Nail Psoriasis and Quality-of-Life Measurement in Clinical Trials: Call for the Use of Nail-Specific Instruments

Overview

Journal Am J Clin Dermatol

Specialty Dermatology

Date 2021 Aug 12

PMID 34383273

Citations 3

Authors

Christine Blome

Matthias Augustin

Toni Maria Klein

Affiliations

Soon will be listed here.

Abstract

Nail involvement is frequent in people with psoriasis. It can considerably impair health-related quality of life (HRQoL) beyond the impairments due to other psoriasis symptoms, for example, because patients feel ashamed of visible nail defects or because of the functional impairment in manual activities and walking. In clinical trials on nail psoriasis, it is therefore crucial to assess whether the treatment reduces HRQoL impairments that are specific to nail psoriasis. For this purpose, two validated patient questionnaires are available, the Nail Psoriasis Quality of Life Scale (NPQ10) and the Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL). The ten-item NPQ10 has the advantage of being short and thus quick to administer. The 20-item NAPPA-QOL, in contrast, assesses the different dimensions of HRQoL which is considered a multi-dimensional construct. Yet most randomized controlled trials on nail psoriasis do not evaluate HRQoL improvement. If they do, a number of different instruments are used, most of which are not nail specific. This makes comparison of trial outcomes difficult. Harmonizing the measurement of HRQoL in future clinical trials on nail psoriasis would improve comparability across studies and would also enhance the reliability of meta-analyses.

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References

Prignano F, Rogai V, Cavallucci E, Bitossi A, Hammen V, Cantini F . Epidemiology of Psoriasis and Psoriatic Arthritis in Italy-a Systematic Review. Curr Rheumatol Rep. 2018; 20(7):43. DOI: 10.1007/s11926-018-0753-1. View

Elewski B, Baker C, Crowley J, Poulin Y, Okun M, Calimlim B . Adalimumab for nail psoriasis: efficacy and safety over 52 weeks from a phase-3, randomized, placebo-controlled trial. J Eur Acad Dermatol Venereol. 2019; 33(11):2168-2178. PMC: 6899987. DOI: 10.1111/jdv.15793. View

Bardazzi F, Starace M, Bruni F, Magnano M, Piraccini B, Alessandrini A . Nail Psoriasis: An Updated Review and Expert Opinion on Available Treatments, Including Biologics. Acta Derm Venereol. 2018; 99(6):516-523. DOI: 10.2340/00015555-3098. View

Blome C, Costanzo A, Dauden E, Ferrandiz C, Girolomoni G, Gniadecki R . Patient-relevant needs and treatment goals in nail psoriasis. Qual Life Res. 2015; 25(5):1179-88. DOI: 10.1007/s11136-015-1136-y. View

Poulin Y, Crowley J, Langley R, Unnebrink K, Goldblum O, Valdecantos W . Efficacy of adalimumab across subgroups of patients with moderate-to-severe chronic plaque psoriasis of the hands and/or feet: post hoc analysis of REACH. J Eur Acad Dermatol Venereol. 2013; 28(7):882-90. PMC: 4229025. DOI: 10.1111/jdv.12198. View

Callis Duffin K, Merola J, Christensen R, Latella J, Garg A, Gottlieb A . Identifying a Core Domain Set to Assess Psoriasis in Clinical Trials. JAMA Dermatol. 2018; 154(10):1137-1144. PMC: 6233740. DOI: 10.1001/jamadermatol.2018.1165. View

Forestier B, Anthoine E, Reguiai Z, Fohrer C, Blanchin M . A systematic review of dimensions evaluating patient experience in chronic illness. Health Qual Life Outcomes. 2019; 17(1):19. PMC: 6341593. DOI: 10.1186/s12955-019-1084-2. View

McKenna S, Cook S, Whalley D, Doward L, Richards H, Griffiths C . Development of the PSORIQoL, a psoriasis-specific measure of quality of life designed for use in clinical practice and trials. Br J Dermatol. 2003; 149(2):323-31. DOI: 10.1046/j.1365-2133.2003.05492.x. View

Elewski B, Okun M, Papp K, Baker C, Crowley J, Guillet G . Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. J Am Acad Dermatol. 2017; 78(1):90-99.e1. DOI: 10.1016/j.jaad.2017.08.029. View

10.

Goldust M, Raghifar R . Clinical Trial Study in the Treatment of Nail Psoriasis with Pulsed Dye Laser. J Cosmet Laser Ther. 2013; . DOI: 10.3109/14764172.2013.854627. View

11.

Langenbruch A, Radtke M, Krensel M, Jacobi A, Reich K, Augustin M . Nail involvement as a predictor of concomitant psoriatic arthritis in patients with psoriasis. Br J Dermatol. 2014; 171(5):1123-8. DOI: 10.1111/bjd.13272. View

12.

Perez-Chada L, Merola J, Armstrong A, Garg A, Latella J, Gottlieb A . Report from the International Dermatology Outcome Measures Initiative. J Investig Dermatol Symp Proc. 2020; 20(1):S80-S83. PMC: 9393900. DOI: 10.1016/j.jisp.2020.05.004. View

13.

Reich K, Conrad C, Kristensen L, Smith S, Puig L, Rich P . Network meta-analysis comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis. J Dermatolog Treat. 2021; 33(3):1652-1660. DOI: 10.1080/09546634.2021.1892024. View

14.

Ali F, Cueva A, Vyas J, Atwan A, Salek M, Finlay A . A systematic review of the use of quality-of-life instruments in randomized controlled trials for psoriasis. Br J Dermatol. 2016; 176(3):577-593. DOI: 10.1111/bjd.14788. View

15.

Mokkink L, Terwee C, Patrick D, Alonso J, Stratford P, Knol D . The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010; 19(4):539-49. PMC: 2852520. DOI: 10.1007/s11136-010-9606-8. View

16.

van der Velden H, Klaassen K, van de Kerkhof P, Pasch M . The impact of fingernail psoriasis on patients' health-related and disease-specific quality of life. Dermatology. 2014; 229(2):76-82. DOI: 10.1159/000360696. View

17.

Ortonne J, Baran R, Corvest M, Schmitt C, Voisard J, Taieb C . Development and validation of nail psoriasis quality of life scale (NPQ10). J Eur Acad Dermatol Venereol. 2010; 24(1):22-7. DOI: 10.1111/j.1468-3083.2009.03344.x. View

18.

Finlay A, Khan G . Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994; 19(3):210-6. DOI: 10.1111/j.1365-2230.1994.tb01167.x. View

19.

FREDRIKSSON T, Pettersson U . Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978; 157(4):238-44. DOI: 10.1159/000250839. View

20.

Augustin M, Ogilvie A . Methods of outcomes measurement in nail psoriasis. Dermatology. 2010; 221 Suppl 1:23-8. DOI: 10.1159/000316177. View