Itch Scores Research Articles

Efficacy of Dupilumab in severe Atopic Dermatitis (AD) using the AD Control Tool (ADCT) Score in the population of Qatar.

Atopic Dermatitis (AD) is a high-burden disease that affects approximately 2-5% of adults. AD patients experience intense pruritus and often report sleep and mental health disturbances accompanied by a diminished quality of life. The patients' perceptions of their treatment benefits are becoming increasingly important in the benefit/risk assessment of therapeutics such as the gold standard in AD therapy, Dupilumab. A survey questionnaire (ADCT) has been recently developed to assess the control of AD symptoms using subjective patient-based reporting only. This study aimed to investigate the self-reported efficacy of Dupilumab in Qatari patients with severe AD using the new ADCT evaluation tool. Methods: 30 patients completed a baseline survey before starting Dupilumab, and ADCT was assessed at four weeks post-therapy initiation. ADCT evaluates six AD symptoms in a severity grading from 0 to 3 (max. 24 points). The impact is assessed over the past week, including overall severity of symptoms, days with intense episodes of itching, the intensity of bother, problems with sleep, impact on daily activities, and impact on mood or emotions. In addition, itch severity was also assessed using a numeric rating scale (NRS11) ranging from 0 to 10. Results: The overall mean ADCT score at baseline was 17.6, and at week 4, it was reduced to 4.1. Patients reported a dramatic change in the overall symptoms already in this early phase. The parried t-test showed a significant difference in ADCT Score before and after therapy. There was a substantial decline in experiencing the associated AD symptoms: overall severity of symptoms (mean baseline =3.1, Dupilumab week 4 =0.9 (3.1/0.9), days with intense episodes of itching (3.2/0.7), the intensity of bother (3.2/0.8), the problem with sleep (2.7/0.4), impact on daily activities (2.5/0.6), and impact on mood or emotions (2.9/0.6). The itch score also reduced from 8/10 at baseline to 0-3 at week 4. Conclusion: Treatment of adult Asian/Arabic patients with severe AD treated with Dupilumab with or without topical steroids was highly effective and significantly improved overall well-being and pruritus as early as after 4 weeks of treatment.

Efficacy of Different Dosing Regimens of IgE Targeted Biologic Omalizumab for Chronic Spontaneous Urticaria in Adult and Pediatric Populations: A Meta-Analysis.

Chronic urticaria is a debilitating skin condition that is defined as itchy hives at least twice a week and lasting for six or more weeks, with or without angioedema. Chronic spontaneous urticaria (CSU) is a form of disease that is witnessed in two-thirds of those with chronic urticaria. This meta-analysis explores the efficacy of differential dosages of omalizumab for outcomes of weekly itching scores, weekly wheal scores, urticarial assessment score 7 (UAS7), and responder rates. Adhering to PRISMA Statement 2020 guidelines, a systematic search of PubMed/MEDLINE, Scopus, Embase, and Web of Science was conducted until 15 September 2022. A combination of the following keywords was used: omalizumab and chronic urticaria. Data comprising clinical trial ID, name, author/year, country, dosage and time of intervention, inclusion criteria, mean age, female gender, and racial grouping information were obtained. The meta-analytical outcomes were analyzed in RevMan 5.4. The risk-of-bias assessment was conducted using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). A total of 10 trials comprising 1705 patients with CSU were included. Notably, 1162 belonged to the intervention group, while 543 were controls. A total of 70.4% of the participants were female in the intervention group, while 65.6% of them were female in the control group. The overall mean age was 38.64 ± 10.66 years. Weekly itch score outcomes were most notable with 150 mg dosage (Cohen's d = -2.6, 95% CI = -4.75, -0.46, p = 0.02). The weekly wheal score outcomes had the largest effect size with 300 mg dosage (Cohen's d = -1.45, 95% CI = -2.2, -0.69, p = 0.0002). For UAS7 outcomes, the largest effect size was yielded with 150 mg dosage (Cohen's d = -6.92, 95% CI: -10.38, -3.47, p < 0.0001). The response rate to omalizumab had a likelihood of being higher with 300 mg of intervention compared to placebo (OR = 8.65, 95% CI = 4.42, 16.93, p < 0.0001). Well-rounded urticarial symptom resolution was observed with 150 mg and 300 mg dosages of omalizumab. Improvement of UAS7 was more comparable with 150 mg dosage, whereas the chance of response to treatment was higher with 300 mg dosage. Our findings support omalizumab as an effective intervention for adult and pediatric populations that are resistant to many therapies, including high-dose H1-antihistamines.

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.

118 High unmet medical need in brachioradial pruritus: results from a large patient survey

A patient survey that aimed to best identify the unmet needs in brachioradial pruritus (BRP) was conducted from 10/2021 to 04/2022 in English online. The survey, created in collaboration with BRP patients and experts in BRP, included 36 questions focusing on the most significant elements of living with BRP: journey to diagnosis, severity and frequency of symptoms, treatment history, and impact on quality of life. 545 anonymous respondents worldwide participated in the survey, with 322 having reported a confirmed BRP diagnosis by a physician. The majority of patients were 50-69 years old (62%), female (94%), and in the US (74%). Data showed it took at least three years since first experiencing BRP symptoms for 43% of patients to receive a correct diagnosis, and 52% visited at least three different physicians before the diagnosis was made. Misdiagnosis [other diagnoses prior to final diagnosis of BRP] was common (in 39%). Most (85%) patients had severe itch (itch score ≥7) in their last episode, and 88% had visible scratch marks or bleeding. 78% suffer from itch at least three months per year, of which 28% suffer for over nine months per year. Patients often tried several drug treatments (mean >4) for itch, with the most helpful receiving only 21% of responses. Sleep quality is highly affected in 77% of patients, and 71% use ice packs at night. For the vast majority (92%), their itch frustrates them often or all the time. These data show that a substantial proportion of BRP patients endure a difficult path to diagnosis, suffer from severe itch for the majority of the year, lack a clear treatment option, and experience a highly negative impact on their quality of life. These results emphasize the need to increase awareness of BRP, address patients’ unmet needs, and develop effective treatments for BRP.

GLIMMER: A Randomized Phase 2b Dose-Ranging Trial of Linerixibat in Primary Biliary Cholangitis Patients With Pruritus

GLIMMER assessed dose-response, efficacy, and safety of linerixibat, an ileal bile acid transporter inhibitor in development for cholestatic pruritus associated with primary biliary cholangitis (PBC). GLIMMER was a Phase 2b, multicenter, randomized, parallel-group study in adults with PBC and moderate-to-severe pruritus (≥4 on 0-10 numerical rating scale [NRS]). After 4 weeks of single-blind placebo, patients with NRS ≥3 were randomized (3:1) to double-blind linerixibat/placebo for 12 weeks (to week 16), followed by single-blind placebo (to week 20). The primary objective was to investigate dose-related changes in mean worst daily itch (MWDI) score. One hundred forty-seven patients received placebo (n= 36) or linerixibat (once daily: 20 mg, n= 16; 90 mg, n= 23; 180 mg, n= 27; twice daily: 40 mg, n= 23; 90 mg, n= 22). Linerixibat groups exhibited ≥2-point mean reductions in MWDI from baseline at week 16; however, differences from placebo were not significant. Post hoc analysis of change from baseline in monthly itch score over the treatment period (Phase 3 endpoint) showed significant differences between placebo and linerixibat 180 mg once daily (P= .0424), 40 mg twice daily (P= .0105), and 90 mg twice daily (P= .0370). A significant relationship between total daily dose and response was observed post hoc in the per protocol population (P= .0542). Consistent with mechanism of action, diarrhea was the most frequent adverse event, and incidence increased with dose. Linerixibat effect on itch was not significantly different versus placebo in the primary intent-to-treat analysis but was associated with a significant dose-dependent reduction in itch in the per protocol population. A well-tolerated dose was identified for Phase 3 investigation for cholestatic pruritus in PBC. gov ID: NCT02966834.

Clinical characterization of consecutive patients treated with endovenous radiofrequency ablation of the great saphenous vein in Northwest China

INTRODUCTION: The goal of this study was to characterize consecutive patients in Northwest China treated with endovenous radiofrequency ablation (RFA) and foam sclerotherapy over a 10-month period in 2020. METHODS: A total of 55 (31 men) patients were analyzed. An ultrasound examination was performed preprocedure and at set intervals up to 6 months postprocedure. The clinical-etiological-anatomical-pathophysiological classification, Venous Clinical Severity Score (VCSS), and heaviness, achiness, swelling, throbbing, and itching (HASTI) score were used. RESULTS: Ultrasound confirmed 23 (41.8%) patients had unilateral disease and 32 (58.2%) had bilateral disease. Of the total 87 limbs, C2 predominated (42;48.3%). At 6 months postprocedure, VCSS improved in the C2, C4, C5, and C6 classes (P < 0.001); HASTI improved in the C2, C3, C4, and C5 classes (P < 0.001). CONCLUSION: This is one of the few clinical characterizations of patients who had RFA and foam sclerotherapy in Northwest China. Overall, both the VCSS and the HASTI score demonstrated improvement postintervention.

Secukinumab in Patients with Psoriasis and a Personal History of Malignancy: A Multicenter Real-Life Observational Study.

IntroductionThere is limited evidence to guide clinicians on the treatment of psoriasis with biologics in patients with a history of malignancy who are often excluded from clinical trials investigating biologics. The aim of this work is to report a multicenter real-life experience of secukinumab treatment in patients with psoriasis and a personal history of cancer.MethodsThis retrospective observational study included adult patients with moderate-to-severe plaque psoriasis treated with secukinumab for at least 24 weeks and a previous diagnosis of cancer at 15 Italian referral centers. The primary endpoint of the study was tumor recurrence or progression and new cancer diagnosis during treatment. Secondary outcome assessment of secukinumab effectiveness (reduction of Psoriasis Area and Severity Index [PASI] score, improvement of Dermatology Life Quality Index [DLQI], itch and pain).ResultsForty-two patients (27 male) were included. Malignancy was diagnosed in the previous 5 years in 21 (56.8%) and in the previous 10 years in 37 (88.1%). The mean interval between cancer diagnosis and the start of secukinumab treatment was 3.5 ± 3.3 years. No tumor recurrence nor progression occurred over a mean of 56 ± 31.7 weeks of treatment. Three patients developed a new malignancy not related to the previous cancer. At week 48, PASI 90 was reached by 64.7% of patients and PASI 100 by 38.2%. Mean DLQI, itch, and pain VAS scores significantly improved during treatment.ConclusionsOur multicenter real-life experience is the largest reported to date focusing on a specific biologic and adds evidence to the safety of secukinumab in psoriatic patients with a personal history of cancer.

Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: A pooled analysis from two randomized phase 3 studies

Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: A pooled analysis from two randomized phase 3 studies

Severe and ChRonic Atopic dermatitis Treatment CoHort (SCRATCH): A Danish Real-world Evidence Atopic Dermatitis Treatment Registry.

Data from real-world use of new systemic treatments in atopic dermatitis (AD) is important for assessing safety and efficacy. The aim of this study is to describe the baseline characteristics of adult patients with moderate-to-severe AD enrolled in the Danish nationwide Severe and ChRonic Atopic dermatitis Treatment CoHort (SCRATCH) database, between October 2017 and August 2021. A total of 282 adult patients were included. Most (62%) were men, the median age at baseline was 43 years (interquartile range (IQR) 29-54 years), and median age at onset of AD was 1 year (IQR 0-6 years). The median Eczema Area and Severity Index at treatment initiation was 19.1 (IQR 11.9-25.7); median Patient Oriented Eczema Measure 21.0 (IQR 16.0-25.0); median Dermatology Life Quality Index 13.0 (IQR 7.0-19.0); and median itch and sleep numerical rating scale scores 8.0 (IQR 6.0-9.0) and 6.0 (IQR 4.0-8.0). Differences were found between the sexes. This registry will provide a source for future efficacy and safety studies.

Intrahepatic cholestasis of pregnancy: Green-top Guideline No. 43 June 2022.

Intrahepatic cholestasis of pregnancy: Green-top Guideline No. 43 June 2022.

Dietary Elimination for the Treatment of Atopic Dermatitis: A Systematic Review and Meta-Analysis

The influence of diet on atopic dermatitis (AD) is complex, and the use of dietary elimination as a treatment has conflicting views. To systematically review the benefits and harms of dietary elimination for the treatment of AD. We searched MEDLINE, Embase, AMED, PsycINFO, and the Cochrane Central Register of Controlled Trials from inception to January 18, 2022, without language restrictions, for randomized controlled trials (RCTs) and observational studies comparing dietary elimination and no dietary elimination for the treatment of AD. We conducted random-effects meta-analyses of eczema outcomes. We used the grading of recommendations, assessment, development, and evaluation approach to assess certainty of evidence (CRD42021237953). Ten RCT (n= 599; baseline median of study mean age, 1.5 years; median of study mean SCOring Atopic Dermatitis index, 20.7, range, 3.5-37.6) were included in the meta-analysis. Compared with no dietary elimination, low-certainty evidence showed that dietary elimination may slightly improve eczema severity (50% with vs 41% without dietary elimination improved the SCOring Atopic Dermatitis index by a minimally important difference of 8.7 points, risk difference of 9% [95% CI, 0-17]), pruritus (daytime itch score [range, 0-3] mean difference, -0.21 [95% CI, -0.57 to 0.15]), and sleeplessness (sleeplessness score [range, 0-3] mean difference, -0.47 [95% CI, -0.80 to -0.13]). There were no credible subgroup differences based on elimination strategy (empiric vs guided by testing) or food-specific sensitization. Insufficient data addressed harms of elimination diets among included RCTs, although indirect evidence suggests that elimination diets may increase the risk for developing IgE-mediated food allergy. Dietary elimination may lead to a slight, potentially unimportant improvement in eczema severity, pruritus, and sleeplessness in patients with mild to moderate AD. This must be balanced against potential risks for indiscriminate elimination diets including developing IgE-mediated food allergy and withholding more effective treatment options for AD.

IL-31 levels correlate with pruritus in patients with cholestatic and metabolic liver diseases and is farnesoid X receptor responsive in NASH.

Pruritus is associated with multiple liver diseases, particularly those with cholestasis, but the mechanism remains incompletely understood. Our aim was to evaluate serum IL-31 as a putative biomarker of pruritus in clinical trials of an farnesoid X receptor (FXR) agonist, cilofexor, in patients with NASH, primary sclerosing cholangitis (PSC), and primary biliary cholangitis (PBC). Serum IL-31 was measured in clinical studies of cilofexor in NASH, PSC, and PBC. In patients with PSC or PBC, baseline IL-31 was elevated compared to patients with NASH and healthy volunteers (HVs). IL-31 correlated with serum bile acids among patients with NASH, PBC, and PSC. Baseline IL-31 levels in PSC and PBC were positively correlated with Visual Analog Scale for pruritus and 5-D itch scores. In patients with NASH, cilofexor dose-dependently increased IL-31 from Week (W)1 to W24. In patients with NASH receiving cilofexor 100 mg, IL-31 was higher in those with Grade 2-3 pruritus adverse events (AEs) than those with Grade 0-1 pruritus AEs. IL-31 weakly correlated with C4 at baseline in patients with NASH, and among those receiving cilofexor 100 mg, changes in IL-31 and C4 from baseline to W24 were negatively correlated. IL-31 messenger RNA (mRNA) was elevated in hepatocytes from patients with PSC and NASH compared to HVs. In a humanized liver murine model, obeticholic acid increased IL-31 mRNA expression in human hepatocytes and serum levels of human IL-31. IL-31 levels correlate with pruritus in patients with cholestatic disease and NASH, with FXR agonist therapy resulting in higher serum levels in the latter group. IL-31 appears to derive in part from increased hepatocyte expression. These findings have therapeutic implications for patients with liver disease and pruritus.

Reproxalap Activity and Estimation of Clinically Relevant Thresholds for Ocular Itching and Redness in a Randomized Allergic Conjunctivitis Field Trial.

IntroductionThis clinical trial assessed the activity of reproxalap, a novel reactive aldehyde species modulator, and estimated clinically relevant thresholds for changes in ocular itching and redness in an allergic conjunctivitis field trial.MethodsThis was a randomized, double-masked, vehicle-controlled phase 2 trial. Patients with ragweed-associated allergic conjunctivitis were assessed over 28 days in an environmental setting with approximately four doses per day of either 0.25% reproxalap, 0.5% reproxalap, or vehicle. Patients recorded ocular itching, redness, tearing, and eyelid swelling scores (each with a 0–4 scale, except for a 0–3 scale for swelling), and completed the Allergic Conjunctivitis Quality of Life Questionnaire at the beginning and end of the trial.ResultsMixed model of repeated measures analysis demonstrated statistically lower itching and tearing scores (pooled P = 0.026 and P < 0.001, respectively) and numerically lower redness and eyelid swelling scores than vehicle on days when pollen exceeded the 95th percentile value. Using three anchor-based and three distribution-based approaches, the meaningful within-patient change and the between-group meaningful difference for patient-reported ocular itching and redness was estimated to be approximately 0.5. The most common treatment-emergent adverse event associated with reproxalap was transient irritation upon instillation.ConclusionIn a field clinical trial, reproxalap was well tolerated and superior to vehicle in reducing ocular itching on high-pollen days. The clinical meaningfulness threshold estimates of 0.5 units are among the first such calculations generated for the standard ocular itching and redness scores, providing important context for the clinical interpretation of clinical trials in allergic conjunctivitis.

Quail egg homogenate with zinc as adjunctive therapy in seasonal allergic rhinitis: a randomised, controlled trial.

Because most available treatments for managing seasonal allergic rhinitis show some side effects without reducing recurrence, natural anti-allergic products could represent an interesting treatment addition. This study aimed to analyse the efficacy and tolerance of quail egg as adjunctive therapy in seasonal allergic rhinitis. In a Consolidated Standards of Reporting Trials compliant framework, patients with seasonal allergic rhinitis were prospectively randomised to receive mometasone nasal spray for four weeks or the same topical corticosteroid therapy plus commercially available oral quail egg and zinc tablets. Forty patients were enrolled. The mometasone + quail egg and zinc tablets group showed a greater reduction in nasal itching, sneezing and total nasal symptom scores than the mometasone nasal spray only group. A higher proportion of participants in the mometasone + quail egg and zinc tablets group had good rhinitis control than in the mometasone nasal spray only group, with no need for rescue medications. Despite the need for a further larger study, quail egg preliminarily appears to be an effective adjunct to topical steroid therapy in seasonal allergic rhinitis.

Efficacy and safety profile of antioxidants in the treatment of atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials.

The use of antioxidants in atopic dermatitis (AD) is controversial. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of antioxidants therapy in AD. Randomized clinical trials were identified from Medline, Embase, and Cochrane library. Changes from baseline in severity and itch score were extracted from individual studies and pooled using random-effects. Eighteen trials including 763 AD patients were eligible. Overall, antioxidants were associated with statistically significant reductions in diseases severity (p < 0.0001), but not with itch score (p=0.59). No serious adverse events were recorded. Subgroup analyses revealed that antioxidants were associated with a significant reduction in severity score regardless of disease severity at baseline and treatment duration (p < 0.05). However, antioxidants had additional benefit only in children (p=0.02) but not in adults (p=0.30). Oral supplementation with vitamin D, combined vitamins D and E, combined vitamins A, D and E and topical vitamin B12 was associated with significantly lower severity score (p < 0.05). There was significant heterogeneity between studies (I2 =50%; p=0.003). The effect estimates did not change statistically after excluding sources of study heterogeneity. This meta-analysis suggests that antioxidants may be a safe and effective treatment for AD patients, especially when supplemented with oral vitamin D and topical vitamin B12 , as well as in pediatric patients.

Cannabis use among patients with cutaneous lymphoma: A cross-sectional survey

ObjectivesTo evaluate patterns of cannabis use in patients with cutaneous lymphoma (CL), as well as the association between cannabis use and itch specifically. DesignCross-sectional survey created in partnership with the Cutaneous Lymphoma Foundation (CLF). SettingThe online survey was distributed electronically via email to the CLF listserv and links posted to social media over a 2-week period. Main outcome measuresRespondents were classified as current cannabis users, prior users, and never users. A visual analog scale (VAS) was used to assess itching severity, improvement of itch, and interest in learning about cannabis. ResultsA total of 119 patient responses (61% female, mean age 59 y) were included in analysis. The majority had mycosis fungoides or Sézary syndrome (74%; 88/119) and early stage (IA-IIA) disease (56%; 48/86). Mean VAS itch score was 3.2 + 2.8 for the cohort. Over half (55%; 60/110) reported ever having used cannabis, with 22% (24/110) endorsing current cannabis use. Common methods of cannabis use were smoking (54%) and vaporizing (46%). 25% (6/24) of current users reported using cannabis specifically to treat itch; these respondents noted that cannabis resulted in moderate improvement of itching (mean 6.6/10). There was strong interest in learning more about cannabis and cancer, and most desired this information from their CL doctor/nurse. ConclusionsCannabis use is common among patients with CL, and patients report improvement of itching as a result of using cannabis. Further studies are needed to elucidate the risks and benefits of cannabis use in this patient population.

As-needed intranasal corticosteroid spray for allergic rhinitis: a systematic review and meta-analysis

As-needed intranasal corticosteroid spray (INCS) is commonly used by patients with allergic rhinitis (AR) who have suboptimal symptom control. This systematic review aimed to assess the effectiveness of as-needed INCS for treating AR. Systematic searches for randomized controlled trials studying the effects of as-needed INCS compared to regular INCS, as-needed antihistamine, or placebo were performed. Primary outcomes were total nasal symptom score (TNSS) and disease-specific quality of life (DSQoL). Eight studies (882 participants) met the criteria. Regular use of INCS showed greater improvements than as-needed INCS in TNSS, DSQoL, nasal peak inspiratory flow, sneezing, and nasal congestion scores with small effect sizes. There were no differences between regular and as-needed INCS usage for ocular symptoms, symptom-free days, nasal itching, and rhinorrhea scores. As-needed INCS was superior to as-needed antihistamine and placebo with medium effect sizes. There were no differences in risk of adverse events between the groups in all three comparisons. Regular use of INCS improved total nasal symptoms score and DSQoL better than as-needed INCS. However, as-needed INCS improved TNSS better than as-needed antihistamine and placebo. The effects of as-needed INCS were closer to regular INCS usage than to placebo or as-needed AH usage.

A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis

We examined the efficacy and safety of seladelpar, a selective peroxisome proliferator-activated receptor-delta agonist, in adults with primary biliary cholangitis (PBC) at risk of disease progression (alkaline phosphatase [ALP] ≥1.67xupper limit of normal [ULN]) who were receiving or intolerant to ursodeoxycholic acid. In this 52-week, phase II, dose-ranging, open-label study, patients were randomized (1:1) to seladelpar 5mg/day (n=53) or 10mg/day (n=55) or assigned to 2mg/day (n=11; United Kingdom sites after interim analysis) for 12 weeks. Doses could then be uptitrated to 10mg/day. The primary efficacy endpoint was ALP change from baseline to Week8. Mean baseline ALP was 300, 345, and 295U/L in the 2mg, 5mg, and 10mg cohorts, respectively. Twenty-one percent of patients had cirrhosis, 71% had pruritus. At Week 8, mean±standard error ALP reductions from baseline were 26±2.8%, 33±2.6%, and 41±1.8% in the 2mg (n=11), 5mg (n=49), and 10mg (n=52) cohorts (all p≤0.005), respectively. Responses were maintained or improved at Week 52, after dose escalation in 91% and 80% of the 2mg and 5mg cohorts, respectively. At Week 52, composite response (ALP <1.67xULN, ≥15% ALP decrease, and normal total bilirubin) rates were 64%, 53%, and 67%, and ALP normalization rates were 9%, 13%, and 33% in the 2mg, 5mg, and 10mg cohorts, respectively. Pruritus visual analog scale score was decreased in the 5mg and 10mg cohorts. There were no treatment-related serious adverse events, and 4 patients discontinued due to adverse events. Seladelpar demonstrated robust, dose-dependent, clinically significant, and durable improvements in biochemical markers of cholestasis and inflammation in patients with PBC at risk of disease progression. Seladelpar appeared safe and well tolerated and was not associated with any increase in pruritus. NCT02955602 CLINICALTRIALSREGISTER. 2016-002996-91 LAY SUMMARY: Current treatment options for patients living with primary biliary cholangitis (PBC) are not optimal due to inadequate effectiveness or undesirable side effects. Patients with PBC who took seladelpar, a new treatment being developed for PBC, at increasing doses (2, 5, or 10mg/day) for 1 year had clinically significant, dose-dependent improvements in key liver tests. Treatment appeared safe and was not associated with any worsening in patient self-reported itch scores.

Validation of the 0-10 verbal numeric scale for assessment of pruritus severity in dogs.

The pruritus Visual Analog Scale (pVAS) is currently the only validated tool for assessing canine pruritus. A verbal numeric scale (VNS) offers an alternative if clients are not present or able to complete the pVAS. To validate the 0-10 VNS and evaluate its interchangeability with the pVAS. 251 dogs were included in the study. Dog owners were asked to assess their pet's pruritus level using the pVAS, the 0-10 VNS and the verbal rating categories (mild, moderate, severe) in one or two subsequent visits. To be valid, VNS must satisfy the following: correlate with pVAS (criterion validity); indicate reduction in itch score after an antipruritic intervention (construct validity); and have scores related to the verbal rating categories that are significantly different (content validity). VNS and pVAS interchangeability and the percentage of clients that preferred the VNS and pVAS also were evaluated. The VNS and pVAS correlation for visits 1 and 2 was good (rICC = 0.9) and excellent (rICC = 0.94). The VNS scores were significantly decreased after antipruritic interventions (P < 0.001). The VNS scores associated with the verbal rating scale categories (mild, moderate and severe) were significantly different (P < 0.001). The 95% limits of agreement for the pVAS and VAS were outside the limit of acceptability of ±2 (-2.0, 2.57). Most clients (69%) preferred the pVAS to the VNS. The VNS is a valid scale to evaluate canine pruritus; however, the VNS and pVAS are not interchangeable.

Is dupilumab effective in adult-onset atopic dermatitis: Real-life experience of 16 patients.

Dupilumab is approved for the treatment of atopic dermatitis (AD). However, there are few studies demonstrating its efficacy and safety, particularly in the treatment of adult-onset AD. The aim of this study is to evaluate the real-life experience regarding the efficacy and safety of dupilumab in the treatment of adult-onset AD. This study is a case series in retrospective design. Patients with the diagnosis of adult-onset AD, using dupilumab at a standard dose for at least 3months, were included in the study. Demographic and laboratory data of the cases, data regarding to dupilumab treatment, were recorded. The eczema area severity index (EASI) and the visual analog scale (VAS) for itch were used to evaluate treatment efficacy. A total of 16 patients, 6 female and 10male, were included. The median age was 41years, the median age of the disease onset was 37.5years, and the median duration of the disease was 90months. The median duration of the dupilumab treatment was 10.5months. The mean percent reduction from baseline in EASI score was 85.8±12.2 at 3months, 90.7±9.3 at 6months, and 93.1±5 at 12months. The mean percent reduction from baseline in VAS itch score was 82.2±8.6 at 3months. Acute vestibular neuritis was developed in one patient during the dupilumab therapy and resolved with anti-inflammatory therapy. Dupilumab seems to be highly effective and safe in the treatment of adult-onset AD. The present study is important as it is the first study to evaluate this patient group specifically.