Skip to main content
NCBI home page
Annals of the Rheumatic Diseases logoLink to Annals of the Rheumatic Diseases
. 2005 Mar;64(Suppl 2):ii49–ii54. doi: 10.1136/ard.2004.034165

Psoriatic arthritis assessment tools in clinical trials

P Mease, C Antoni, D Gladman, W Taylor
PMCID: PMC1766888  PMID: 15708937

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.

Full Text

The Full Text of this article is available as a PDF (87.8 KB).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Bathon J. M., Martin R. W., Fleischmann R. M., Tesser J. R., Schiff M. H., Keystone E. C., Genovese M. C., Wasko M. C., Moreland L. W., Weaver A. L. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000 Nov 30;343(22):1586–1593. doi: 10.1056/NEJM200011303432201. [DOI] [PubMed] [Google Scholar]
  2. 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. doi: 10.1097/00002281-200203000-00006. [DOI] [PubMed] [Google Scholar]
  3. Belza B. L., Henke C. J., Yelin E. H., Epstein W. V., Gilliss C. L. Correlates of fatigue in older adults with rheumatoid arthritis. Nurs Res. 1993 Mar-Apr;42(2):93–99. [PubMed] [Google Scholar]
  4. Blackmore M. G., Gladman D. D., Husted J., Long J. A., Farewell V. T. Measuring health status in psoriatic arthritis: the Health Assessment Questionnaire and its modification. J Rheumatol. 1995 May;22(5):886–893. [PubMed] [Google Scholar]
  5. Buskila D., Langevitz P., Gladman D. D., Urowitz S., Smythe H. A. Patients with rheumatoid arthritis are more tender than those with psoriatic arthritis. J Rheumatol. 1992 Jul;19(7):1115–1119. [PubMed] [Google Scholar]
  6. Calin A., Garrett S., Whitelock H., Kennedy L. G., 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] [Google Scholar]
  7. 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. doi: 10.1080/16501960410015353. [DOI] [PubMed] [Google Scholar]
  8. Clegg D. O., Reda D. J., Mejias E., Cannon G. W., Weisman M. H., Taylor T., Budiman-Mak E., Blackburn W. D., Vasey F. B., Mahowald M. L. 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. doi: 10.1002/art.1780391210. [DOI] [PubMed] [Google Scholar]
  9. DEANDRADE J. R., CASAGRANDE P. A. A SEVEN-DAY VARIABILITY STUDY OF 499 PATIENTS WITH PERIPHERAL RHEUMATOID ARTHRITIS. Arthritis Rheum. 1965 Apr;8:302–334. [PubMed] [Google Scholar]
  10. Daltroy L. H., Larson M. G., Roberts N. W., Liang M. H. A modification of the Health Assessment Questionnaire for the spondyloarthropathies. J Rheumatol. 1990 Jul;17(7):946–950. [PubMed] [Google Scholar]
  11. Daunt A. O., Cox N. L., Robertson J. C., Cawley M. I. Indices of disease activity in psoriatic arthritis. J R Soc Med. 1987 Sep;80(9):556–558. doi: 10.1177/014107688708000907. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Dougados M., Gueguen A., Nakache J. P., 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] [Google Scholar]
  13. Feldman S. R., Krueger G. G. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005 Mar;64 (Suppl 2):ii65–ii73. doi: 10.1136/ard.2004.031237. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Felson D. T., Anderson J. J., Boers M., Bombardier C., Furst D., Goldsmith C., Katz L. M., Lightfoot R., Jr, Paulus H., Strand V. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995 Jun;38(6):727–735. doi: 10.1002/art.1780380602. [DOI] [PubMed] [Google Scholar]
  15. Finlay A. Y., Kelly S. E. Psoriasis--an index of disability. Clin Exp Dermatol. 1987 Jan;12(1):8–11. doi: 10.1111/j.1365-2230.1987.tb01844.x. [DOI] [PubMed] [Google Scholar]
  16. Finlay A. Y., Khan G. K. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210–216. doi: 10.1111/j.1365-2230.1994.tb01167.x. [DOI] [PubMed] [Google Scholar]
  17. Fries J. F., Spitz P., Kraines R. G., Holman H. R. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137–145. doi: 10.1002/art.1780230202. [DOI] [PubMed] [Google Scholar]
  18. Fuchs H. A. 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] [Google Scholar]
  19. Garrett S., Jenkinson T., Kennedy L. G., 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] [Google Scholar]
  20. Gladman D. D., Brubacher B., Buskila D., Langevitz P., Farewell V. T. Psoriatic spondyloarthropathy in men and women: a clinical, radiographic, and HLA study. Clin Invest Med. 1992 Aug;15(4):371–375. [PubMed] [Google Scholar]
  21. Gladman D. D., Farewell V. T., 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. doi: 10.1002/1529-0131(199806)41:6<1103::AID-ART18>3.0.CO;2-N. [DOI] [PubMed] [Google Scholar]
  22. Gladman D. D., Shuckett R., Russell M. L., Thorne J. C., Schachter R. K. Psoriatic arthritis (PSA)--an analysis of 220 patients. Q J Med. 1987 Feb;62(238):127–141. [PubMed] [Google Scholar]
  23. Gladman D. D., Strand V., Mease P. J., Antoni C., Nash P., Kavanaugh A. OMERACT 7 psoriatic arthritis workshop: synopsis. Ann Rheum Dis. 2005 Mar;64 (Suppl 2):ii115–ii116. doi: 10.1136/ard.2004.032615. [DOI] [PMC free article] [PubMed] [Google Scholar]
  24. 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. 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] [Google Scholar]
  25. 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. doi: 10.1002/art.11417. [DOI] [PubMed] [Google Scholar]
  26. Gupta M. A., Gupta A. K. The Psoriasis Life Stress Inventory: a preliminary index of psoriasis-related stress. Acta Derm Venereol. 1995 May;75(3):240–243. doi: 10.2340/0001555575240243. [DOI] [PubMed] [Google Scholar]
  27. Helliwell P. S., Taylor W. J. Classification and diagnostic criteria for psoriatic arthritis. Ann Rheum Dis. 2005 Mar;64 (Suppl 2):ii3–ii8. doi: 10.1136/ard.2004.032318. [DOI] [PMC free article] [PubMed] [Google Scholar]
  28. 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. doi: 10.1136/ard.62.2.127. [DOI] [PMC free article] [PubMed] [Google Scholar]
  29. Husted J. A., Gladman D. D., Cook R. J., Farewell V. T. 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] [Google Scholar]
  30. Husted J. A., Gladman D. D., Farewell V. T., Long J. A., Cook R. J. Validating the SF-36 health survey questionnaire in patients with psoriatic arthritis. J Rheumatol. 1997 Mar;24(3):511–517. [PubMed] [Google Scholar]
  31. Husted J. A., Gladman D. D., Long J. A., Farewell V. T. A modified version of the Health Assessment Questionnaire (HAQ) for psoriatic arthritis. Clin Exp Rheumatol. 1995 Jul-Aug;13(4):439–443. [PubMed] [Google Scholar]
  32. Husted J., Gladman D. D., Farewell V. T., Long J. A. 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] [Google Scholar]
  33. Husted J., Gladman D. D., Long J. A., Farewell V. T. 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] [Google Scholar]
  34. Jenkinson T. R., Mallorie P. A., Whitelock H. C., Kennedy L. G., Garrett S. L., Calin A. Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index. J Rheumatol. 1994 Sep;21(9):1694–1698. [PubMed] [Google Scholar]
  35. Kaltwasser J. Peter, Nash Peter, Gladman Dafna, Rosen Cheryl F., Behrens Frank, Jones Peter, Wollenhaupt Jürgen, Falk Franziska G., Mease Philip, Treatment of Psoriatic Arthritis Study Group 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. doi: 10.1002/art.20253. [DOI] [PubMed] [Google Scholar]
  36. Kirby B., Fortune D. G., Bhushan M., Chalmers R. J., Griffiths C. E. The Salford Psoriasis Index: an holistic measure of psoriasis severity. Br J Dermatol. 2000 Apr;142(4):728–732. doi: 10.1046/j.1365-2133.2000.03418.x. [DOI] [PubMed] [Google Scholar]
  37. Krupp L. B., LaRocca N. G., Muir-Nash J., Steinberg A. D. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121–1123. doi: 10.1001/archneur.1989.00520460115022. [DOI] [PubMed] [Google Scholar]
  38. Mander M., Simpson J. M., McLellan A., Walker D., Goodacre J. A., Dick W. C. Studies with an enthesis index as a method of clinical assessment in ankylosing spondylitis. Ann Rheum Dis. 1987 Mar;46(3):197–202. doi: 10.1136/ard.46.3.197. [DOI] [PMC free article] [PubMed] [Google Scholar]
  39. McKenna S. P., Cook S. A., Whalley D., Doward L. C., Richards H. L., Griffiths C. E. M., 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. doi: 10.1046/j.1365-2133.2003.05492.x. [DOI] [PubMed] [Google Scholar]
  40. McKenna S. P., Doward L. C., Whalley D., Tennant A., Emery P., Veale D. J. Development of the PsAQoL: a quality of life instrument specific to psoriatic arthritis. Ann Rheum Dis. 2004 Feb;63(2):162–169. doi: 10.1136/ard.2003.006296. [DOI] [PMC free article] [PubMed] [Google Scholar]
  41. Mease P. J., Antoni C. E. Psoriatic arthritis treatment: biological response modifiers. Ann Rheum Dis. 2005 Mar;64 (Suppl 2):ii78–ii82. doi: 10.1136/ard.2004.034157. [DOI] [PMC free article] [PubMed] [Google Scholar]
  42. Mease P. J., Goffe B. S., Metz J., VanderStoep A., Finck B., Burge D. J. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial. Lancet. 2000 Jul 29;356(9227):385–390. doi: 10.1016/S0140-6736(00)02530-7. [DOI] [PubMed] [Google Scholar]
  43. Mease P. TNFalpha therapy in psoriatic arthritis and psoriasis. Ann Rheum Dis. 2004 Jul;63(7):755–758. doi: 10.1136/ard.2004.020719. [DOI] [PMC free article] [PubMed] [Google Scholar]
  44. 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. doi: 10.1002/art.20335. [DOI] [PubMed] [Google Scholar]
  45. Meenan R. F., Gertman P. M., Mason J. H. Measuring health status in arthritis. The arthritis impact measurement scales. Arthritis Rheum. 1980 Feb;23(2):146–152. doi: 10.1002/art.1780230203. [DOI] [PubMed] [Google Scholar]
  46. Moll J. M., Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55–78. doi: 10.1016/0049-0172(73)90035-8. [DOI] [PubMed] [Google Scholar]
  47. Morgan M., McCreedy R., Simpson J., Hay R. J. Dermatology quality of life scales--a measure of the impact of skin diseases. Br J Dermatol. 1997 Feb;136(2):202–206. [PubMed] [Google Scholar]
  48. Ory P. A., Gladman D. D., Mease P. J. Psoriatic arthritis and imaging. Ann Rheum Dis. 2005 Mar;64 (Suppl 2):ii55–ii57. doi: 10.1136/ard.2004.033928. [DOI] [PMC free article] [PubMed] [Google Scholar]
  49. Prevoo M. L., van Gestel A. M., van T Hof M. A., van Rijswijk M. H., van de Putte L. B., van Riel P. L. 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. doi: 10.1093/rheumatology/35.11.1101. [DOI] [PubMed] [Google Scholar]
  50. Prevoo M. L., van Riel P. L., van 't Hof M. A., van Rijswijk M. H., van Leeuwen M. A., Kuper H. H., van de Putte L. B. 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. doi: 10.1093/rheumatology/32.7.589. [DOI] [PubMed] [Google Scholar]
  51. Ritchie D. M., Boyle J. A., McInnes J. M., Jasani M. K., Dalakos T. G., Grieveson P., Buchanan W. W. 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] [Google Scholar]
  52. 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. doi: 10.1016/s0149-2918(03)80119-4. [DOI] [PubMed] [Google Scholar]
  53. Smets E. M., Garssen B., Bonke B., De Haes J. C. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315–325. doi: 10.1016/0022-3999(94)00125-o. [DOI] [PubMed] [Google Scholar]
  54. Sokoll K. B., Helliwell P. S. Comparison of disability and quality of life in rheumatoid and psoriatic arthritis. J Rheumatol. 2001 Aug;28(8):1842–1846. [PubMed] [Google Scholar]
  55. Swen W. A., Jacobs J. W., Bussemaker F. E., de Waard J. W., Bijlsma J. W. Carpal tunnel sonography by the rheumatologist versus nerve conduction study by the neurologist. J Rheumatol. 2001 Jan;28(1):62–69. [PubMed] [Google Scholar]
  56. Taylor William J. Assessment of outcome in psoriatic arthritis. Curr Opin Rheumatol. 2004 Jul;16(4):350–356. doi: 10.1097/01.bor.0000129716.12154.06. [DOI] [PubMed] [Google Scholar]
  57. 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. doi: 10.1002/art.20421. [DOI] [PubMed] [Google Scholar]
  58. Tennant A., Hillman M., Fear J., Pickering A., Chamberlain M. A. Are we making the most of the Stanford Health Assessment Questionnaire? Br J Rheumatol. 1996 Jun;35(6):574–578. doi: 10.1093/rheumatology/35.6.574. [DOI] [PubMed] [Google Scholar]
  59. Thorstensson C. A., Petersson I. F., Jacobsson L. T. H., Boegård T. L., Roos E. M. Reduced functional performance in the lower extremity predicted radiographic knee osteoarthritis five years later. Ann Rheum Dis. 2004 Apr;63(4):402–407. doi: 10.1136/ard.2003.007583. [DOI] [PMC free article] [PubMed] [Google Scholar]
  60. Torre Alonso J. C., Rodriguez Perez A., Arribas Castrillo J. M., Ballina Garcia J., Riestra Noriega J. L., Lopez Larrea C. Psoriatic arthritis (PA): a clinical, immunological and radiological study of 180 patients. Br J Rheumatol. 1991 Aug;30(4):245–250. doi: 10.1093/rheumatology/30.4.245. [DOI] [PubMed] [Google Scholar]
  61. Veale D., Rogers S., Fitzgerald O. Classification of clinical subsets in psoriatic arthritis. Br J Rheumatol. 1994 Feb;33(2):133–138. doi: 10.1093/rheumatology/33.2.133. [DOI] [PubMed] [Google Scholar]
  62. Ware J. E., Jr, Sherbourne C. D. 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] [Google Scholar]
  63. 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. doi: 10.1186/1477-7525-1-79. [DOI] [PMC free article] [PubMed] [Google Scholar]
  64. Wells G. A., Tugwell P., Kraag G. R., Baker P. R., Groh J., Redelmeier D. A. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol. 1993 Mar;20(3):557–560. [PubMed] [Google Scholar]
  65. van Gestel A. M., Anderson J. J., van Riel P. L., Boers M., Haagsma C. J., Rich B., Wells G., Lange M. L., Felson D. T. 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] [Google Scholar]
  66. van Gestel A. M., Haagsma C. J., van Riel P. L. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845–1850. doi: 10.1002/1529-0131(199810)41:10<1845::AID-ART17>3.0.CO;2-K. [DOI] [PubMed] [Google Scholar]
  67. van Gestel A. M., Prevoo M. L., van 't Hof M. A., van Rijswijk M. H., van de Putte L. B., van Riel P. L. 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. doi: 10.1002/art.1780390105. [DOI] [PubMed] [Google Scholar]
  68. van der Heijde D. M., van 't Hof M. A., van Riel P. L., Theunisse L. A., Lubberts E. W., van Leeuwen M. A., van Rijswijk M. H., van de Putte L. B. 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. doi: 10.1136/ard.49.11.916. [DOI] [PMC free article] [PubMed] [Google Scholar]
  69. van der Heijde D. M., van't Hof M. A., van Riel P. L., van Leeuwen M. A., van Rijswijk M. H., van de Putte L. B. Validity of single variables and composite indices for measuring disease activity in rheumatoid arthritis. Ann Rheum Dis. 1992 Feb;51(2):177–181. doi: 10.1136/ard.51.2.177. [DOI] [PMC free article] [PubMed] [Google Scholar]
  70. van der Heijde D., Sharp J., Wassenberg S., Gladman D. D. Psoriatic arthritis imaging: a review of scoring methods. Ann Rheum Dis. 2005 Mar;64 (Suppl 2):ii61–ii64. doi: 10.1136/ard.2004.030809. [DOI] [PMC free article] [PubMed] [Google Scholar]

Articles from Annals of the Rheumatic Diseases are provided here courtesy of BMJ Publishing Group

RESOURCES