Improvement In Dermatology Life Quality Index Research Articles

Role of Lactium™ in Psychodermatology: The CERTAIN Trial# on Patients with Acne Vulgaris.

Stress plays an important role in the causation and aggravation of psychodermatological conditions such as acne vulgaris. Alpha casein hydrolysate (αs1-casein hydrolysate; Lactium) has been shown to decrease serum cortisol levels, reduce stress-related symptoms, and promote relaxation. “This study aimed to compare the efficacy and safety of Lactium™ plus standard care to those of standard of care alone in reducing stress levels and acne severity in patients with acne vulgaris.” The C.E.R.T.A.I.N trial (Name registered with Clinical Trials Registry-India-No. CTRI/2019/01/017172) is a randomized, controlled, multicenter, open-label, two-arm, investigator-initiated clinical trial. A total of 100 patients with moderate-to-severe acne vulgaris were enrolled and randomly assigned to one of the two groups: Lactium™ plus standard care or standard care alone. Stress levels were assessed using serum cortisol levels, Investigator's Global Assessment (IGA) acne severity scale scores, Perceived Stress Scale (PSS) scores, and the Hamilton Anxiety Rating Scale (HAM-A) scores. The Dermatology Life Quality Index (DLQI) was also used to assess the impact of the skin disease on patients' quality of life. At 12 weeks, stress levels were significantly lower in group A (Nixiyax plus standard of care) than that in group B(only standard care), as measured by the change in serum cortisol levels (4.75 ± 4.46 vs. −0.24 ± 5.22). Furthermore, the mean change in PSS scores (3.09 ± 2.04 vs. 0.90 ± 2.76) and HAM-A scores (5.11 ± 1.94 vs. 1.25 ± 3.13) was significant. Patients in both arms had a significant decrease in total, inflammatory, and noninflammatory acne lesions, as well as a significant improvement in DLQI and IGA scores. In patients with moderate-to-severe acne vulgaris, Lactium™ was found to be both safe and well-tolerated. Lactium™ plus standard care is more effective than standard care alone in reducing acne severity through stress reduction.

Biologics Can Significantly Improve Dermatology Life Quality Index (DLQI) in Psoriatic Patients: A Systematic Review.

BackgroundThe quality of life in psoriatic patients is significantly impaired. Since this century, there have been biologics as a treatment for psoriasis. These biologics reduce symptoms, but more knowledge is needed about potential improvements in quality of life. As a result, biological therapy may be more valuable for patients who experience a lot of burden from their chronic skin condition in daily life. The aim of this systematic review was to investigate the possible improvement of the Dermatology Life Quality Index (DLQI) in psoriatic patients using biologics.Materials and MethodsAn online search was performed in the PubMed database to identify relevant articles. Inclusion criteria for studies were psoriatic patients, a measurement of DLQI with biologics and without biologics. Exclusion criteria for studies were abstracts not written in English, publications before 2012, full text unavailable, quality of life measurements other than DLQI. Results from the studies with different biologics were combined into the outcome measure: ≥5 points of improvement in the DLQI score. Results of the studies in which biologics were compared with (conventional) systemic therapy were combined in the outcome measure: improvement of the DLQI score is better with biologics than with systemic therapy.ResultsThere were nine included articles with a total of 19.926 patients. Adalimumab, alefacept, etanercept, infliximab, ustekinumab and secukinumab were included biologics. Six studies measured the change in DLQI of different biologics in number of points. Of these six studies, 22 sub-analyses were performed and 20 of them showed a DLQI improvement of ≥5 points. The improvement in DLQI was better with biologics than with systemic therapy in two of the three measured studies.ConclusionQuality of life of psoriatic patients will be improved by the studied biologics. In the future, more research is needed into biologics on patient and quality of life characteristics.

Probiotic as an adjuvant therapy in chronic urticaria: a blinded randomized controlled clinical trial.

Background. Chronic spontaneous urticaria (CSU) is a common and treatment challenging disorder which may involve about 2% of normal population and in 50% do not respond properly even to the second line therapies. We aimed to evaluate the efficacy and safety of a synbiotic (prebiotic + probiotic) named as LactoCare in treatment of CSU in the RCT for the first time. Methods. This blinded RCT conducted on 42 patients (21 patients in control antihistamine group and 21 in intervention antihistamine + probiotic group) with CSU during 8 weeks. The efficacy assessed by Urticaria Activity Score (UAS7) and quality of life measured by Persian validated Dermatology Life Quality Index (DLQI). Results. Before and after UAS7 score in control group was 35.33 ± 7.81 and 16.86 ± 13.54, respectively. There was 53% score reduction in control group. Before and after UAS7 score in intervention group was 32 ± 7.84 and 11 ± 11.41, respectively. There was 66% score reduction in intervention group. Improvement of DLQI in control and intervention group was 44% and 66%, respectively. At the end, UAS7 score reduction and DLQI improvement in both groups was statistically significant. Conclusions. Probiotics are effective, safe and satisfactory adjuvant therapy for CSU. Combination of probiotic and antihistamines had no statistically significant different efficacy than the antihistamine alone, based on UAS7 score. But Patients with combination therapy may experience higher reduction rate of itch, number of urticaria and total UAS7 score that is clinically of great value and is really practical by itself. Patients with combination therapy experienced more improvement of quality of life (DLQI).

Rapid Improvement in Skin Pain Severity and Its Impact on Quality of Life in Adult Patients With Moderate-to-Severe Atopic Dermatitis From a Double-Blind, Placebo-Controlled Baricitinib Phase 3 Study

Skin pain (discomfort/soreness) is a common symptom associated with atopic dermatitis (AD). To evaluate rapid changes in skin pain severity with baricitinib, and its impact on patient quality of life (QoL) in adults with moderate-to-severe AD who were inadequate responders to topical therapy. Adult patients with moderate-to-severe AD who were inadequate responders to topical therapies (N = 440, BREEZE-AD5 [NCT03435081]) were randomized to once-daily placebo, baricitinib 1 mg, or baricitinib 2 mg for 16 weeks. Change in Skin Pain Numeric Rating Scale (NRS) scores were assessed for the randomized population. Skin Pain NRS and Dermatology Life Quality Index (DLQI) scores were assessed for Skin Pain Response groups and patients with Body Surface Area (BSA) 10% to 50%. Skin Pain NRS improvement was significant versus placebo by day 1 baricitinib 2 mg (least squares mean [LSM] difference -4.4%, P = .048) and by day 2 for baricitinib 1 mg (-6.7%, P = .011). As measured weekly, improvement was significant starting at Week 1 and remained significant through Week 16 for both doses. At Week 16, 70.9% of Skin Pain NRS responders vs 10.4% of nonresponders had a clinically meaningful improvement in DLQI (P < .0001). At week 16, LSM DLQI change from baseline was -11.1 for all Skin Pain NRS responders versus -3.5 for nonresponders (P < .0001). Patients with BSA 10% to 50% showed similar trends. Patients with moderate-to-severe AD, treated with baricitinib, reported rapid improvements in skin pain severity by day 1 for baricitinib 2 mg and day 2 for baricitinib 1 mg and remained effective through 16 weeks of treatment, which positively impacted patient QoL.

Do anti-psoriatic drugs work better in women than men?

Linked Article:Maul etal. Br J Dermatol 2021; 185:1160-1168. Psoriasis is a chronic, scaly skin condition affecting about 2·5% of the population. It has a negative impact on people's quality of life, more so in women. It is usually treated with creams but is sometimes severe enough to need strong medicines, which are not always effective. This study examines differences between men and women in their responses to treatment. The 5346 adult patients were identified from Swiss and German patient registries; 60% were male. The men were heavier than women (average 91 kg versus 78 kg). At the start of treatment men had worse psoriasis whereas women had worse quality of life scores. All received systemic medicines, including non-biologics (methotrexate, fumaric acid esters, ciclosporin, acitretin or apremilast) or biologics (adalimumab, etanercept, infliximab, ustekinumab or secukinumab). They were followed up for up to a year after starting treatment and women showed better improvements on two scales called the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) than men. These results might reflect better drug adherence in women, or their lower bodyweight - where the same dose is used for men and women, women will receive a higher dose per kilogram of body tissue. Also, because of hormonal factors, women's bodies contain a higher proportion of fat, which may allow the drug to spread more easily through the body. Finally, women experience their psoriasis more negatively than men and so there was more room for improvement in DLQI. These findings indicate a need for more personalized treatment, taking gender into account.

Efficacy of biologics and oral small molecules for atopic dermatitis: a systematic review and meta-analysis

Background As new targeted therapies continue to emerge for atopic dermatitis (AD), comparisons between agents are necessary to inform clinical decision-making. Objectives Assess the efficacy of biologics and oral small molecules on the clinical signs, symptoms, and quality of life in AD. Methods A systematic literature review identified phase II and III randomized clinical trials of biologics and oral small molecules in AD. Clinical benefit was assessed for three outcome measures: Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI), and Peak Pruritus Numerical Rating Scale (PP-NRS) by performing a meta-analysis using the inverse variance heterogeneity model ((IVhet)). Results The highest achievement of 75% reduction in EASI was seen with the higher dose of upadacitinib (30 mg) followed by abrocitinib and lebrikizumab, which outperformed dupilumab. Similarly, the highest proportion achieving at least a 4-point reduction of PP-NRS was seen with lebrikizumab followed by upadacitinib and abrocitinib which had greater reduction of itch than dupilumab. Abrocitinib had the greatest improvement in DLQI. Conclusions Upadacitinib, abrocitinib, and lebrikizumab had greater improvement of clinical signs, symptoms, and quality of life in AD compared to dupilumab and other targeted therapies.

Deterioration of Health-Related Quality of Life After Withdrawal of Risankizumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis: A Machine Learning Predictive Model.

IntroductionRisankizumab has demonstrated efficacy in treating moderate-to-severe psoriasis. The phase-3 IMMhance trial (NCT02672852) examined the effect of continuing versus withdrawing from risankizumab treatment on psoriasis severity, including the Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA). However, the effect of withdrawal on health-related quality of life (HRQL) was not assessed. Therefore, this study was conducted to evaluate the impact of risankizumab withdrawal on HRQL measured by the Dermatology Life Quality Index (DLQI). Because DLQI was not measured beyond week 16 in IMMhance, a machine learning predictive model for DLQI was developed.MethodsA machine learning model for DLQI was fitted using repeated measures data from three phase-3 trials (NCT02684370, NCT02684357, NCT02694523) (pooled N = 1602). An elastic-net algorithm performed automated variable selection among candidate predictors including concurrent PASI and sPGA, demographics, and interaction terms. The machine learning model was used to predict DLQI at weeks 28–104 of IMMhance among patients re-randomized to continue (N = 111) or withdraw from (N = 225) risankizumab after achieving response (sPGA = 0/1) at week 28.ResultsThe machine learning predictive model demonstrated good statistical fit during tenfold cross-validation and external validation against observed DLQI at weeks 0–16 of IMMhance (N = 507). Predicted improvements in DLQI from baseline were lower in the withdrawal versus the continuation cohort (mean DLQI change at week 104, −5.9 versus −11.5, difference [95% CI] = 5.6 [4.1, 7.3]). Predicted DLQI deteriorated more extensively than PASI (49.7% versus 36.4%) after treatment withdrawal.ConclusionsThe predicted DLQI score deteriorated more rapidly after risankizumab withdrawal than the PASI score, an objective measure of disease. These findings suggest that the deterioration in HRQL reflects more substantial impacts after risankizumab discontinuation than those measured by PASI only.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13555-021-00550-8.

POS1044 EFFECT OF SECUKINUMAB VERSUS ADALIMUMAB ON ACR CORE COMPONENTS AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM THE EXCEED STUDY

Background:EXCEED (NCT02745080) was the first fully blinded head-to-head trial to evaluate the efficacy and safety of secukinumab (SEC) versus (vs) adalimumab (ADA) monotherapy in patients with active psoriatic arthritis (PsA) with a primary endpoint of American College of Rheumatology (ACR) 20 at Week 52. Although SEC narrowly missed statistical significance for superiority vs ADA, numerically higher response for other musculoskeletal endpoints and composite indices were observed with SEC.1Objectives:To explore the effect of SEC and ADA on ACR core components, function and Health-related Quality of Life (HRQoL) outcomes.Methods:Patients were randomised 1:1 to receive SEC 300 mg (N=426) subcutaneous (s.c.) at baseline, Week 1-4, followed by every 4 weeks until Week 48 or ADA 40 mg (N=427) s.c. at baseline followed by same dosing every 2 weeks until Week 50. The primary, key secondary and some exploratory endpoints at Week 52 were previously reported.1 A supportive analysis for ACR50 response using logistic regression model and trimmed means model for Health Assessment Questionnaire-Disability Index (HAQ-DI) with gender and smoking status as factors was performed to adjust for imbalances in baseline characteristics. An exploratory analysis of ACR core components with SEC vs ADA at Week 52 was conducted using a mixed-effects repeated measures model that included tender and swollen joint counts, patient and physician global assessment, PsA pain (VAS) and erythrocyte sedimentation rate. HRQoL variables were also exploratory and assessed based on Short Form Health Survey Physical/Mental Component Summary (SF-36 PCS/MCS) scores and Dermatology Life Quality Index (DLQI).Results:The demographic and baseline disease characteristics were comparable across treatment groups, except for an imbalance in sex (females: 51.2% vs 46.4%) and smoking status (yes: 21.8% vs 17.8%) in SEC and ADA group, respectively. At Week 52, ACR50 responses were 49.0% and 44.8% (P=0.0929) and HAQ-DI mean change from baseline were −0.69 and −0.58 (P=0.0314) in SEC and ADA treatment groups, respectively after adjusting for gender and smoking status. No major difference across ACR core components was observed in both treatment groups at Week 52 (Table 1). At Week 52, SEC presented similar improvement in SF-36 PCS/MCS score and numerically higher improvement in DLQI compared to ADA (Figure 1).Conclusion:Secukinumab provided similar improvements in ACR core components and SF-36 based quality of life at Week 52 with adalimumab. Greater improvement in HAQ-DI response and DLQI was demonstrated with secukinumab compared to adalimumab.

Dermatology Life Quality Index in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab or Ustekinumab.

IntroductionTargeted biological therapies for psoriasis have resulted in significant benefits, with therapeutic goals such as clear or almost clear skin accompanied by improvements in health-related quality of life (HRQoL). The objective of this study was to compare the effects of 52 weeks of treatment with brodalumab or ustekinumab on HRQoL in patients with moderate-to-severe plaque psoriasis.MethodsData were pooled from two randomised controlled phase 3 trials (AMAGINE-2 and -3) which included patients with moderate-to-severe plaque psoriasis treated with brodalumab 210 mg or ustekinumab 45 or 90 mg for 52 weeks. HRQoL outcomes were measured using the Dermatology Life Quality Index (DLQI) as well as the DLQI-Relevant (DLQI-R) version which excludes ‘not relevant’ responses.ResultsA total of 929 patients were included, 339 in the brodalumab group and 590 in the ustekinumab group. A significantly greater reduction (improvement) in DLQI score from baseline was observed in the brodalumab group compared with the ustekinumab group at weeks 4 [least-squares (LS) mean difference − 2.9, 95% confidence interval [CI] − 3.6 to − 2.2; p < 0.001), 12 (LS mean difference − 0.85, 95% CI − 1.5 to − 0.2; p = 0.01) and 52 (LS mean difference − 0.94, 95% CI − 1.6 to − 0.2; p = 0.009)]. Significantly greater proportions of patients treated with brodalumab achieved a DLQI score of 0 at weeks 4 (15.0 vs. 5.4%; p < 0.0001), 12 (37.5 vs. 28.0%; p = 0.0140) and 52 (46.3 vs. 30.3%; p < 0.0001), or of ≤ 1 [DLQI (0/1): 33.9 vs. 15.4%, 59.9 vs. 45.6% and 54.9 vs. 39.8%, respectively; all p < 0.0001]. Similar results were observed using the DLQI-R scoring system. Significantly more patients achieved a ≥ 4 or ≥ 5 improvement in DLQI with brodalumab compared to ustekinumab at weeks 4 and 52. Treatment with brodalumab was associated with significantly more patients achieving a DLQI of 0 compared to ustekinumab for all domains after 4 and 52 weeks.ConclusionBrodalumab was associated with a significantly greater improvement in HRQoL compared to ustekinumab in patients with moderate-to-severe psoriasis.

Dupilumab treatment induced similar improvements in signs, symptoms, and quality of life in adults with moderate-to-severe atopic dermatitis with baseline Eczema Area and Severity Index Score

In multiple phase 3 trials, dupilumab improved signs, symptoms (including pruritus), and quality-of-life (QoL) in adults with moderate-to-severe atopic dermatitis (AD). In Italy, dupilumab received innovation status but is currently only reimbursed by the National Health Service for adults with Eczema Area Severity Index (EASI) scores ≥24. This analysis assesses disease burden and dupilumab efficacy in adults with EASI scores above and below this threshold. This post-hoc analysis included 299 adults pooled from two, randomized, placebo-controlled, phase 3 trials, LIBERTY AD CAFÉ (NCT02755649) and LIBERTY AD CHRONOS (NCT02260986), who received the approved dupilumab regimen (300 mg every 2 weeks) or placebo, with concomitant topical corticosteroids. EASI, Peak Pruritus Numerical Rating Scale (PP-NRS), and Dermatology Life Quality Index (DLQI) were assessed in patients with EASI scores ≥20 to <24 and ≥24 at week 16. At baseline, EASI was weakly correlated with PP-NRS and DLQI (Spearman's correlation coefficient: 0.22 and 0.29, respectively). At week 16, in both the EASI<24 and EASI≥24 populations, respectively, significantly more patients vs. control achieved: ≥50% improvement in EASI (95.5% vs. 55.6%; 80.6% vs. 33.1%); ≥3-point improvement in PP-NRS (68.4% vs. 35.3%; 55.3% vs. 17.7%); and ≥4-point improvement in DLQI (83.3% vs. 43.8%; 84.2% vs. 41.9%); from baseline. Dupilumab was generally well tolerated with an acceptable safety profile. Dupilumab treatment improves signs, symptoms, and QoL in moderate-to-severe AD adults with EASI<24, who can present with high disease burden. Opportunity may exist to use additional parameters to define disease severity and access to new therapies.

Relationship Between Rapid Skin Clearance and Quality of Life Benefit: Post Hoc Analysis of Japanese Patients with Moderate-to-Severe Psoriasis Treated with Ixekizumab (UNCOVER-J).

IntroductionIxekizumab has demonstrated rapid onset of action, high levels of skin clearance, and improvements in quality of life in patients with moderate-to-severe psoriasis, including plaque, erythrodermic, or generalized pustular psoriasis.MethodsThis was a post hoc analysis of UNCOVER-J, a phase 3, multicenter, single-arm, open-label study of ixekizumab for treatment of Japanese patients with psoriasis. The objective was to assess the proportion of patients who achieved Dermatology Life Quality Index (DLQI) (0,1) and Itch Numeric Rating Scale (NRS) (0) at weeks 4 and 12 according to Psoriasis Area and Severity Index (PASI) percentage improvement levels. All intent-to-treat patients with plaque, erythrodermic, or generalized pustular psoriasis were analyzed.ResultsA total of 91 patients were treated with ixekizumab and included in the analysis. Rapid improvements in PASI at weeks 4 and 12 were associated with improvements in DLQI (0,1) response at week 4 and at week 12. Complete skin clearance (PASI 100) achieved either at week 4 or week 12 was associated with a higher Itch NRS (0) response at week 12.ConclusionsPatients with rapid improvement in clinical symptoms of psoriasis had better patient outcomes than those with slower responses. These findings highlight the clinical importance of achieving a fast response in patients with psoriasis, which may lead to better treatment outcomes.Trial RegistrationClinicalTrials.gov identifier, NCT01624233.Graphic Electronic supplementary materialThe online version of this article (10.1007/s13555-020-00441-4) contains supplementary material, which is available to authorized users.

Comparing the efficacy and tolerability of biologic therapies in psoriasis: an updated network meta‐analysis

The rapid expansion of psoriasis biologics has led to an urgent need to understand their relative efficacy and tolerability to inform treatment decisions better and, specifically, to inform guideline development. To update a 2017 meta-analysis on the comparative efficacy and tolerability of biologic treatments for psoriasis. We searched the MEDLINE, PubMed, Embase and Cochrane databases for randomized controlled trials (RCTs), published up to 7 September 2018, of 11 licensed, NICE-approved biologics targeting tumour necrosis factor (adalimumab, etanercept, infliximab, certolizumab pegol), interleukin (IL)-12/IL-23p40 (ustekinumab), IL-17A (secukinumab, ixekizumab), IL-17RA (brodalumab) and IL-23p19 (guselkumab, tildrakizumab, risankizumab). A frequentist network meta-analysis ascertained direct or indirect evidence comparing biologics with one another, methotrexate or placebo. This was combined with hierarchical cluster analyses to consider efficacy (≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90) or Physician's Global Assessment 0 or 1; PASI 75; Dermatology Life Quality Index improvement) and tolerability (drug withdrawal due to adverse events) outcomes at 10-16 weeks, followed by assessments of study quality, heterogeneity and inconsistency. We identified 62 RCTs presenting data on direct comparisons (31 899 participants). All biologics were efficacious compared with placebo or methotrexate at 10-16 weeks. Hierarchical cluster analyses revealed that adalimumab, brodalumab, certolizumab pegol, guselkumab, risankizumab, secukinumab, tildrakizumab and ustekinumab were comparable with respect to high short-term efficacy and tolerability. Infliximab and ixekizumab clustered together, with high short-term efficacy but relatively lower tolerability than the other agents, although the number of drug withdrawal events across the network was low, so these findings should be treated with caution. Using our methodology we found that most biologics cluster together with respect to short-term efficacy and tolerability, and we did not identify any single agent as 'best'. These data need to be interpreted in the context of longer-term efficacy, effectiveness data, safety, posology and drug acquisition costs when making treatment decisions.

A study of effectiveness and safety of topical combination therapy for acne vulgaris patients in dermatology department of a tertiary care teaching hospital

Background: Acne vulgaris is a dermatological disorder characterised by formation of comedones and inflammatory lesions. Acne is one of the most common reason for visiting a dermatologist in early adulthood. The current line of management for mild to moderate acne is topical medications with antimicrobials and retinoids. The present study assessed the effectiveness and safety of topical combination therapy for mild to moderate acne vulgaris.Methods: An observational, prospective and comparative study conducted on newly diagnosed acne vulgaris patients who were treated with topical combination therapy. Changes in the total, inflammatory and non-inflammatory lesion counts, investigator global assessment (IGA) and dermatology life quality index (DLQI) scales were recorded to check effectiveness. Treatment emergent adverse events were recorded in suspected ADR reporting form for safety assessment.Results: Participants (n=97) were treated with three topical combination treatments either clindamycin-benzoyl peroxide (group-A), clindamycin-adapalene (group-B) or benzoyl peroxide-adapalene (group C). Majority of participants (42.3%) were treated with clindamycin-benzoyl peroxide group. Reduction from baseline of total, inflammatory and non-inflammatory lesion counts were highly significant within group comparison (p&lt;0.001), but between group differences were not significant. Significant improvement in DLQI and IGA scores were noted in all three groups, but between group comparison showed no significant differences. All three groups were safe and well tolerated and equally improve participant’s quality of life.Conclusions: all three topical combination drugs for mild acne vulgaris had similar effectiveness in terms of reduction in acne lesions with similar safety profile.

Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study

Manypatients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp. To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis. This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was the proportion of patients who achieved Scalp Physician Global Assessment response, defined as score of 0 (clear) or 1 (almost clear), with at least a 2-point reduction, at week 16. Secondary endpoints included at least a 4-point improvement from baseline in Whole Body Itch and Scalp Itch Numeric Rating Scales (NRSs) and mean improvement in Dermatology Life Quality Index (DLQI) at week 16. There were 303 randomized patients (placebo: n= 102; apremilast: n=201). With apremilast, significantly more patients achieved Scalp Physician Global Assessment (43.3% vs 13.7%), Scalp Itch NRS (47.1% vs 21.1%), and Whole Body Itch NRS (45.5% vs 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs -3.8; all P<.0001). Common adverse events with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%). Patients with mild disease were not enrolled. Apremilast showed efficacy for the treatment of moderate to severe scalp psoriasis.

Complete skin clearance and Psoriasis Area and Severity Index response rates in clinical practice: predictors, health-related quality of life improvements and implications for treatment goals.

Psoriasis Area and Severity Index (PASI) 90 is suggested to be the new standard endpoint for randomized controlled trials of biologics for psoriasis, whereas treatment guidelines often still refer to PASI 75. To analyse in a real-world setting: firstly, what factors are associated with higher levels of treatment response to biologics; secondly, the health-related quality of life gains associated with different response levels in clinical practice. Biologically naïve patients with PASI, Dermatology Life Quality Index (DLQI) and EuroQol (EQ)-5D outcomes before (maximum 6 months) and after (3-12 months) switch to biologics during registration in the Swedish National Registry for Systemic Treatment of Psoriasis (PsoReg) were included (n = 515). Patient characteristics associated with higher treatment response were analysed by regression analyses. Improvements in absolute PASI, DLQI and EQ-5D were assessed in different PASI percentage response levels. High PASI percentage response was associated with higher PASI before switch and lower body mass index. DLQI and EQ-5D improved within all responder groups (P < 0·001). The magnitude of improvements in DLQI (P = 0·02) differed between responder groups. The mean (SD) DLQI improvements for PASI 75<90 responders, PASI 90<100 responders and patients achieving complete skin clearance (PASI 100) were 9·9 (7·4), 11·5 (7·0) and 8·0 (6·1), respectively. PASI percentage change is largely dependent on absolute PASI before switch. Patients in clinical practice lack 'baseline' PASI values as they may switch directly from one treatment to another or stay successfully treated for a longer time period. Treatment goals such as PASI 90 are thus not suitable for treatment guidelines or for follow-up in clinical practice. What's already known about this topic? Randomized clinical trials of biologics as well as treatment guidelines include treatment goals based on a percentage improvement compared with baseline Psoriasis Area and Severity Index (PASI), such as PASI 75 or PASI 90. Few studies have assessed which factors are associated with high skin clearance rates, or health-related quality of life (HRQoL) improvements associated with different levels of skin clearance in clinical practice. What does this study add? A high absolute PASI before switch to biologics and low body mass index are associated with higher PASI percentage response. Few patients with baseline PASI >30 achieved complete skin clearance (CSC). All responder groups achieved significant HRQoL improvements. Patients achieving CSC (PASI 100) had lower absolute PASI before switch and lower improvements in absolute PASI and HRQoL than patients with almost cleared skin. What are the clinical implications of this work? Relative measures based on PASI percentage, such as PASI 75 or PASI 90, are not suitable for treatment guidelines or for follow-up in clinical practice.

The impact of medium dose UVA1 phototherapy on pruritus, DLQI and SCORAD index in patients with atopic dermatitis.

IntroductionAtopic dermatitis (AD) is featured by pruritus, which causes diminished quality of life. Little clinical data exists concerning the use, efficacy and side effects of UVA1 phototherapy in AD patients.AimTo determine the effectiveness of medium-dose UVA1 phototherapy in AD treatment.Material and methodsThirty-six patients with AD were irradiated with medium-dose UVA1 (45 J/cm2) as monotherapy for 4 weeks for a total of 20 sessions (daily irradiations during weekdays only). Clinical status was evaluated with the visual analogue scale for pruritus, Dermatology Life Quality Index (DLQI) for evaluating general well-being and the SCORAD index. All parameters were measured twice: before and after phototherapy.ResultsUVA1 phototherapy resulted in a significant (p < 0.001) decrease in pruritus, improvement in DLQI (p < 0.001) and SCORAD (p < 0.001). Before phototherapy, the intensity of pruritus and SCORAD index correlated with DLQI (r = 0.34, p < 0.05 and r = 0.61, p < 0.05, respectively). Similarly, after irradiation, pruritus correlated with DLQI, and SCORAD index correlated with DLQI (r = 0.51, p < 0.05 and r = 0.55, p < 0.05, respectively). No severe adverse effects were noted during the study.ConclusionsPhototherapy with medium-dose UVA1 irradiation exerts a significant antipruritic effect, decreases the severity of the disease and improves the quality of life of AD patients. This technique can therefore be used as a safe and effective treatment method.

Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1).

ObjectiveTo report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks.MethodsIn SPIRIT-P1, biologic-naïve patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N = 107) or every 2 weeks (IXEQ2W; N = 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N = 101) or placebo (PBO; N = 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem.ResultsThe IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP.ConclusionIn biologic-naïve patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity.Trial RegistrationClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49

Common Contact Allergens in Patients with Palmoplantar and Scalp Psoriasis and Impact of their Avoidance on Dermatology Life Quality Index: A Hospital-Based Study.

Background:Scalp psoriasis and psoriasis limited to palms and/or soles have been referred to as difficult to control psoriasis. Contact allergy has long been suspected to aggravate existing lesions and cause resistance to therapy in these psoriasis variants.Objectives:The objective of the study was to assess common contact allergens in patients with palmoplantar and scalp psoriasis and the impact of their avoidance on dermatology life quality index (DLQI).Materials and Methods:A total of 54 patients with palmoplantar and scalp psoriasis were patch tested with Indian Standard Series. The patch test results were read on day 2 and day 4. DLQI was calculated before patch testing and at 1 month and 3 month in patch test positive patients after instructing allergen avoidance.Results:Sixteen out of fifty-four patients (29.62%) showed positive patch test reactions. Metal antigens like nickel and cobalt were the most common sensitizers identified. Statistically significant improvement in DLQI was observed at 1 month and at 3 month of allergen avoidance.Conclusion:Patch testing is a useful test to determine the triggering or aggravating antigens in patients with palmoplantar and scalp psoriasis and subsequent allergen avoidance should be stressed on.

Minimal disease activity in patients with psoriatic arthritis treated with ustekinumab: results from a 24-week real-world study.

Psoriatic arthritis (PsA) is a chronic inflammatory joint disease affecting around 40% of psoriasis patients. Minimal disease activity (MDA) criteria have been proposed to identify a state of low disease activity, one of the principal goals of treatment for psoriatic disease. This study investigated treatment with ustekinumab (UST) in the context of a real-world setting. Thirty-four PsA patients who had failure or inadequate response to conventional synthetic disease-modifying antirheumatic drugs or to anti-tumour necrosis factor alpha were enrolled. Demographic and clinical features, MDA criteria, and the impact of psoriatic skin manifestations on patients' quality of life (QoL) using the dermatology life quality index (DLQI) questionnaire were evaluated at baseline and after 24-week treatment. Adverse events were recorded. At week 24, 70.5% of patients (n=24) achieved MDA. A sub-analysis of dermatological indices of the MDA criteria showed that the psoriasis area severity index score was significantly improved and body surface area was significantly decreased at 24weeks compared with that at baseline (both p<0.001). For the rheumatologic indexes, tender joint count, swollen joint count, and tender entheseal points were all significantly improved at 24weeks of therapy (all p<0.01 vs. baseline). Mean DLQI value decreased approximately fourfold, and there were no safety concerns. The achievement of MDA as well as the significant improvement in DLQI and lack of adverse events in the context of a real-life setting shown here confirms the efficacy and safety of UST in PsA.

Improvement in Quality of Life in Patients with Moderate to Severe Psoriasis Treated with Adalimumab or Ustekinumab

Introduction: Quality of life (QoL) is an important issue in psoriatic disease that should be included when assessing therapeutic efficacy of treatments. The objective of this study was to compare improvement in the dermatology life quality index (DLQI) between patients treated with adalimumab and ustekinumab. Methods: Analysis was based on two separate open-label 24-week clinical trials assessing DLQI and the Psoriasis Area and Severity Index (PASI) at four-week intervals in adult subjects with moderate to severe psoriasis treated with adalimumab or ustekinumab. Results: There were no statistically significant differences in the improvement in DLQI and PASI between the adalimumab and ustekinumab groups except at week 12 for DLQI and week 8 for PASI (ustekinumab &gt; adalimumab). Discussion: Both adalimumab and ustekinumab improve QoL, but further research is necessary to determine specific factors that improve QoL and if one medication improves QoL more than another.