Application of the Dermatology Life Quality Index in Clinical Trials of Biologics for Psoriasis

The significance of patient-reported outcomes（PROs） is increasingly being acknowledged and quality of life（QOL） has become an integral element of the assessment of overall burden of disease.Psoriasis has been known for its major impact on patients＇ QOL and various generic,dermatology-specific and psoriasis-specific self- administered psychometric instruments have been used over the years to assess the QOL of psoriasis patients.However,the Dermatology Life Quality Index（DLQI） is the most widely used QOL measure among these measures in psoriasis-related clinical trials. A number of topical and systemic treatments have been used in the management of psoriasis and lately biologics have emerged as a new and promising treatment modality for difficuIt-to-treat psoriasis.The evidence on the efficacy of these agents has been growing dramatically with QOL being used as one of the primary outcome measures in many clinical trials.The aim of this paper is to give an overview of the use of the DLQI as an outcome measure for assessing the QOL impact of biologies on psoriasis patients.Furthermore,the efficacy of five commonly used biologics has been compared in terms of their ability to improve the QOL assessed by the DLQI.This review has revealed that there is a variation in the efficacy of various biologies in terms of QOL improvement with the mean reduction in the DLQI scores being highest for ustekinumab 90 mg（mean DLQI score reduction=9.5）,followed by infliximab（8.5）,etanercept 50 mg,twice a week（7.7）,adalimumab（6.3）,and alefacept（4.0）.

Effects of Biologics on Mental Health and Health-Related Quality of Life in Patients With Psoriasis:A Repeated Cross-Sectional Survey in Chinese Population

Objective:Psoriasis is a chronic inflammatory systemic disease that severely impacts patients’ quality of life (QoL) and psychological health.While biologics have been shown to be effective in treating psoriatic lesions,thus improving QoL,real-life data regarding such effects remain scant.We administered a repeated cross-sectional survey to assess the effects of 8 weeks of biologics treatment on the QoL and mental health status of patients with moderate-to-severe plaque psoriasis.Methods:From March to May 2022,patients with moderate-to-severe plaque psoriasis were enrolled and treated with biologics in the outpatient clinic at the Dermatology Hospital of Southern Medical University.Assessments were performed before treatment and after 4 and 8 weeks of treatment with biologics.Psoriasis severity,QoL,and mental health status were evaluated using the Psoriasis Area and Severity Index (PASI),Dermatology Life Quality Index (DLQI),36-Item Short-form Health Survey (SF-36),and Hospital Anxiety and Depression Scale (HADS).A multivariate generalized estimating equations (GEE) analysis was used to account for repeated measures and to determine the effects of treatment duration and type of biological agent on relevant indicators.Results:Among the 78 enrolled patients,the ranges of pretreatment scores were 4.6 to 46.8 for the PASI,1 to 30 for the DLQI,31.5 to 100.0 for the physical component score (PCS) of the SF-36,16.6 to 100.0 for the mental component score (MCS) of the SF-36,0 to 15 for the HADS-A,and 0 to 17 for the HADS-D.After 8 weeks of biologics treatment,98.7% (77/78) of patients had obtained PASI 75.All assessed scores changed over time (GEE,P < 0.001).Moreover,there were group-by-time interaction effects for the DLQI score (GEE,P = 0.023) and PCS (GEE,P = 0.029).The HADS-A and HADS-D scores were both decreased at week 8 compared with pretreatment values.Correlation analyses revealed that higher DLQI scores were associated with lower levels of QoL and higher levels of anxiety or depression.Conclusion:Biologics are not only effective in the treatment of skin lesions but also exert beneficial effects upon the QoL and mental health of patients with psoriasis as determined in the short-term assessments conducted in this study.

Evaluation of Depression and Quality of Life in Patients With Psoriasis

Objective:To measure the prevalence of depression in patients with psoriasis and to evaluate the relationship between the severity of psoriasis and depression and its effect on patients’quality of life.Methods:A total of 154 patients with a confirmed diagnosis of psoriasis were assessed to determine the severity of psoriasis based on the psoriasis area and severity index score,presence,and severity of depression using the patient health questionnaire 9,and quality of life using the dermatology life quality index 10.Pearson correlation coefficient was used to demonstrate the relationship between continuous variables with 95%confidence intervals(CIs);P<0.00001 was taken to indicate statistical significance.Results:The severity of psoriasis was mild in 36.36%of patients,moderate in 25.97%,severe in 32.47%,and very severe in 5.20%.Of the 154 patients,139(90.3%)had depression;the severity of depression was mild in most affected patients(46.7%)and severe in 2.6%of patients.Psoriasis had a moderate effect on the quality of life in 37.01%of patients and a very large effect in 33.77%of patients.The severity of psoriasis was positively correlated with depression(Pearson correlation coefficient,r=0.42,P<0.00001,95%CI:0.28–0.54)and quality of life(r=0.43,P<0.00001,95%CI:0.29–0.55).Conclusion:Depression is a common comorbidity in patients with psoriasis.The severity of psoriasis is positively correlated with the severity of depression and is associated with poor quality of life.

Major Clinical Features and Epidemic Characteristics of Erosive Vulvar Lichen Planus:A Retrospective Analysis

Objective:Vulvar lichen planus(VLP),especially erosive VLP(EVLP),seriously affects women’s physiological function and quality of life.A retrospective analysis of erosive vulvar lichen planus(EVLP)was performed to raise awareness on this chronic,deforming,and painful vulvar disease.Methods:This observational retrospective study involved 40 patients with EVLP among 1,368 patients with vulvar disease from 2017 to 2020.The patients’vulvar clinical features and extravulvar mucosal involvement were investigated.The patients’pain and quality of life were evaluated with the numeric rating scale and the Dermatology Life Quality Index(DLQI),respectively.Clinical characteristics were reported using frequencies and proportions for categorical variables.Continuous variables are expressed as mean±standard deviation.The association between NRS score for pain and DLQI score was analyzed by Pearson’s correlation test.Results:EVLP accounted for 2.9%(40/1,368)of all cases of vulvar disease,and the median age at onset was 42 years.Erosion mostly occurred on the labia minora and introitus.Half(20/40)of the patients had extravulvar mucosal involvement.Seventeen(42.5%)patients had oral lichen planus,and seven(17.5%)patients were diagnosed with vulvovaginal-gingival syndrome.The numeric rating scale score showed that 47.5%(19/40)of patients experienced mild pain,whereas 12.5%(5/40)described the pain as severe.Thirty-one patients(77.5%,31/40)had dyspareunia,and nine patients had aggravated pain after sexual intercourse.The mean DLQI score was 9.1±6.0,with 37.5%(15/40)of patients indicating that EVLP had severely affected their lives.The numeric rating scale score for pain was significantly correlated with the DLQI score(P=0.007).Conclusion:EVLP can affect the quality of women’s lives and cause severe deformations and painful architectural changes.The description of the characteristics of EVLP in this report will benefit the diagnosis and early treatment of this disease.

Impact of Adverse Events Associated With Acitretin Treatment of Moderate-to-Severe Plaque Psoriasis:Based on an Observational,Single-Center Study in Shanghai,China

Objective:Acitretin is a widely used systemic retinoid that is to treat psoriasis but has significant variations in efficacy and adverse events(AEs)among individuals.This study aimed to determine the impact of AEs associated with acitretin treatment of moderate-to-severe plaque psoriasis on the Dermatology Life Quality Index(DLQI)and Hospital Anxiety and Depression Scale(HADS)scores.Methods:This prospective,observational,single-center study was conducted from March 2021 to June 2022 and analyzed 116 patients with moderate-to-severe plaque psoriasis treated with acitretin who were followed up for 12 weeks.The primary outcome was the incidence of AEs related to acitretin,and the secondary objective was to investigate the effect of AEs on the DLQI and HADS scores.The generalized linear models were used to assess the association between AEs related to acitretin and DLQI scores or HADS scores,and the association between the involved system/tissue and DLQI scores or HADS scores.Results:A final total of 45 patients were included in the analysis,and a total of 157 treatment-related AEs involving nine organs or systems were reported in 41 patients.The most common AE was skin-or mucosa-related,with 72 cumulative events in 31 patients.AEs also commonly affected the endocrine,digestive,and genitourinary systems.Compared with the group with 0-2 AEs,the group with 3-5 AEs had a significantly increased DLQI score by 5.49 points(95%CI,1.47-9.51)(P=0.0089).Compared with AEs involving 0 to 1 system,AEs affecting 2 to 3 systems resulted in a significant increase in the DLQI score by 5.75 points(95%CI,1.67-9.83)(P=0.0071).Generalized linear models showed no statistically significant associations between AEs and the HADS scores.Conclusion:Our study demonstrates a high incidence of acitretin-related AEs.These AEs may affect quality of life but rarely cause psychological problems such as anxiety and depression.