Current Dermatology Reports

, Volume 7, Issue 4, pp 261–268 | Cite as

Current Psoriasis Efficacy Outcome Measures in Clinical Trials

  • Todd Wechter
  • Michael Heath
  • David Aung-Din
  • Dev Sahni
  • Abigail Cline
  • Steven R. FeldmanEmail author
Psoriasis (J Wu, Section Editor)
Part of the following topical collections:
  1. Topical Collection on Psoriasis


Purpose of Review

This review sought to examine currently used psoriasis efficacy outcome measures. In particular, we wanted to know what outcome measures are currently being used most frequently, in addition to the advantages and disadvantages of each outcome measure.

Recent Findings

In the past year, Psoriasis Area and Severity Index (PASI) was the most frequently used outcome measure in phase III and IV clinical trials evaluating psoriasis treatments. PASI scores were also the most frequently used primary outcome measure. Psoriasis Scalp Severity Index (PSSI) was the most commonly utilized regional physician reported outcome measure and Dermatology Quality of Life Index (DLQI) was the most commonly used patient reported outcome.


It is important for clinical trials to utilize outcome measures that are both accurate and take into account patients’ perspectives. Standardization of outcome measures will allow for better comparison of treatments across clinical trials.


Psoriasis Outcome measures PASI DLQI 


Compliance with Ethical Standards

Conflict of Interest

Dr. Feldman reports grants and personal fees from Abbvie, grants and personal fees from Celgene, grants and personal fees from Janssen, grants and personal fees from Lilly, grants and personal fees from Novartis, personal fees from Ortho Dermatology, grants and personal fees from Pfizer, personal fees from Sun Pharma, personal fees from Leo Pharma, outside the submitted work.

Todd Wechter, Michael Heath, David Aung-Din, Dev Sahni, and Abigail Cline declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.


Papers of particular interest, published recently, have been highlighted as: •• Of major importance

  1. 1.
    Kim J, Krueger JG. Highly effective new treatments for psoriasis target the IL-23/type 17 T cell autoimmune axis. Annu Rev Med. 2017;68:255–69.CrossRefGoogle Scholar
  2. 2.
    Ashcroft DM, et al. Clinical measures of disease severity and outcome in psoriasis: a critical appraisal of their quality. Br J Dermatol. 1999;141(2):185–91.CrossRefGoogle Scholar
  3. 3.
    •• Bozek A, Reich A. The reliability of three psoriasis assessment tools: psoriasis area and severity index, body surface area and physician global assessment. Adv Clin Exp Med. 2017;26(5):851–6 An informative study assessing the inter- and intra-rater reliability of three commonly employed psoriasis tools. CrossRefGoogle Scholar
  4. 4.
    •• Langley RG, et al. The 5-point Investigator’s Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatol Treat. 2015;26(1):23–31 This initial description of the novel 5-point IGA scale provides the foundation for its use in clinical trials and practice. CrossRefGoogle Scholar
  5. 5.
    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(3):369–75.CrossRefGoogle Scholar
  6. 6.
    Scarisbrick JJ, Morris S. How big is your hand and should you use it to score skin in cutaneous T-cell lymphoma? Br J Dermatol. 2013;169(2):260–5.CrossRefGoogle Scholar
  7. 7.
    Augustin M, Ogilvie A. Methods of outcomes measurement in nail psoriasis. Dermatology. 2010;221(Suppl 1):23–8.CrossRefGoogle Scholar
  8. 8.
    Rich P, Scher RK. Nail Psoriasis Severity Index: a useful tool for evaluation of nail psoriasis. J Am Acad Dermatol. 2003;49(2):206–12.CrossRefGoogle Scholar
  9. 9.
    Aktan S, İlknur T, Akin Ç, Özkan Ş. Interobserver reliability of the Nail Psoriasis Severity Index. Clin Exp Dermatol. 2007;32(2):141–4.CrossRefGoogle Scholar
  10. 10.
    Frez ML, et al. Recommendations for a patient-centered approach to the assessment and treatment of scalp psoriasis: a consensus statement from the Asia Scalp Psoriasis Study Group. J Dermatol Treat. 2014;25(1):38–45.CrossRefGoogle Scholar
  11. 11.
    Thaci D, et al. Calcipotriol solution for the treatment of scalp psoriasis: evaluation of efficacy, safety and acceptance in 3,396 patients. Dermatology. 2001;203(2):153–6.CrossRefGoogle Scholar
  12. 12.
    Menter A, Warren RB, Langley RG, Merola JF, Kerr LN, Dennehy EB, et al. Efficacy of ixekizumab compared to etanercept and placebo in patients with moderate-to-severe plaque psoriasis and non-pustular palmoplantar involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2 and UNCOVER-3). J Eur Acad Dermatol Venereol. 2017;31(10):1686–92.CrossRefGoogle Scholar
  13. 13.
    Wozel G, et al. Scalp psoriasis. J Dtsch Dermatol Ges. 2011;9(1):70–4.PubMedGoogle Scholar
  14. 14.
    Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, et al. Efficacy of guselkumab compared with adalimumab and placebo for psoriasis in specific body regions: a secondary analysis of 2 randomized clinical trials. JAMA Dermatol. 2018;154(6):676–83.CrossRefGoogle Scholar
  15. 15.
    Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210–6.CrossRefGoogle Scholar
  16. 16.
    Basra MK, et al. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27–33.CrossRefGoogle Scholar
  17. 17.
    Nijsten T. Dermatology life quality index: time to move forward. J Invest Dermatol. 2012;132(1):11–3.CrossRefGoogle Scholar
  18. 18.
    Nijsten TE, et al. Testing and reducing skindex-29 using Rasch analysis: Skindex-17. J Invest Dermatol. 2006;126(6):1244–50.CrossRefGoogle Scholar
  19. 19.
    Twiss J, Meads DM, Preston EP, Crawford SR, McKenna SP. Can we rely on the Dermatology Life Quality Index as a measure of the impact of psoriasis or atopic dermatitis? J Invest Dermatol. 2012;132(1):76–84.CrossRefGoogle Scholar
  20. 20.
    Fernandez-Penas P, et al. Comparison of Skindex-29, Dermatology Life Quality Index, Psoriasis Disability Index and Medical Outcome Study Short Form 36 in patients with mild to severe psoriasis. Br J Dermatol. 2012;166(4):884–7.CrossRefGoogle Scholar
  21. 21.
    Tarescavage AM, Ben-Porath YS. Psychotherapeutic outcomes measures: a critical review for practitioners. J Clin Psychol. 2014;70(9):808–30.CrossRefGoogle Scholar
  22. 22.
    Brazier J. The Short-Form 36 (SF-36) Health Survey and its use in pharmacoeconomic evaluation. Pharmacoeconomics. 1995;7(5):403–15.CrossRefGoogle Scholar
  23. 23.
    Wu JJ, Feldman SR, Koo J, Marangell LB. Epidemiology of mental health comorbidity in psoriasis. J Dermatol Treat. 2018;29(5):487–95.CrossRefGoogle Scholar
  24. 24.
    Valenzuela F, Paul C, Mallbris L, Tan H, Papacharalambous J, Valdez H, et al. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016;30(10):1753–9.CrossRefGoogle Scholar
  25. 25.
    Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64(Suppl 2):ii65–8 discussion ii69–73.PubMedPubMedCentralGoogle Scholar
  26. 26.
    •• Lindstrom Egholm C, et al. Discordance of global assessments by patient and physician is higher in female than in male patients regardless of the physician’s sex: data on patients with rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis from the DANBIO registry. J Rheumatol. 2015;42(10):1781–5 Highlights the importance of distinguishing differences between patient and physician assessment of disease. CrossRefGoogle Scholar
  27. 27.
    Dandorfer SW, et al. Differences in the patient's and the physician's perspective of disease in psoriatic arthritis. Semin Arthritis Rheum. 2012;42(1):32–41.CrossRefGoogle Scholar
  28. 28.
    Reich A, Heisig M, Phan N, Taneda K, Takamori K, Takeuchi S, et al. Visual analogue scale: evaluation of the instrument for the assessment of pruritus. Acta Derm Venereol. 2012;92(5):497–501.CrossRefGoogle Scholar
  29. 29.
    Reich A, Riepe C, Anastasiadou Z, Mędrek K, Augustin M, Szepietowski J, et al. Itch assessment with visual analogue scale and numerical rating scale: determination of minimal clinically important difference in chronic itch. Acta Derm Venereol. 2016;96(7):978–80.CrossRefGoogle Scholar
  30. 30.
    •• Rentz AM, et al. The content validity of the PSS in patients with plaque psoriasis. J Patient Rep Outcomes. 2017;1(1):4 An influential study reflecting on the effectiveness and importance of the psoriasis severity scale for use in clinical trials, and as an understandable tool for patients. CrossRefGoogle Scholar
  31. 31.
    •• Kitchen H, et al. Patient-reported outcome measures in psoriasis: the good, the bad and the missing! Br J Dermatol. 2015;172(5):1210–21 This extensive review examines and critiques the validity, reliability, and senstivity of patient-reported outcomes in psoriasis. CrossRefGoogle Scholar
  32. 32.
    Puzenat E, Bronsard V, Prey S, Gourraud PA, Aractingi S, Bagot M, 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):10–6.CrossRefGoogle Scholar
  33. 33.
    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(4):563–9.CrossRefGoogle Scholar
  34. 34.
    Berth-Jones J, Grotzinger K, Rainville C, Pham B, Huang J, Daly S, 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(4):707–13.CrossRefGoogle Scholar
  35. 35.
    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(6):859–66.CrossRefGoogle Scholar
  36. 36.
    Marks R, et al. Assessment of disease progress in psoriasis. Arch Dermatol. 1989;125(2):235–40.CrossRefGoogle Scholar
  37. 37.
    Yune YM, Park SY, Oh HS, Kim DJ, Yoo DS, Kim IH, et al. Objective assessment of involved surface area in patients with psoriasis. Skin Res Technol. 2003;9(4):339–42.CrossRefGoogle Scholar
  38. 38.
    Krueger GG, Feldman SR, Camisa C, Duvic M, Elder JT, Gottlieb AB, 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(2 Pt 1):281–5.CrossRefGoogle Scholar
  39. 39.
    Hahn HB, Melfi CA, Chuang TY, Lewis CW, Gonin R, Hanna MP, et al. Use of the Dermatology Life Quality Index (DLQI) in a midwestern US urban clinic. J Am Acad Dermatol. 2001;45(1):44–8.CrossRefGoogle Scholar
  40. 40.
    Bronsard V, Paul C, Prey S, Puzenat E, Gourraud PA, Aractingi S, et al. What are the best outcome measures for assessing quality of life in plaque type psoriasis? A systematic review of the literature. J Eur Acad Dermatol Venereol. 2010;24(Suppl 2):17–22.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Todd Wechter
    • 1
  • Michael Heath
    • 1
  • David Aung-Din
    • 1
  • Dev Sahni
    • 1
  • Abigail Cline
    • 1
  • Steven R. Feldman
    • 1
    • 2
    • 3
    Email author
  1. 1.Center for Research, Department of DermatologyWake Forest School of MedicineWinston-SalemUSA
  2. 2.Department of PathologyWake Forest School of MedicineWinston-SalemUSA
  3. 3.Department of Social Sciences & Health PolicyWake Forest School of MedicineWinston-SalemUSA

Personalised recommendations