Minimal Disease Activity Among Active Psoriatic Arthritis Patients Treated With Secukinumab: 2-Year Results From a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Study

被引:34
作者
Coates, Laura C. [1 ]
Mease, Philip J. [2 ,3 ]
Gossec, Laure [4 ,5 ]
Kirkham, Bruce [6 ]
Sherif, Bintu [7 ]
Gaillez, Corine [8 ]
Mpofu, Shephard [8 ]
Jugl, Steffen M. [8 ]
Karyekar, Chetan [9 ]
Gandhi, Kunal K. [9 ]
机构
[1] Univ Oxford, Oxford, England
[2] Swedish Med Ctr, Seattle, WA USA
[3] Univ Washington, Seattle, WA 98195 USA
[4] UPMC Univ Paris 06, GRC UPMC 08, Sorbonne Univ, Paris, France
[5] Hop La Pitie Salpetriere, AP HP, Paris, France
[6] Guys & St Thomas NHS Fdn Trust, London, England
[7] RTI Hlth Solut, Res Triangle Pk, NC USA
[8] Novartis Pharma AG, Basel, Switzerland
[9] Novartis Pharmaceut, E Hanover, NJ USA
关键词
TRIAL;
D O I
10.1002/acr.23537
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectiveTo evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study. MethodsPatients with active PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75 mg or placebo. MDA was assessed in the overall population (anti-tumor necrosis factor [anti-TNF]-naive and inadequate responders [anti-TNF-IR]) and in patients stratified by prior anti-TNF exposure and by time since diagnosis at weeks 16, 24, 52, and 104. Function and patient-reported outcomes (PROs), including health-related quality of life (QoL) and work productivity, were assessed in MDA responders versus nonresponders. ResultsOverall, 28% of patients (27 of 98) and 23% (23 of 100) achieved MDA at week 16 with secukinumab 300 and 150 mg, respectively, versus 10% (9 of 94) with placebo. In the anti-TNF-naive cohort, a higher proportion of patients achieved MDA at week 16 with secukinumab 300 and 150 mg (34% and 32%, respectively) versus placebo (13%). The corresponding value in the anti-TNF-IR cohort was 15% and 8% with secukinumab 300 and 150 mg, respectively, versus with placebo (3%). At week 16, 27.1% of MDA responders (16 of 59) achieved a very low disease activity (VLDA) response, with the percentage being numerically greater with secukinumab 300 and 150 mg (30% [8 of 27] and 26% [6 of 23], respectively) versus placebo (22% [2 of 9]). The MDA and VLDA responses with secukinumab 300 and 150 mg were sustained through 2 years. MDA responders showed greater improvements in QoL outcomes compared to nonresponders through 2 years. ConclusionA greater proportion of patients achieved MDA with secukinumab versus placebo at week 16, with response rates sustained through 2 years. MDA was associated with improved PROs, including QoL, through 2 years.
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收藏
页码:1529 / 1535
页数:7
相关论文
共 15 条
  • [1] Burden of Disease: Psoriasis and Psoriatic Arthritis
    Boehncke, Wolf-Henning
    Menter, Alan
    [J]. AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, 2013, 14 (05) : 377 - 388
  • [2] Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment
    Coates, L. C.
    Fransen, J.
    Helliwell, P. S.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2010, 69 (01) : 48 - 53
  • [3] Validation of Minimal Disease Activity Criteria for Psoriatic Arthritis Using Interventional Trial Data
    Coates, Laura C.
    Helliwell, Philip S.
    [J]. ARTHRITIS CARE & RESEARCH, 2010, 62 (07) : 965 - 969
  • [4] Frequency, Predictors, and Prognosis of Sustained Minimal Disease Activity in an Observational Psoriatic Arthritis Cohort
    Coates, Laura C.
    Cook, Richard
    Lee, Ker-Ai
    Chandran, Vinod
    Gladman, Dafna D.
    [J]. ARTHRITIS CARE & RESEARCH, 2010, 62 (07) : 970 - 976
  • [5] Coates LC, 2016, ARTHRITIS RHEUMA S10, V68
  • [6] Minimal Disease Activity and Anti-Tumor Necrosis Factor Therapy in Psoriatic Arthritis
    Haddad, Amir
    Thavaneswaran, Arane
    Ruiz-Arruza, Ioana
    Pellett, Fawnda
    Chandran, Vinod
    Cook, Richard J.
    Gladman, Dafna D.
    [J]. ARTHRITIS CARE & RESEARCH, 2015, 67 (06) : 842 - 847
  • [7] Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo-Controlled Study
    Kavanaugh, Arthur
    van der Heijde, Desiree
    Beutler, Anna
    Gladman, Dafna
    Mease, Philip
    Krueger, Gerald G.
    McInnes, Iain B.
    Helliwell, Philip
    Coates, Laura C.
    Xu, Stephen
    [J]. ARTHRITIS CARE & RESEARCH, 2016, 68 (02) : 267 - 274
  • [8] Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial
    McInnes, Iain B.
    Mease, Philip J.
    Kirkham, Bruce
    Kavanaugh, Arthur
    Ritchlin, Christopher T.
    Rahman, Proton
    Van der Heijde, Desiree
    Landewe, Robert
    Conaghan, Philip G.
    Gottlieb, Alice B.
    Richards, Hanno
    Pricop, Luminita
    Ligozio, Gregory
    Patekar, Manmath
    Mpofu, Shephard
    [J]. LANCET, 2015, 386 (9999) : 1137 - 1146
  • [9] McInnes IB, 2016, ARTHRITIS RHEUMA S10, V68
  • [10] Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT
    Mease, Philip J.
    Heckaman, Michele
    Kary, Sonja
    Kupper, Hartmut
    [J]. JOURNAL OF RHEUMATOLOGY, 2013, 40 (05) : 647 - 652