Inclusion and exclusion criteria in phase III trials with systemic agents in psoriasis: the external validity of drug development

被引:22
作者
Kirsten, N. [1 ]
Livideanu, C. Bulai [1 ]
Richard, M. A. [2 ,3 ]
Konstantinou, M. P. [1 ]
Khemis, A. [4 ,5 ]
Balluteaud, C. [1 ]
Goujon, C. [6 ]
Beylot-Barry, M. [7 ,8 ]
Paul, C. [1 ]
机构
[1] Toulouse Univ, Larrey Hosp, Dept Dermatol, 24 Chemin Pouvourville, F-31059 Toulouse 9, France
[2] Marseille Univ, Marseille, France
[3] La Timone Hosp, Marseille, France
[4] Univ Nice, Nice, France
[5] LArchet 2 Hosp, Nice, France
[6] Lyon Sud Hosp, Hosp Civils Lyon, Lyon, France
[7] Bordeaux Univ, Bordeaux, France
[8] St Andre Hosp, Bordeaux, France
关键词
REGISTRY; PSOLAR; RISK;
D O I
10.1111/bjd.14622
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100227 [皮肤病学];
摘要
引用
收藏
页码:636 / 638
页数:3
相关论文
共 8 条
[1]
Garcia-Doval I, 2012, ARCH DERMATOL, V148, P463, DOI 10.1001/archdermatol.2011.2768
[2]
International Council for Harmonisation, 2000, SAF PHARM STUD HUM P
[3]
Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR) [J].
Kalb, Robert E. ;
Fiorentino, David F. ;
Lebwohl, Mark G. ;
Toole, John ;
Poulin, Yves ;
Cohen, Arnon D. ;
Goyal, Kavitha ;
Fakharzadeh, Steven ;
Calabro, Stephen ;
Chevrier, Marc ;
Langholff, Wayne ;
You, Yin ;
Leonardi, Craig L. .
JAMA DERMATOLOGY, 2015, 151 (09) :961-969
[4]
Impact of Body Mass Index and Obesity on Clinical Response to Systemic Treatment for Psoriasis [J].
Naldi, Luigi ;
Addis, Antonio ;
Chimenti, Sergio ;
Giannetti, Alberto ;
Picardo, Mauro ;
Tomino, Carlo ;
Maccarone, Mara ;
Chatenoud, Liliane ;
Bertuccio, Paola ;
Caggese, Eugenia ;
Cuscito, Rosanna .
DERMATOLOGY, 2008, 217 (04) :365-373
[5]
Papp KA, 2012, J DRUGS DERMATOL, V11, P1210
[6]
Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest [J].
Reich, K. ;
Mrowietz, U. ;
Radtke, M. A. ;
Thaci, D. ;
Rustenbach, S. J. ;
Spehr, C. ;
Augustin, M. .
ARCHIVES OF DERMATOLOGICAL RESEARCH, 2015, 307 (10) :875-883
[7]
Sample size slippages in randomised trials: exclusions and the lost and wayward [J].
Schulz, KF ;
Grimes, DA .
LANCET, 2002, 359 (9308) :781-785
[8]
Sobell JM, 2014, SEMIN CUTAN MED SURG, V33, pS69, DOI 10.12788/j.sder.0098