Itch Severity Score Research Articles

Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels.

In chronic spontaneous urticaria (CSU), interleukin (IL)-4 and IL-13 may promote mast cell activation directly via IL-4 receptor expression, or indirectly via upregulated immunoglobulin E (IgE) production. Dupilumab significantly improved CSU signs and symptoms in the phase 3, randomized, placebo-controlled LIBERTY-CSU CUPID Study A. This analysis explores the impact of dupilumab on CSU signs and symptoms and serum IgE levels in patients from LIBERTY-CSU CUPID Study A with serum total IgE above and below 100IU/mL at baseline. Patients with H1-antihistamine-refractory CSU received dupilumab (n = 70) or placebo (n = 68) for 24 weeks. Efficacy endpoints were change from baseline to weeks 12 and 24 in serum total IgE levels, Itch Severity Score over 7 days (ISS7), Urticaria Activity Score over 7 days (UAS7), and Hives Severity Score over 7days (HSS7) in dupilumab- or placebo-treated patients with serum total IgE above and below 100IU/mL at baseline. Dupilumab treatment significantly reduced median (interquartile range) IgE levels at week 12 [dupilumab: -31.9% (-41.9; -22.6); placebo: -6.3% (-21.3; 14.9)] and week 24 [dupilumab: -48.2% (-56.8; - 39.5); placebo: - 6.3% (-34.5; 14.8)]. Similar IgE reductions relative to baseline were observed in dupilumab-treated patients regardless of baseline IgE level. Dupilumab treatment improved ISS7, UAS7, and HSS7 over 12 and 24 weeks, regardless of baseline serum IgE level (interaction p ≥ 0.59 for all treatment by subgroup comparisons), with weak correlations (r < 0.2) observed between IgE level changes and ISS7, UAS7, and HSS7 outcomes. Dupilumab significantly improved CSU signs and symptoms and reduced serum IgE, regardless of baseline IgE levels. In the current analysis, baseline total IgE had no predictive value as a dupilumab treatment response biomarker in CSU. Downregulation of IgE, a key mediator of mast cell activation and histamine release, may at least partially explain the effectiveness of dupilumab in reducing CSU signs and symptoms. ClinicalTrials.gov Identifier: NCT04180488.

Comparative efficacy and safety of the treatment by Omalizumab for chronic idiopathic urticaria in the general population: A systematic review and network meta-analysis.

Omalizumab is the only licensed drug that serves as a third-line treatment for chronic idiopathic urticaria (CIU). The optimum doses of omalizumab remain controversial. Therefore, this study aims to estimate the efficacy and safety of different doses of omalizumab in the treatment of CIU patients. Four databases were searched from the database's creation to April 8, 2023. Several keywords such as omalizumab and urticarias were used to retrieve related studies. The meta-analytical outcomes were analyzed in R 4.2.1 software and Stata 15.1 software. Cochrane risk-of-bias tool Ver. 2 was used to evaluate the risk of bias in randomized controlled trials (RCTs). In total, 2331 patients were included. Five indexes were employed to assess, including weekly Itch Severity Score (ISS7), weekly Hive Severity Score (HSS7), weekly Urticaria Activity Score (UAS7), Dermatology Life Quality Index (DLQI), and adverse events (AE). A 300mg dose of omalizumab was the optimum dose to treat CIU, followed by the 150mg dose. Furthermore, 600mg of omalizumab only showed a significant difference from the placebo in HSS7. No significant statistical difference was observed in AE. Meta-regression analysis revealed that time, as a covariate, was statistically significant in the comparison of omalizumab 150mg with placebo. 300mg of omalizumab was the optimum dosage to treat CIU patients, with a 150mg dose also exhibiting good efficacy. Further studies are required to explore the efficacy and safety of different doses of omalizumab in the treatment of CIU patients.

Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials

Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by recurrent pruritic wheals (hives) and/or angioedema. Patients with CSU could remain symptomatic despite standard-of-care H1 antihistamines (H1-AH) or anti-IgE (omalizumab) treatment. Dupilumab blocks IL-4/IL-13 signaling and is approved for multiple type 2/atopic indications. We conducted two phase 3, randomized, placebo-controlled, double-blind trials comparing dupilumab with placebo in patients with symptomatic CSU despite H1-AH. In LIBERTY-CSU CUPID Study A, patients were omalizumab-naive (n= 138, aged ≥6 years). In Study B, patients were omalizumab-intolerant/incomplete responders (n= 108, aged ≥12 years). The primary end point was either change from baseline over 7 days in the Urticaria Activity Score (UAS7) or Itch Severity Score (ISS7) at week 24, with the other as a key secondary end point, depending on regional regulatory requirements. Studies were pooled for safety assessment. In Study A, UAS7 and ISS7 improved with dupilumab versus placebo (difference -8.5 [95% CI, -13.2 to -3.9; P= .0003] and -4.2 [95% CI, -6.6 to -1.8; P= .0005]). In Study B, tested at α= 0.043 after interim analysis, UAS7 improved (difference -5.8 [95% CI, -11.4 to -0.3; P= .0390]), with a numerical trend in ISS7 (difference -2.9 [95% CI, -5.7 to -0.07; nominal P= .0449, not significant]). Pooled safety data were consistent between dupilumab and placebo and with the known dupilumab safety profile. Dupilumab reduced urticaria activity by reducing itch and hives severity in omalizumab-naive patients with CSU uncontrolled with H1-AH. Although the primary end point for Study B was not met, dupilumab effects were small in patients who were omalizumab-intolerant/incomplete responders.

Benralizumab does not elicit therapeutic effect in patientswith chronic spontaneous urticaria: results from the phase IIb multinational randomized double-blind placebo-controlled ARROYO trial.

Chronic spontaneous urticaria (CSU) is a relatively common skin disease associated with hives and angio-oedema. Eosinophils play a role in CSU pathogenesis. Benralizumab, an anti-interleukin-5 receptor-α monoclonal antibody, has been shown to induce nearly complete depletion of eosinophils. To determine the clinical efficacy and safety of benralizumab in patients with CSU who were symptomatic despite H1 antihistamine treatment. The 24-week, randomized, double-blind, placebo-controlled, phase IIb portion of the ARROYO trial enrolled adult patients with CSU who were currently on H1 antihistamine treatment. Patients were randomized to one of five treatment groups according to benralizumab dose and regimen for a 24-week treatment period. The primary endpoint was change from baseline in Itch Severity Score (ISS)7 at week 12. The key secondary endpoint was change from baseline in Urticaria Activity Score (UAS)7 at week 12. Additional secondary endpoints included other metrics to assess CSU at week 24, blood eosinophil levels, and pharmacokinetics and immunogenicity assessments. Exploratory subgroup analyses were conducted to explore responses according to demographics, clinical features and biomarkers. Safety was assessed in all treatment groups. Of 155 patients, 59 were randomized to benralizumab 30 mg, 56 to benralizumab 60 mg and 40 to placebo. Baseline and disease characteristics were consistent with what was expected for patients with CSU. There were no significant differences in change from baseline in ISS7 score at week 12 between benralizumab and placebo [benralizumab 30 mg vs. placebo, least-squares mean difference -1.01, 95% confidence interval (CI) -3.28 to 1.26; benralizumab 60 mg vs. placebo, least-squares mean difference -1.79, 95% CI -4.09 to 0.50] nor in change from baseline in UAS7 score at week 12 between benralizumab and placebo (benralizumab 30 mg vs. placebo, P = 0.407; benralizumab 60 mg vs. placebo, P = 0.082). Depletion of blood eosinophil levels was observed at week 24 in patients treated with benralizumab. All other secondary endpoints and exploratory/subgroup analyses indicated no significant differences between benralizumab and placebo. Safety results were consistent with the known profile of benralizumab. Although benralizumab resulted in near-complete depletion of blood eosinophils, there was no clinical benefit over placebo.

507 - Dupilumab demonstrates greater improvement in disease activity than standard-of-care H1-antihistamines in CSU

Abstract IntroductionChronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by wheals and/or angioedema recurring for &amp;gt;6 weeks. Cumulative distribution function (CDF) curves compare cumulative probabilities of response between treatments across responder definition spectrums. Methods LIBERTY-CSU CUPID Study A (NCT04180488) was a randomized, placebo-controlled, phase 3 trial of dupilumab treatment for 24 weeks in patients with CSU remaining symptomatic despite standard-of-care (SOC) H1-antihistamines. Patients were randomized to receive add-on dupilumab (dupilumab/SOC) or placebo (placebo/SOC) subcutaneously every 2 weeks. CDF curves were plotted for the distribution of possible within-patient response for Urticaria Activity Score over 7 days (UAS7), Itch Severity Score over 7 days (ISS7), and Hives Severity Score over 7 days (HSS7) for dupilumab/SOC and placebo/SOC arms. Results In CDF analysis at Week 24, more patients experienced UAS7, ISS7, and HSS7 improvements with dupilumab/SOC than placebo/SOC; 74.2% vs 50.0% of patients (dupilumab/SOC vs placebo/SOC) achieved ≥11-point reductions (minimal important difference [MID] threshold) in UAS7. Similarly, 78.8% vs 51.7% of patients (dupilumab/SOC vs placebo/SOC) reached ≥5-point reductions (MID threshold) in ISS7 and HSS7. The responder proportion was ≥20% greater for dupilumab/SOC vs placebo/SOC for response thresholds of 9.5- to 22-point reductions for UAS7, 4.5- to 11-point reductions for ISS7, and 5- to 11-point reductions for HSS7. Conclusion Irrespective of within-patient responder thresholds, greater proportions of patients experienced improvement in UAS7, ISS7, and HSS7 with dupilumab/SOC vs placebo/SOC at Week 24. Overall safety was consistent with the known dupilumab safety profile.

Severity, impact on quality of life and mental health burden of pruritus in prurigo nodularis: a cross-sectional study of a diverse patient cohort.

We performed a cross-sectional study using validated survey instruments, finding severe pruritus, reduced quality of life (QoL) and a significant mental health burden in a diverse cohort of patients with prurigo nodularis (PN) from the USA. Itch severity and QoL scores were comparable to those found in European populations, aside from ItchyQoL scores (higher scores in this US cohort). Black patients reported higher itch intensity scores than White patients. More than 37% of patients met the cutoff for severe depression, but only 26% had a clinical diagnosis of depression. Dermatologists should be aware that PN extends beyond severe pruritus, consider screening for psychiatric comorbidities and address other concerns that affect QoL as needed.

Comparison of Study Designs for Primary Phase III Trials for Omalizumab Versus Dupilumab for Patients With Chronic Spontaneous Urticaria

Introduction&#x0D; Omalizumab is currently the only biologic approved and recommended as second-line treatment for patients with chronic spontaneous urticaria (CSU). However, clinical trial programs are underway for other biologic treatments such as dupilumab. Given head-to-head trials will not be conducted, consideration of study design may be important.&#x0D; Methods&#x0D; Comparison of participants, interventions, outcomes, and results for phase III primary efficacy clinical trials for omalizumab versus dupilumab for patients with CSU. The omalizumab trials were ASTERIA I/II (NCT01287117 and NCT01292473) and the dupilumab trial was LIBERTY-CSU CUPID (NCT04180488) that consisted of Study A, B, and C.&#x0D; Results&#x0D; Participants in ASTERIA I/II were 12 to 75 years with a diagnosis of CSU refractory to H1 antihistamines. Participants in LIBERTY-CSU CUPID were 6 to 80 years (Study A and C) or 12 to 80 years (Study B) with a diagnosis of CSU refractory to H1 antihistamines, and Urticaria Activity Score (UAS)7≥16 and Itch Severity Score (ISS)7≥8 during the 7 days before randomization; Study A and C included participants who were omalizumab naïve and Study B included intolerant or incomplete responders to omalizumab. For ASTERIA I and II, the interventions were placebo or omalizumab (75mg, 150mg, 300mg) every 4 weeks for 24 and 12 weeks, respectively. For LIBERY-CSU CUPID, the interventions were placebo or dupilumab (200mg or 300mg, weight based) every 2 weeks for 24 weeks. The primary efficacy outcome for ASTERIA I/II was change from baseline in ISS7 at Week 12. The primary efficacy outcome for LIBERTY-CSU CUPID was change from baseline in ISS7 at Week 24. For the ASTERIA I primary outcome, the change from baseline in ISS7 at Week 12 was -3.6 for placebo and -6.5, -6.7, and ‑9.4 for omalizumab 75mg, 150mg, and 300mg, respectively. For the ASTERIA II primary outcome, the change from baseline in ISS7 at Week 12 was -5.1 for placebo and ‑5.9, ‑8.1, and ‑9.8 for omalizumab 75mg, 150mg, and 300mg, respectively. For the LIBERTY-CSU CUPID Study A primary outcome, the change from baseline in ISS7 at Week 24 was ‑6.0 for placebo and -10.2 for dupilumab. The LIBERTY-CSU CUPID Study B was stopped due to futility based on a pre-specified interim analysis.&#x0D; Conclusion&#x0D; Comparing study designs for primary clinical trials for omalizumab and dupilumab for patients with CSU will aid in the comparative analysis and clinical evaluation of final trial results.&#x0D; Funding: ASTERIA I/II were funded by Genentech Inc. and Novartis Pharma AG.

Comparison of Study Designs for Primary Phase III Trials for Omalizumab Versus Dupilumab for Patients With Chronic Spontaneous Urticaria

Introduction&#x0D; Omalizumab is currently the only biologic approved and recommended as second-line treatment for patients with chronic spontaneous urticaria (CSU). However, clinical trial programs are underway for other biologic treatments such as dupilumab. Given head-to-head trials will not be conducted, consideration of study design may be important.&#x0D; Methods&#x0D; Comparison of participants, interventions, outcomes, and results for phase III primary efficacy clinical trials for omalizumab versus dupilumab for patients with CSU. The omalizumab trials were ASTERIA I/II (NCT01287117 and NCT01292473) and the dupilumab trial was LIBERTY-CSU CUPID (NCT04180488) that consisted of Study A, B, and C.&#x0D; Results&#x0D; Participants in ASTERIA I/II were 12 to 75 years with a diagnosis of CSU refractory to H1 antihistamines. Participants in LIBERTY-CSU CUPID were 6 to 80 years (Study A and C) or 12 to 80 years (Study B) with a diagnosis of CSU refractory to H1 antihistamines, and Urticaria Activity Score (UAS)7≥16 and Itch Severity Score (ISS)7≥8 during the 7 days before randomization; Study A and C included participants who were omalizumab naïve and Study B included intolerant or incomplete responders to omalizumab. For ASTERIA I and II, the interventions were placebo or omalizumab (75mg, 150mg, 300mg) every 4 weeks for 24 and 12 weeks, respectively. For LIBERY-CSU CUPID, the interventions were placebo or dupilumab (200mg or 300mg, weight based) every 2 weeks for 24 weeks. The primary efficacy outcome for ASTERIA I/II was change from baseline in ISS7 at Week 12. The primary efficacy outcome for LIBERTY-CSU CUPID was change from baseline in ISS7 at Week 24. For the ASTERIA I primary outcome, the change from baseline in ISS7 at Week 12 was -3.6 for placebo and -6.5, -6.7, and ‑9.4 for omalizumab 75mg, 150mg, and 300mg, respectively. For the ASTERIA II primary outcome, the change from baseline in ISS7 at Week 12 was -5.1 for placebo and ‑5.9, ‑8.1, and ‑9.8 for omalizumab 75mg, 150mg, and 300mg, respectively. For the LIBERTY-CSU CUPID Study A primary outcome, the change from baseline in ISS7 at Week 24 was ‑6.0 for placebo and -10.2 for dupilumab. The LIBERTY-CSU CUPID Study B was stopped due to futility based on a pre-specified interim analysis.&#x0D; Conclusion&#x0D; Comparing study designs for primary clinical trials for omalizumab and dupilumab for patients with CSU will aid in the comparative analysis and clinical evaluation of final trial results.

PK/PD modeling to characterize placebo and treatment effect of omalizumab for chronic spontaneous urticaria.

The pharmacokinetic (PK) characteristics of omalizumab and its pharmacodynamic (PD) effect in patients has yet to be fully characterized in chronic spontaneous urticaria, which could elucidate its pathogenesis and treatment response. This study has two objectives; (1) characterize the population PK of omalizumab and its PD effect on IgE, and (2) develop a drug effect model of omalizumab in urticaria (via change in weekly itch severity score). The target-mediated population of PK/PD model incorporating omalizumab-IgE binding and turnover adequately described PK and PD of omalizumab. The effect compartment model and linear drug effect and additive placebo response adequately described placebo and treatment effects of omalizumab. Several baseline covariates were identified for PK/PD and drug effect models. The developed model has the potential to aid in understanding variability in PK/PD as well as response to omalizumab treatment.

Efficacy and Safety of Autologous Serum Therapy in Chronic Spontaneous Urticaria in the Pediatric Population: A Prospective Pilot Study.

Chronic spontaneous urticaria (CSU) in children is mostly spontaneous in onset (57%). Treatment comprises long-term antihistaminic therapy without need for elaborate investigations. A subset of such patients don't respond to conventional treatment and novel therapies to help reduce pill burden is the need of the hour. To determine the efficacy and safety of autologous serum therapy (AST) in pediatric patients with chronic spontaneous urticaria. All pediatric patients, aged between 6-16 years, attended to our OPD from March 2019 to March 2020 were recruited. Clinico-demographic data and baseline investigations of all patients were performed. Two-weekly AST therapy was given for 8 visits with levocetrizine tablet 5mg on an on-demand basis. Urticaria activity score (UAS) sheet was provided to record and return every 2 weeks. Statistical analysis was done using the IBM SPSS 26 software package. Autologous serum skin test (ASST) was positive in 63% patients. Both the ASST positive and ASST negative group showed significant reduction in UAS7 score at week 14 compared to baseline. The reduction in mean UAS7 score was associated with a decreased pill burden and positive response in the patient and physician global assessment scale. No statistically significant difference between the two groups in terms of mean UAS7 reduction was found. This study has explored the efficacy and safety of autologous serum therapy in the pediatric CSU patients. Both ASST positive and ASST negative group respond to AST therapy.

DUPILUMAB EFFICACY IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA BY IGE LEVEL: LIBERTY-CSU CUPID STUDY A

<h3>Introduction</h3> Chronic spontaneous urticaria (CSU) causes recurrent itchy hives and/or angioedema, significantly impacting quality of life. Many patients experience a substantial disease burden despite treatment with licensed and escalated doses of H1 antihistamines. <h3>Methods</h3> In LIBERTY-CSU CUPID Study A (NCT04180488), a randomized, placebo-controlled, 24-week, phase 3 trial, patients (≥6 years) with CSU who remained symptomatic despite H1 antihistamine treatment received add-on dupilumab (n=70) (adults/adolescents ≥60kg: 300mg; adolescents <60kg/children ≥30kg: 200 mg) or matching placebo (n=68) subcutaneously every 2 weeks. Endpoints included change from baseline at Week-24 over 7 days in Itch Severity Score (ISS7), Hives Severity Score (HSS7), and Urticaria Activity Score (UAS7). <h3>Results</h3> Baseline characteristics were balanced; mean ISS7 and UAS7 (dupilumab/placebo) were 16.1/15.7 and 31.9/30.8, respectively. At Week-24, least squares (LS) mean change from baseline in ISS7 (range: 0–21) was –10.2/–6.0 (dupilumab/placebo, respectively) (LS mean difference –4.2; <i>P</i>=0.0005) and for UAS7 (range: 0–42) was –20.5/–12.0 (difference –8.5; <i>P</i>=0.0003). Baseline median serum total IgE was 101.0IU/mL (overall population). Dupilumab significantly reduced itch (ISS7), hives (HSS7), and urticaria activity (UAS7) at Week-24 regardless of baseline serum total IgE (<100 /≥100IU/mL): ISS7 LS mean difference vs placebo(95% confidence interval) −4.2(−7.86, −0.62)/−4.6(−8.22, −1.04), respectively; HSS7, −4.2(−7.60, −0.70)/−6.1(−9.95, −2.33); UAS7, –8.2(–15.04, –1.29)/–10.6(–17.72, –3.54). Occurrence of treatment-emergent adverse events (TEAEs) for dupilumab/placebo were 35(50.0%)/40(58.8%); injection-site reactions, 8(11.4%)/9(13.2%); conjunctivitis, 0/1(1.5%); serious TEAEs, 2(2.9%)/5(7.4%). <h3>Conclusion</h3> Dupilumab demonstrated clinically meaningful and statistically significant improvements in patients with H1 antihistamine-resistant CSU regardless of baseline IgE level and was well tolerated.

MO915: Factors Related to Chronic Kidney Disease–Associated Pruritus in Patients Undergoing Haemodialysis and its Effects on Quality of Life

Abstract BACKGROUND AND AIMS Chronic kidney disease-associated pruritus (CKD-aP) is an often overlooked, common and debilitating problem for patients undergoing haemodialysis. Although the prevalance of CKD-aP has decreased over the years, it continues to be a problem associated with quality of life impairment, sleep disturbances, increased mortality and morbidity. With this study, we aim to investigate factors related to CKD-aP and its impact on patients’ quality of life. METHOD We conducted a cross-sectional study of in-centre HD patients in the city of Eskişehir, Turkey. A total of 298 patients undergoing HD for &amp;gt;3 months were enrolled in the study. We analysed demographic characteristics, routine laboratory values, interdialytic weight gain, residual urine output, xerosis, 5D itch scale scores (multidimensional itch-related questionnaire), VAS score (ranging from no itching to the worst itching imaginable) and LANSS score (neuropathic pain assessment scale) of enrolled patients. RESULTS Mean age of 298 patients was 64.6 ± 13.2 and 52% of patients were male. Pruritus prevalence in the study group was 45%. The 5D scores were higher among patients with &amp;lt; 200 mL residual urine output versus patients with &amp;gt;500 mL residual urine output (P = .034). The 5D scores were higher among patients with xerosis (P &amp;lt; .001). The 5D scores were again higher among patients with a LANSS score of ≥ 12 (P &amp;lt; .001). The 5D scores were lower among the low-flux membrane group versus the high-flux membrane group (P = .001). The 5D scores were correlated with interdialytic weight gain (r = 0.124; P = .033), Kt/V (r = –0.228; P &amp;lt; .001), ALT levels (r = 0.135; P = .02), total iron binding capacity (r = .13; P = .025) and VAS scores (r = 0.969; P &amp;lt; .001). There were no statistically significant correlations between 5D scores and age, body mass index, HD duration, creatinine, BUN, calcium, phosphorus, calcium-phosphorus product (CAxP) and other routinely tested laboratory values. CONCLUSION In our study, we identified residual urine output, xerosis, neuropathic pain, HD membrane type, interdialytic weight gain, Kt/V, ALT and TIBC as factors related to CKD-aP. The strong relationship between itch severity and neropathic pain scores was especially notable. More research in this field may be beneficial for identifying new therapeutic targets for CKD-aP.

A prospective, post-marketing clinical study to evaluate the effectiveness of luliconazole 1% cream in treating cutaneous mycoses

&lt;p class="abstract"&gt;&lt;strong&gt;&lt;span lang="EN-US"&gt;Background: &lt;/span&gt;&lt;/strong&gt;&lt;span lang="EN-US"&gt;Superficial (or cutaneous) mycoses are fungal infections that affect the superficial layers of the skin, hair, and nails. Luliconazole is an azole antifungal, used in the treatment of infections caused by fungus and yeast. The objective of the study is to assess the effectiveness and safety of new topical formulation of luliconazole (1% w/w luliconazole with 1% pramoxine added as excipient) in patients with cutaneous mycoses.&lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;&lt;span lang="EN-US"&gt;Methods: &lt;/span&gt;&lt;/strong&gt;&lt;span lang="EN-US"&gt;Patients with cutaneous mycoses aged 18 years and older were included in the post-marketing open-label, monocentric, prospective study. Effectiveness was assessed on patients prescribed with new 1% w/w luliconazole cream. The primary endpoint was a change in itch severity as assessed on 10-point Visual analogue scale score. The secondary endpoints include the number of patients who achieved all-night relief from itching and the type of adverse events during the treatment. Clinical effectiveness for itching was assessed at different time points after baseline.&lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;&lt;span lang="EN-US"&gt;Results:&lt;/span&gt;&lt;/strong&gt;&lt;span lang="EN-US"&gt; The mean itch severity scores at 2 min, 5 min, 10 min, 1 hour, 4 hour, and 8 hour time points were observed on 30 clinically diagnosed patients. A significant reduction of the mean±standard deviation score was observed from 6.82±0.72 at baseline to 3.37±1.68 after 8 hours. About 66.6% of patients achieved all-night relief from itching. There were no adverse events reported by any participant over the study duration.&lt;/span&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;&lt;span lang="EN-US"&gt;Conclusions: &lt;/span&gt;&lt;/strong&gt;&lt;span lang="EN-US"&gt;This new topical formulation of luliconazole (1% w/w) containing 1% pramoxine as excipient significantly reduced itch in cutaneous mycoses with no reported adverse events. Large randomised controlled studies are required to confirm our findings.&lt;/span&gt;&lt;/p&gt;

Efficacy and safety of omalizumab in Chinese patients with anti‐histamine refractory chronic spontaneous urticaria

Chronic spontaneous urticaria (CSU) is characterized by the spontaneous development of wheals, itching, and/or angioedema, for ≥6 weeks. In China, non‐sedating H1‐antihistamines (H1AH) are the recommended first‐line treatment, with escalation up to 4× the standard dose in symptomatic patients to achieve control. Treatment options for Chinese patients who remain symptomatic on H1AH treatment are limited. This 20‐week randomized, double blind, placebo‐controlled, parallel‐group study investigated the efficacy and safety of omalizumab as an add‐on therapy for the treatment of patients with CSU who remained symptomatic despite H1AH treatment in China. Adult patients (N = 418) diagnosed with refractory CSU for ≥6 months were randomized (2:2:1) to receive omalizumab 300 mg (OMA300), omalizumab 150 mg (OMA150) or placebo, subcutaneously, every 4 weeks. Primary outcome was change from baseline to week 12 in weekly itch severity score (ISS7). Safety was assessed by rates of adverse events (AEs). Demographic and disease characteristics at baseline were comparable across treatment groups. At week 12, statistically significant greater decreases from baseline were observed in ISS7 with OMA300 (least square mean difference [LSM]: −4.23; 95% confidence interval [CI]: −5.70, −2.77; p < 0.001) and OMA150 (LSM: −3.79; 95% CI: −5.24, −2.33; p < 0.001) versus placebo. Incidence of treatment‐emergent AEs over 20 weeks was slightly higher with OMA300 (71.3%) compared to OMA150 and placebo groups (64.7% and 63.9%, respectively). The incidences of serious AEs were balanced between groups. This study demonstrated the efficacy and safety of omalizumab in Chinese adult patients with CSU who remained symptomatic despite H1AH therapy.

Treatment of adult atopic dermatitis patients according to disease characteristics and demographics.

Little is currently known about possible associations between disease specific characteristics of atopic dermatitis (AD) and use of medical treatments. We explored the use of AD treatments within the past 12 months in Danish adults according to distinct patient characteristics. Patients who had received a diagnosis of AD in a hospital in- or outpatient setting as adults were surveyed and data cross-linked to a national prescription registry. AD severity was measured by the Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD). A total of 3834 patients participated. Use of topical medication in the past 12 months increased with increasing AD severity, whereas no difference was observed for systemic medication use. Positive associations between AD in the face and neck, and use of mild and moderately potent topical corticosteroids were observed, while involvement of palms and chest was associated with use of more potent topical corticosteroids. The mean DLQI, skin pain, and itch severity scores were lower in patients managed only with topical corticosteroids (5.5, 3.2, and 4.3, respectively) compared to patients treated with both oral and topical medication (7.1, 3.8, and 5.0, respectively). Patients with frequent topical corticosteroid use tended to be older (50.7 vs 48.6 years), males (50.0% vs 33.6%), current daily smokers (17.3% vs 13.7%), and having asthma (59.1% vs 43.8%) compared with infrequent users of topical corticosteroids. We found a disconnect between the severity of AD signs and symptoms, and use of AD therapies. In particular, a very modest use of systemic immunosuppressants was seen even among patients with severe AD symptoms. However, the underlying clinical decisions and reasons behind this disconnect is not clear based on the current data.

Efficacy and safety of treatment with omalizumab for chronic spontaneous urticaria: A systematic review for the EAACI Biologicals Guidelines.

This systematic review evaluates the efficacy and safety of omalizumab for chronic spontaneous urticaria (CSU). PubMed, Embase, and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75years old treated with omalizumab for 16 to 40weeks were evaluated. Omalizumab 150mg does not result in clinically meaningful improvement (high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) -5; 95%CI -7.75 to -2.25), and the itch severity score (ISS)7 (MD -2.15; 95% CI -3.2 to -1.1) does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD -2.01; 95%CI -3.22 to -0.81) and decreases (moderate certainty) rescue medication use (MD -1.68; 95%CI -2.95 to -0.4). Omalizumab 300mg results in clinically meaningful improvements (moderate certainty) of the UAS7 (MD -11.05; 95%CI -12.87 to -9.24), the ISS7 (MD -4.45; 95%CI -5.39 to -3.51), and QoL (high certainty) (DLQI; MD -4.03; 95% CI -5.56 to -2.5) and decreases (moderate certainty) rescue medication use (MD -2.04; 95%CI -3.19 to -0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91).

Clinically meaningful change in itch intensity scores: An evaluation in patients with chronic kidney disease–associated pruritus

Clinically meaningful change in itch intensity scores: An evaluation in patients with chronic kidney disease–associated pruritus

Intralesional triamcinolone acetonide in notalgia paresthetica: Treatment outcomes in five patients.

Numerous treatment modalities have been tried with diverse results for pruritus due to notalgia paresthetica (NP). Corticosteroids suppress ectopic neural discharges from injured nerve fibers and also have short-lived suppressive effect on transmission in normal C-fibers. Herein, we evaluated the efficacy of intralesional triamcinolone acetonide in the treatment of NP. The medical reports of five patients who had been diagnosed with NP and treated with intralesional triamcinolone acetonide injections were retrospectively evaluated. Triamcinolone acetonide solution was injected intradermally (10 mg/mL; 0.1 mL/cm2 ) every 3 weeks for a maximum of four treatments. The severity of itch was scored by the patients on a combined numerical and visual analogue scale. After treatment, reduction in itch severity scores varied between 33% and 100%.

Omalizumab chronic spontaneous urticaria: Efficacy, safety, predictors of treatment outcome, and time to response

BackgroundOmalizumab is a recombinant anti-immunoglobulin E (IgE) antibody used in the treatment of patients with chronic spontaneous urticaria (CSU). ObjectiveThis multicentric study assessed the safety and efficacy of omalizumab in patients (n=322) with CSU refractory to second-generation antihistamines, also investigating predictors of poor treatment outcome and time lag to response to anti-IgE therapy by serum auto-reactivity. MethodsThis retrospective observational study comprised a 4-week pretreatment period, a 24-week treatment period with omalizumab (300 mg/month), and a 16-week follow-up period. Primary efficacy endpoints were mean and median change in 7-day urticaria activity score (UAS7), weekly itch severity score (ISS), and hive score from baseline to 4-, 12-, and 24-week values. Secondary endpoints included the proportion of patients (defined “responders”) with well-controlled urticaria (UAS7 ≤ 6) and complete treatment response (UAS7=0). Safety in terms of side effects was also assessed. ResultsOmalizumab significantly and consistently reduced the mean UAS7, ISS, and hive score from baseline to weeks 4, 12, and 24, with a clear decreasing trend over time. At the end of the treatment period (week 24), 84.2% of patients had a UAS7 score of 6 or less and 66.7% had a UAS7 of 0. Higher pretreatment IgE levels were less likely to be associated with poor treatment response (ie, UAS7 > 6). Patients with a positive autologus serum skin test (ASST) were significantly more likely to be “slow responders” to omalizumab treatment (ie, response beyond 8 days since omalizumab administration) than ASST-negative patients (P < .001). No treatment-related adverse events were recorded. ConclusionMonitoring baseline characteristics of patients before introduction of omalizumab therapy may help to predict treatment outcome in CSU patients.

Omalizumab in elderly patients with chronic spontaneous urticaria: An Italian real-life experience

BackgroundOmalizumab therapy is effective and safe in patients with chronic spontaneous urticaria (CSU) resistant to nonsedating histamine1 (H1) antihistamines (nsAHs). ObjectiveTo evaluate the efficacy and safety of omalizumab in elderly (aged ≥65 years) patients with nonsedating H1-antihistamine–refractory CSU in a real-life setting. MethodsPatients with nonsedating H1-antihistamine–refractory CSU (n = 322) treated with omalizumab administered every 4 weeks in doses of 300 mg for 24 weeks were divided into 2 groups according to age at omalizumab treatment onset: 15 to 64 years and 65 years or older. Treatment response was assessed using a 7-day urticaria activity score (UAS7). Adverse effects of omalizumab therapy were recorded. ResultsAmong patients, 32 (9.9%) were 65 years or older. At baseline, CSU characteristics were generally similar among the groups, although the presence of angioedema was statistically significantly lower in patients younger than 65 years. Any differences in weekly itch severity score, hive score, and UAS7 between the 2 age groups were not significant at weeks 4, 12, and 24, with the exception of the hive score at 24 weeks and the UAS7 at week 24. No significant between-group differences were seen in the proportion of patients with a UAS7 of 6 or lower and with a UAS7 score of 0 at weeks 4, 12, 24, and 40. The proportion of patients with at least one adverse event reported as suspected to be caused by study drug was 10% in the younger group vs 6.3% in the older group (P = .53). ConclusionOur study found that omalizumab is a well-tolerated and effective therapy for elderly patients with nonsedating H1-antihistamine–refractory CSU.