Improvement Of Pruritus Research Articles

Successful Achievement of Demanding Outcomes in Upadacitinib-Treated Atopic Dermatitis Patients: A Real-World, 96-Week Single-Centre Study.

Results from randomized controlled trials of upadacitinib, a Janus kinase (JAK) inhibitor, have led to its approval for the treatment of moderate-to-severe atopic dermatitis (AD) in patients aged ≥ 12years. The aim of this study was to report the effectiveness and safety of upadacitinib in real-world settings over a period of 96weeks. This retrospective study included all patients treated with upadacitinib at our centre between April 2022 and September 2024. Clinical and patient-reported outcomes were recorded and assessed at each follow-up visit and included the eczema area severity index (EASI), investigator global assessment (IGA), scoring atopic dermatitis (SCORAD), dermatology life quality index (DLQI) and the worst pruritus numerical scale score (WP-NRS). All drug-related adverse events (AEs) were documented. In total, 36 patients (44.4% female) were retrospectively included. After 4weeks of treatment, the mean EASI was reduced from 29.97 to 3.72 with 83.3/52.8/19.4% achieving EASI75/90/100 respectively. Similar reductions were observed in the DLQI, which was reduced from 20.78 to 2.92, and in the WP-NRS, from 7.78 to 1.31. Further improvements were observed at week16, with a mean EASI of 0.75 and 96.4% of the patients achieving EASI75 and EASI90. At week48 of treatment, EASI75/90/100 were achieved by 100/93.8/81.3% along with a mean DLQI and pruritus NRS of 0.81. All nine patients that reached the 72- and 96-week timepoints had clear skin with no pruritus. Six (16.7%) patients experienced AEs with four of them discontinuing medication; no patient discontinued because of upadacitinib inefficacy. This long-term real-world study of patients with moderate-to-severe AD receiving upadacitinib demonstrated that treatment success (EASI75/90/100) can be achieved in a high proportion of patients by week16 and can be maintained for up to 96weeks along with substantial improvements in pruritus and quality of life.

An innovative multicomponent compression system in a single bandage for venous leg ulcer and/or oedema treatment: a real-life study in 343 patients

Objective: This study aimed to evaluate the performance of an innovative multicomponent compression system in a single bandage (UrgoK1, Laboratoires Urgo, France) in the treatment of patients with venous leg ulcers (VLUs) and/or lower limb oedema in everyday practice. Method: A prospective, observational, clinical study with the evaluated compression system was conducted in 39 centres in Germany between March 2022 and July 2023. Main outcomes included a description of the treated patients, changes in wound healing and oedema progression, local tolerance and acceptability of the compression system. Results: In total, 343 patients were treated with the evaluated compression system for a mean period of 48±30 days; 196 had a VLU and 275 had oedema, mostly of venous origin. By the final visit, 49% of VLUs healed (75% in absence of oedema and 61% in VLUs of ≤1 month's duration). Oedema was completely resolved or greatly improved in 87% of patients, with significant reduction in calf and ankle circumferences. Improvement in pruritus, pain, age-related ankle mobility and skin changes were also reported in patients who experienced them at baseline. The system was judged ‘very easy’ to apply (median: 108 seconds, three times a week), ‘extremely useful’ and ‘very well accepted’ by most patients who reported an improvement in comfort compared with previous systems. Similar results were observed when patients and/or their relatives were involved in the bandage application between the study visits. During the study, three cases of local intolerance related to the system and five early terminations (unrelated to the system) were reported. Conclusion: These results are consistent with the previous clinical evidence available on this new compression system and further support its good efficacy, tolerability, acceptability and usefulness in the treatment of patients with VLUs and/or oedema. Declaration of interest: This study was supported by a grant from Laboratoires Urgo, France. EH, UM and LT are employees of Laboratoires Urgo. CS, TB, WK, MS and JD provide advisory and speaking services to pharmaceutical and other healthcare organisations including, but not limited to, Laboratoires Urgo. Data management and statistical analyses were conducted independently by INPADS GmbH, Germany.

Preliminary clinical evaluation of the treatment efficacy of a temperature-adjustable cryotherapy device for chronic, recurrent blepharitis in dogs.

To preliminarily evaluate the treatment efficacy of a temperature-adjustable cryotherapy device for chronic, recurrent blepharitis in dogs. Five dogs (eight eyes) of different breeds with blepharitis, which was unresponsive to systemic steroids. The dogs were subjected to ophthalmic examination, including Schirmer tear test-1 (STT-1), tear film break-up time (TFBUT) test, and slit-lamp biomicroscope examination. Cryotherapy was performed using a device featuring precise low-temperature control. A bandage lens and ointment (2% hypromellose) were applied before cryotherapy to protect the cornea. Carbon dioxide gas at 0°C was sprayed on the lesion for 10 s. In all patients, only topical antibiotics and corticosteroid were applied twice a day; systemic corticosteroids were not used. Pruritus and ocular discharge were scored based on the visual analog scale (VAS) before and 3 weeks after cryotherapy. Qualitative changes in tear film were measured using STT-1 and a TFBUT test. The effects on erythema and swelling were evaluated by ophthalmic examination. Pruritus improvement was confirmed in all eight eyes (five dogs). After cryotherapy, the average VAS score of pruritus significantly decreased from 4.12 ± 2.64 to 0.37 ± 0.51 (p < .001), and the average TFBUT significantly increased from 5.75 ± 4.80 to 13.75 ± 4.43 (p = .010). STT-1 and the VAS score of ocular discharge did not significantly differ. Erythema and swelling were improved in three out of eight eyes. Cryotherapy is effective in treating blepharitis with pruritus and may become a new treatment option in patients in whom systemic corticosteroids are difficult to administer.

Long-term (68 weeks) administration of nemolizumab in paediatric patients aged 6-12 years with atopic dermatitis with moderate-to-severe pruritus: efficacy and safety data from a phase III study.

A phase III clinical trial in Japanese children aged 6-12 years with atopic dermatitis (AD) and inadequately controlled moderate-to-severe pruritus found that 16 weeks of nemolizumab treatment (30 mg every 4 weeks [Q4W]) was clinically effective and tolerable, with early improvement in pruritus and associated skin signs and a positive impact on patient quality of life (QoL). To report the findings from the long-term extension period of the study, and evaluate the efficacy and safety profiles of nemolizumab when administered concomitantly with topical agents over 68 weeks. The study included a 16-week, randomized, placebo-controlled, double-blind, parallel-group period during which patients received nemolizumab 30 mg or placebo Q4W; those who completed this period could enter a 52-week, long-term treatment period during which all patients received nemolizumab Q4W. Efficacy endpoints assessed treatment impact on pruritus, AD signs, and QoL. Treatment-emergent adverse events (TEAEs) were tabulated to evaluate long-term safety. Among the 89 paediatric patients evaluated, efficacy outcome measures showed a tendency towards improvement between weeks 16 and 68, and sustained efficacy during the subsequent follow-up period after treatment cessation. At week 68, among patients who received nemolizumab treatment throughout the study, the mean change from baseline in the 5-level itch score was -1.8 (standard deviation [SD] 0.8), the mean percentage change from baseline in the Average Pruritus Numerical Rating Scale score was -65.9 (SD 25.0), and the mean percentage change from baseline in the Eczema Area and Severity Index score was -77.1 (SD 23.1). Data from the Dermatitis Family Impact questionnaire indicated that the burden of housework on family members was reduced, parent/caregiver fatigue was reduced, and sleep of family members was improved by week 16, with further improvement at week 68. The overall safety profile was similar to that recorded in nemolizumab-treated patients aged ≥13 years, with no late-onset TEAEs observed during long-term treatment. These data confirm the safety of long-term nemolizumab for paediatric patients with AD, and demonstrate improvements in pruritus, skin symptoms, and both patient and caregiver QoL over 68 weeks of treatment. (Funded by Maruho; Japan Registry of Clinical Trials identifier: jRCT2080225289).

Comparison of Efficacy of Luliconazole 1% w/w Cream Versus Amorolfine 0.25% w/w Cream in the Treatment of Tinea cruris: A Single-center, Randomized, Double-blind, Non-inferiority Study

Dermatophytosis is a superficial fungal infection involving the keratinized tissues. Limited dermatophytosis is usually treated with topical antifungals. Amorolfine and luliconazole are relatively newer and superior topical antifungals much in use in recent times. To study the therapeutic efficacy and safety of luliconazole 1% and amorolfine 0.25% cream in patients with tinea cruris. A single-center, randomized, double-blind, non-inferiority study comparing luliconazole and amorolfine was conducted on patients with localized tinea cruris. 81 patients completed the study, with 40 patients treated with luliconazole and 41 patients treated with amorolfine. Both groups of patients were followed up at the end of 2 weeks. No statistically significant difference was found between luliconazole and amorolfine regarding improvement in erythema, scaling, pruritus, and mycological cure. Both the medications were safe and well tolerated by the patients. The duration of the study was short, and there was no long-term follow-up. Amorolfine is not inferior to luliconazole in treating limited tinea cruris.

Recalcitrant Scalp Psoriasis Successfully Treated with Once-Daily Roflumilast Cream 0.3%

Scalp psoriasis is a chronic, immune-mediated skin disease with varying phenotypes and is estimated to affect up to 80% of individuals suffering from psoriasis [1]. The physical symptoms, along with social and emotional impacts of scalp psoriasis can significantly reduce quality of life, necessitating long-term treatment for most patients [3]. Numerous topical and systemic treatments are available for scalp psoriasis, yet the condition remains challenging to manage, underscoring a persistent unmet need for safe and effective therapies [2]. Treatment of the scalp and other hair bearing areas is challenging and can affect the ability to apply topical products and hinder their efficacy [2, 3]. Roflumilast cream 0.3% is a highly selective, non-steroidal and potent topical phosphodiesterase 4 (PDE4) inhibitor approved in 2022 by the FDA for the treatment of psoriasis, including intertriginous disease; in 2023 as a foam for the treatment of seborrheic dermatitis and in 2024, roflumilast cream 0.15% was approved for the treatment of atopic dermatitis. Roflumilast has demonstrated a higher affinity for binding to PDE4 relative to other approved PDE4 inhibitors resulting in greater potency [4, 5]. The results of a phase 3 study investigating roflumilast foam 0.3% in patients with scalp and body psoriasis showed that once daily treatment produced significant clearance of affected areas, rapid improvement in pruritus, and was well-tolerated [6]. Here we report a case involving a 28-year-old female with recalcitrant scalp psoriasis following 10 years of unsuccessful treatment with topical products. Due to the severity of adverse effects experienced with prior therapies, the patient was reluctant to initiate systemic therapy and a trial of once daily topical roflumilast cream 0.3% was initiated. The patient demonstrated rapid improvement after 3 days and clearance of the scalp lesion following daily application for 5 days without any reported adverse effects. Lesions on the patient’s torso also cleared. Upon clearance of lesions, the patient discontinued application of roflumilast cream, and lesions remained clear for several weeks and applies only as needed with any recurrence. Our patient’s case demonstrates the significant potential of roflumilast cream 0.3% in addressing the inflammatory etiology of scalp psoriasis.

Prevalence and Association of Pruritus and Its Current Treatment During the First Year of Dialysis: A DOMESTICO Study.

Pruritus is common in dialysis patients and associated with impaired health-related quality of life (HRQoL) and sleep disturbances. Its pathophysiology remains unclear resulting in limited treatment options and lack of treatment guidelines. The exact trajectory of pruritus after dialysis initiation nor the state of current medical treatment has been studied. Incident dialysis patients (n=1438), included in the Dutch nOcturnal and hoME dialysis Study To Improve Clinical Outcomes (DOMESTICO), were studied. Outcome parameters were prevalence of pruritus, severity of pruritus and the use of antipruritic medication, repeatedly measured during the first year of dialysis. Associations between treatment, pruritus and quality of life were longitudinally studied using linear mixed models. The prevalence of pruritus ranged from 50.5% to 56.6% during the first year of dialysis. Throughout the year approximately 35% experienced persistent pruritus and 40% fluctuating pruritus. During follow-up 21.5% to 26.5% received medical treatment for pruritus. Emollients were associated with more severe pruritus (adjusted β = 0.31, 95% CI 0.15; 0.48), the remaining treatments did not show any association. Pruritus was significantly associated with lower physical and mental HRQoL (adjusted β = -2.04, 95% CI -2.78; -1.30 and β = -1.73, 95% CI -2.51; -0.94, respectively), irrespective of treatment. During the first year of dialysis, pruritus is highly prevalent, predominantly fluctuating, and associated with impaired HRQoL. The minority of patients received medical treatment; in our study current treatment was not associated with an improvement of pruritus. These results highlight the need for more awareness among clinicians and for the development of effective treatment options.

Beyond hyperhidrosis: The use of topical glycopyrronium in plantar acuagenic keratoderma.

This letter presents a clinical case detailing the efficacy of topical glycopyrronium in the treatment of plantar acuagenic keratoderma. Our report not only highlights a significant improvement in pruritus but also underscores notable clinical and dermatoscopic advancements following treatment.

Uses of Dupilumab in Dermatology: A Systematic Review of the Randomized Controlled Trials

ABSTRACTBackgroundDupilumab has shown promise as a therapeutic option in dermatology, particularly in conditions like atopic dermatitis (AD), prurigo nodularis, and alopecia areata. This systematic review aimed to analyze the efficacy, safety, and benefits of dupilumab based on findings from placebo‐controlled trials in dermatological conditions.Study AimThe objective was to systematically review placebo‐controlled trials evaluating dupilumab in dermatological conditions and analyze the outcomes related to efficacy, safety, and patient‐reported outcomes (PROs).MethodologyA comprehensive search was conducted in electronic databases (PubMed/MEDLINE, Embase, Cochrane Library, Scopus, and Web of Science) using keywords related to “dupilumab,” “dermatology,” “randomized controlled trial,” and “placebo.” Inclusion criteria encompassed randomized controlled trials comparing dupilumab against placebo, reporting relevant outcomes, and excluding non‐randomized studies or those with interventions other than dupilumab.ResultsThe review included nine placebo‐controlled trials with a total sample size of 6797 participants. Dupilumab demonstrated significant improvements in clinical severity, PROs, anxiety/depression symptoms, and health‐related quality of life (HRQoL) compared to placebo in patients with moderate‐to‐severe AD. In prurigo nodularis, dupilumab showed significant improvements in pruritus and nodule reduction compared to placebo. Promising results were observed in alopecia areata, particularly in patients with high baseline IgE levels, with improvements in SALT scores and hair regrowth. PROs such as itch, sleep, mental health, and overall quality of life were improved with dupilumab, especially with the 300 mg dose regimens.ConclusionThe findings from placebo‐controlled trials support the efficacy and safety of dupilumab in dermatological conditions, including AD, prurigo nodularis, and alopecia areata. Dupilumab appears to be a valuable therapeutic option, with potential benefits in improving clinical outcomes and PROs. Further research is warranted to explore its efficacy in other conditions and optimize dosing regimens for personalized treatment approaches.

Efficacy of Methotrexate Microinfusion in Scalp Lesions of Patients with Frontal Fibrosing Alopecia: A Prospective Controlled Trial

Introduction: Topical and systemic drugs, as methotrexate (MTX), do not control the frontal fibrosing alopecia (FFA) activity in most of the cases showing the need for new therapies. Therefore, we aimed to evaluate the effectiveness of MTX microinfusion in FFA. Methods: Prospective, controlled clinical trial, carried out with 17 volunteers with clinical and histological diagnosis of FFA. Applications of MTX by MMP® (microinfusion of drugs into the skin method) were made every 30 days, in a total of 03 applications, in the right half of the alopecia area; the other half served as a control. Results: There was a significant reduction in frontal-glabella and frontal temporoparietal measurements at treated site while in the untreated site the FFA increased. Patient’s referred improvement of pruritus and desquamation but not in hair loss and local erythema. Analysis of the dermoscopic photos and the LPPAI calculation did not show relevant changes. About 95% of the participants were satisfied or very satisfied with the results and none of them had alteration in the laboratory test results. Conclusion: The MTX application by MMP® improved symptoms associated with FFA, and the frontal-glabella and frontal temporoparietal measurements. This technique proved to be safe and well tolerated.

Chronic kidney disease-associated pruritus and quality of life with difelikefalin treatment: a post hoc analysis of phase 3 data using the Skindex-10 questionnaire.

Pruritus is a common condition in chronic kidney disease (CKD), especially for patients receiving haemodialysis. CKD-associated pruritus (CKD-aP) can be distressing and have a negative impact on quality of life (QoL). This post hoc analysis aimed to assess the relationship between pruritus relief and QoL. Data from phase 3 trials [(NCT03422653, NCT03636269 grouped), and NCT03998163] of the novel antipruritic difelikefalin (N=914) were used to assess the relationship between reductions in pruritus intensity at Week 12 (24-h Worst Itching Intensity Numeric Rating Scale; WI-NRS), perceived improvement in itch (Patient Global Impression of Change, PGI-C) and pruritus-related QoL (Skindex-10 questionnaire). Patients receiving difelikefalin had greater improvements in Skindex-10 total scores than those receiving placebo [LS mean treatment difference -3.4; 95% confidence interval (CI) -5.5, -1.3; P=.002] and greater improvements across Skindex-10 domains (disease, mood and social functioning) at Week 12. In patients receiving difelikefalin, those with clinically meaningful improvements in pruritus (≥3-point reduction in WI-NRS score) at Week 12 had a greater improvement in Skindex-10 total score (mean difference 14.2; 95% CI 11.0, 17.3; P<.001) and Skindex-10 domains than those with a <3-point reduction in WI-NRS score. Improvements in Skindex-10 total scores correlated with PGI-C. Improvements in pruritus intensity following 12 weeks of treatment with difelikefalin were associated with improvements in QoL. Larger improvements in Skindex-10 scores were seen in patients with a greater reduction in pruritus intensity, indicating that improvements in pruritus are associated with a range of factors, such as mood and social functioning, that affect pruritus-related QoL.

Long-Term Safety and Efficacy of Lenabasum, a Cannabinoid Receptor Type 2 Agonist, in Patients with Dermatomyositis with Refractory Skin Disease: Follow-Up Data from a 3-Year Open-Label Extension Study

BackgroundDermatomyositis (DM) is a rare autoimmune condition involving skin manifestations often resistant to standard treatments like immunosuppressants and antimalarials. Biopsies show elevated inflammatory cells such as CD4+ T cells, dendritic cells, and cytokines. Lenabasum, a selective CB2 agonist, has demonstrated significant benefits in treating autoimmune skin diseases. ObjectivesThis study utilizes data from the open-label extension (OLE) phase of the lenabasum phase 2 trial and additional post-OLE follow-up data. Key aims include evaluating the drug's long-term effectiveness and assessing disease manifestation recurrence. MethodsThe phase 2 lenabasum trial enrolled patients with treatment-resistant, skin-predominant DM. The OLE consisted of a 3-year period during which 20 patients were on the drug for the entire duration, with assessments every 8 weeks to evaluate drug safety and efficacy. Subsequently, a follow-up retrospective chart review was performed on patients who completed the OLE, as well as on control subjects with DM who did not participate in the lenabasum trial. ResultsBy week 68, patients exhibited reductions in CDASI activity score (-21.8), Patient Skin Activity VAS (-3.0), and Skindex-29 (-28.0) from OLE baseline. Post-OLE, 58.3% maintained stable disease, significantly higher than controls (p=0.035), with 41.7% not experiencing flares compared to 91.6% of controls. Additionally, 50% of patients reported sustained pruritus improvement. ConclusionsData from OLE and subsequent follow-up periods demonstrate lenabasum's efficacy in maintaining disease stability, reducing flares, and improving DM symptoms, suggesting it is a promising option for treatment-resistant skin-predominant DM patients.

#2131 Difelikefalin in the management of pruritus associated with chronic kidney disease (Pa-CKD) in hemodialysis: Results from Andalusia

Abstract Background and Aims Pruritus associated with chronic kidney disease (CKD-aP) is a debilitating and common symptom in patients with chronic kidney disease on hemodialysis, with a prevalence of moderate to severe pruritus around 40–45%. The pathogenesis is not yet fully understood. It has been formally attributed mainly to abnormal levels of uremic toxins. The most recent data indicate a significant role for the dysregulation of the kappa opioid receptor (KOR) along with an imbalance in the mu-opioid receptor (MOR). Difelikefalin (DFK) is a KOR agonist approved for the treatment of moderate to severe CKD-aP in patients on hemodialysis in the USA, European Union (EU), Switzerland, Canada, Singapore, and Australia. It has shown rapid and sustained improvement in pruritus and is generally very well tolerated. Method We present the real-world experience of DFK in an early access program for patients in a hemodialysis (HD) program three times a week, diagnosed with CKD-aP, receiving the administration of DFK at 0.5 mcg/kg per HD session. A total of 14 HD patients with severe to very severe CKD-aP (WI-NRS &amp;gt;7) and (moderate-severe SADS) were treated with DFK. The severity of itching was assessed using the numerical rating scale (WI-NRS). Quality of life was assessed using the Self-Assessed Disease Severity Score (SADS). Results The results are shown in Table 1. 78.5% of the patients showed a reduction in WI-NRS of at least 3 points within the first 2 weeks and 92% showed a reduction of ≥ 5 points at 4 weeks, with positive effects on the patients' quality of life, describing a change from SADS C (severe deterioration of quality of life) to SADS A (mild deterioration). Conclusion Currently, 11 out of the 14 patients continue with Difelikefalin and maintain a sustained response in both itch intensity and quality of life. The availability of this new treatment, along with a new understanding of the impact of pruritus on our patients, has the potential to significantly improve the lives of patients living with CKD-aP. Sharing the clinical experience of DFK in series like this is important to raise awareness, not only of DFK but also of CKD-aP, particularly in the absence of specific treatments.

Serum bile acid change correlates with improvement in pruritus in patients with primary biliary cholangitis receiving linerixibat.

Total serum bile acid (TSBA) levels are elevated in patients with primary biliary cholangitis (PBC) and may mediate cholestatic pruritus. Linerixibat, an ileal bile acid transporter inhibitor, improved pruritus in patients with PBC. We explored the relationship between linerixibat dose, TSBA concentration, and pruritus. Data from Phase 1/2 trials were used to develop a population kinetic-pharmacodynamic model to characterize the linerixibat dose-TSBA relationship. Individual Bayesian parameter estimates for participants in the GLIMMER study were used to derive the area under the TSBA concentration curve over 24 h (AUC0-24). Time-matched post hoc estimates of AUC0-24 were correlated with pruritus reported on a 0-10 numerical rating scale. Baseline TSBA concentration was correlated with change from baseline (ΔBL) in monthly itch score (MIS). ΔBL in model-estimated TSBA AUC0-24 was correlated with time-matched ΔBL in weekly itch score (WIS) or MIS. Linerixibat dose dependently reduced TSBA AUC0-24, reaching steady state after 5 days. Baseline TSBA levels in GLIMMER did not correlate with ΔBL in MIS. ΔBL in TSBA AUC0-24 correlated with improved WIS over 12 weeks of treatment (r = 0.52, p < 0.0001). Of participants with a ≥30% decrease in TSBA AUC0-24, 60% were pruritus responders (≥2-point improvement in WIS from baseline). Linerixibat treatment leads to rapid, dose-dependent TSBA reductions. Baseline TSBA levels do not correlate with on-treatment pruritus change, suggesting they do not predict linerixibat response. Change in TSBA AUC0-24 correlates significantly with, and can be predictive of, pruritus improvement in patients with PBC.

Effectiveness of Combined Hemodialysis-Hemadsorption Therapy in Improving Uremic Toxin Clearance, Inflammatory Markers, and Symptoms in Maintenance Hemodialysis Patients

Introduction: Combined hemodialysis (HD) and hemadsorption (HA) therapy has shown the highest clearance rates for middle and large-sized uremic toxin molecules and reduced mortality rates among maintenance HD (MHD) patients. This study aimed to investigate the effectiveness of combined HD and HA therapy in patients undergoing MHD. Methods: Forty patients with end-stage renal disease (ESRD) were divided into three groups: HD only (14), HD + biweekly HA (14), and HD + weekly HA (12). The duration of the study was 8 weeks. Uremic toxins (β2-microglobulin, leptin, parathyroid hormone), inflammatory markers (interleukin-6, C-reactive protein), and symptoms (appetite, pruritus, sleep quality) were assessed before the start and at the completion of therapy. Changes in the parameters were compared between the three groups. Mean differences of parameters in each group were also compared between before and after therapy. Results: Decrease in BUN level (−61.34 mg/dL [95% CI: −71.33 to −51.34], p < 0.0001) and pruritus score (−3.93 [95% CI: −6.89 to −0.97], p = 0.013) was significantly larger in HD + biweekly HA group compared to the others. Only HD + biweekly HA group showed significant reductions in CRP level (−0.10 mg/L [95%: −0.18 to −0.01], p = 0.034), VAS appetite score (10.43 [95% CI: 4.99–15.87], p = 0.001), and pruritus score (−3.93 [95% CI: −6.89 to −0.97], p = 0.013) after therapy. Both HD + biweekly HA (−2.79 [95% CI: −4.97 to −0.60], p = 0.016) and HD + weekly HA group (−2.33 [95% CI: −4.59 to −0.08], p = 0.044) exhibited a significant improvement in sleep quality score after therapy. Conclusions: HD combined with a biweekly HA is associated with a greater reduction in BUN level and better improvement of pruritus in ESRD patients compared to HD alone. HD + biweekly HA can significantly reduce CRP levels, alleviate pruritus, improve appetite, and enhance sleep quality.

Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials

Tapinarof cream 1% once daily (QD), a topical aryl hydrocarbon receptor agonist, downregulates pro-inflammatory Th2 cytokines, upregulates skin-barrier components, and reduces oxidative stress. To assess tapinarof efficacy and safety in adults and children down to 2 years of age with atopic dermatitis (AD). Eight hundred and thirteen patients were randomized to tapinarof or vehicle QD in two 8-week phase 3 trials. The primary efficacy endpoint, Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and ≥2-grade improvement from baseline at Week 8, was met with statistical significance in both trials: 45.4% versus 13.9% and 46.4% versus 18.0% (tapinarof vs vehicle; both P<.0001). Significantly superior Eczema Area and Severity Index 75 (EASI75) responses were also observed with tapinarof versus vehicle at Week 8: 55.8% versus 22.9% and 59.1% versus 21.2% (both P<.0001). Rapid improvements in patient-reported pruritus were also significant with tapinarof versus vehicle. Common adverse events (≥5%) of folliculitis, headache, and nasopharyngitis were mostly mild or moderate, with lower discontinuations due to adverse events in the tapinarof groups than with vehicle. Long-term efficacy was not assessed. Tapinarof demonstrated highly significant efficacy and favorable safety and tolerability in a diverse population of patients with AD down to 2years of age.

Fire acupuncture for plaque psoriasis case series.

To investigate the clinical efficacy of fire acupuncture (FA) on plaque psoriasis (PP), exploring its suitable syndrome types, in order to achieve better therapeutic effects, accelerate the possibility of psoriasis skin lesion recovery, and provide assistance for clinical treatment. A total of 8 patients with PP aged between 18 and 60 years were recruited and treated with FA once a week, and the lesion area and severity index (PASI), visual analog scale and pruritus were measured before, 2, 4 and 8 weeks after treatment and at the follow-up period (week 12), respectively. Visual analog scale, and dermoscopy were used for assessment. All patients showed improvement in pruritus after 1 FA treatment, and lesions were reduced to varying degrees after 2 weeks. Except for patients 5 and 8, who only achieved effective results due to severe disease, all other patients with psoriasis achieved significant results at 8 weeks after treatment. FA can significantly control the development of lesions, reduce the symptoms of PP lesions and pruritus, and help prevent psoriasis recurrence.

Odevixibat as an adjunctive treatment for refractory pruritus in rare variants of cholestatic liver disease.

Odevixibat, a reversible ileal bile acid transport inhibitor, has been shown to reduce serum bile acids (sBA) and pruritus mostly in children with progressive familial intrahepatic cholestasis (PFIC) 1 and 2 in clinical trials and case reports. There are currently no published case reports or series describing its use in rare variants of cholestatic liver disease. We describe three children with progressive cholestatic liver disease who developed refractory pruritus, who had a genotypic diagnosis of AKR1D1, ABCB4 variant, and PKHD1 and PKHD2 variants; all being variants of unknown significance as per the American College of Medical Genetics and Genomics guidelines. On Odevixibat there was a significant improvement in sBA (absolute change from baseline: -196 and -393 μmol/L) and pruritus in two children with heterozygous AKR1D1 and ABCB4 mutations. The child with ABCB4 variants was found to have features of sclerosing cholangitis along with a diagnosis of Crohn's disease, which represents the first reported usage of Odevixibat in such a case with good response. There was some reported improvement in the third child with PKHD1 and PKHD2 variants; however, we hypothesize that no sustained improvement could be due to severe and progressive nature of the disease. There were no side effects reported and it was well tolerated in all. We suggest that Odevixibat may be used as an adjunctive drug in refractory pruritus and could be started early in the course of disease if clinically and phenotypically indicated.

Effective keloid management using a combinatorial continuous-wave and repeat fractionated ablative CO2 laser regimen.

Keloids are benign proliferative scars that form as a result of dysregulated growth and collagen deposition in response to cutaneous injury. Laser therapies have emerged as promising options for the treatment of keloids, with performance varying by laser type and lesion characteristics. To assess the combined continuous wave and repetitive fractionated CO2 laser treatment of keloids. A retrospective chart review of 22 cases of keloid scars treated with combined CO2 laser modes. A single session of continuous wave followed by five sessions of fractional delivery. Efficacy was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and the Vancouver Scar Scale. The Numeric Rating Scale was used to assess patient satisfaction and pain. Most patients were female (77.3%) with skin type IV (72.7%), age was 24.3 ± 9.3 years, most keloids were located on the earlobe (56.5%) or arm or hand (17.4%), size ranged from 5 to 10 cm, and time since injury ranged from 3 months to 35 years. No serious adverse events were reported. At 6 months, significant improvements from baseline occurred in all characteristics, scar color (4.8 ± 2.8 to 1.9 ± 1.1), rigidity (5.0 ± 2.8 vs. 5.4 ± 2.8), thickness (5.4 ± 2.8 vs. 2.0 ± 1.1), and irregularity (5.9 ± 2.4 vs. 1.9 ± 0.9). The Vancouver scores followed a similar trend. Patient-rated overall improvement from 37 ± 17.6 at baseline to 16.1 ± 8.5 at 6 months, and improvement in associated pain and pruritus. Combination of two ablative laser delivery modes within a single laser platform provided for effective and safe keloid management and left patients highly satisfied.

Tapinarof Cream 1% Once Daily Improves Patient-Reported Outcomes in the Treatment of Mild to Severe Plaque Psoriasis in the Head and Neck Region

Introduction: Tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) is a non-steroidal, topical aryl hydrocarbon receptor agonist approved for the treatment of plaque psoriasis in adults with no restrictions on location, extent, or duration of use. In the phase 3 PSOARING trial program, tapinarof cream 1% once daily (QD) for the treatment of plaque psoriasis was efficacious and well tolerated. Plaque psoriasis affecting the head and neck region occurs commonly, with a high impact on patients’ health-related quality of life, through pruritus and psychological distress. Patients may consider topicals unacceptable for scalp/facial use due to poor cosmetic properties (e.g., greasiness), leading to low medication adherence. There is a need for efficacious, cosmetically elegant, non-steroidal topicals that can be used without restrictions.Objective: To assess patient-reported outcomes (PROs) with tapinarof cream for adults with mild to severe plaque psoriasis in the head and neck region, including the scalp, in a phase 4, open-label trial.Methods: Adults with head and neck region target lesion Physician Global Assessment (tPGA) score of 2 (mild), 3 (moderate), or 4 (severe) received tapinarof for 12 weeks. PROs included Peak Pruritus Numerical Rating Scale (PP-NRS) score for the head and neck region; achievement of ≥4-point reduction in PP-NRS score; Dermatology Life Quality Index (DLQI) score by visit; and responses to a Patient Satisfaction Questionnaire© (PSQ) at Week 12.Results: 31 patients received tapinarof; 58.1% (18/31) had the target lesion on the scalp. Baseline mean PP-NRS (head and neck region) and total DLQI scores were 5.8 and 9.7, respectively, demonstrating significant pruritus and disease impact. Improvement in mean PP-NRS score was demonstrated at Week 1 (–1.6), the earliest assessment, surpassing the minimal clinically important ≥4-point improvement by Week 12 (−4.2). At Week 12, 70.0% (n=14/20) achieved ≥4-point reduction in PP-NRS score. Mean DLQI minimal clinically important difference of −4.0 was demonstrated as early as Week 1 (−4.0), improving to −7.2 at Week 12. Most patients strongly agreed or agreed with PSQ questions assessing satisfaction with cosmetic elegance (93.3%), quick absorption (96.7%), application ease (86.7%), efficacy (83.3%), and confidence in tapinarof (83.3%). Compared with topicals used previously for plaque psoriasis, most strongly agreed or agreed that tapinarof was more effective (76.9%) and easier to use (76.9%).Conclusions: In patients with plaque psoriasis affecting the head and neck region, tapinarof cream 1% QD demonstrated rapid and clinically meaningful improvements in patient-reported pruritus and disease impact as early as Week 1, the first assessment, with continued improvement through Week 12. Patients reported high rates of satisfaction and positive perceptions of tapinarof.Funding Support: Dermavant Sciences, Inc.