Improvement In Dermatology Life Quality Index Research Articles

Effectiveness of calcipotriol/betamethasone dipropionate aerosol foam in patients with small versus large plaque psoriasis in routine practice in South Korea.

Small plaque psoriasis is the typical form of chronic plaque psoriasis affecting adults in South Korea. The effectiveness of calcipotriol/betamethasone dipropionate (Cal/BD) aerosol foam for large and small psoriasis plaques has not previously been examined. We performed a post hoc analysis of a recent, 4-week observational study of Cal/BD aerosol foam use in routine clinical practice in South Korea. Investigator Global Assessment response ([IGA] 0/1 at week 4), Patient Global Assessment response ([PaGA] 0/1 at week 4), change in Psoriasis Area and Severity Index (PASI), changes in psoriasis symptom scores, change in the Dermatology Life Quality Index (DLQI), and the proportion of patients achieving DLQI ≤5 were analyzed for patients with small (≤5 cm; n = 131) or large (>5 cm; n = 35) baseline plaque size. IGA response rates were similar for patients with small and large plaques (59.5% and 51.4% respectively). Similarly, there was no significant difference between the small and large groups in mean change in PASI (-2.20 vs -3.34), the proportions of patients with DLQI ≤5 (62.3% vs 54.3%) or PaGA 0/1 (29.2% vs 40.0%). Mean improvements in DLQI (-4.04 vs -6.20) and in psoriasis symptoms including itching (-1.50 vs -2.83), sleep loss (-0.67 vs -1.89), dryness (-1.57 vs -2.97), scaling (-1.21 vs -3.57), and redness (-1.17 vs -3.11) were greater in patients with large plaques than those with small plaques. Itching and DLQI differences were not statistically significant after adjustment for baseline characteristics. Stratification by body surface area affected eliminated statistically significant differences between the groups for most outcomes. In conclusion, this analysis suggests that Cal/BD aerosol foam is an effective, well-accepted treatment for adult patients with the small plaques typical of chronic plaque psoriasis in South Korea, as well as for those with large plaques.

Effects of 15% Azelaic Acid Gel in the Management of Post-Inflammatory Erythema and Post-Inflammatory Hyperpigmentation in Acne Vulgaris.

The aim of this study was to assess the efficacy and safety of 15% azelaic acid (AzA) gel in treating acne-induced post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH). The effects of 15% AzA gel on acne, skin barrier function, and quality of life were also evaluated. A total of 72 patients with mild to moderate acne were enrolled in a randomized, double-blind, placebo-controlled trial. Patients were divided into two groups: patients in the AzA group applied 15% AzA gel twice daily for 12weeks, and those in the placebo group applied AzA-free gel. Clinical evaluations using non-invasive skin detection technologies, including VISIA skin analysis, dermoscopy, and skin physiological function tests, were performed at 0, 4, 8, and 12weeks. Main outcome measures included the post-acne hyperpigmentation index (PAHPI), melanin, hemoglobin, individual typology angle, water content, transepidermal water loss, and sebum. Investigator Global Assessment) and Dermatology Life Quality Index (DLQI) assessments were conducted at weeks 0 and 12. Adverse reactions were recorded. Of the 72 patients at study initiation, 60 completed the trial. At 8 and 12 weeks, patients in the AzA group showed significantly reduced PAHPI for PIE lesions compared to baseline and patients receiving placebo (P < 0.05). Patients in both groups exhibited reduced PIH lesions at weeks 8 and 12 that differed significantly from baseline (P < 0.05). Hemoglobin content decreased significantly in AzA-treated PIE lesions compared to those treated with placebo at week 12 (P < 0.05). Melanin content decreased significantly in AzA-treated PIH lesions at week 12 (P < 0.05). The AzA group showed higher improvement in DLQI (P < 0.05), and greater overall satisfaction (P < 0.05) compared to placebo. The results indicate that 15% AzA gel effectively improved acne-induced PIE and PIH with minimal adverse reactions, making it a viable clinical application. In the study population, it had no adverse effects on skin barrier function and contributed positively to acne improvement and patient quality of life. This study was registered with the Chinese Clinical Trial Registry (ChiCTR.org.cn) under the identifier ChiCTR2300076959. The registration date was 25 October 2023, retrospectively registered.

Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials

Background Lebrikizumab improved itch, interference of itch on sleep, and quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD), in two Phase 3 trials at 16 weeks compared to placebo. Objectives We assess improvements in itch and sleep interference due to itch and their impact on QoL measurements after treatment. Methods Data were analyzed from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967) in patients with moderate-to-severe AD. QoL was evaluated using Dermatology Life Quality Index (DLQI) at Week 16 in patients (>16 years of age) who were itch responders/non-responders (defined as ≥4-point improvement in Pruritus Numeric Rating Scale) or Sleep-Loss Scale responders/non-responders (defined as ≥2-point improvement in itch interference on sleep). Results In ADvocate1 and ADvocate2, significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders. Conclusions Improvement in itch and sleep interference due to itch is associated with improvement in the QoL of patients after treatment with lebrikizumab for moderate-to-severe AD. ClinicalTrials.gov registration NCT04146363 (ADvocate1) and NCT04178967 (ADvocate2).

Matching-Adjusted Indirect Comparison of the Efficacy at Week32 of Tralokinumab and Dupilumab in the Treatment of Moderate-to-Severe Atopic Dermatitis.

Tralokinumab and dupilumab are biological agents licensed for the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients who are candidates for systemic treatment. However, no head-to-head studies of their efficacy have been conducted. This study indirectly compared the efficacy of tralokinumab and dupilumab, both in combination with topical corticosteroids (TCS), at week32. An unanchored matching-adjusted indirect comparison was conducted using individual patient data (IPD) from the ECZTRA3 tralokinumab trial and aggregate data from the LIBERTY AD CHRONOS dupilumab trial. IPD were selected by applying inclusion criteria from LIBERTY AD CHRONOS and weighting to match summary baseline characteristics-age, sex, race, body mass index, disease duration, Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI) and SCORing Atopic Dermatitis index-of patients treated with dupilumab. Week32 outcomes of interest were 50%, 75% or 90% improvements in EASI (EASI-50, EASI-75 and EASI-90), IGA scores of 0 or 1 (IGA0/1), ≥ 4-point improvement in worst daily pruritus numerical rating scale (NRS) score, and mean improvements in DLQI and the Patient Oriented Eczema Measure (POEM). After matching, tralokinumab and dupilumab, both in combination with TCS, showed similar efficacy across clinical response endpoints at week32 (IGA0/1, tralokinumab 49.9% vs dupilumab 39.3%; EASI-50, 78.9% vs 77.5%; EASI-75, 71.5% vs 71.9%; EASI-90, 53.3% vs 56.2%). The mean change from baseline in DLQI was statistically significantly larger in the matched tralokinumab plus TCS population than in the dupilumab plus TCS arm (- 12.1 vs - 10.4, p = 0.005). Changes in POEM and worst daily pruritus NRS were similar in the two groups. The results of this analysis demonstrate that, in combination with TCS, tralokinumab and dupilumab have similar efficacy in the treatment of moderate-to-severe AD at 32weeks of therapy.

Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands.

Psoriasis is a chronic inflammatory condition that can significantly impact the quality of life (QoL), regardless of the level of skin involvement. Apremilast is indicated for the treatment of moderate to severe psoriasis. Real-world data regarding the impact of apremilast on patient-reported outcomes in clinical practice in the Netherlands is lacking. The prospective, multicenter observational Apremilast in Real-Life Psoriasis Treatment (APRIL) study enrolled patients ≥ 18years old with moderate to severe plaque psoriasis receiving apremilast in clinical practice in the Netherlands. Patients were followed-up for 12 months, with assessments scheduled at 6 and 12 months. The primary outcome was Dermatology Life Quality Index (DLQI) response (score ≤ 5 or ≥ 5-point improvement from baseline) at 6 months. Secondary patient-reported outcomes included EQ-5D and skin-specific parameters; exploratory outcomes were Patient Benefit Index (PBI) and Work Productivity and Activity Impairment (WPAI). Of the 155 patients enrolled (February 2016-June 2019), 153 received apremilast; 69 (45%) and 39 (26%) continued treatment at 6 and 12months, respectively. Psoriasis in special areas was common (scalp, 65%; nail, 51%; palmoplantar, 27%). Most patients (92%) had received prior systemic antipsoriatic therapies. Of the 151 patients with a baseline DLQI value, 56 (37%) achieved DLQI response at 6months. Mean (standard deviation) PBI scores were 3.5 (1.2) and 3.8 (1.1) at 6 and 12months, respectively. Improvements in DLQI, EQ-5D, and WPAI scores and disease signs and symptoms, including itch and special areas, were observed at 6 and 12months. Adverse events were consistent with the known safety profile. In the Netherlands, patients with moderate to severe psoriasis receiving apremilast for up to 12months reported improved disease-related QoL, skin involvement, and patient-reported outcomes. These data add to the growing body of evidence demonstrating apremilast is an effective treatment for psoriasis, itch, and special areas (scalp and palms). ClinicalTrials.gov, NCT02652494.

Dermatology Life Quality Index in Thai Patients with Facial Port-Wine Stains.

Port-wine stains (PWS) are congenital capillary abnormalities caused by immature, venule-like vasculature that progressively dilates due to poor endothelial cell differentiation. PWS affects between 0.3% and 0.9% of newborns, with 90% of cases occurring on the face. Individuals with facial PWS and their parents had a significant negative impairment on their quality of life (QoL) and also suffered from psychological disabilities. This was a cross-sectional questionnaire-based survey study in Thailand from July 2021 to April 2022. The questionnaires included demographic data, subjective evaluation (SE), and the Dermatology Life Quality Index (DLQI). The questionnaire was performed with a full scale and adjusted scale of validity and reliability test of DLQI using factor analysis and Cronbach's alpha. The study outcome was a subjective evaluation and DLQI in patients who received pulsed dye laser (PDL) treatment. Of the 54 patients, 35.2% (19) are male, and 64.8% (35) are female. Regarding age groups, 64.8% (35) are below 5years old, and 35.2% (19) are older than 5years. SE results showed that males evaluated an improvement of the facial PWS lesion significantly better than females (P < 0.05). The older age group graded the percentage of improvement better than the younger age group (P < 0.01). The result of the DLQI showed no difference in DLQI between gender. Older age result resulted in a significantly different DLQI compared with younger age (P < 0.01). Parent-reported DLQI improvement was less than self-reported DLQI improvement in patientswith PWS treated with PDL (P < 0.05). Concerning the instrument of the study, the validity and reliability analysis of the DLQI questionnaire using factor analysis and Cronbach's alpha have been performed. The adjusted scale with the 5-item DLQI questionnaire is more appropriate in terms validity and reliability. This study demonstrates that facial PWS reduces the QoL as measured by DLQI. We discovered that the QoL of patients and parents with PWS was significantly impaired. The main influencing factors were older age, the improved perception between gender, and PDL treatments. In addition, we found only five questions that are reliable for PWS. The adjusted five-item DLQI questionnaires are more appropriate regarding validity and reliability. TCTR20230210001, COA no. si 1059/2020.

P98 Real-world effectiveness of guselkumab in absolute Psoriasis Area and Severity Index-stratified patients with psoriasis: data from the British Association of Dermatologists Biologics and Immunomodulators Register

Abstract Guselkumab is a fully human monoclonal antibody that inhibits interleukin-23 by selectively targeting the p19 subunit. Long-term evaluations have demonstrated high levels of clinical response and improvement in patient-reported outcomes over 5 years of guselkumab treatment in patients with psoriasis. Psoriasis has a significant and negative impact on a patient’s quality of life, even among patients with a Psoriasis Area and Severity Index (PASI) score &amp;lt; 10. Both absolute PASI (aPASI) and the Dermatology Life Quality Index (DLQI) are widely used tools to assess disease impact, as well as treatment eligibility and response. This retrospective analysis evaluated the impact of guselkumab treatment over 1 year across aPASI-stratified patients with psoriasis in BADBIR, a national pharmacovigilance registry documenting longitudinal clinical data for individuals with psoriasis initiating systemic therapies. Retrospective analyses of the guselkumab cohort were carried out using BADBIR data collected up to September 2021. Data were analysed for patients who had initiated guselkumab treatment and had recorded aPASI and DLQI assessments at both baseline and the 12-month follow-up. Patients were stratified according to psoriasis severity at baseline: aPASI &amp;lt; 5, aPASI ≥ 5 to ≤ 10 and aPASI &amp;gt; 10 disease. Treatment effect was defined as the mean improvement in DLQI and aPASI scores for the overall group of guselkumab-treated patients and for subsets of patients with aPASI &amp;lt; 5, aPASI ≥ 5 to ≤ 10 and aPASI &amp;gt; 10 at baseline. Five patients were excluded owing to treatment cessation prior to the 12-month cutoff. Following 12 months of guselkumab treatment, patients with aPASI &amp;lt; 5, aPASI ≥ 5 to ≤ 10 and aPASI &amp;gt; 10 at baseline achieved a mean (SD) DLQI score of 2.18 (5.64), 2.79 (5.15) and 1.80 (3.56), representing a decrease of 62.0%, 74.8% and 89.1% from baseline, respectively. Additionally, patients with aPASI &amp;lt; 5, aPASI ≥ 5 to ≤ 10 and aPASI &amp;gt; 10 at baseline achieved a mean (SD) aPASI score of 0.96 (1.84), 3.16 (3.90) and 2.78 (4.93), representing a decrease of 40%, 58.6% and 84.5% from baseline, respectively. Among patients with an aPASI score &amp;lt; 10 at baseline (n = 53), 83.0% (n = 44) achieved aPASI score ≤ 3; of these, 67.9% (n = 36) achieved an aPASI score ≤ 2 and 54.7% (n = 29) achieved an aPASI score ≤ 1. These data demonstrate that guselkumab produces an effective and consistent response in patients with a broad range of disease severity at baseline, as reflected by mean improvements in aPASI and DLQI. Greater reductions in DLQI and aPASI scores were observed after 12 months of guselkumab treatment in patients with more severe psoriasis at baseline.

BI16 (P41) An emerging role of interferon-targeted therapy for the treatment of cutaneous systemic lupus erythematosus: a prospective real-world evaluation of anifrolumab for refractory cutaneous lupus

Abstract Cutaneous lupus erythematosus (CLE), particularly discoid lupus erythematosus (DLE), is frequently unresponsive to standard therapies, including antimalarial and immunosuppressive therapies. Recent evidence has identified the importance of type-1 interferon (IFN-1) in the pathogenesis of disease. Anifrolumab is a monoclonal antibody that targets IFN-1 and has been licensed for the treatment of systemic lupus erythematosus (SLE). It is unclear which clinical subtypes of CLE are associated with an IFN-1 signature and may be responsive to anifrolumab therapy. We sought to evaluate the efficacy of anifrolumab on (i) DLE and (ii) rituximab-refractory CLE; and (iii) to compare IFN-specific biomarkers and (iv) early and late immunophenotypic and clinical responses. Anifrolumab was available through an early access to medicines scheme. Patients with SLE for whom the phenotype was predominantly cutaneous were treated with anifrolumab 300 mg intravenously every 4 weeks. The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and Dermatology Life Quality Index (DLQI) were reported. Seven patients were enrolled (five with DLE, one with chilblain and one with subacute CLE). All patients were female (median age 46 years; median disease duration 17 years). The median number of failed therapies was six: rituximab in six, belimumab in two and thalidomide in four patients. Four patients required long-term oral prednisolone &amp;gt; 10 mg daily. Median baseline CLASI activity score was 17 and DLQI was 16/30. Median CLASI score reduced after 4 weeks to 6 (range 0–13; P = 0.016) with a median decrease from baseline of 60% (range 19–100%), which was maintained at 6 months. Clinical responses were associated with significant improvements in DLQI (P &amp;lt; 0.001) and EQ-5D visual analogue scale (P = 0.002) by 3 months. All patients had a marked suppression of IFN-stimulated genes at 4 weeks (mean difference 2.92; P &amp;lt; 0.01). Treatment was generally well tolerated with the exception of one patient who had shingles complicated by sensorineural hearing loss while on anifrolumab and prednisolone &amp;gt; 15 mg daily. This required prolonged aciclovir for effective management. This case series highlights the potential role for anifrolumab in managing treatment-resistant CLE with particular responses observed in DLE and chilblain lupus. The need for enhanced awareness of viral infections, particularly varicella-zoster virus, needs to be considered in higher-risk patients.

P41 An emerging role of interferon targeted therapy for the treatment of cutaneous systemic lupus erythematosus: a prospective real-world evaluation of anifrolumab for refractory cutaneous lupus

Abstract Cutaneous lupus erythematosus (CLE), particularly discoid lupus erythematosus (DLE), is frequently unresponsive to standard therapies, including antimalarial and immunosuppressive therapies. Recent evidence has identified the importance of type-1 interferon (IFN-1) in the pathogenesis of disease. Anifrolumab is a monoclonal antibody that targets IFN-1 and has been licensed for the treatment of systemic lupus erythematosus (SLE). It is unclear which clinical subtypes of CLE are associated with an IFN-1 signature and may be responsive to anifrolumab therapy. We sought to evaluate the efficacy of anifrolumab on (i) DLE and (ii) rituximab-refractory CLE and (iii) to compare IFN-specific biomarkers and (iv) early and late immunophenotypic and clinical responses. Anifrolumab was available through an early access to medicines scheme. Patients with SLE for whom the phenotype was predominantly cutaneous were treated with anifrolumab 300 mg intravenously every 4 weeks. The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and Dermatology Life Quality Index (DLQI) were reported. Seven patients were identified (five with DLE, one with chilblain and one with subacute CLE were enrolled). All patients were female (median age 46 years; median disease duration 17 years). The median number of failed therapies was six: rituximab in six, belimumab in two and thalidomide in four patients. Four patients required long-term oral prednisolone &amp;gt; 10 mg daily. The median baseline CLASI activity score was 17 and DLQI was 16/30. The median CLASI score reduced after 4 weeks to 6 (range 0–13; P = 0.016) with a median decrease from baseline of 60% (range 19–100%), which was maintained at 6 months. Clinical responses were associated with significant improvements in DLQI (P &amp;lt; 0.001) and the EQ-5D visual analogue scale (P = 0.002) by 3 months. All patients had a marked suppression of IFN-stimulated genes at 4 weeks (mean difference 2.92; P &amp;lt; 0.01). Treatment was generally well tolerated with the exception of one patient who had shingles complicated by sensorineural hearing loss while on anifrolumab and prednisolone &amp;gt; 15 mg daily. This required prolonged aciclovir for effective management. This case series highlights the potential role for anifrolumab in managing treatment-resistant CLE with particular responses observed in DLE and chilblain lupus. The need for enhanced awareness of viral infections, particularly varicella-zoster virus, needs to be considered in higher-risk patients.

P164 An emerging role of interferon targeted therapy in mucocutaneous SLE: a prospective real-world evaluation of anifrolumab for refractory cutaneous lupus

Abstract Background/Aims Advances in rational drug design and recent clinical trials are leading to emergence of a range of novel therapies for SLE and therapeutic options in clinical practice are expected to broaden rapidly. The optimal real-world place of emerging and established agents will be guided by understanding their differential efficacy on specific SLE manifestations as well as efficacy for more resistant disease. Anifrolumab, a type-I interferon receptor blocking monoclonal antibody, showed efficacy in SLE in phase III trials with a notable effect on mucocutaneous disease although specific lesion subtypes and chroncicity were not explored. Severe refractory mucocutaneous SLE such as scarring discoid lesions are an important and common clinical challenge in current practice. We therefore prospectively evaluated the real-world efficacy and quality of life impact of anifolumab for active mucocutaneous SLE, recalcitrant to multiple biologic and immunosuppressant therapies. Methods Seven patients commenced anifrolumab (300 mg by monthly iv infusion) following application to the manufacturer’s early access programme (NCT 04750057). Prior biologic therapies were discontinued at least 5 half-lives in advance. Mucocutaneous disease activity was captured by Cutaneous Lupus Disease Area and Severity Index (CLASI) activity score and medical photography. Patient reported health-related quality of life comprising the Dermatology Life Quality Index (DLQI); Lupus-QoL and EQ5D-5L were evaluated at baseline, three and six months. Results Seven female patients with active mucocutaneous SLE (Discoid LE n = 5, chilblain LE n = 1, subacute cutaneous LE n = 1) and median disease duration of 17 years were evaluated. Median baseline CLASI activity score was 17 (range 10-26; higher scores indicating severe disease). Median number of previously failed therapies was 7 and included rituximab in 6/7, belimumab in 2/7 and thalidomide in 4/7. Rapid resolution of scale and erythema in DLE was established within 1 month of anifrolumab treatment. Improvements to chilblain lupus were evident by three months. CLASI activity score was improved ≥75% in all patients at 3 months. Clinical responses were associated with significant improvements in DLQI (p &amp;lt; 0.001) and EQ5D-VAS (p = 0.002) by three months. Lupus-QoL trended toward improvement across all domains but most strongly for fatigue (p = 0.01) and pain (p = 0.002) by 6 months. One patient discontinued treatment after 4 months due to polydermatomal shingles complicated by sensorineural hearing loss. Infection coincided with background prednisolone dose &amp;gt;15 mg daily, recent COVID-19 infection and new on-treatment hypogammaglobulinaemia (IgG &amp;lt;5 g/L). Prolonged aciclovir treatment was required for lesion resolution. Conclusion We report rapid real-world efficacy and quality of life impact of anifrolumab on highly refractory mucocutaneous SLE, which exceeded that anticipated from existing clinical trial data. Findings suggest a unique role for emerging interferon targeting therapies in management of mucocutaneous SLE but emphasize need for enhanced VZV precautions among higher risk patients. Disclosure L. Carter: Consultancies; UCB. Z. Wigston: None. P. Laws: Consultancies; Amgen, Celgene, Janssen, Leo, Lilly and Sanofi. Member of speakers’ bureau; AbbVie, Actelion and BMS. Grants/research support; UCB, Almirall, and Novartis. E.M. Vital: Consultancies; Roche, GSK, AstraZeneca, Aurinia Pharmaceuticals, Lilly and Novartis. Grants/research support; Roche, AstraZeneca and Sandoz.

Efficacy of Secukinumab in Psoriasis: Post Hoc Gender-Wise Analysis of the SUPREME Study

Psoriasis, a common systemic inflammatory disorder, presents with gender-related differences in the quality of life (QoL) and treatment outcomes. This post hoc analysis from the Phase 3b SUPREME study explored gender-related differences in patient characteristics and efficacy of secukinumab 300 mg on Psoriasis Area and Severity Index (PASI) 75/90/100 and impact on QoL using the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis through week 24. The proportion of patients achieving PASI 75/90/100 was computed using a nonresponder imputation approach. Differences between cohorts were analyzed using a logistic regression model. The mean change from baseline in DLQI was computed using the Wilcoxon test. Among the 433 patients (males: 71.6%), females had a higher DLQI than males at baseline (13.1 vs 9.5; P<0.0001). Males had a slightly higher response for PASI 90 than females at week 16 (80.7% vs 78.1%; P=0.0779) and 24 (83.2% vs 79.7%; P=0.0319). No differences were observed between genders in PASI 100/75 responses at week 24. Both genders showed an improvement in DLQI with secukinumab at week 24 (-10.9 vs -8.1, respectively, in females vs males; P=0.0004). In summary, secukinumab was effective in the treatment of psoriasis, irrespective of gender.

A novel, fixed-dose calcipotriol and betamethasone dipropionate cream for the topical treatment of plaque psoriasis: Direct and indirect evidence from phase 3 trials discussed at the 30th EADV Congress 2021.

Four posters about the novel, fixed-dose calcipotriol and betamethasone dipropionate cream (CAL/BDP cream) based on Poly-Aphron Dispersion (PAD) Technology were presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress 2021 and are summarized here. CAL/BDP cream was compared in two randomized, phase 3 trials to vehicle and active comparator (CAL/BDP gel/topical suspension [TS]) in adults with plaque psoriasis (NCT03802344 and NCT03308799). Pooled data from both trials demonstrated significant greater efficacy in favour of CAL/BDP cream for all efficacy endpoints, including PGA treatment success, mPASI, and mPASI75 compared to CAL/BDP gel/TS. CAL/BDP cream was well tolerated and comparable to CAL/BDP gel/TS with no adverse drug reactions with a frequency >1%. In the NCT03308799 study, CAL/BDP cream demonstrated a substantial improvement in the proportion of participants achieving a minimum 4-point improvement on the peak pruritus numeric rating scale (NRS) score compared with vehicle at Weeks 1, 4 and 8. CAL/BDP cream also improved quality of life (QoL), as assessed through the Dermatology Life Quality Index (DLQI), and the EQ-VAS at Week 8 compared with active comparator. Treatment convenience of CAL/BDP cream, as measured by the Psoriasis Treatment Convenience Scale, was superior to CAL/BDP gel/TS at all studied timepoints, including questions addressing formulation's greasiness and overall treatment satisfaction. Finally, an indirect comparison following the Bucher's method of adjusted indirect comparison and the difference-in-differences method was conducted to compare CAL/BDP cream and CAL/BDP foam, as both therapies have been compared to CAL/BDP gel/TS. Indirect evidence showed that treatment with CAL/BDP cream was associated with a trend for greater QoL improvement than CAL/BDP foam when DLQI improvement was assessed at the recommended treatment duration of 8 weeks for CAL/BDP cream and 4 weeks for CAL/BDP foam. CAL/BDP cream was statistically superior versus CAL/BDP foam in four out of five treatment satisfaction domains.

Ustekinumab therapy for Netherton syndrome.

Netherton syndrome (NS) is a rare disorder of cornification associated with high morbidity. It is caused by bi-allelic mutations in SPINK5 encoding the serine protease inhibitor LEKTI. Previous studies have shown Th17 skewing with IL-23 upregulation in NS, raising the possibility that targeting these inflammatory pathways may alleviate disease manifestations. We ascertained the therapeutic efficacy of six doses of ustekinumab administered to three patients with NS over a period of 13 months using the Ichthyosis Area and Severity Index (IASI), the Dermatology Life Quality Index (DLQI), a visual analogue scale (VAS) for itch and the peak-pruritus numeric rating scale (PP-NRS). Histopathology analysis including CD3, CD4, CD8 and interleukin 17 (IL-17) immunostaining, was performed at baseline and 4 weeks following the last ustekinumab dose. Total IASI scores were reduced by 28% in two patients at week 16 with sustained response by week 56. No consistent improvement in DLQI, VAS for itch and PP-NRS scores was observed. The inflammatory infiltrate and the degree of acanthosis were slightly reduced at week 56 as compared to baseline. No significant change in immunostaining of the various inflammatory markers was observed at week 56. In conclusion, this case series did not demonstrate a significant therapeutic effect of ustekinumab in NS.

33006 Long-term improvement of patient-reported outcomes in adult patients with atopic dermatitis treated with baricitinib in the US and Canada

Objective: To evaluate long-term patient-reported outcome (PRO) improvements in patients with atopic dermatitis (AD) treated with baricitinib, a Janus kinase (JAK)1/JAK2 inhibitor. Methods: Data were derived from 2 phase 3 studies: double-blind placebo-controlled BREEZE-AD5 (NCT03435081) and long-term open-label extension BREEZE-AD6 (NCT03559270) through 52 weeks of treatment. Low-potency topical corticosteroids were permitted after Week 16 in BREEZE-AD5 and throughout BREEZE-AD6. PROs [Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), and Hospital Anxiety Depression Scale (HADS-anxiety and HADS-depression)] were assessed to Week 52 using descriptive statistics with missing data imputed by last observation carried forward. Results: In 146 patients receiving baricitinib 2 mg, the quality of life measure DLQI (mean ± standard deviation at baseline 15.0 ± 7.6) showed a mean change from baseline of −7.0 ± 8.2 at Weeks 48-52. Patient-reported improvements in skin symptoms as measured by POEM were −7.3 ± 8.8 at Weeks 48-52 from mean baseline value of 21.7 ± 5.4. By Weeks 48-52, 68.9% and 57.6% of patients had achieved a clinically meaningful ≥4-point improvement in DLQI and POEM, respectively. HADS-anxiety and HADS-depression scores were 7.0 ± 4.4 and 5.2 ± 4.3 at baseline, respectively, with patients reporting a change from baseline of −1.9 ± 3.7 and −1.8 ± 3.3 at Weeks 48-52. Conclusion: Patients with moderate to severe AD treated with baricitinib 2 mg experienced clinically meaningful PRO improvements in skin symptoms, quality of life, and anxiety and depression over 52 weeks.

Tralokinumab Plus Topical Corticosteroids as Needed Provides Progressive and Sustained Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Over a 32-Week Period: An ECZTRA 3 Post Hoc Analysis.

BackgroundThe efficacy and safety of tralokinumab, a fully human monoclonal antibody that specifically neutralizes interleukin-13, plus topical corticosteroids (TCS) as needed were evaluated over 32 weeks in the phase III ECZTRA 3 trial. Significantly more tralokinumab- versus placebo-treated patients achieved the primary endpoints of Investigator’s Global Assessment (IGA) score of 0/1 and 75% improvement in Eczema Area and Severity Index (EASI-75) and all confirmatory endpoints at Week 16.ObjectiveThis post hoc analysis investigated the impact of tralokinumab plus TCS on atopic dermatitis (AD) severity, symptoms, and health-related quality of life (QoL) over the entire 32-week treatment period of ECZTRA 3, including all patients initiated on tralokinumab irrespective of the response achieved at Week 16.MethodsPatients were randomized 2:1 to receive subcutaneous tralokinumab 300 mg or placebo every 2 weeks (q2w) with TCS as needed for an initial 16 weeks. At Week 16, patients who achieved the clinical response criteria (IGA 0/1 and/or EASI-75) with tralokinumab were re-randomized 1:1 to tralokinumab q2w or every 4 weeks (q4w), with TCS as needed, for another 16 weeks. Patients not achieving the clinical response criteria with tralokinumab received tralokinumab q2w plus TCS from Week 16. All patients randomized to tralokinumab in the initial treatment period were pooled for this analysis, irrespective of response at Week 16 or dosing regimen beyond Week 16.ResultsContinued tralokinumab (q2w, N = 164; q4w, N = 69) plus TCS treatment provided progressive improvements from Week 16 onwards in AD signs, with 70.2% (177/252) of patients achieving EASI-75 and 50.4% (127/252) achieving EASI-90 at Week 32. Improvements in patient-reported outcomes were observed within the first few weeks of tralokinumab q2w plus TCS treatment and were sustained throughout the 32-week period. At Week 32, patients initiated on tralokinumab q2w plus TCS achieved a relative improvement versus baseline of 70.8% (standard error (SE), 2.4) in eczema-related sleep interference numeric rating scale (NRS) and 66.8% (SE, 3.1) in Dermatology Life Quality Index (DLQI). Mean TCS use during Weeks 16–32 ranged from 9.2 to 13.6 g (SE, 1.2–2.0) q2w. Most patients (89.9% (222/247)) initiated on tralokinumab q2w plus TCS achieved a meaningful improvement in at least one of the three disease domains, including AD signs (EASI-50), symptoms (pruritus NRS improvement ≥ 3), and QoL (DLQI improvement ≥ 4) at Week 16. Of patients initiated on tralokinumab q2w plus TCS, 53.4% (132/247) achieved a clinically meaningful improvement in all three domains at Week 16 (vs. placebo, 28.5% (35/123); p < 0.001).ConclusionsContinued tralokinumab treatment plus TCS as needed provides progressive and sustained improvements in AD signs, symptoms, and health-related QoL over 32 weeks.Clinical trial registrationNCT03363854; study start date: 22 February 2018; primary completion date: 8 March 2019; study completion date: 26 September 2019.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40257-022-00702-2.

Efficacy, quality of life and treatment satisfaction: an indirect comparison of calcipotriol/betamethasone dipropionate cream versus foam for treatment of psoriasis

Objective: To assess how the use of calcipotriol and betamethasone dipropionate (Cal/BDP) cream impacted efficacy, patients’ quality of life (QoL), and treatment satisfaction versus Cal/BDP foam. Methods: Data from clinical trials of Cal/BDP cream and foam were analyzed, applying the common anchor Cal/BDP gel. Efficacy was assessed by Physician Global Assessment (PGA) treatment success and ≥75% reduction in Psoriasis Area and Severity Index (PASI75 response); QoL by Dermatology Life Quality Index (DLQI); treatment satisfaction by Psoriasis Treatment Convenience Scale (PTCS) and Topical Product Usability Questionnaire (TPUQ). Results: Treatment with Cal/BDP cream was on par with foam on PGA treatment success (risk ratio (RR) for Cal/BDP cream vs foam: 0.80; 95%CI: 0.56, 1.14; p = 0.21) and PASI75 response (RR for Cal/BDP cream vs foam: 0.85; 95%CI: 0.64, 1.13; p = 0.27) when assessed at the treatment duration of 8 weeks for Cal/BDP cream and 4 weeks for Cal/BDP foam. Treatment with Cal/BDP cream was associated with significantly greater treatment satisfaction versus foam on the domains: overall treatment satisfaction (p = 0.01), ‘ease of application’ (p < 0.001), ‘lack of greasiness’ (p < 0.001), ‘moisturizing effect’ (p = 0.01), and almost significantly greater improvement on the domain ‘easily incorporated into daily routine’ (p = 0.07). Furthermore, there was a trend for greater DLQI improvement with cream versus foam when assessed at recommended treatment duration (mean difference (MD) for Cal/BDP cream vs foam: -1.00; 95%CI: -2.20, 0.20; p = 0.10). Conclusions: Indirect comparison analyses showed that Cal/BDP cream significantly improves treatment satisfaction and tends to improve QoL versus foam. Cal/BDP cream is on par with foam on efficacy.

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.