Current Psoriasis Efficacy Outcome Measures in Clinical Trials
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.
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.
KeywordsPsoriasis 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
- 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.•• 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.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
- 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
- 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
- 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
- 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
- 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
- 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