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Ann Rheum Dis. 2005 March; 64(Suppl 2): ii49–ii54.
doi: 10.1136/ard.2004.034165.
PMCID: PMC1766888
Psoriatic arthritis assessment tools in clinical trials
P Mease, C Antoni, D Gladman, and W Taylor
Abstract
In order to measure disease activity, progression, and change with therapy in psoriatic arthritis (PsA), it is important to use accurate, reliable, and feasible outcome measures that can ideally be employed in longitudinal cohorts, clinical trials, and clinical practice. Until recently, there has been little focus on this methodology in PsA. Clinical trials and long term clinical registries have used disparate outcome measures. With emerging therapies, the focus on the methodology of outcome assessment has increased to ensure that discriminant and responsive instruments are used. The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), in conjunction with the society, Outcome Measures in Rheumatology (OMERACT), is focused on refining and developing outcome measures for a variety of disease domains reviewed in this report. Key domains to assess include joints, skin, enthesitis, dactylitis, spine, joint damage as assessed radiologically, quality of life, and function. These domains can be assessed by individual and composite measures. A number of measures have been "borrowed" from the fields of rheumatoid arthritis, ankylosing spondylitis, and psoriasis and adapted to PsA. Others are being developed specifically for PsA. Few are validated but most have been shown to perform well in distinguishing placebo from treatment response. This report reviews the current state of the art of assessment in PsA and points toward future directions of development of this field.
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Selected References
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  • Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii65–ii73. [PubMed]
  • Ory PA, Gladman DD, Mease PJ. Psoriatic arthritis and imaging. Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii55–ii57. [PubMed]
  • van der Heijde D, Sharp J, Wassenberg S, Gladman DD. Psoriatic arthritis imaging: a review of scoring methods. Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii61–ii64. [PubMed]
  • Helliwell PS, Taylor WJ. Classification and diagnostic criteria for psoriatic arthritis. Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii3–ii8. [PubMed]
  • Moll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55–78. [PubMed]
  • Gladman Dafna D, Helliwell Philip, Mease Philip J, Nash Peter, Ritchlin Christopher, Taylor William. Assessment of patients with psoriatic arthritis: a review of currently available measures. Arthritis Rheum. 2004 Jan;50(1):24–35. [PubMed]
  • Taylor William J. Assessment of outcome in psoriatic arthritis. Curr Opin Rheumatol. 2004 Jul;16(4):350–356. [PubMed]
  • DEANDRADE JR, CASAGRANDE PA. A SEVEN-DAY VARIABILITY STUDY OF 499 PATIENTS WITH PERIPHERAL RHEUMATOID ARTHRITIS. Arthritis Rheum. 1965 Apr;8:302–334. [PubMed]
  • Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, Katz LM, Lightfoot R, Jr, Paulus H, Strand V, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995 Jun;38(6):727–735. [PubMed]
  • van der Heijde DM, van 't Hof MA, van Riel PL, Theunisse LA, Lubberts EW, van Leeuwen MA, van Rijswijk MH, van de Putte LB. Judging disease activity in clinical practice in rheumatoid arthritis: first step in the development of a disease activity score. Ann Rheum Dis. 1990 Nov;49(11):916–920. [PubMed]
  • van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum. 1996 Jan;39(1):34–40. [PubMed]
  • Ritchie DM, Boyle JA, McInnes JM, Jasani MK, Dalakos TG, Grieveson P, Buchanan WW. Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis. Q J Med. 1968 Jul;37(147):393–406. [PubMed]
  • Daunt AO, Cox NL, Robertson JC, Cawley MI. Indices of disease activity in psoriatic arthritis. J R Soc Med. 1987 Sep;80(9):556–558. [PubMed]
  • Clegg DO, Reda DJ, Mejias E, Cannon GW, Weisman MH, Taylor T, Budiman-Mak E, Blackburn WD, Vasey FB, Mahowald ML, Cush JJ, Schumacher HR, Jr, Silverman SL, Alepa FP, Luggen ME, Cohen MR, Makkena R, Haakenson CM, Ward RH, Manaster BJ, Anderson RJ, Ward JR, Henderson WG. Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A Department of Veterans Affairs Cooperative Study. Arthritis Rheum. 1996 Dec;39(12):2013–2020. [PubMed]
  • Mease PJ, Goffe BS, Metz J, VanderStoep A, Finck B, Burge DJ. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 2000 Jul 29;356(9227):385–390. [PubMed]
  • Kaltwasser J Peter, Nash Peter, Gladman Dafna, Rosen Cheryl F, Behrens Frank, Jones Peter, Wollenhaupt Jürgen, Falk Franziska G, Mease Philip. Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and psoriasis: a multinational, double-blind, randomized, placebo-controlled clinical trial. Arthritis Rheum. 2004 Jun;50(6):1939–1950. [PubMed]
  • Mease PJ, Antoni CE. Psoriatic arthritis treatment: biological response modifiers. Ann Rheum Dis. 2005 Mar;64 (Suppl 2):ii78–ii82. [PubMed]
  • Mease Philip J, Kivitz Alan J, Burch Francis X, Siegel Evan L, Cohen Stanley B, Ory Peter, Salonen David, Rubenstein Joel, Sharp John T, Tsuji Wayne. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 2004 Jul;50(7):2264–2272. [PubMed]
  • Thorstensson CA, Petersson IF, Jacobsson LTH, Boegård TL, Roos EM. Reduced functional performance in the lower extremity predicted radiographic knee osteoarthritis five years later. Ann Rheum Dis. 2004 Apr;63(4):402–407. [PubMed]
  • van der Heijde DM, van't Hof MA, van Riel PL, van Leeuwen MA, van Rijswijk MH, van de Putte LB. Validity of single variables and composite indices for measuring disease activity in rheumatoid arthritis. Ann Rheum Dis. 1992 Feb;51(2):177–181. [PubMed]
  • Prevoo ML, van Riel PL, van 't Hof MA, van Rijswijk MH, van Leeuwen MA, Kuper HH, van de Putte LB. Validity and reliability of joint indices. A longitudinal study in patients with recent onset rheumatoid arthritis. Br J Rheumatol. 1993 Jul;32(7):589–594. [PubMed]
  • Fuchs HA. The use of the disease activity score in the analysis of clinical trials in rheumatoid arthritis. J Rheumatol. 1993 Nov;20(11):1863–1866. [PubMed]
  • van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845–1850. [PubMed]
  • Prevoo ML, van Gestel AM, van T Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Remission in a prospective study of patients with rheumatoid arthritis. American Rheumatism Association preliminary remission criteria in relation to the disease activity score. Br J Rheumatol. 1996 Nov;35(11):1101–1105. [PubMed]
  • van Gestel AM, Anderson JJ, van Riel PL, Boers M, Haagsma CJ, Rich B, Wells G, Lange ML, Felson DT. ACR and EULAR improvement criteria have comparable validity in rheumatoid arthritis trials. American College of Rheumatology European League of Associations for Rheumatology. J Rheumatol. 1999 Mar;26(3):705–711. [PubMed]
  • Gladman DD, Strand V, Mease PJ, Antoni C, Nash P, Kavanaugh A. OMERACT 7 psoriatic arthritis workshop: synopsis. Ann Rheum Dis. 2005 Mar;64 Suppl 2:ii115–ii116. [PubMed]
  • Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Genovese MC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Finck BK. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000 Nov 30;343(22):1586–1593. [PubMed]
  • Schiff Michael. A rationale for the use of summary measurements for the assessment of the effects of rheumatoid arthritis therapies. Clin Ther. 2003 Mar;25(3):993–1001. [PubMed]
  • Buskila D, Langevitz P, Gladman DD, Urowitz S, Smythe HA. Patients with rheumatoid arthritis are more tender than those with psoriatic arthritis. J Rheumatol. 1992 Jul;19(7):1115–1119. [PubMed]
  • Gladman DD, Brubacher B, Buskila D, Langevitz P, Farewell VT. Psoriatic spondyloarthropathy in men and women: a clinical, radiographic, and HLA study. Clin Invest Med. 1992 Aug;15(4):371–375. [PubMed]
  • Gladman DD, Shuckett R, Russell ML, Thorne JC, Schachter RK. Psoriatic arthritis (PSA)--an analysis of 220 patients. Q J Med. 1987 Feb;62(238):127–141. [PubMed]
  • Torre Alonso JC, Rodriguez Perez A, Arribas Castrillo JM, Ballina Garcia J, Riestra Noriega JL, Lopez Larrea C. Psoriatic arthritis (PA): a clinical, immunological and radiological study of 180 patients. Br J Rheumatol. 1991 Aug;30(4):245–250. [PubMed]
  • Veale D, Rogers S, Fitzgerald O. Classification of clinical subsets in psoriatic arthritis. Br J Rheumatol. 1994 Feb;33(2):133–138. [PubMed]
  • Dougados M, Gueguen A, Nakache JP, Nguyen M, Mery C, Amor B. Evaluation of a functional index and an articular index in ankylosing spondylitis. J Rheumatol. 1988 Feb;15(2):302–307. [PubMed]
  • Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286–2291. [PubMed]
  • Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281–2285. [PubMed]
  • Jenkinson TR, Mallorie PA, Whitelock HC, Kennedy LG, Garrett SL, Calin A. Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index. J Rheumatol. 1994 Sep;21(9):1694–1698. [PubMed]
  • Swen WA, Jacobs JW, Bussemaker FE, de Waard JW, Bijlsma JW. Carpal tunnel sonography by the rheumatologist versus nerve conduction study by the neurologist. J Rheumatol. 2001 Jan;28(1):62–69. [PubMed]
  • Taylor William J, Harrison Andrew A. Could the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) be a valid measure of disease activity in patients with psoriatic arthritis? Arthritis Rheum. 2004 Jun 15;51(3):311–315. [PubMed]
  • Mander M, Simpson JM, McLellan A, Walker D, Goodacre JA, Dick WC. Studies with an enthesis index as a method of clinical assessment in ankylosing spondylitis. Ann Rheum Dis. 1987 Mar;46(3):197–202. [PubMed]
  • Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A, Landewé R, van ver Tempel H, Mielants H, Dougados M, van der Heijde D. Assessment of enthesitis in ankylosing spondylitis. Ann Rheum Dis. 2003 Feb;62(2):127–132. [PubMed]
  • Gladman Dafna D, Cook Richard J, Schentag Cathy, Feletar Marie, Inman Robert I, Hitchon Carol, Karsh Jacob, Klinkhoff Alice V, Maksymowych Walter P, Mosher Dianne P, Nair Bindu, Stone Millicent A. The clinical assessment of patients with psoriatic arthritis: results of a reliability study of the spondyloarthritis research consortium of Canada. J Rheumatol. 2004 Jun;31(6):1126–1131. [PubMed]
  • Ware JE, Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473–483. [PubMed]
  • Husted JA, Gladman DD, Farewell VT, Long JA, Cook RJ. Validating the SF-36 health survey questionnaire in patients with psoriatic arthritis. J Rheumatol. 1997 Mar;24(3):511–517. [PubMed]
  • Husted JA, Gladman DD, Cook RJ, Farewell VT. Responsiveness of health status instruments to changes in articular status and perceived health in patients with psoriatic arthritis. J Rheumatol. 1998 Nov;25(11):2146–2155. [PubMed]
  • Sokoll KB, Helliwell PS. Comparison of disability and quality of life in rheumatoid and psoriatic arthritis. J Rheumatol. 2001 Aug;28(8):1842–1846. [PubMed]
  • Meenan RF, Gertman PM, Mason JH. Measuring health status in arthritis. The arthritis impact measurement scales. Arthritis Rheum. 1980 Feb;23(2):146–152. [PubMed]
  • Husted J, Gladman DD, Farewell VT, Long JA. Validation of the revised and expanded version of the Arthritis Impact Measurement Scales for patients with psoriatic Arthritis. J Rheumatol. 1996 Jun;23(6):1015–1019. [PubMed]
  • Husted J, Gladman DD, Long JA, Farewell VT. Relationship of the Arthritis Impact Measurement Scales to changes in articular status and functional performance in patients with psoriatic arthritis. J Rheumatol. 1996 Nov;23(11):1932–1937. [PubMed]
  • McKenna SP, Doward LC, Whalley D, Tennant A, Emery P, Veale DJ. Development of the PsAQoL: a quality of life instrument specific to psoriatic arthritis. Ann Rheum Dis. 2004 Feb;63(2):162–169. [PubMed]
  • Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210–216. [PubMed]
  • Morgan M, McCreedy R, Simpson J, Hay RJ. Dermatology quality of life scales--a measure of the impact of skin diseases. Br J Dermatol. 1997 Feb;136(2):202–206. [PubMed]
  • Finlay AY, Kelly SE. Psoriasis--an index of disability. Clin Exp Dermatol. 1987 Jan;12(1):8–11. [PubMed]
  • Gupta MA, Gupta AK. The Psoriasis Life Stress Inventory: a preliminary index of psoriasis-related stress. Acta Derm Venereol. 1995 May;75(3):240–243. [PubMed]
  • McKenna SP, Cook SA, Whalley D, Doward LC, Richards HL, Griffiths CEM, Van Assche D. Development of the PSORIQoL, a psoriasis-specific measure of quality of life designed for use in clinical practice and trials. Br J Dermatol. 2003 Aug;149(2):323–331. [PubMed]
  • Kirby B, Fortune DG, Bhushan M, Chalmers RJ, Griffiths CE. The Salford Psoriasis Index: an holistic measure of psoriasis severity. Br J Dermatol. 2000 Apr;142(4):728–732. [PubMed]
  • Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137–145. [PubMed]
  • Daltroy LH, Larson MG, Roberts NW, Liang MH. A modification of the Health Assessment Questionnaire for the spondyloarthropathies. J Rheumatol. 1990 Jul;17(7):946–950. [PubMed]
  • Blackmore MG, Gladman DD, Husted J, Long JA, Farewell VT. Measuring health status in psoriatic arthritis: the Health Assessment Questionnaire and its modification. J Rheumatol. 1995 May;22(5):886–893. [PubMed]
  • Husted JA, Gladman DD, Long JA, Farewell VT. A modified version of the Health Assessment Questionnaire (HAQ) for psoriatic arthritis. Clin Exp Rheumatol. 1995 Jul–Aug;13(4):439–443. [PubMed]
  • Tennant A, Hillman M, Fear J, Pickering A, Chamberlain MA. Are we making the most of the Stanford Health Assessment Questionnaire? Br J Rheumatol. 1996 Jun;35(6):574–578. [PubMed]
  • Beaton Dorcas E, Boers Marteen, Wells George A. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol. 2002 Mar;14(2):109–114. [PubMed]
  • Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol. 1993 Mar;20(3):557–560. [PubMed]
  • Cieza Alarcos, Ewert Thomas, Ustün T Berdirhan, Chatterji Somnath, Kostanjsek Nenad, Stucki Gerold. Development of ICF Core Sets for patients with chronic conditions. J Rehabil Med. 2004 Jul;(44 Suppl):9–11. [PubMed]
  • Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315–325. [PubMed]
  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121–1123. [PubMed]
  • Webster Kimberly, Cella David, Yost Kathleen. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003 Dec 16;1:79–79. [PubMed]
  • Belza BL, Henke CJ, Yelin EH, Epstein WV, Gilliss CL. Correlates of fatigue in older adults with rheumatoid arthritis. Nurs Res. 1993 Mar–Apr;42(2):93–99. [PubMed]
  • Gladman DD, Farewell VT, Wong K, Husted J. Mortality studies in psoriatic arthritis: results from a single outpatient center. II. Prognostic indicators for death. Arthritis Rheum. 1998 Jun;41(6):1103–1110. [PubMed]
  • Mease P. TNFalpha therapy in psoriatic arthritis and psoriasis. Ann Rheum Dis. 2004 Jul;63(7):755–758. [PubMed]