Article
Secukinumab Improves Physical Function, Quality of Life, Fatigue and Work Productivity in Patients with Active Psoriatic Arthritis in FUTURE 2, A Phase 3 Trial
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Authors
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Florian Schuch
- Praxisgemeinschaft Rheumatologie Nephrologie Erlangen, Dres. Kleinert, Rapp, Schuch u. Wendler, Erlangen
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V. Strand
- Stanford University, Palo Alto, United States of America
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Proton Rahman
- Memorial University of Newfoundland, St. John`s, Kanada
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Iain McInnes
- University of Glasgow, Glasgow, England
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Helena Marzo-Ortega
- University of Leeds, Leeds, United Kingdom
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Eva Dokoupilova
- Medical Plus, Uherske Hradiste, Czech Republic
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Melvin Churchill
- Arthritis Center of Nebraska, Lincoln, USA
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Sekhar Kandala
- Novartis Healthcare, Hyderabad, India
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Luminita Pricop
- Novartis Pharmaceuticals Corporation, New Jersey, USA
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Shepard Mpofu
- Novartis Pharma AG, Basel, Switzerland
| Published: | September 1, 2015 |
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Outline
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Introduction: Psoriatic arthritis (PsA) has a significant negative impact on patients’ (pts) health-related quality of life (HRQoL). Secukinumab improved the signs and symptoms of active PsA in the randomized, double-blind, placebo (PBO)-controlled phase 3 FUTURE 2 study (NCT01752634) [1]. The objective of this study is to investigate the effect of secukinumab through Week (Wk) 24 on patient-reported outcomes (PROs) in the FUTURE 2 study.
Methods: 397 adults with active PsA were randomized to subcutaneous (s.c.) secukinumab (300, 150 or 75 mg) or placebo (PBO) at baseline, Wks 1, 2, 3 and 4, and every 4 wks thereafter. At Wk 16 PBO non-responders were switched to secukinumab 300 or 150 mg (1:1). From Wk 24 all pts initially randomized to PBO received secukinumab 300 or 150 mg (1:1). PROs were assessed using the following instruments: Short Form-36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS); Health Assessment Questionnaire-Disability Index (HAQ-DI); Psoriatic Arthritis Quality of Life (PsAQoL); Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) and Work Productivity and Activity Impairment Questionnaire (WPAI-GH). SF-36 Physical Component Summary (PCS) and HAQ-DI were secondary study endpoints that were included in a hierarchical testing analysis to adjust for multiplicity at Wk 24. The other PROs were exploratory endpoints. Statistical analyses used a mixed-effect model repeated measures method.
Results: At baseline, dose groups were comparable with respect to demographics and disease activity; subjects had moderate to severe physical impairment, fatigue levels and impaired HRQoL. At Wk 24, secukinumab 300 and 150 mg improved SF-36 PCS scores vs PBO (P≤0.01) and HAQ-DI (P≤0.01 for 300 mg). In exploratory analyses, secukinumab also improved FACIT-F and PsAQoL scores, as well as aspects of work productivity, as assessed by WPAI, vs PBO at Wk 24.
Conclusion: In pts with active PsA, secukinumab had a positive effect in terms of improving quality of life and reducing fatigue and the impact of disease on work productivity.
