Vol. 7; no. 2; p. e001600 |
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Main Authors | , , , , , , , , , , , |
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01.07.2021
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Abstract | ObjectiveSecukinumab 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.MethodsAdults 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.ResultsOf 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).ConclusionSecukinumab 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 numberNCT02404350. |
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AbstractList | 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
. 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. 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. 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. 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). 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. NCT02404350. ObjectiveSecukinumab 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.MethodsAdults 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.ResultsOf 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).ConclusionSecukinumab 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 numberNCT02404350. |
Author | Navarra, Sandra Singhal, Atul Pricop, Luminita van der Heijde, Desirée Boettcher, Elke Landewé, Robert Mpofu, Shephard Mease, Philip J Rahman, Proton Tahir, Hasan Readie, Aimee Delicha, Eumorphia Maria |
AuthorAffiliation | 3 Department of Rheumatology, Atrium Medical Centre , Amsterdam , The Netherlands 10 Rheumatology, Novartis AG , Basel , Basel-Stadt , Switzerland 5 Rheumatology , Whipps Cross University Hospital , London , UK 11 Rheumatology , Leiden University Medical Center , Leiden , The Netherlands 1 Rheumatology Research Division, Providence St. Joseph Health and University of Washington , Swedish Medical Center , Seattle , Washington , USA 2 Department of Rheumatology , University of Amsterdam , Amsterdam , The Netherlands 6 Southwest Rheumatology , Dallas , Texas , USA 8 Section of Rheumatology, University of Santo Tomas Hospital , Manila , Philippines 4 Faculty of Medicine , Memorial University of Newfoundland , St. John's , Newfoundland , Canada 7 Rheumazentrum , Favoriten Hospital , Vienna , Austria 9 Rheumatology, Novartis Pharmaceuticals Corp , East Hanover , New Jersey , USA |
AuthorAffiliation_xml | – name: 3 Department of Rheumatology, Atrium Medical Centre , Amsterdam , The Netherlands – name: 8 Section of Rheumatology, University of Santo Tomas Hospital , Manila , Philippines – name: 1 Rheumatology Research Division, Providence St. Joseph Health and University of Washington , Swedish Medical Center , Seattle , Washington , USA – name: 11 Rheumatology , Leiden University Medical Center , Leiden , The Netherlands – name: 6 Southwest Rheumatology , Dallas , Texas , USA – name: 9 Rheumatology, Novartis Pharmaceuticals Corp , East Hanover , New Jersey , USA – name: 5 Rheumatology , Whipps Cross University Hospital , London , UK – name: 7 Rheumazentrum , Favoriten Hospital , Vienna , Austria – name: 10 Rheumatology, Novartis AG , Basel , Basel-Stadt , Switzerland – name: 2 Department of Rheumatology , University of Amsterdam , Amsterdam , The Netherlands – name: 4 Faculty of Medicine , Memorial University of Newfoundland , St. John's , Newfoundland , Canada |
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Keywords | psoriatic cytokines arthritis inflammation biological therapy |
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Snippet | ObjectiveSecukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA)... Secukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA) in the... Objective Secukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA)... Objective Secukinumab provided sustained efficacy, low radiographic progression and consistent safety over 52 weeks in patients with psoriatic arthritis (PsA)... |
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SubjectTerms | Adult Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal, Humanized Arthritis Arthritis, Psoriatic - diagnostic imaging Arthritis, Psoriatic - drug therapy Clinical medicine Cytokines Disease Progression Double-Blind Method Humans Monoclonal antibodies Patients Psoriasis Psoriatic Arthritis Rheumatology Tumor necrosis factor-TNF |
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Title | 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 |
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