Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial

被引:123
作者
Gottlieb, Alice [1 ]
Sullivan, John [2 ]
van Doorn, Martijn [3 ]
Kubanov, Alexey [4 ]
You, Ruquan [5 ]
Parneix, Anne [6 ]
Hugot, Sophie [7 ]
Milutinovic, Marina [7 ]
机构
[1] New York Med Coll, Dept Dermatol, Valhalla, NY 10595 USA
[2] Holdsworth House Med Practice, Darlinghurst, NSW, Australia
[3] Erasmus MC, Rotterdam, Netherlands
[4] State Sci Ctr Dermatol Venereol & Cosmetol, Moscow, Russia
[5] Beijing Novartis Pharma Co Ltd, Shanghai, Peoples R China
[6] Novartis Pharmaceut, E Hanover, NJ USA
[7] Novartis Pharma AG, Basel, Switzerland
关键词
palmoplantar psoriasis; clear or almost clear skin; clinical trial; secukinumab; superiority; quality of life; SEVERE PLAQUE PSORIASIS; QUALITY-OF-LIFE; DOUBLE-BLIND; CLINICAL-PRACTICE; MODERATE; SAFETY; BIOLOGICS; SEVERITY; THERAPY; LESIONS;
D O I
10.1016/j.jaad.2016.07.058
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background: Plaque psoriasis affecting palms and soles is disabling and often resistant to treatment. Objective: Evaluate the efficacy and safety of secukinumab, an anti-interleukin 17A antibody, in subjects with palmoplantar psoriasis. Methods: In this double-blinded, randomized controlled trial, 205 subjects were randomized 1: 1: 1 to secukinumab 300 mg, 150 mg, or placebo. The primary endpoint was Palmoplantar Investigator's Global Assessment (ppIGA) 0 (clear) or 1 (almost clear/minimal) response at week 16. Results: At week 16, the percentage of subjects who achieved clear or almost clear palms and soles (or ppIGA 0/1) with secukinumab 300 mg (33.3%) and 150 mg (22.1%) was superior to the percentage achieved with placebo (1.5%, P < . 001). Palmoplantar Psoriasis Area and Severity Index (ppPASI) was significantly reduced with secukinumab 300 mg (-54.5%) and 150 mg (-35.3%) compared with placebo (-4.0%, P < . 001). Dermatology Life Quality Index (DLQI) 0/1 responses from subjects in the secukinumab groups were also significantly higher compared with placebo at week 16 (P < . 01) and pain and function of palms and soles was markedly improved with secukinumab as measured by the palmoplantar Quality-of-Life Instrument. Secukinumab 300 mg consistently showed the best outcomes. The safety profile was favorable and similar to previous studies. Limitations: Lack of active comparator. Conclusion: In GESTURE, the largest randomized controlled trial in palmoplantar psoriasis, secukinumab demonstrated the greatest efficacy to date for treating difficult-to-treat psoriasis.
引用
收藏
页码:70 / 80
页数:11
相关论文
共 31 条
[21]   National Psoriasis Foundation clinical consensus on disease severity [J].
Pariser, David M. ;
Bagel, Jerry ;
Gelfand, Joel M. ;
Korman, Neil J. ;
Ritchlin, Christopher T. ;
Strober, Bruce E. ;
Van Voorhees, Abby S. ;
Young, Melodie ;
Rittenberg, Sheila ;
Lebwohl, Mark G. ;
Horn, Elizabeth J. .
ARCHIVES OF DERMATOLOGY, 2007, 143 (02) :239-242
[22]   Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE) [J].
Paul, C. ;
Lacour, J. -P. ;
Tedremets, L. ;
Kreutzer, K. ;
Jazayeri, S. ;
Adams, S. ;
Guindon, C. ;
You, R. ;
Papavassilis, C. .
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2015, 29 (06) :1082-1090
[23]   Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial [J].
Paul, C. ;
Reich, K. ;
Gottlieb, A. B. ;
Mrowietz, U. ;
Philipp, S. ;
Nakayama, J. ;
Harfst, E. ;
Guettner, A. ;
Papavassilis, C. .
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2014, 28 (12) :1670-1675
[24]   Patients with palmoplantar psoriasis have more physical disability and discomfort than patients with other forms of psoriasis: Implications for clinical practice [J].
Pettey, AA ;
Balkrishnan, R ;
Rapp, SR ;
Fleischer, AB ;
Feldman, SR .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2003, 49 (02) :271-275
[25]   Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study [J].
Rich, P. ;
Sigurgeirsson, B. ;
Thaci, D. ;
Ortonne, J. -P. ;
Paul, C. ;
Schopf, R. E. ;
Morita, A. ;
Roseau, K. ;
Harfst, E. ;
Guettner, A. ;
Machacek, M. ;
Papavassilis, C. .
BRITISH JOURNAL OF DERMATOLOGY, 2013, 168 (02) :402-411
[26]   Prioritizing the global research agenda in psoriasis: an International Psoriasis Council Delphi consensus exercise [J].
Strober, B. E. ;
Griffiths, C. E. M. ;
O'Dell, S. J. ;
Tebbey, P. W. ;
Barker, J. N. W. N. .
BRITISH JOURNAL OF DERMATOLOGY, 2016, 174 (01) :212-215
[27]   Biologics are more potent than other treatment modalities for improvement of quality of life in psoriasis patients [J].
Takahashi, Hidetoshi ;
Iinuma, Shin ;
Tsuji, Hitomi ;
Honma, Masaru ;
Iizuka, Hajime .
JOURNAL OF DERMATOLOGY, 2014, 41 (08) :686-689
[28]   Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial [J].
Thaci, Diamant ;
Blauvelt, Andrew ;
Reich, Kristian ;
Tsai, Tsen-Fang ;
Vanaclocha, Francisco ;
Kingo, Kuelli ;
Ziv, Michael ;
Pinter, Andreas ;
Hugot, Sophie ;
You, Ruquan ;
Milutinovic, Marina .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2015, 73 (03) :400-409
[29]  
Van Voorhees A, PSORIASIS PSORIATIC
[30]  
Weisman S, 2003, J Dermatolog Treat, V14, P158, DOI 10.1080/09546630310013360