Secukinumab efficacy in anti-TNF-naive and anti-TNF-experienced subjects with active ankylosing spondylitis: results from the MEASURE 2 Study

被引:135
|
作者
Sieper, Joachim [1 ]
Deodhar, Atul [2 ]
Marzo-Ortega, Helena [3 ,4 ]
Aelion, Jacob A. [5 ]
Blanco, Ricardo [6 ]
Jui-Cheng, Tseng [7 ]
Andersson, Mats [8 ]
Porter, Brian [9 ]
Richards, Hanno B. [8 ]
机构
[1] Charite, Berlin, Germany
[2] Oregon Hlth & Sci Univ, Portland, OR 97201 USA
[3] Univ Leeds, Leeds Teaching Hosp NHS Trust, NIHR Leeds Musculoskeletal Biomed Res Unit, Leeds, W Yorkshire, England
[4] Univ Leeds, Leeds Inst Rheumat & Musculoskeletal Med, Leeds, W Yorkshire, England
[5] Arthrit Clin, Jackson, TN USA
[6] Hosp Univ Marques Valdecilla, IDIVAL, Santander, Spain
[7] Kaohsiung Vet Gen Hosp, Kaohsiung, Taiwan
[8] Novartis Pharma AG, Basel, Switzerland
[9] Novartis Pharmaceut, E Hanover, NJ USA
关键词
PLACEBO-CONTROLLED TRIAL; ANTI-INTERLEUKIN-17A MONOCLONAL-ANTIBODY; DOUBLE-BLIND; PSORIATIC-ARTHRITIS; SAFETY; INTERLEUKIN-17A; MULTICENTER; ADALIMUMAB; INHIBITOR; THERAPY;
D O I
10.1136/annrheumdis-2016-210023
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background There is significant unmet need in patients with ankylosing spondylitis (AS) who have inadequate response or intolerance to anti-tumour necrosis factor (TNF) treatment. Secukinumab, an antiinterleukin- 17A monoclonal antibody, significantly improved signs and symptoms of AS in the MEASURE 2 study (NCT01649375). Methods Subjects with active AS (N=219) received secukinumab (150 or 75 mg) or placebo at baseline, weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Randomisation was stratified by prior anti-TNF use: antiTNF- naive or inadequate response/intolerance to one anti-TNF (anti-TNF-IR). The primary endpoint was Assessment of SpondyloArthritis International Society criteria (ASAS) 20 at week 16. Results At week 16, 68.2% of anti-TNF-naive subjects treated with secukinumab 150 mg achieved ASAS20 compared with 31.1% treated with placebo (p<0.001). In the anti-TNF-IR group, 50.0% of subjects treated with secukinumab 150 mg achieved an ASAS20 response compared with 24.1% treated with placebo (p<0.05). Numerically greater improvements were observed with secukinumab than with placebo for most secondary endpoints. Clinical responses were sustained through week 52. Conclusions Secukinumab 150 mg provided sustained improvements in signs and symptoms of AS in anti-TNFnaive and anti-TNF-IR subjects through 52 weeks of therapy.
引用
收藏
页码:571 / 575
页数:5
相关论文
共 50 条
  • [1] NETAKIMAB EFFICACY IN ANTI-TNF-NAIVE AND ANTI-TNF-EXPERIENCED PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL
    Erdes, S.
    Mazurov, V.
    Dubinina, T.
    Gaydukova, I.
    Kundzer, A.
    Soroka, N.
    Eremeeva, A.
    ANNALS OF THE RHEUMATIC DISEASES, 2021, 80 : 726 - 727
  • [2] SECUKINUMAB EFFICACY IN ANTI-TNF-NAIVE PATIENTS AND PATIENTS PREVIOUSLY EXPOSED TO ANTI-TNF THERAPY: RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY (MEASURE 2) IN ACTIVE ANKYLOSING SPONDYLITIS
    Sieper, J.
    Braun, J.
    Baraliakos, X.
    Baeten, D. L.
    Dougados, M.
    Emery, P.
    Deodhar, A.
    Porter, B.
    Andersson, M.
    Richards, H.
    ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 : 272 - 272
  • [3] Secukinumab Efficacy in Anti-TNF-Naive Patients and Patients Previously Exposed to Anti-TNF Therapy: Results of A Randomized, Double-Blind, Placebo- Controlled Phase 3 Study (MEASURE 2) in Active Ankylosing Spondylitis
    Jean, Dudler
    Braun, J.
    Baraliakos, X.
    Baeten, D.
    Dougados, M.
    Emery, P.
    Deodhar, A.
    Porter, B.
    Andersson, M.
    Richards, H.
    SWISS MEDICAL WEEKLY, 2016, 146 : 7S - 7S
  • [4] Comparison of Anti-TNF-Naive and Anti-TNF-Experienced Patients with Rheumatoid Arthritis at Initiation of Treatment with Adalimumab: Baseline Results of the Optimization of Humira Trial
    Pope, Janet
    Thorne, Carter
    Haraoui, Boulos
    Psaradellis, Fotoula
    Sampalis, John
    JOURNAL OF RHEUMATOLOGY, 2009, 36 (11) : 2603 - 2603
  • [5] Effectiveness of a supervised group exercise therapy based on the biopsychosocial model introduced simultaneously with anti-TNF therapy in anti-TNF-naive patients with active ankylosing spondylitis
    Karaca, Nur Banu
    Unal, Edibe
    Karakaya, Jale
    Kalyoncu, Umut
    Kiraz, Sedat
    TURKISH JOURNAL OF MEDICAL SCIENCES, 2022, 52 (03) : 667 - +
  • [6] SECUKINUMAB EFFICACY IN ANTI-TNF-NAIVE AND ANTI-TNF-IR PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS OF A PHASE 3 MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY (FUTURE 2)
    Kavanaugh, A.
    McInnes, I. B.
    Hall, S.
    Chinoy, H.
    Kivitz, A.
    Kandala, S.
    Patekar, M.
    Mpofu, S.
    ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 : 345 - 346
  • [7] SECUKINUMAB PROVIDES SUSTAINED IMPROVEMENTS IN THE SIGNS AND SYMPTOMS OF ACTIVE ANKYLOSING SPONDYLITIS IN ANTI-TNF-NAIVE PATIENTS AND THOSE PREVIOUSLY EXPOSED TOANTI-TNF THERAPY: 52-WEEK RESULTS FROM TWO INTERNATIONAL PHASE 3 TRIALS
    Deodhar, Atul
    Baeten, Dominique
    Blanco, Ricardo
    Sieper, Joachim
    Martin, Ruvie
    Porter, Brian
    Richards, Hanno
    JCR-JOURNAL OF CLINICAL RHEUMATOLOGY, 2016, 22 (03) : 137 - 138
  • [8] Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Ankylosing Spondylitis in Anti-TNF-Naive Patients and Those Previously Exposed to Anti-TNF Therapy: 52-Week Results from Two Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials
    Baeten, Dominique
    Blanco, Ricardo
    Geusens, Piet
    Sieper, Joachim
    Tseng Jui-Cheng
    Martin, Ruvie
    Porter, Brian
    Richards, Hanno
    ARTHRITIS & RHEUMATOLOGY, 2015, 67
  • [9] Factors affecting discontinuation of adalimumab and etanercept therapy in anti-TNF-naive patients with ankylosing spondylitis: Nationwide population-based cohort study
    Chen, Hsin-Hua
    Chen, Yi-Ming
    Lai, Kuo-Lung
    Lin, Ching-Heng
    Tang, Chao-Hsiung
    Chen, Der-Yuan
    MODERN RHEUMATOLOGY, 2015, 25 (06) : 903 - 907
  • [10] A cost efficacy analysis on anti-TNF therapy in ankylosing spondylitis
    Singh, G
    Tandon, N
    Bala, M
    VALUE IN HEALTH, 2004, 7 (06) : 663 - 664