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Comparison of remission and low disease activity states with DAPSA, MDA and VLDA in a clinical trial setting in psoriatic arthritis patients: 2-year results from the FUTURE 2 study.

التفاصيل البيبلوغرافية
العنوان: Comparison of remission and low disease activity states with DAPSA, MDA and VLDA in a clinical trial setting in psoriatic arthritis patients: 2-year results from the FUTURE 2 study.
المؤلفون: Coates LC; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research centre, Windmill Road, Oxford OX3 7LD, UK. Electronic address: laura.coates@ndorms.ox.ac.uk., Nash P; School of Medicine, Griffith University, Brisbane, Australia., Kvien TK; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway., Gossec L; Sorbonne Université, GRC08, Paris France; Pitié Salpêtrière Hospital, APHP, Rheumatology Department, Paris, France., Mease PJ; Division of Rheumatology Research, Swedish Medical Center and University of Washington, Seattle, WA, USA., Rasouliyan L; RTI Health Solutions, Barcelona, Spain., Pricop L; Novartis Pharmaceuticals Corporation, East Hanover, USA., Jugl SM; Novartis Pharma AG, Basel, Switzerland., Gandhi KK; Novartis Pharmaceuticals Corporation, East Hanover, USA., Gaillez C; Novartis Pharma AG, Basel, Switzerland., Smolen JS; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.
المصدر: Seminars in arthritis and rheumatism [Semin Arthritis Rheum] 2020 Aug; Vol. 50 (4), pp. 709-718. Date of Electronic Publication: 2020 May 15.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: W.B. Saunders Country of Publication: United States NLM ID: 1306053 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-866X (Electronic) Linking ISSN: 00490172 NLM ISO Abbreviation: Semin Arthritis Rheum Subsets: MEDLINE
أسماء مطبوعة: Publication: Philadelphia Pa : W.B. Saunders
Original Publication: New York, Stratton.
مواضيع طبية MeSH: Antibodies, Monoclonal, Humanized/*administration & dosage , Antirheumatic Agents/*administration & dosage , Arthritis, Psoriatic/*drug therapy , Remission Induction/*methods, Arthritis, Psoriatic/physiopathology ; Disease Progression ; Double-Blind Method ; Female ; Humans ; Male ; Quality of Life
مستخلص: Objectives: Remission (REM) or low disease activity (LDA) states were compared in a clinical trial setting of the FUTURE 2 study (NCT01752634) using Disease Activity Index for Psoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA) composite indices in secukinumab treated PsA patients.
Methods: The proportion of patients reaching DAPSA-REM (cut-off ≤4) or REM+LDA (≤14), and very low disease activity (VLDA; achieving 7/7 criteria) or MDA (≥5/7), were compared in the overall population, by prior use of anti-TNF therapy, and by time since diagnosis using as observed data. The proportion of patients who met individual core component and other variables of interest were also computed to assess residual disease activity in DAPSA-REM/REM+LDA states and VLDA/MDA responses. The relationship between DAPSA/MDA and patient reported outcomes (PROs), including health-related quality of life, physical function, and fatigue were assessed using mixed model for repeated measures.
Results: More patients could achieve DAPSA-REM or DAPSA-REM+LDA status than VLDA or MDA responses, respectively, at all the time points in the overall population, irrespective of anti‒TNF status and time since diagnosis. Higher proportion of patients reaching DAPSA-REM or VLDA achieved more thresholds of core components (joints, pain, patient and physician global assessments, and function) than DAPSA-REM+LDA or MDA over Week 104. There were differences with numerically higher proportion of patients achieving patient global assessment ≤10 mm and ≤20 mm, and physician global assessment ≤10 mm with MDA than with DAPSA-REM+LDA, and patient pain VAS ≤15 mm, PASI ≤1, HAQ ≤0.5 with VLDA or MDA than with DAPSA-REM or DAPSA-REM+LDA, respectively, through 104 weeks. Improvements in PROs were significantly better for patients in DAPSA-REM+LDA versus DAPSA-moderate+high disease activity status, and for MDA responders versus non-responders.
Conclusion: These analysis add to the evidence that both DAPSA and MDA composite index measures can be used for evaluation of the status and treatment response utilizing a treat to target approach in PsA patients in a clinical trial setting and improve patient health related outcomes.
Funding: The study and analysis was funded by Novartis Pharma AG, Basel, Switzerland.
Competing Interests: Declaration of Competing Interests LCC: Consultant and honoraria: AbbVie, Amgen, Celgene, Galapagos, Lilly, Janssen, Pfizer, Novartis, and UCB PN: Research grants and honoraria: Novartis, AbbVie, Roche, Pfizer, BMS, Janssen, Sanofi, Janssen, UCB, Lilly, and Celgene TKK: Consultant: AbbVie, Biogen, Celltrion, Janssen, MSD, Novartis, Oktal, Hospira/Pfizer, Sandoz, Eli Lilly and UCB; Speakers bureau: Biogen, Celltrion, Oktal, Hospira/Pfizer, Sandoz, and Eli Lilly LG: Grant/research support: BMS, UCB, Eli Lilly and Pfizer; Consultant: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Roche and UCB PJM: Grant/research support, Consultant and Speakers bureau: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, SUN Pharma, and UCB LR: Consultant for: Novartis through employment at RTI, Employee of: RTI Health Solutions LP: Shareholder and employee of Novartis SJ: Shareholder and employee of Novartis KG: Shareholder and employee of Novartis CG: Shareholder and employee of Novartis and Shareholder of BMS JS: Grant/research support: AbbVie, Janssen, Eli Lilly, MSD, Pfizer, Roche, Amgen, AstraZeneca, Astro, Celgene, Celltrion, Gilead, ILTOO, Novartis-Sandoz, Pfizer, Samsung, Sanofi, and UCB. Consultant: AbbVie, Janssen, Eli Lilly, MSD, Pfizer, Roche, Amgen, AstraZeneca, Astro, Celgene, Celltrion, Gilead, ILTOO, Novartis-Sandoz, Pfizer, Samsung, Sanofi, and UCB.
(Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)
معلومات مُعتمدة: CS-2016-16-016 United Kingdom DH_ Department of Health
فهرسة مساهمة: Keywords: DAPSA; Disease activity; MDA; Psoriatic arthritis; Remission; Spondyloarthritis
المشرفين على المادة: 0 (Antibodies, Monoclonal, Humanized)
0 (Antirheumatic Agents)
DLG4EML025 (secukinumab)
تواريخ الأحداث: Date Created: 20200611 Date Completed: 20210713 Latest Revision: 20210713
رمز التحديث: 20231215
DOI: 10.1016/j.semarthrit.2020.03.015
PMID: 32521325
قاعدة البيانات: MEDLINE
الوصف
تدمد:1532-866X
DOI:10.1016/j.semarthrit.2020.03.015