Correlation Analysis of Clinician- and Patient-Reported Outcomes Among Japanese Adults with Atopic Dermatitis

Overview

Journal Dermatol Ther (Heidelb)

Date 2024 Feb 7

PMID 38326699

Authors

Hidehisa Saeki

Yoko Kataoka

Takafumi Etoh

Norito Katoh

Satoshi Teramukai

Yuki Tajima

Hiroyuki Fujita

Marius Ardeleanu

Kazuhiko Arima

Affiliations

Soon will be listed here.

Abstract

Introduction: Atopic dermatitis (AD) is a chronic relapsing condition with high disease burden and impact on health-related quality of life (HRQoL). Correlations between clinician- and patient-reported outcomes tend to be poor, and limited data in Asian patients are available.

Methods: ADDRESS-J was a prospective, non-interventional, longitudinal study that evaluated the real-world effectiveness and safety of AD treatment in Japanese adults (aged 20-59 years) with moderate-to-severe AD. Three clinician-reported AD severity outcomes (Investigator's Global Assessment, Eczema Area and Severity Index, and body surface area affected), three dermatological patient-reported outcomes (Patient-Oriented Eczema Measure, Dermatology Life Quality Index, and Worst Itch Numerical Rating Scale), and two general HRQoL patient-reported outcomes (5-dimension EuroQoL questionnaire and EuroQol Visual Analog Scale) were collected at baseline and every 3 months throughout the 24-month observation period. Four biomarkers were also analyzed when available (thymus and activation-regulated chemokine [TARC], lactate dehydrogenase [LDH], total immunoglobulin E [IgE], and peripheral blood eosinophil counts [PB EOS]). Spearman's correlation coefficients were calculated using all available pooled data from baseline through 24 months.

Results: Correlations between the three clinician-reported outcomes were high/very high (Spearman's correlation coefficients 0.76-0.92); those between the three dermatological patient-reported outcomes were moderate (0.53-0.64), and those between the clinician-reported and dermatological patient-reported outcomes were low/moderate (0.37-0.51). Correlations between the general HRQoL patient-reported outcomes and the clinician-reported and dermatological patient-reported outcomes were negligible-moderate (0.26-0.60). Biomarker correlations with the clinician-reported and dermatological patient-reported outcomes were low/moderate for TARC and LDH (0.44-0.63), but negligible/low for PB EOS and total IgE (0.01-0.41).

Conclusions: These results show that clinician- and patient-reported outcomes do not necessarily correlate well in Japanese adults with AD. This highlights the importance of including patient-reported outcomes when assessing disease severity/impact, planning treatment, and assessing response to treatment.

Trial Registration: UMIN Clinical Trials Registry (UMIN-CTR) Identifier UMIN000022623.

References

de Bruin-Weller M, Biedermann T, Bissonnette R, Deleuran M, Foley P, Girolomoni G . Treat-to-Target in Atopic Dermatitis: An International Consensus on a Set of Core Decision Points for Systemic Therapies. Acta Derm Venereol. 2021; 101(2):adv00402. PMC: 9366686. DOI: 10.2340/00015555-3751. View

Silverberg J, Lei D, Yousaf M, Janmohamed S, Vakharia P, Chopra R . Comparison of Patient-Oriented Eczema Measure and Patient-Oriented Scoring Atopic Dermatitis vs Eczema Area and Severity Index and other measures of atopic dermatitis: A validation study. Ann Allergy Asthma Immunol. 2020; 125(1):78-83. DOI: 10.1016/j.anai.2020.03.006. View

Katoh N, Saeki H, Kataoka Y, Etoh T, Teramukai S, Takagi H . Atopic dermatitis disease registry in Japanese adult patients with moderate to severe atopic dermatitis (ADDRESS-J): Baseline characteristics, treatment history and disease burden. J Dermatol. 2019; 46(4):290-300. PMC: 6594225. DOI: 10.1111/1346-8138.14787. View

Leshem Y, Hajar T, Hanifin J, Simpson E . What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015; 172(5):1353-7. DOI: 10.1111/bjd.13662. View

Mukaka M . Statistics corner: A guide to appropriate use of correlation coefficient in medical research. Malawi Med J. 2013; 24(3):69-71. PMC: 3576830. View

Patel K, Singam V, Vakharia P, Chopra R, Sacotte R, Patel N . Measurement properties of three assessments of burden used in atopic dermatitis in adults. Br J Dermatol. 2018; 180(5):1083-1089. PMC: 6431274. DOI: 10.1111/bjd.17243. View

Mizuno M, Horiguchi G, Teramukai S, Ichiyama S, Ito M, Hoashi T . Association study of transition of laboratory marker levels and transition of disease activity of atopic dermatitis patients treated with dupilumab. Australas J Dermatol. 2021; 62(4):e504-e509. DOI: 10.1111/ajd.13719. View

Miyano K, Tsunemi Y . Current treatments for atopic dermatitis in Japan. J Dermatol. 2020; 48(2):140-151. DOI: 10.1111/1346-8138.15730. View

Konnopka A, Koenig H . The "no problems"-problem: an empirical analysis of ceiling effects on the EQ-5D 5L. Qual Life Res. 2017; 26(8):2079-2084. DOI: 10.1007/s11136-017-1551-3. View

10.

Katoh N, Saeki H, Kataoka Y, Etoh T, Teramukai S, Takagi H . Evaluation of standard treatments for managing adult Japanese patients with inadequately controlled moderate-to-severe atopic dermatitis: Two-year data from the ADDRESS-J disease registry. J Dermatol. 2022; 49(9):903-911. PMC: 9543354. DOI: 10.1111/1346-8138.16485. View

11.

Barbier N, Paul C, Luger T, Allen R, de Prost Y, Papp K . Validation of the Eczema Area and Severity Index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. Br J Dermatol. 2004; 150(1):96-102. DOI: 10.1111/j.1365-2133.2004.05696.x. View

12.

Thomas K, Apfelbacher C, Chalmers J, Simpson E, Spuls P, Gerbens L . Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting. Br J Dermatol. 2021; 185(1):139-146. PMC: 8359383. DOI: 10.1111/bjd.19751. View

13.

Saeki H, Ohya Y, Furuta J, Arakawa H, Ichiyama S, Katsunuma T . English Version of Clinical Practice Guidelines for the Management of Atopic Dermatitis 2021. J Dermatol. 2022; 49(10):e315-e375. DOI: 10.1111/1346-8138.16527. View

14.

Yosipovitch G, Reaney M, Mastey V, Eckert L, Abbe A, Nelson L . Peak Pruritus Numerical Rating Scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol. 2019; 181(4):761-769. PMC: 6850643. DOI: 10.1111/bjd.17744. View