Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5

被引:51
作者
van der Heijde, Desiree [1 ]
Mease, Philip J. [2 ,3 ]
Landewe, Robert B. M. [4 ,5 ]
Rahman, Proton [6 ]
Tahir, Hasan [7 ]
Singhal, Atul [8 ]
Boettcher, Elke [9 ]
Navarra, Sandra [10 ]
Zhu, Xuan [11 ]
Ligozio, Gregory [11 ]
Readie, Aimee [11 ]
Mpofu, Shephard [12 ]
Pricop, Luminita [11 ]
机构
[1] Leiden Univ, Dept Rheumatol, Med Ctr, Leiden, Netherlands
[2] Providence St Joseph Hlth, Swedish Med Ctr, Seattle, WA USA
[3] Univ Washington, Seattle, WA 98195 USA
[4] Univ Amsterdam, Dept Rheumatol, Amsterdam, Netherlands
[5] Atrium Med Ctr, Amsterdam, Netherlands
[6] Mem Univ, Fac Med, St John, NF, Canada
[7] Whipps Cross Hosp & Chest Clin, Rheumatol, London, England
[8] Southwest Rheumatol, Dallas, TX USA
[9] Rheumazentrum Favoriten, Vienna, Austria
[10] Univ Santo Tomas Hosp, St Lukes Med Ctr, Manila, Philippines
[11] Novartis Pharmaceut, E Hanover, NJ USA
[12] Novartis Pharma AG, Basel, Switzerland
关键词
spondylarthropathies (including psoriatic arthritis); biological therapies; immunotherapy; cytokines and inflammatory mediators; inflammation; pain assessment and management; DISEASE-ACTIVITY; DAMAGE; CRITERIA; JOINT;
D O I
10.1093/rheumatology/kez420
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective. To evaluate the effect of secukinumab on radiographic progression through 52 weeks in patients with PsA from the FUTURE 5 study. Methods. Patients with active PsA, stratified by prior anti-TNF use (naive or inadequate response), were randomized to s.c. secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load regimens or placebo at baseline, at weeks 1, 2 and 3 and every 4 weeks starting at week 4. Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers). Statistical analysis used a linear mixed-effects model (random slope) at weeks 24 and 52, and observed data at week 52. Assessments at week 52 included additional efficacy endpoints (non-responders imputation and mixed-effects models for repeated measures) and safety. Results.The majority (86.6%) of patients completed 52 weeks of treatment. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS 0.5) was 91.8, 85.2 and 87.2% in 300, 150 and 150 mg no load groups, respectively, at week 52. The change in vdH-mTSS from baseline to week 52 using random slope [mean change (s.e.)] was -0.18 (0.17), 0.11 (0.18) and -0.20 (0.18) in 300, 150 and 150 mg no load groups, respectively; the corresponding observed data [mean change (s.d.)] was -0.09 (1.02), 0.13 (1.39) and 0.21 (1.15). Clinical efficacy endpoints were sustained, and no new or unexpected safety signals were reported through 52 weeks. Conclusion. Secukinumab 300 and 150 mg with or without s.c. loading regimen provided sustained low rates of radiographic progression through 52 weeks of treatment.
引用
收藏
页码:1325 / 1333
页数:9
相关论文
共 29 条
  • [1] Predictors for radiological damage in psoriatic arthritis: results from a single centre
    Bond, Simon J.
    Farewell, Vernon T.
    Schentag, Catherine T.
    Gladman, Dafna D.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2007, 66 (03) : 370 - 376
  • [2] Inflammation in an individual joint predicts damage to that joint in psoriatic arthritis
    Cresswell, Lynne
    Chandran, Vinod
    Farewell, Vernon T.
    Gladman, Dafna D.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2011, 70 (02) : 305 - 308
  • [3] Psoriatic Arthritis
    Day, Michael Sean
    Nam, Denis
    Goodman, Susan
    Su, Edwin P.
    Figgie, Mark
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS, 2012, 20 (01) : 28 - 37
  • [4] AMERICAN-COLLEGE-OF-RHEUMATOLOGY PRELIMINARY DEFINITION OF IMPROVEMENT IN RHEUMATOID-ARTHRITIS
    FELSON, DT
    ANDERSON, JJ
    BOERS, M
    BOMBARDIER, C
    FURST, D
    GOLDSMITH, C
    KATZ, LM
    LIGHTFOOT, R
    PAULUS, H
    STRAND, V
    TUGWELL, P
    WEINBLATT, M
    WILLIAMS, HJ
    WOLFE, F
    KIESZAK, S
    [J]. ARTHRITIS AND RHEUMATISM, 1995, 38 (06): : 727 - 735
  • [5] MEASUREMENT OF PATIENT OUTCOME IN ARTHRITIS
    FRIES, JF
    SPITZ, P
    KRAINES, RG
    HOLMAN, HR
    [J]. ARTHRITIS AND RHEUMATISM, 1980, 23 (02): : 137 - 145
  • [6] Adalimumab for long-term treatment of psoriatic arthritis - Forty-eight week data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial
    Gladman, Dafna D.
    Mease, Philip J.
    Ritchlin, Christopher T.
    Choy, Ernest H. S.
    Sharp, John T.
    Ory, Peter A.
    Perdok, Renee J.
    Sasso, Eric H.
    [J]. ARTHRITIS AND RHEUMATISM, 2007, 56 (02): : 476 - 488
  • [7] Psoriatic arthritis: epidemiology, clinical features, course, and outcome
    Gladman, DD
    Antoni, C
    Mease, P
    Clegg, DO
    Nash, P
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2005, 64 : 14 - 17
  • [8] Guidelines of care for the management of psoriasis and psoriatic arthritis - Section 2. Psoriatic arthritis: Overview and guidelines of care for treatment with an emphasis on the biologics
    Gottlieb, Alice
    Korman, Neil J.
    Gordon, Kenneth B.
    Feldman, Steven R.
    Lebwohl, Mark
    Koo, John Y. M.
    Van Voorhees, Abby S.
    Elmets, Craig A. K.
    Leonardi, Craig L.
    Beutner, Karl R.
    Bhushan, Reva
    Menter, Alan
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2008, 58 (05) : 851 - 864
  • [9] Measuring clinical enthesitis in psoriatic arthritis: Assessment of existing measures and development of an instrument specific to psoriatic arthritis
    Healy, Paul J.
    Helliwell, Philip S.
    [J]. ARTHRITIS & RHEUMATISM-ARTHRITIS CARE & RESEARCH, 2008, 59 (05): : 686 - 691
  • [10] Helliwell PS, 2005, J RHEUMATOL, V32, P1745