Dermatology Quality Of Life Index Scores Research Articles

Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis

BackgroundPathogenic variants in filaggrin (FLG) are associated with an increased risk of atopic dermatitis (AD). ObjectiveTo evaluate the influence of FLG variants on the effectiveness of dupilumab treatment in AD. MethodsThis prospective observational study included adult AD patients treated with dupilumab from the BioDay Registry. FLG was analysed with smMIP targeted sequencing. Novel mutations were confirmed by Sanger sequencing. Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), Numeric Rating Scale (NRS) pruritus, Dermatology Quality of Life Index (DLQI) and Patient Oriented Eczema Measure (POEM) were assessed at baseline, week 16 and 52. ResultsGenetic analysis of 285 included patients showed bi-allelic pathogenic variants (FLG-/-) in n=41 (14%), mono-allelic pathogenic variants (FLG-/+) in n=64 (23%) and wild-type alleles (FLG+/+) in n=180 (63%). Three novel pathogenic variants were found. We observed no clinically relevant differences in EASI, IGA, NRS pruritus, DLQI and total POEM scores for patients with and without pathogenic FLG variants at all time points. The FLG-/- group showed significantly higher POEM flaking and dryness scores at week 16 (p<0.001 and p=0.002, respectively) and 52 (p<0.001 and p=0.016, respectively) compared to FLG+/+, and also significant differences compared with FLG-/+, while differences in delta scores were non-significant. ConclusionThis study suggests that the effectiveness of dupilumab treatment in AD patients was not influenced by pathogenic FLG variants. However, patients with bi-allelic pathogenic FLG variants tended to have a drier skin before and during dupilumab treatment compared to patients with mono-allelic pathogenic variants or wild-type alleles.

The impact of genital lichen sclerosus in men and women on quality of life: a prospective cohort study.

Genital lichen sclerosus (LS) is a chronic inflammatory skin disorder that affects both sexes of all ages. The clinical characteristics include erosions, redness, and white plaques with atrophic skin, with symptoms such as pruritus, pain, dysuria, and dyspareunia. This prospective cohort study aimed to assess quality of life (QoL) in men and women with genital LS, both before and after treatment, using the Dermatology Quality of Life Index (DLQI) questionnaire. Patients diagnosed with genital LS were enrolled continuously in the study and were asked to complete the DLQI questionnaire before treatment and again after individualized treatment 12 weeks apart. This study included 136 patients (48 females and 88 males) diagnosed with genital LS, with a median age of 62 years (range 18-86). The results showed a statistically significant decrease (P < .001) in DLQI score before treatment (median 6.0 [interquartile range (IQR), 1.0-11.0]) compared to after treatment (median 2.0 [IQR, 0.0-4.0)]. In males and females, the median DLQI scores before treatment were 3.0 (IQR, 0.0-10.0) and 8.0 (IQR, 4.5-11.5), respectively, and after treatment were 1.0 (IQR, 0.0-3.0) and 4.0 (IQR, 0.0-9.0), respectively. Females scored significantly higher (P < .001) than males. The study's limited generalizability stems from a small sample size of 136 patients, potentially restricting the application of findings to a broader population with genital lichen sclerosus. Additionally, the 12-week follow-up period may not adequately capture the long-term effects of interventions on quality of life. Reliance on self-reported data through the DLQI questionnaire introduces the possibility of bias, as participants may not accurately represent their symptoms and quality of life. The absence of a control group hinders the ability to attribute observed changes solely to the treatment, and the lack of detail on specific interventions makes it challenging to assess the effectiveness of individualized treatment approaches. The wide age range among participants (18-86 years) introduces potential confounding variables, as different age groups may respond differently to treatment. The study findings confirmed that individuals with genital LS experience a small decline in QoL, as observed in both males and females. This study also highlights that effective management of genital LS can significantly improve QoL in both sexes.

Safety and efficacy of dupilumab in adult atopic dermatitis in Singapore.

Dupilumab, a biologic approved for treatment of moderate-to-severe atopic dermatitis (AD), has been reported to be largely effective with minimal adverse effects. However, being a targeted therapy, its effectiveness and side effects are expected to be varied in a heterogeneous ethnic population. Currently, the majority of studies on dupilumab are based on Western populations. A retrospective cohort of 51 patients with moderate-to-severe AD treated with dupilumab at a tertiary skin institute from January 2018 to February 2020 was included. Outcome measures such as Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI) and Dermatology Quality of Life Index (DLQI) were analysed at baseline and after 16 weeks of treatment. Laboratory tests at the respective time points were also measured. Patients treated with dupilumab showed consistent reduction in body surface area (BSA) involved, SCORAD, EASI and DLQI scores. Concurrently, serum immunoglobulin E (IgE) and absolute eosinophil count showed a downward trend at 4 months of treatment. There was a transient increase in mean serum IgE at 1 month of dupilumab treatment. Also, 42.0% and 35.3% of patients developed eye symptoms, and head and neck dermatitis, respectively, but there were no major adverse events reported. Childhood-onset AD was more likely to have improved BSA scores compared to adult-onset AD. Our study confirms the efficacy of dupilumab with real-world data in an adult Asian population. Higher proportions of eye symptoms, and head and neck dermatitis were observed in our cohort compared to other Asian clinical cohort studies. Further studies are needed to evaluate these differences.

Time to Onset of a Minimal Clinically Important Difference in DLQI with Guselkumab Treatment in VOYAGE 1

Introduction Psoriasis (PsO) is a chronic inflammatory disease of the skin. While skin clearance, as measured by the Psoriasis Area and Severity Index (PASI), is a clinical goal, PsO patients also suffer from reduced health-related quality of life (HRQoL). In the Phase 3 VOYAGE 1 trial, guselkumab (GUS) demonstrated improvements on patient reported outcomes compared with placebo (PBO) and adalimumab (ADA). Here we report an analysis of the estimated time to onset of the minimal clinically important difference (MCID) in HRQoL, as measured by the Dermatology Quality of Life Index (DLQI) and associated PASI response in GUS-treated patients from VOYAGE 1.&#x0D; Methods The VOYAGE 1 trial enrolled patients with moderate-to-severe PsO who were randomized to receive PBO, GUS, or ADA. The DLQI is a self-report measure for HRQoL ranging from 0 (no impact) to 30 (maximum impact) that assesses the effect of skin problems on 6 HRQoL domains. An accepted MCID in DLQI is 4, previously reported as the smallest difference in DLQI total score that patients’ rate as beneficial. DLQI score and PASI improvement (percent change from baseline) were analyzed at Weeks 0, 8, 16, and 24 for the subset of VOYAGE 1 patients with a baseline DLQI score &gt;4. Earliest time to onset of MCID in mean DLQI and corresponding mean PASI improvement were estimated using linear interpolation for the GUS group between Weeks 0 and 8.&#x0D; Results Among patients randomized to GUS, n=279 (85%) had DLQI &gt;4 at baseline. By first assessment at Week 8 (W8), we observed a reduction in the mean DLQI score from 15.6 (baseline) to 5.0 (W8) with median DLQI decreasing from 15.0 (baseline) to 3.0 (W8). The interpolated onset of MCID in DLQI occurred at 21.1 days (W3) following the initial GUS dose. In GUS-treated patients, the estimated mean PASI improvement corresponding to the onset of MCID in mean DLQI occurring at Week 3 was 29.2%.&#x0D; Conclusions These data indicate that the onset of clinically meaningful improvements in mean DLQI occur as early as after the first dose of GUS in patients with moderate-to-severe PsO.

Quality of Life Benefit and Clinical Predictors of Complete Skin Clearance in Psoriasis: A Multicenter, Prospective, Real-World Study

Background: Newer biologics, such as interleukin (IL)-17 inhibitors, make it possible to achieve complete skin clearance (CSC) in patients with moderate-to-severe psoriasis. However, the clinical meaningfulness and predictive factors of CSC in daily practice have not yet been fully investigated. Objective: The study was conducted to, first, assess the impact of CSC on quality of life (QoL) improvements compared with treatment responses without clearance and, second, identify clinical parameters as predictors of CSC response in psoriasis patients treated with ixekizumab. Methods: Patients attending 26 dermatology centers across China were recruited into this real-world setting between August 2020 and May 2022. Prospective cohort study in which response to ixekizumab was assessed using the Psoriasis Area and Severity Index (PASI) and Dermatology Quality of Life Index (DLQI). The absolute DLQI score and DLQI (0) response at week 12 were compared between groups achieving various levels of skin clearance. A stepwise logistic regression analysis was applied to identify which baseline clinical characteristics were predictive factors for CSC. Results: After 12 weeks of treatment, 226 of 511 (44.2%) patients achieved CSC, defined as 100% improvement in PASI score (PASI-100). A significantly higher proportion of patients with CSC versus almost clear skin (PASI 90-99) achieved DLQI score of 0, corresponding to the experience of no impairment on QoL (54.4% vs. 37.7%, p = 0.001). Females patients were more likely than males to achieve CSC response (odds ratio [OR] = 1.83; 95% confidence interval [CI]: 1.24–2.70), while previous biologic treatment (OR = 0.43; 95% CI: 0.24–0.81) and joint affected (OR = 0.61; 95% CI: 0.42–0.89) were significantly associated with less CSC response. Conclusions: This study highlights the fact that clinical parameters are important in determining CSC response in psoriasis. In daily practice, achieving CSC represents a clinically meaningful treatment goal, especially from the patient perspective.

Measurement properties of the Patient Global Assessment numerical rating scale in moderate-to-severe psoriasis.

Patient Global Assessment (PtGA) has been recommended as one of the core domains in psoriasis clinical trials. Among multiple versions of PtGA, the single-question 11-point PtGA numeric rating scale (NRS) remains to be validated in patients with plaque psoriasis. To evaluate the psychometric charateristics of a 11-point PtGA NRS for disease severity in patients with moderate-to-severe plaque psoriasis. Data were analyzed from 759 patients with moderate-to-severe psoriasis in the Shanghai Psoriasis Effectiveness Evaluation CoHort (SPEECH), a prospective, multicenter, and observational registry assessing the comparative effectiveness and safety of biologics (adalimumab, ustekinumab, secukinumab or ixekizumab), conventional systemic therapies (acitretin or methotrexate), or phototherapy. The test-retest reliability of the PtGA NRS showed good agreement (intraclass correlation coefficient range 0.79-0.83). No floor or ceiling effects of PtGA NRS were observed. The PtGA NRS was significantly correlated with Psoriasis Area and Severity Index (PASI), static Physician Global Assessment (sPGA), body surface area, Dermatology Quality of Life Index (DLQI), and Hospital Anxiety and Depression Scale. Relatively large correlations of PtGA NRS with PASI and DLQI Symptoms and feelings domain (all correlations ≥ 0.4 except at baseline) supported convergent validity. The presence of psoriatic arthritis or joint symptoms had no significant association with the PtGA NRS. In multivariate regression analyses, the PtGA NRS at baseline was predicted by age, lesion extent, lesion intensity, patients' symptoms and feelings, and impact on work or school. The PtGA NRS displayed known-groups validity with the PASI, sPGA and DLQI score bands. The PtGA NRS was responsive to change in PASI and DLQI after treatment. Anchor- and distribution-based approaches supported -3 as the minimal important difference for PtGA NRS. An absolute PtGA NRS ≤ 2 during follow-ups was concordant with the state of minimal disease activity based on PASI 90 or PASI 90 plus DLQI 0/1. Sensitivity analysis using subgroup comparison and multiple imputation model yielded consistent conclusions. The PtGA NRS showed good reliability, validity, and responsiveness in patients with psoriasis, and was feasible in clinical trials and daily practice.

Quality of life and satisfaction with life in patients with skin diseases

ABSTRACT Individuals with skin disease may experience negative symptoms such as itching and pain, social stigma, and isolation. This cross-sectional study included 378 patients with skin diseases. The Dermatology Quality of Life Index (DLQI) score was found to be higher in individuals with skin disease. A high score indicates an impaired quality of life. Married people than single people, those who are 31 years old and older than those who are 30 years old and younger have higher DLQI scores. And also those who work than those who are unemployed, those who have diseases than those who do not have any other diseases, and those who smoke than those who are non-smokers have higher DLQI scores. In order to increase the quality of life of individuals with skin diseases, it is necessary to detect risky situations as well as symptom control and add psychosocial and psychotherapeutic interventions to the treatment plan.

Impact on quality of life of an intervention providing additional information to patients with allergic contact dermatitis; a randomized clinical trial.

Allergic contact dermatitis can negatively impact an individual's daily life in terms of work and interpersonal relationships. Patch-tested individuals show an improved quality of life (QoL). We aimed to assess the impact on QoL after patch testing and what value an intervention would have on QoL. Dermatology Quality of Life Index (DLQI) were assessed in participants with positive patch test reaction. The participants were randomized, in parallel design, into two groups that received either standard information (controls, n = 70) or a reminder letter in addition to standard information (intervention group, n = 66), ClinicalTrials.gov NCT01953380. The response rate was 74% (n = 136). The DLQI score was significantly lower 1 year after patch testing in comparison with baseline in the entire group (mean DLQI 6.3 and 4.5 respectively, 95% CI 0.93-2.72, P < 0.001). However, linear regression analyses showed no significant differences in DLQI score at follow-up between the intervention and control groups. Neither age nor gender had impact on DLQI score. There was an improvement of QoL at follow-up in the entire group. However, the intervention performed did not show any significantly greater improvement concerning QoL. Further research is needed to understand what factors apart from patch testing and medical care may affect QoL in patients with contact dermatitis, and what interventions are needed to improve QoL.

A real-world, non-interventional, prospective study of the effectiveness and safety of apremilast in bio-naïve adults with moderate plaque psoriasis treated in the routine care in Greece - the 'APRAISAL' study.

Real-world data in patients with moderate psoriasis treated with apremilast is limited. To evaluate the effectiveness and safety of apremilast in bio-naïve patients with moderate psoriasis in real-world clinical settings. This was a 52-week multicenter, observational, prospective study of adult outpatients with moderate psoriasis {[10% < body surface area < 20% or 10 < psoriasis area severity index (PASI) < 20] and 10 < dermatology quality of life index (DLQI) < 20} initiated on apremilast ≤7 days before enrollment. Missing data were imputed using the last observation carried forward method. A total of 287 eligible patients (median age: 54.2 years; median psoriasis duration: 9.8 years) were consecutively enrolled. At baseline, the median DLQI and PASI scores were 12.0 and 11.8, respectively. The 52-week DLQI ≤ 5 and PASI75 response rates were 68.3% and 61.0%. At 52 weeks, 70.8% and 72.7% of the patients shifted from moderate/severe/very severe to clear/minimal scalp and palmoplantar psoriasis involvement, respectively; the pruritus severity state improved in 67.2%. The 52-week Kaplan-Meier estimated drug continuation rate was 85.3%. The adverse drug reaction rate was 19.9%. Apremilast is a safe and effective treatment for bio-naïve patients with moderate psoriasis and specific psoriasis manifestations.

Intralesional Purified Protein Derivative of Tuberculin Versus Intralesional Mycobacterium W Vaccine in Treatment of Recalcitrant Extragenital Warts: A Randomized, Single-Blinded, Comparative Study.

Introduction:Of late, immunotherapy has emerged as a promising therapeutic modality for the treatment of recalcitrant and difficult to treat warts. Purified protein derivative of tuberculin (PDD) and mycobacterium w (Mw) vaccine hold promising prospects for the treatment of verruca, especially in a country like ours where a majority of the population is already sensitized to mycobacterium tuberculosis both due to disease endemicity and Bacillus Calmette-Guérin (BCG) vaccination.Aims and Objectives:We aimed at evaluating the treatment outcome of intralesional PPD tuberculin and Mw vaccine in the treatment of recalcitrant extragenital warts in immunocompetent subjects.Materials and Methods:The patients included immunocompetent subjects between the ages of 16 and 65 years with two or more extragenital warts. The patients were randomized into two groups, namely A (PPD Tuberculin) and B (Mw vaccine). In both groups, 0.1 mL of active intralesional immunogen was injected at the base of the largest wart. The doses were repeated at 4 weeks' intervals for a maximum of 5 injections. Additionally, the improvement in quality of life was measured using the Hindi-validated version of the Dermatology Quality of Life Index (DLQI) questionnaire.Results:Ninety-seven patients completed the study, with 46 in group A and 51 in group B. In group A, 24 (52.17%) patients had complete clearance in all warts, and in group B, 32 (62.75%) (P = 0.38). The most common adverse event in patients of group A was transient injection site erythema and swelling, whereas that in group B was mild transient fever. None of the patients showed any signs of recurrence in the ensuing follow-up period. There was a statistically significant improvement in the mean DLQI scores after treatment in both groups (P < 0.0001).Conclusion:Both PPD Tuberculin and Mw vaccine are effective in the treatment of recalcitrant warts with minimal recurrence rate. The safety profile of PPD is superior to Mw vaccine. We suggest both to be used as first-line therapy in the treatment of difficult to treat warts.

Wide Local Excisions and Pedicled Perforator Flaps in Hidradenitis Suppurativa: A Study of Quality of Life.

Hidradenitis suppurativa (HS) is a chronic skin pathology characterized by the occurrence of inflamed and swollen lesions, with a devastating impact of the disease on patient's quality of life. Wide local excision (WLE) of the affected tissue is the criterion-standard treatment, but there is no general consensus on the best reconstructive technique. The aim of this article is to evaluate the quality of life before and after WLE combined with pedicled perforator flap reconstruction, in patients suffering from HS. We analyzed 26 consecutive patients suffering from Hurley stage III HS. Every patient underwent WLE, followed by reconstruction with pedicled perforator flap. Dermatology Quality of Life Index (DLQI) tests were administered to every patient preoperatively and 6 months after surgery, when the clinical condition was considered stable. Dermatology Quality of Life Index scores were compared in terms of means with Student t test. Linear regression studies were used to compare the changes in DLQI score with the surgical and clinical variables. Axillary area involvement was found in 21 of 27 patients; 6 patients had more than 1 body region involved. Thirty-two pedicled perforator flaps were performed, and 22 were thoracodorsal artery perforator flaps. Mean DLQI test score before the first operation was 21.31 ± 4.79; the average DLQI score after the last follow-up was 5 ± 2.95 (P < 0.0001). Dermatology Quality of Life Index scores were not influenced by complications including reoperation. There were also no correlations found between DLQI score delta and number of reoperation (-0.18) or days of hospital stay (-0.13). Wide local excision followed by pedicled perforator flap reconstruction allows a radical excision of HS areas with short postoperative healing periods. Dermatology Quality of Life Index scores confirmed high levels of patients' satisfaction. Disadvantages of this technique include difficult learning curve, long operating time, and a nonnegligible complications rate.

Increased Trend of Cosmetic Procedures in Patients With Psoriasis Who Attain 75% or Greater Improvement.

Background: The relationship between the clearance of psoriasis and improved quality of life together with an increased uptake of cosmetic procedures has not been reported to date. Objective: A survey was conducted at a single dermatology center to determine if there was an increased trend in cosmetic procedures in patients with moderate to severe psoriasis who attained 75% or greater reduction of the body surface area (BSA) with biologic agents and oral systemic therapies, and if this was related to an improvement in quality of life following psoriasis clearance. Study Design: In this case series, 138 patients with a history of moderate to severe psoriasis who attained 75% or greater body surface area (BSA) reduction with biologic agents or oral systemic therapies and had undergone at least one cosmetic procedure in the past 2 years were surveyed. Patient characteristics were collected including age, sex, percent BSA at initiation of therapy, the class of biologic or oral systemic therapies, and the different types of cosmetic procedures. Patients were asked to answer a 5-question survey on quality of life improvement, satisfaction with treatment, and correlation with the cosmetic procedure they had undergone, Patients also completed the Dermatology Quality of Life Index (DLQI) questionnaire in the survey. Results: The majority of patients who had undergone a cosmetic procedure after achieving 75% BSA stated that their psoriasis had previously prevented them from undergoing a cosmetic procedure. Regardless of therapy, all patients felt their quality of life had improved as a result of their treatment, and 91% of patients stated this was the impetus to undergo a cosmetic procedure. The mean DLQI score prior to therapy was 14.3 and 71% of patients reported a DLQI score of 0/1 after their psoriasis improved. Conclusion: There was a correlation between improvement in quality of life in patients who had achieved at least a 75% reduction in BSA with either a biologic agent, oral agent, or both, and the uptake of cosmetic procedures. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5104R1.

IL-17A in the Psoriatic Patients' Serum and Plaque Scales as Potential Marker of the Diseases Severity and Obesity.

The aim of the study was to evaluate concentrations of IL-17 in the serum and plaque scales of psoriatic patients. We analyzed their association with the clinical activity of the disease and with body mass index (BMI). Demographic data, medical history, serum, and scale from psoriatic plaques for assessment of IL-17 were collected from all the participants. The disease severity was assessed with PASI (Psoriasis Area and Severity Index), BSA (Body Surface Area), PGA (Physician Global Assessment), NAPSI (Nail Psoriasis Severity Index), and DLQI (Dermatology Quality of Life Index) scores. Obesity was diagnosed by calculating body mass index. Serum and scale concentration of IL-17 was determined with Human IL-17A High Sensitivity ELISA kit and Human IL-17 ELISA kit. In the psoriatic patients, BMI was statistically significantly higher than in the control group. Most of the patients presented BMI higher than normal. Our study confirms that overweight is a problem among psoriatic patients. A significant positive correlation between the IL-17 serum and scale concentrations and psoriasis severity indicates that IL-17 can be used as the marker of disease severity. More data from human studies can be crucial for understanding that relationship between IL-17, psoriasis, and obesity.

CLINICAL AND DEMOGRAPHIC PROFILE OF PATIENTS WITH PSORIASIS AND ITS EFFECT ON THE QUALITY OF LIFE USING DERMATOLOGY QUALITY OF LIFE INDEX: A CROSS SECTIONAL STUDY

OBJECTIVES: To determine clinical and demographic patterns among patients with psoriasis and their effects on quality of life (QoL) using Dermatology Quality of Life Index (DLQI).METHODS: This cross-sectional study was conducted at Khyber teaching hospital Peshawar, Pakistan from September 2016 to October 2017. Consecutive sampling technique was used to select 168 patients with psoriasis. DLQI used on all patients, was split in to two groups and score >10 was taken as very large effect on patient's life. Data was analyzed through SPSS v.20 software. RESULTS: Out of total 168 patients, 115 (68.5%) were female. Plaque was the commonest (n=106; 63.1%) type of psoriasis followed by guttate (n=24; 14.3%) and palmoplantar (n=24; 14.3%). Majority of psoriasis were young adults (n=60; 35.7%), followed by adults (n=56; 33.3%). Mean DLQI score was 10.98±4.300. Group-1 (DLQI score=0-10) included 86 (51.2%) patients and Group-2 (DLQI score >10) included 82 (48.8%) patients. A significant mean difference was recorded among the two groups of DLQI and age of the patient on Independent sample t-test {t (167) =-15.432, p = 0.000}. In group-1, 59 (51.3%) were female and 27 (50.9%) were males; while in group-2, 56 (48.7%) were females and 26 (49.1%) were males.CONCLUSION: Psoriasis is almost twice more common in female and plaque psoriasis is the commonest variety. Psoriasis has a very large effect on QoL in almost half of the patients. Impact of psoriasis on QoL of the patient is the same in both genders and is more for the erythrodermic form of psoriasis.

A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis.

IntroductionPsoriasis is estimated to affect 0.44–2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern in an Indian context are lacking. Hence, this real-world study on an intensive plant-based butter moisturizing cream (Venusia ® Max) was conducted among Indian patients with psoriasis.MethodsThis was an observational, patient-reported outcomes (PRO) study in patients with psoriasis aged 18–75 years who were prescribed the cream in routine clinical practice, as per clinician’s discretion, over 4 weeks. The primary outcome measure was improvement from baseline in quality of life assessed using the Dermatology Quality of Life Index (DLQI) at 4 weeks of the study period. The secondary outcome measures were improvement in dryness using the Dry Skin/Ichthyosis Area and Severity Index (DASI) score at 4 weeks, safety and compliance. The DLQI and DASI scores were recorded by the clinicians at baseline and after 2 (optional) and 4 weeks of starting the cream. Safety was assessed throughout the study.ResultsThe study included 400 patients from 9 outpatient dermatology centers across India. Of 400 patients, 384 completed the study. A significant reduction in both the mean DLQI score (66.7%; p < 0.001) and mean DASI score (84.6%; p < 0.001) was observed at week 4 after starting the cream vs. baseline in the overall population. Overall, the cream showed a good safety and compliance profile during the study period. There were no serious adverse events or deaths.ConclusionsThe evidence from the PRO study suggests that use of the intensive plant-based butter moisturizing cream in a real-world scenario has a noticeable impact on improving the quality of life and reducing the skin dryness associated with psoriasis over 4 weeks. The moisturizing cream may serve as a valuable adjuvant treatment option for the management of psoriasis.Trial Registration NumberCTRI/2017/03/008023.FundingDr. Reddy’s Laboratories Ltd.Electronic supplementary materialThe online version of this article (10.1007/s13555-019-0307-0) contains supplementary material, which is available to authorized users.

Real-World, Non-Interventional, Observational Study of Hydroxyzine Hydrochloride in Chronic Pruritus: a Prospective, Non-Comparative Study.

IntroductionAlthough hydroxyzine is widely used for symptom relief in pruritus, its clinical safety and efficacy data in the Indian setting are scarce. We conducted a study to assess the effectiveness and tolerability of hydroxyzine in the management of Indian patients with chronic pruritus in a real-world setting.MethodsThis was a prospective, observational, patient-reported outcomes (PRO) study in patients with chronic pruritus due to dermatological causes treated with hydroxyzine as per the clinician’s discretion for a period of up to 12 weeks. The primary outcome was improvement in quality of life from baseline, assessed using the 10-point Dermatology Quality of Life Index (DLQI) at week 12 of the study period. Secondary outcomes were improvement in the pruritus scores (5-D itch scale) at 12 weeks, improvements in the DLQI and 5-D itch scores at 2, 4 and 8 weeks and safety.ResultsThe study included 400 patients (179 males, 221 females) from 7 dermatology centres across India. Of the 400 patients recruited, 391 patients completed at least 2 weeks of treatment. There was significant (p < 0.0001) improvement from baseline in the DLQI scores and 5-D itch scores at 2, 4, 8 and 12 weeks; 189/391 (48.34%) patients had symptom relief leading to early termination. Overall, the treatment was well tolerated with a total of 11 mild-to-moderate adverse events reported during the study, which included dizziness, constipation, drowsiness, dry mouth and sedation. All events resolved without any intervention. There were no serious adverse events.ConclusionThis real-world, observational, PRO study demonstrates that hydroxyzine significantly improves symptoms of pruritus and quality of life in patients with chronic pruritus due to dermatological causes over 12 weeks. Despite the sedating potential of the drug, hydroxyzine is well tolerated in real-world settings.Trial RegistrationCTRI/2017/06/008847.FundingDr. Reddy’s Laboratories.Electronic supplementary materialThe online version of this article (10.1007/s13555-019-0293-2) contains supplementary material, which is available to authorized users.

Using a novel scoring system for paronychia related to oncologic treatments (SPOT) for assessing paronychia severity and its correlation with pain index and quality of life.

Oncologic treatments may lead to the development of paronychia, which may cause severe pain and disability. However, a detailed objective scoring system is lacking. To develop an objective scoring system to quantify the severity of paronychia and also examine the correlation of this score with a pain index and patients' quality of life. A novel scoring system for paronychia related to oncologic treatments (SPOT), consisting of four parameters, namely redness, oedema, discharge and granulation tissue, was designed to assess the severity of paronychia. The visual analogue scale (VAS) and Dermatology Quality of Life Index (DLQI) were recorded, and their association with the SPOT scores was analysed. Ninety patients were enrolled from three medical centres in Taiwan. Severity of paronychia was determined by the scores of SPOT. Patients in the severe group had higher DLQI scores (severe vs. mild: P = 0.0018; severe vs. moderate: P = 0.0015). Both the DLQI and pain index scores were significantly higher in patients with higher dominant hand SPOT scores. The SPOT scores demonstrated the association of the paronychia severity with DLQI and pain. It may thus be useful in clinical practice and future studies.

PSS22 - Real World, Prospective, Observational, Patient Reported Outcome Study of Hydroxyzine Hydrochloride in Indian Patients with Chronic Pruritis

To assess effectiveness & tolerability of hydroxyzine hydrochloride in management of Indian patients with chronic pruritus in real world setting A prospective, observational, patient reported outcomes study of 400 patients across 7 centres (179 male, 221 female), >18 years of age, having chronic pruritus due to dermatological cause and treated with hydroxyzine hydrochloride as per clinician's discretion upto period of 12 weeks. Primary outcome was improvement from baseline in quality of life, assessed using 10-point Dermatology Quality of Life Index (DLQI) after 12 weeks of study period. Secondary outcomes were improvement in the pruritus scores (5D-Itch scale) after 12 weeks, improvements in DLQI and 5D-Itch scores at 2, 4, and 8 weeks, and clinical safety during the study period were recorded. Wilcoxon test is used to compare baseline and follow-up data for DLQI and pruritus scores. The per-protocol set (PPS) included 177 patients and full-analysis set (FAS) had 391 patients. There was significant improvement (p<0.0001) in DLQI scores at 2 weeks (13.10%), 4 weeks (37.40%), 8 weeks (57.01%) and 12 weeks (76.33%) period in PPS patients. Similar significant improvement in DLQI was noted in FAS at 2, 4, 8 & 12 weeks (p<0.0001). The pruritus scores also decreased significantly (p<0.0001) at 2 weeks (10.56%), 4 weeks (26.32%), 8 weeks (37.71%) and 12 weeks (57.76%) period in PPS patients. Similar significant reduction in pruritus scores was observed in FAS patients at 2, 4, 8 & 12 weeks (p<0001). Total 10 (2.5%) patients reported mild to moderate adverse events (total 11 events) which were dizziness (4), constipation (2), drowsiness (2), dry mouth (2) and sedation (1). All events resolved without any intervention. This real world, observational, patient reported outcome study demonstrates hydroxyzine hydrochloride to significantly decrease symptoms of pruritus and improve quality of life in patients with chronic pruritus over 12 weeks treatment period

Outcomes assessment of hepatitis C virus-positive psoriatic patients treated using pegylated interferon in combination with ribavirin compared to new Direct-Acting Antiviral agents.

AIMTo evaluate the outcomes in biological treatment and quality of life of psoriatic patients with chronic hepatitis C (CHC) treated with new Direct-Acting Antiviral agents (DAAs) compared to pegylated interferon-2α plus ribavirin (P/R) therapy.METHODSThis is a retrospective study involving psoriatic patients in biological therapy who underwent anti-hepatitis C virus (HCV) treatment at the Department of Dermatology Galeazzi Orthopaedic Institute Milan, Italy from January 2010 to November 2017. The patients were divided into two groups: patients that underwent therapy with DAAs and patients that underwent HCV treatment with P/R. Patients were assessed by a dermatologist for psoriasis symptoms, collecting Psoriasis Area Severity Index (PASI) scores and the Dermatology Quality of Life Index (DLQI). PASI and DLQI scores were evaluated 24 wk after the end of HCV treatment and were assumed as an outcome of the progression of psoriasis. Switching to a different bDMARD was considered as an inadequate response to biological therapy. The dropout of HCV therapy and sustained virological response (SVR) were considered as outcomes of HCV therapy.RESULTSFifty-nine psoriatic patients in biological therapy underwent antiviral therapy for CHC. Of this, 27 patients were treated with DAAs and 32 with P/R. After 24 wk post treatment, the DLQI and the PASI scores were significantly lower (P < 0.001 and P < 0.005, respectively) in the DAAs group compared with P/R group. None of the patients in the DAAs group (0/27) compared to 8 patients of the P/R group (8/32) needed a shift in biological treatment.CONCLUSIONDAAs seem to be more effective and safe than P/R in HCV-positive psoriatic patients on biological treatment. Fewer dermatological adverse events may be due to interferon-free therapy.

Efficacy of oxymatrine for treatment and relapse suppression of severe plaque psoriasis: results from a single-blinded randomized controlled clinical trial.

Drugs that are currently used in the treatment of psoriasis are associated with drawbacks such as rapid recrudescence, high costs and unwanted side-effects. Oxymatrine has a long history of clinical use in the treatment of hepatitis and cancer in China. To explore the efficacy and safety of intravenous oxymatrine in patients with severe plaque psoriasis. A total of 67 patients were randomly allocated to receive oxymatrine injections (0.6 g per day for 8 weeks) or acitretin capsules (0.75 mg kg-1 per day from week 0 to week 2 and 20-30 mg per day from week 3 to week 8) and followed up for another 24 weeks. The primary end point was the percentage of patients with ≥ 50% reduction of Psoriasis Area and Severity Index (PASI 50) at week 32. The secondary end points included the skin classification grade and the Dermatology Quality of Life Index (DLQI) score. Side-effects were recorded throughout the whole study to assess the safety profile. Treatment with oxymatrine or acitretin for 8 weeks significantly decreased PASI score, skin classification grade and DLQI score (P < 0.001), with no significant differences between the oxymatrine and acitretin groups in terms of PASI 50. However, at week 32, the relapse rate in the oxymatrine group was significantly lower than that of the acitretin group (P < 0.001). Moreover, while there was an increase in the number of patients with metabolic abnormalities in the acitretin group, a significant reduction was observed in the oxymatrine group. Furthermore, rates of adverse reactions were significantly decreased in the oxymatrine group compared with that of the acitretin group (P < 0.001). Treatment with oxymatrine effectively ameliorated severe plaque psoriasis, and was accompanied by only minor adverse effects.