Greater cumulative benefits from ixekizumab versus ustekinumab treatment over 52 weeks for patients with moderate-to-severe psoriasis in a randomized, double-blinded phase 3b clinical trial

被引:10
作者
Blauvelt, Andrew [1 ]
Lomaga, Mark [2 ]
Burge, Russel [3 ,4 ]
Zhu, Baojin [3 ]
Shen, Wei [3 ]
Shrom, David [3 ]
Dossenbach, Martin [5 ]
Pinter, Andreas [6 ]
机构
[1] Oregon Med Res Ctr, 9495 SW Locust St,Suite G, Portland, OR 97223 USA
[2] DermEdge Res, Mississauga, ON, Canada
[3] Eli Lilly & Co, Indianapolis, IN 46285 USA
[4] Univ Cincinnati, Winkle Coll Pharm, Div Pharmaceut Sci, Cincinnati, OH USA
[5] Eli Lilly Reg Operat GmbH, Vienna, Austria
[6] Univ Hosp Frankfurt, Dept Dermatol Venerol & Allergol, Frankfurt, Germany
关键词
Cumulative clinical benefits; ixekizumab; ustekinumab; interleukin-17A; psoriasis; LIFE-COURSE IMPAIRMENT;
D O I
10.1080/09546634.2019.1587146
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background: Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, has shown superiority to ustekinumab (UST) and etanercept in skin clearance from randomized clinical trials in patients with moderate-to-severe psoriasis.Objective: To compare cumulative benefits of IXE versus UST over 52weeks of treatment.Methods: Cumulative clinical benefit of IXE and UST was assessed by evaluating the area under the curve (AUC) for responders of Psoriasis Area and Severity Index (PASI), itch numeric rating scale (Itch NRS), and Dermatology Life Quality Index (DLQI) outcomes over 52weeks using data from IXORA-S trial comparing IXE (N=136) and UST (N=166). Normalized cumulative benefit was calculated to obtain the percentage of the maximum AUC for each outcome measure. Missing values were imputed using non-responder imputation.Results: Significantly greater cumulative benefits were obtained for IXE compared with UST. Normalized cumulative benefit with IXE versus UST for PASI 75/90/100, Itch NRS (0), and DLQI (0,1) were 83.1% and 67.6%; 68.9% and 46.5%; 41.1% and 23.4%; 40.4% and 30.9%; and 62.2% and 46.6%, respectively. Cumulative clinical benefit ratios for IXE:UST were 1.23 for PASI 75, 1.48 for PASI 90, and 1.76 for PASI 100, indicating an increase in the cumulative clinical benefit for IXE versus UST as the clearance levels increased.Conclusions: IXE showed greater cumulative clinical benefit than UST.
引用
收藏
页码:141 / 146
页数:6
相关论文
共 13 条
[1]   Assessing the overall benefit of a medication: cumulative benefit of secukinumab over time in patients with moderate-to-severe plaque psoriasis [J].
Armstrong, April W. ;
Feldman, Steven R. ;
Korman, Neil J. ;
Meng, Xiangyi ;
Guana, Adriana ;
Nyirady, Judit ;
Herrera, Vivian ;
Zhao, Yang .
JOURNAL OF DERMATOLOGICAL TREATMENT, 2017, 28 (03) :200-205
[2]   DERMATOLOGY LIFE QUALITY INDEX (DLQI) - A SIMPLE PRACTICAL MEASURE FOR ROUTINE CLINICAL USE [J].
FINLAY, AY ;
KHAN, GK .
CLINICAL AND EXPERIMENTAL DERMATOLOGY, 1994, 19 (03) :210-216
[3]   Treatment Approaches to Moderate to Severe Psoriasis [J].
Gisondi, Paolo ;
Del Giglio, Micol ;
Girolomoni, Giampiero .
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, 2017, 18 (11)
[4]  
Institute for Clinical and Economic Review, 2001, ICER PSOR UPD REP AD
[5]   Psoriasis: is the impairment to a patient's life cumulative? [J].
Kimball, A. B. ;
Gieler, U. ;
Linder, D. ;
Sampogna, F. ;
Warren, R. B. ;
Augustin, M. .
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2010, 24 (09) :989-1004
[6]  
Liu L, 2016, J INFLAMM RES, V9, P39, DOI [10.2147/JIR.S100940, 10.3993/jfbim00203]
[7]  
Mattei PL, 2013, CURR PROBL DERMATOL, V44, P82, DOI 10.1159/000350008
[8]   Gender and age significantly determine patient needs and treatment goals in psoriasis - a lesson for practice [J].
Maul, J. -T. ;
Navarini, A. A. ;
Sommer, R. ;
Anzengruber, F. ;
Sorbe, C. ;
Mrowietz, U. ;
Drach, M. ;
Blome, C. ;
Boehncke, W. -H. ;
Thaci, D. ;
Reich, K. ;
von Kiedrowski, R. ;
Koerber, A. ;
Yawalkar, N. ;
Mainetti, C. ;
Laffitte, E. ;
Streit, M. ;
Rustenbach, S. ;
Conrad, C. ;
Borradori, L. ;
Gilliet, M. ;
Cozzio, A. ;
Itin, P. ;
Hausermann, P. ;
French, L. E. ;
Radtke, M. A. ;
Augustin, M. .
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2019, 33 (04) :700-708
[9]   Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: Results from IXORA-S, a phase 3 study [J].
Paul, Carle ;
Griffiths, Christopher E. M. ;
van de Kerkhof, Peter C. M. ;
Puig, Lluis ;
Dutronc, Yves ;
Henneges, Carsten ;
Dossenbach, Martin ;
Hollister, Kristin ;
Reich, Kristian .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2019, 80 (01) :70-+
[10]   Comparison of ixekizumab with ustekinumab in moderate-to-severe psoriasis: 24-week results from IXORA-S, a phase III study [J].
Reich, K. ;
Pinter, A. ;
Lacour, J. P. ;
Ferrandiz, C. ;
Micali, G. ;
French, L. E. ;
Lomaga, M. ;
Dutronc, Y. ;
Henneges, C. ;
Wilhelm, S. ;
Hartz, S. ;
Paul, C. .
BRITISH JOURNAL OF DERMATOLOGY, 2017, 177 (04) :1014-1023