Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY)

被引:34
作者
Bagel, J. [1 ]
Blauvelt, A. [2 ]
Nia, J. [3 ]
Hashim, P. [3 ]
Patekar, M. [4 ]
de Vera, A. [4 ]
Ahmad, K. [5 ]
Paguet, B. [4 ]
Xia, S. [6 ]
Muscianisi, E. [7 ]
Lebwohl, M. [3 ]
机构
[1] Psoriasis Treatment Ctr Cent New Jersey, East Windsor, NJ 08520 USA
[2] Oregon Med Res Ctr, Portland, OR USA
[3] Icahn Sch Med Mt Sinai, New York, NY 10029 USA
[4] Novartis Pharma AG, Basel, Switzerland
[5] Novartis Healthcare Pvt Ltd, Hyderabad, India
[6] Beijing Novartis Pharma Co Ltd, Shanghai, Peoples R China
[7] Novartis Pharmaceut, E Hanover, NJ USA
关键词
D O I
10.1111/jdv.16558
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background: Secukinumab demonstrated superior efficacy over ustekinumab in the treatment of moderate to severe plaque psoriasis over 16 weeks in the CLARITY study and over 52 weeks in the CLEAR study. Objective: To compare the efficacy and safety of secukinumab vs. ustekinumab over 52 weeks in CLARITY. Methods: Analysis of 52-week data from CLARITY (NCT02826603), a phase 3b study in which patients were randomized to receive secukinumab 300 mg (n = 550) or ustekinumab 45/90 mg (n = 552) per label. Results: At week 52, secukinumab was superior to ustekinumab in the proportion of patients who achieved = 90% improvement in Psoriasis Area and Severity Index (73.2% vs. 59.8%; odds ratio [OR], 1.84 [95% CI, 1.41-2.41]; P < 0.0001), Investigator's Global Assessment modified 2011 responses of clear (0) or almost clear (1) skin (76.0% vs. 60.2%; OR, 2.12 [95% CI, 1.61-2.79]; P < 0.0001) and Dermatology Life Quality Index response of no effect (0/1) (69.9% vs. 61.2%; P = 0.0028). Proportions of patients with any adverse events were comparable between treatment arms. Conclusions: This second head-to-head study confirmed the superior efficacy of secukinumab over ustekinumab in skin clearance and quality of life through 52 weeks, with safety comparable to that reported in previous trials.
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收藏
页码:135 / 142
页数:8
相关论文
共 35 条
[1]   Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis [J].
Baeten, Dominique ;
Sieper, Joachim ;
Braun, Juergen ;
Baraliakos, Xenofon ;
Dougados, Maxime ;
Emery, Paul ;
Deodhar, Atul ;
Porter, Brian ;
Martin, Ruvie ;
Andersson, Mats ;
Mpofu, Shephard ;
Richards, Hanno B. .
NEW ENGLAND JOURNAL OF MEDICINE, 2015, 373 (26) :2534-2548
[2]   Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results) [J].
Bagel, Jerry ;
Nia, John ;
Hashim, Peter W. ;
Patekar, Manmath ;
de Vera, Ana ;
Hugot, Sophie ;
Sheng, Kuan ;
Xia, Summer ;
Gilloteau, Isabelle ;
Muscianisi, Elisa ;
Blauvelt, Andrew ;
Lebwohl, Mark .
DERMATOLOGY AND THERAPY, 2018, 8 (04) :571-579
[3]   Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5years of treatment (SCULPTURE Extension Study) [J].
Bissonnette, R. ;
Luger, T. ;
Thaci, D. ;
Toth, D. ;
Lacombe, A. ;
Xia, S. ;
Mazur, R. ;
Patekar, M. ;
Charef, P. ;
Milutinovic, M. ;
Leonardi, C. ;
Mrowietz, U. .
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2018, 32 (09) :1507-1514
[4]   Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study [J].
Blauvelt, Andrew ;
Reich, Kristian ;
Tsai, Tsen-Fang ;
Tyring, Stephen ;
Vanaclocha, Francisco ;
Kingo, Kulli ;
Ziv, Michael ;
Pinter, Andreas ;
Vender, Ronald ;
Hugot, Sophie ;
You, Ruquan ;
Milutinovic, Marina ;
Thaci, Diamant .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2017, 76 (01) :60-+
[5]   Long-term safety of secukinumab in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post-marketing surveillance data [J].
Deodhar, A. ;
Mease, P. J. ;
McInnes, I. B. ;
Baraliakos, X. ;
Reich, K. ;
Blauvelt, A. ;
Leonardi, C. ;
Porter, B. ;
Gupta, A. Das ;
Widmer, A. ;
Pricop, L. ;
Fox, T. .
ARTHRITIS RESEARCH & THERAPY, 2019, 21 (1)
[6]   Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease [J].
Feagan, B. G. ;
Sandborn, W. J. ;
Gasink, C. ;
Jacobstein, D. ;
Lang, Y. ;
Friedman, J. R. ;
Blank, M. A. ;
Johanns, J. ;
Gao, L. -L. ;
Miao, Y. ;
Adedokun, O. J. ;
Sands, B. E. ;
Hanauer, S. B. ;
Vermeire, S. ;
Targan, S. ;
Ghosh, S. ;
de Villiers, W. J. ;
Colombel, J. -F. ;
Tulassay, Z. ;
Seidler, U. ;
Salzberg, B. A. ;
Desreumaux, P. ;
Lee, S. D. ;
Loftus, E. V., Jr. ;
Dieleman, L. A. ;
Katz, S. ;
Rutgeerts, P. .
NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (20) :1946-1960
[7]   Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials [J].
Griffiths, Christopher E. M. ;
Reich, Kristian ;
Lebwohl, Mark ;
van de Kerkhof, Peter ;
Paul, Carle ;
Menter, Alan ;
Cameron, Gregory S. ;
Erickson, Janelle ;
Zhang, Lu ;
Secrest, Roberta J. ;
Ball, Susan ;
Braun, Daniel K. ;
Osuntokun, Olawale O. ;
Heffernan, Michael P. ;
Nickoloff, Brian J. ;
Papp, Kim .
LANCET, 2015, 386 (9993) :541-551
[8]   Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis [J].
Griffiths, Christopher E. M. ;
Strober, Bruce E. ;
van de Kerkhof, Peter ;
Ho, Vincent ;
Fidelus-Gort, Roseanne ;
Yeilding, Newman ;
Guzzo, Cynthia ;
Xia, Yichuan ;
Zhou, Bei ;
Li, Shu ;
Dooley, Lisa T. ;
Goldstein, Neil H. ;
Menter, Alan .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (02) :118-128
[9]   Dynamic Moment Model for Numerical Simulation of a 6-DOF Plate Trajectory around an Aircraft [J].
Ignatowicz, Kevin ;
Morency, Francois ;
Lopez, Pierre .
JOURNAL OF AEROSPACE ENGINEERING, 2019, 32 (05)
[10]   Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study [J].
Kivitz, Alan J. ;
Nash, Peter ;
Tahir, Hasan ;
Everding, Andrea ;
Mann, Herman ;
Kaszuba, Andrzej ;
Pellet, Pascale ;
Widmer, Albert ;
Pricop, Luminita ;
Abrams, Ken .
RHEUMATOLOGY AND THERAPY, 2019, 6 (03) :393-407