Comparison of three methods for measuring psoriasis severity in clinical studies (Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment
dc.contributor.author | Chow, C. | en_US |
dc.contributor.author | Simpson, M.J. | en_US |
dc.contributor.author | Luger, T.A. | en_US |
dc.contributor.author | Chubb, H. | en_US |
dc.contributor.author | Ellis, C.N. | en_US |
dc.date.accessioned | 2015-07-01T20:56:29Z | |
dc.date.available | 2016-08-08T16:18:39Z | en |
dc.date.issued | 2015-07 | en_US |
dc.identifier.citation | Chow, C.; Simpson, M.J.; Luger, T.A.; Chubb, H.; Ellis, C.N. (2015). "Comparison of three methods for measuring psoriasis severity in clinical studies (Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment." Journal of the European Academy of Dermatology and Venereology 29(7): 1406-1414. | en_US |
dc.identifier.issn | 0926-9959 | en_US |
dc.identifier.issn | 1468-3083 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/111966 | |
dc.description.abstract | BackgroundAccurate and reliable assessment of changes in psoriasis severity is critical in clinical trials of therapies.ObjectiveTo compare Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment (sPGA), and the Lattice System Physician's Global Assessment (LS‐PGA) in a trial of systemic treatments for plaque psoriasis vulgaris and to assess whether they measure change in psoriasis induced by therapy.MethodsPatients were randomized to voclosporin or cyclosporine for 24 weeks (the ‘24‐week‐treatment’ group, n = 366), or placebo for 12 weeks followed by voclosporin for 12 weeks (the ‘initial‐placebo’ group, n = 89).ResultsAll scoring systems changed in concert and were sensitive enough to detect reductions in severity during placebo therapy as well as with active therapy (P < 0.01 for each measurement). At study onset, there were poorer correlations of sPGA with PASI (r = 0.45) and LS‐PGA (r = 0.39) than between PASI and LS‐PGA (r = 0.68). After therapy, all correlations were stronger, but sPGA continued to be less well correlated (with PASI, r = 0.85; with LS‐PGA, r = 0.79) than LS‐PGA with PASI (r = 0.90). Two‐ or three‐step improvements in LS‐PGA showed very good to excellent accuracy in corresponding to PASI‐50 and PASI‐75, respectively, and were more accurate than comparable changes in sPGA.ConclusionPASI, sPGA and LS‐PGA are responsive to the varying degrees of improvement in psoriasis induced by either placebo or active therapy. While the three systems capture similar information, each has different reasons for use in a clinical trial. | en_US |
dc.publisher | Wiley Periodicals, Inc. | en_US |
dc.title | Comparison of three methods for measuring psoriasis severity in clinical studies (Part 1 of 2): change during therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Dermatology | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/111966/1/jdv13132.pdf | |
dc.identifier.doi | 10.1111/jdv.13132 | en_US |
dc.identifier.source | Journal of the European Academy of Dermatology and Venereology | en_US |
dc.identifier.citedreference | Wittkowski KM, Leonardi C, Gottlieb A et al. Clinical symptoms of skin, nails, and joints manifest independently in patients with concomitant psoriasis and psoriatic arthritis. PLoS ONE 2011; 6: e20279. | en_US |
dc.identifier.citedreference | Jensen JD, Fujita M, Dellavalle RP. Validation of psoriasis clinical severity and outcome measures: searching for a gold standard. Arch Dermatol 2010; 147: 95 – 98. | en_US |
dc.identifier.citedreference | Long CC, Finlay AY, Averill RW. The rule of hand: 4 Hand Areas = 2 FTU = 1 g. Arch Dermatol 1992; 128: 1129 – 1130. | en_US |
dc.identifier.citedreference | Simpson MJ, Chow C, Morgenstern H, Luger TA, Ellis CN. Comparison of three methods for measuring psoriasis severity in clinical studies (Part 2 of 2): Use of quality of life to assess construct validity of the Lattice System Physician's Global Assessment, Psoriasis Area and Severity Index, and Static Physician's Global Assessment. JEADV 2015; in press. | en_US |
dc.identifier.citedreference | Paul C, Gourraud P‐A, Bronsard V et al. Evidence‐based recommendations to assess psoriasis severity: systematic literature review and expert opinion of a panel of dermatologists. J Eur Acad Dermatol Venereol 2010; 24 ( Suppl 2 ): 2 – 9. | en_US |
dc.identifier.citedreference | Puzenat E, Bronsard V, Prey S et al. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol 2010; 24 ( Suppl 2 ): 10 – 16. | en_US |
dc.identifier.citedreference | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline for good clinical practice [Internet]. 1996. European Medicines Agency. URL http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (last accessed: 6 February 2015). | en_US |
dc.identifier.citedreference | Chandran V, Gottlieb A, Cook RJ et al. International multicenter psoriasis and psoriatic arthritis reliability trial for the assessment of skin, joints, nails, and dactylitis. Arthritis Rheum 2009; 61: 1235 – 1242. | en_US |
dc.identifier.citedreference | Ellis CN, Barker JN, Haig AE, Parker CA, Daly S, Jayawardene DA. Placebo response in two long‐term randomized psoriasis studies that were negative for rosiglitazone. Am J Clin Dermatol 2007; 8: 93 – 102. | en_US |
dc.identifier.citedreference | Lamel SA, Myer KA, Younes N, Zhou JA, Maibach H, Maibach HI. Placebo response in relation to clinical trial design: a systematic review and meta‐analysis of randomized controlled trials for determining biologic efficacy in psoriasis treatment. Arch Dermatol Res 2012; 304: 707 – 717. | en_US |
dc.identifier.citedreference | Chren MM. Giving “scale” new meaning in dermatology: measurement matters. Arch Dermatol 2000; 136: 788 – 790. | en_US |
dc.identifier.citedreference | Jacobson CC, Kimball AB. Rethinking the Psoriasis Area and Severity Index: the impact of area should be increased. Br J Dermatol 2004; 151: 381 – 387. | en_US |
dc.identifier.citedreference | Robinson A, Kardos M, Kimball AB. Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): Why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis. J Am Acad Dermatol 2012; 66: 369 – 375. | en_US |
dc.identifier.citedreference | Naldi L. Scoring and monitoring the severity of psoriasis. What is the preferred method? What is the ideal method? Is PASI passé? Facts and controversies. Clin Dermatol 2010; 28: 67 – 72. | en_US |
dc.identifier.citedreference | Krueger GG, Feldman SR, Camisa C et al. Two considerations for patients with psoriasis and their clinicians: what defines mild, moderate, and severe psoriasis? What constitutes a clinically significant improvement when treating psoriasis? J Am Acad Dermatol 2000; 43: 281 – 285. | en_US |
dc.identifier.citedreference | Carlin CS, Feldman SR, Krueger JG, Menter A, Krueger GG. A 50% reduction in the Psoriasis Area and Severity Index (PASI 50) is a clinically significant endpoint in the assessment of psoriasis. J Am Acad Dermatol 2004; 50: 859 – 866. | en_US |
dc.identifier.citedreference | Schäfer I, Hacker J, Rustenbach SJ, Radtke M, Franzke N, Augustin M. Concordance of the Psoriasis Area and Severity Index (PASI) and patient‐reported outcomes in psoriasis treatment. Eur J Dermatol 2010; 20: 62 – 67. | en_US |
dc.identifier.citedreference | European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. 2004. URL www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf (last accessed: 6 February 2015). | en_US |
dc.identifier.citedreference | Spuls PI, Lecluse LL, Poulsen ML, Bos JD, Stern RS, Nijsten T. How good are clinical severity and outcome measures for psoriasis?: quantitative evaluation in a systematic review. J Invest Dermatol 2010; 130: 933 – 943. | en_US |
dc.identifier.citedreference | Naldi L, Svensson A, Diepgen T et al. Randomized clinical trials for psoriasis 1977‐2000: the EDEN survey. J Invest Dermatol 2003; 120: 738 – 741. | en_US |
dc.identifier.citedreference | Marks R, Barton SP, Shuttleworth D, Finlay AY. Assessment of disease progress in psoriasis. Arch Dermatol 1989; 125: 235 – 240. | en_US |
dc.identifier.citedreference | Bigby M, Gadenne AS. Understanding and evaluating clinical trials. J Am Acad Dermatol 1996; 34: 555 – 590. | en_US |
dc.identifier.citedreference | McKenna KE, Stern RS. The outcomes movement and new measures of the severity of psoriasis. J Am Acad Dermatol 1996; 34: 534 – 538. | en_US |
dc.identifier.citedreference | van de Kerkhof PC. The Psoriasis Area and Severity Index and alternative approaches for the assessment of severity: persisting areas of confusion. Br J Dermatol 1997; 137: 661 – 662. | en_US |
dc.identifier.citedreference | Ashcroft DM, Wan Po AL, Williams HC, Griffiths CE. Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol 1999; 141: 185 – 191. | en_US |
dc.identifier.citedreference | Chalmers RJ, Griffiths CE. Resetting the research agenda for psoriasis. J Invest Dermatol 2003; 120: ix – x. | en_US |
dc.identifier.citedreference | Langley RG, Ellis CN. Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System – Physician's Global Assessment. J Am Acad Dermatol 2004; 51: 563 – 569. | en_US |
dc.identifier.citedreference | Jemec GB, Wulf HC. The applicability of clinical scoring systems: SCORAD and PASI in psoriasis and atopic dermatitis. Acta Derm Venereol 1997; 77: 392 – 393. | en_US |
dc.identifier.citedreference | Fredriksson T, Pettersson U. Severe psoriasis—oral therapy with a new retinoid. Dermatologica 1978; 157: 238 – 244. | en_US |
dc.identifier.citedreference | Finlay AY, Gibson SL. Error in the original description of the psoriasis area and severity index. Br J Dermatol 1998; 139: 534. | en_US |
dc.identifier.citedreference | Harari M, Shani J, Hristakieva E, Stanimirovic A, Seidl W, Burdo A. Clinical evaluation of a more rapid and sensitive Psoriasis Assessment Severity Score (PASS), and its comparison with the classic method of Psoriasis Area and Severity Index (PASI), before and after climatotherapy at the Dead‐Sea. Int J Dermatol 2000; 39: 913 – 918. | en_US |
dc.identifier.citedreference | Berth‐Jones J, Grotzinger K, Rainville C et al. A study examining inter‐ and intrarater reliability of three scales for measuring severity of psoriasis: Psoriasis Area and Severity Index, Physician's Global Assessment and Lattice System – Physician's Global Assessment. Br J Dermatol 2006; 155: 707 – 713. | en_US |
dc.identifier.citedreference | Puig L. Shortcomings of PASI75 and practical calculation of PASI area component. J Am Acad Dermatol 2013; 68: 180 – 181. | en_US |
dc.identifier.citedreference | Schmitt J, Wozel G. The Psoriasis Area and Severity Index is the adequate criterion to define severity in chronic plaque‐type psoriasis. Dermatology 2005; 210: 194 – 199. | en_US |
dc.identifier.citedreference | Feldman SR. A quantitative definition of severe psoriasis for use in clinical trials. J Dermatolog Treat 2004; 15: 27 – 29. | en_US |
dc.identifier.citedreference | Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis 2005; 64 ( Suppl 2 ): ii65 – ii68; discussion ii69‐73. | en_US |
dc.identifier.citedreference | McGuire J Jr, Mindel J, Rosenberg W et al. Dermatologic and Ophthalmic Drugs Advisory Committee 49th meeting, Open Session [Internet]. U.S. Food and Drug Administration; March 1998. URL http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3402t2.pdf (last accessed: 6 February 2015). | en_US |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
Files in this item
Remediation of Harmful Language
The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.
Accessibility
If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.