BACKGROUND:Nivolumab plus cabozantinib demonstrated significantly better clinical and patient-reported outcomes (PROs) compared with sunitinib as first-line therapy for advanced renal cell carcinoma (aRCC) in CheckMate 9ER. This post-hoc analysis identified key factors contributing to improvements in health-related quality of life (HRQOL) in these patients. MATERIALS AND METHODS:Mediation analyses were conducted using first-year CheckMate 9ER data to delineate treatment effects as reflected by HRQOL improvements measured with the EuroQoL 5-Dimension 3-Level questionnaire (EQ-5D-3L) and 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) Functional Well-Being Subscale (FKSI-FWB). The incremental benefits of nivolumab plus cabozantinib over sunitinib were partitioned into mediated effects through symptom and emotional well-being improvements (FKSI-19 scales). RESULTS:Nivolumab plus cabozantinib (n = 323) resulted in significantly greater improvement in EQ-5D utility versus sunitinib (n = 328; difference = 0.08 [95% confidence interval [CI], 0.05-0.12]) and numerically greater FKSI-FWB improvement (difference = 0.22 [95% CI, -0.19 to 0.63]), both primarily driven by greater reductions in fatigue, pain, shortness of breath, and cough, and improvements in emotional well-being (all P < 0.05). Reduced fatigue was the largest contributor to gains in both scales (24.0% and 21.1% of total mediated effect, respectively); improvement in emotional well-being accounted for 5.0% and 17.2% of the total mediated effect. CONCLUSION:These findings highlight underlying pathways contributing to HRQOL improvement in patients with aRCC receiving nivolumab plus cabozantinib. These data suggest that treatment with nivolumab plus cabozantinib is associated with an improvement in symptoms that can be quantified using PRO measures, supporting the utility of incorporating patient-centric outcomes into treatment decision making. CLINICALTRIALS.GOV:NCT03141177.

OBJECTIVES:Prurigo nodularis (PN) is a chronic skin condition characterized by itchy nodules. Understanding the comprehensive patient perspective is essential for guiding treatment strategies. This study evaluated PN disease burden, and satisfaction with non-biologic therapies in France, Germany, Italy, and the UK. METHODS:A cross-sectional survey was conducted in adult patients with a self-reported diagnosis of PN. Disease burden was evaluated using worst itch numeric rating scale (WI-NRS; 0-10, higher indicates more severe), non-itch skin symptoms, EQ-5D-5L, Dermatology Life Quality Index, Patient-Reported Outcomes Measurement Information System Sleep Disturbance, Hospital Anxiety and Depression Scale, and Work Productivity and Activity Impairment. RESULTS:The survey included 165 patients with 67.3%, 30.3%, and 2.4% reporting a WI-NRS score of ≥7, 3-6, and 0-2, respectively. Less than half (45.5%) reported satisfaction with non-biologic treatments. Patients with WI-NRS ≥7 (vs. 3-6) experienced significantly more severe non-itch skin symptoms, and greater negative impacts on health-related quality of life and productivity. CONCLUSION:Disease burden was high and satisfaction with non-biologic treatments was low. Patient-reported number of nodules did not strongly correlate with burden, suggesting that mild disease can induce high burden. Therefore, all aspects of disease should be considered to improve clinical management of PN.

Background Atopic dermatitis (AD) (also known as eczema) is a long-term skin disease affecting 13% of children in the United States. These children often have other inflammatory conditions, including asthma, hay fever (allergic rhinitis), and food allergies. Currently, little is known about the use of healthcare resources (hospital visits and admissions and emergency room/urgent care visits) and the associated healthcare costs in children with AD. In this study, we looked at the treatment received for AD, use of healthcare, and associated costs in patients with AD in the United States aged between 6 months and 6 years who were treated for their AD. Patients were split into 3 groups based on received treatments: low-potency topical treatment (LTT) used to treat mild AD, medium-to-high-potency topical treatment (MHTT) for moderate AD, and systemic treatments (ST) for severe AD. Of 23,098 patients studied, 5,452 received LTT, 6,778 received MHTT, and 10,868 received ST. The use of healthcare was similar in children treated with LTT and MHTT, but higher in children treated with ST, including hospital admissions and emergency room/urgent care visits. Healthcare costs per patient were higher in AD patients treated with MHTT and ST, compared to LTT, primarily due to medical expenses. Children had a high number of AD-related inflammatory conditions, with highest burden in the ST group The study showed that patients treated with ST had higher healthcare utilization and costs, suggesting a higher disease burden. Objective To assess healthcare resource utilization and healthcare costs in this patient group. Methods This retrospective, 1-year, cross-sectional, observational study (July 2016-December 2019) of US patients used data from the IQVIA PharMetrics Plus Database. Patients were assigned to cohorts based on treatments received: LTTs, MHTTs, and STs. Results Overall, 23,098 patients were included (LTT: 5452; MHTT: 6778; ST: 10,868). All-cause health care resource utilization was generally similar for the MHTT and LTT cohorts, but was higher in the ST cohort, including inpatient admissions (1.5% and 1.5% vs 6.5%) and emergency room/urgent care visits (22.0% and 22.0% vs 37.5%). The mean all-cause healthcare costs per patient were higher in the ST and MHTT cohorts vs LTT cohort ($9272.24 and $5671.60 vs $5249.69), with the majority being medical costs ($8135.93 and $4669.39 vs $4221.56). Limitations Possibility of selection bias and misclassification if treatments were used for conditions other than atopic dermatitis; exclusion of patients using over-the-counter treatments; neglecting out-of-pocket costs. Conclusion Patients receiving ST had higher healthcare resource utilization and costs than patients receiving LTT, with medical costs being the main driver.

Background: Vulvar lichen sclerosus (VLS), vulvar lichen planus (VLP), and vulvar lichen simplex chronicus (VLSC) are inflammatory dermatoses with overlapping clinical features, posing diagnostic challenges. VLS and VLP carry malignant potential, unlike VLSC. Comparative studies are limited despite frequent misclassification. Objective: To compare the clinical characteristics of VLS, VLP, and VLSC and identify distinguishing diagnostic features. Methods: A retrospective study was conducted on clinical data from patients diagnosed with VLS, VLP, or VLSC at the Beijing Hospital Vulvar Clinic (March 2017-August 2024). Epidemiological data, symptoms, and physical findings were compared. Results: Patients with VLP had a significantly higher median onset age (44 years) than VLS (30 years) or VLSC (34 years) (P<0.001). Diagnostic delay was longest in VLS (median 5 years vs 3 years for VLP/VLSC). Pruritus prevalence and intensity (median Numerical Rating Scale [NRS]) were highest in VLSC (100%; NRS 7), followed by VLS (92%; NRS 5) and VLP (60%; NRS 2). Pain was most frequent in VLP (79%) vs VLS (14%) and VLSC (<1%). VLSC patients reported the highest mean Dermatology Life Quality Index scores (8.67), driven by severe pruritus. Sexual dysfunction was common in both VLS (81%) and VLP (85%). Anatomically, VLS primarily affected the clitoris, labia minora, and interlabial sulci; VLSC predominantly involved the labia majora and perianal region. Vaginal introitus involvement characterized VLP (90%). Lesion morphology differed: VLS featured white patches (84%) and lichenification (61%), VLP erosion (76%), and VLSC marked lichenification (89%). Conclusion: VLS, VLP, and VLSC exhibit distinct differences in age of onset, clinical manifestations, lesion morphology, and anatomical distribution despite clinical overlap. Recognizing these features facilitates accurate diagnosis, guides individualized treatment, improves long-term outcomes, and enables early detection of malignant potential in VLS/VLP.

OBJECTIVE:Untreated vulvar lichen sclerosus (VLS) can lead to irreversible anatomical changes and increase malignancy risk. Some patients show poor response to standard treatments, resulting in refractory cases (RVLS). METHODS:To explore risk factors associated with RVLS and integrate treatment strategies for improved clinical management, we conducted a retrospective analysis, which included patients with VLS who visited our outpatient clinic between March 2017 and March 2025. Additionally, an evidence synthesis of the currently reported treatment regimens for RVLS was conducted. RESULTS:A total of 457 patients were included, of whom 36 were diagnosed with RVLS (7.9%). A multivariable logistic regression model identified comorbid autoimmune thyroid diseases (OR 2.45; 95%CI 1.09-5.34), perianal region involvement (OR 3.20; 95%CI 1.19-8.09), and presence of erosion/fissures (OR 3.13; 95%CI 1.44-7.29) as independent predictors for RVLS. Furthermore, the treatment approaches for 281 patients with RVLS across 20 studies included Janus kinase inhibitors (JAK), adalimumab, methotrexate, cyclosporine, photodynamic therapy (PDT), and laser therapy, with assessments of efficacy, side effects, and recurrence. CONCLUSIONS:Our study identified three predictive factors for RVLS, which may help in treatment decisions and reduce ineffective therapy. And therapies such as JAK and PDT show promise as optimized options, although larger studies are needed.

Introduction Dupilumab, a fully human VelocImmune®-derived monoclonal antibody, is the first approved treatment in the US for adult patients with prurigo nodularis (PN). This real-world analysis evaluated improvements in disease control, concomitant medication use, and treatment satisfaction among the dupilumab-treated adult patients with PN in the US. Methods RELIEVE-PN is an ongoing longitudinal prospective patient survey study assessing the real-world effectiveness of dupilumab in the treatment of adults with PN. Adult patients with PN were recruited through the US dupilumab patient support program; they were surveyed before (baseline) and 1, 2, 3, and 6 months after dupilumab initiation. Disease control over the past 2 weeks was assessed using the Prurigo Control Tool (PCT; range: 0–20; scores ≥10 indicate controlled chronic prurigo). Concomitant medication use over the past 4 weeks was patient-reported and included topical treatments, oral corticosteroids, oral pain medications, oral antidepressants, and oral anxiolytics. Patient-reported satisfaction with the current treatment(s) was evaluated using a 7-point Likert scale, which ranged from “extremely satisfied” to “extremely dissatisfied.” A subgroup analysis was conducted for patients who continued treatment at the time of the surveys. Results Of the 181 patients (mean age, 57.9 years; 78.5% female; 85.6% White) who completed the baseline survey and initiated dupilumab treatment, 156, 130, and 85 patients completed the survey at months 1, 3, and 6, respectively; their characteristics were similar to baseline patient characteristics. At baseline, 12.7% patients had well-controlled chronic prurigo, and 22.1% were satisfied with non-dupilumab treatments; patients were treated with topical treatments (89.5%), oral corticosteroids (12.7%), oral pain medications (71.8%), oral antidepressants (43.1%), and oral anxiolytics (45.3%) in the past month. At Months 1, 3, and 6, 51.9%, 66.9%, and 63.5% patients, respectively, had well-controlled prurigo, and 69.9%, 86.2%, and 70.6% patients, respectively, were satisfied with their PN treatments (p<0.001 vs baseline values for all). Among the 67 patients who continued dupilumab treatment at month 6, 71.6% had well-controlled prurigo and 85.1% were satisfied with the treatment. The proportion of patients on concomitant treatments in the past month decreased over time. At Month 6, patients were on topical treatments (68.2%), oral corticosteroids (5.9%), oral pain medications (30.6%), oral antidepressants (29.4%), and oral anxiolytics (30.6%) in the past 4 weeks. Among the patients who continued dupilumab treatment at month 6, 68.7%, 3.0%, 29.9%, 28.4%, and 29.9% were treated with topical treatments, oral corticosteroids, oral pain medications, oral antidepressants, and oral anxiolytics, respectively, in the past 4 weeks. Conclusion The results from this real-world RELIEVE-PN study demonstrate improvements in patient-reported disease control, reduction in concomitant medication use, and treatment satisfaction in dupilumab-treated patients with PN as early as 1 month and further maintained till 6 months post treatment.

Introduction Patients with prurigo nodularis (PN) experience significant itch, skin pain, and skin burning/stinging. Dupilumab, a fully human VelocImmune®-derived monoclonal antibody, was the first approved treatment for patients aged ≥18 years with PN in the United States (US). This analysis evaluated improvements in itch, skin pain, and skin burning or stinging/tingling in US adults with PN treated with dupilumab in the real-world setting. Methods RELIEVE-PN is an ongoing longitudinal prospective patient survey study assessing the real-world effectiveness of dupilumab in the treatment of adult patients with PN. Adults with PN were recruited through the US dupilumab patient support program and surveyed before (baseline) and 1, 2, 3, and 6 months after dupilumab initiation. Patients reported PN symptoms over the last 7 days using the worst itch-numeric rating scale (WI-NRS), average itch-NRS, skin pain NRS, and skin burning or stinging/tingling NRS (range 0 [no symptoms] to 10 [most severe symptoms] for all). The mean scores based on outcomes were compared to baseline values using t-tests. A subgroup analysis was conducted on patients who remained under treatment at the time of the surveys. Results Of the 181 patients (mean age, 57.9 years; 78.5% female; 85.6% White) who completed the baseline survey and initiated dupilumab, 156, 130, and 85 patients completed the Month 1, 3, and 6 surveys, respectively. Characteristics of patients who completed Month 1, 3, and 6 surveys were similar to baseline patient characteristics. At baseline, the mean (standard deviation) WI-NRS, average itch-NRS, skin pain NRS, and skin burning/tingling NRS scores were 7.6 (2.3), 6.3 (2.3), 4.9 (2.9), and 5.3 (3.0), respectively. The mean (SD) WI-NRS and average itch-NRS scores at months 1, 3, and 6 were 6.0 (2.9), 5.1 (2.8), and 4.7 (2.9), and 4.5 (2.4), 3.9 (2.5), and 3.5 (2.3), respectively (p<0.001 compared to baseline values for all). The mean (SD) Skin pain NRS and skin burning or stinging/tingling NRS scores were 3.6 (2.5), 3.2 (2.6), and 2.7 (2.3) and 3.9 (2.7), 3.3 (2.6), and 3.0 (2.7) at months 1, 3, and 6, respectively (p<0.001 compared to baseline values for all). Among the 67 patients continuing to take dupilumab at 6 months, the WI-NRS, average itch NRS, skin pain NRS, and skin burning/tingling NRS scores were 4.4 (2.8), 3.3 (2.3), 2.4 (2.2), and 2.6 (2.6), respectively. Conclusion Results from the real-world RELIEVE-PN study demonstrate improvement in patient-reported itch, skin pain, and skin burning or stinging/tingling in patients with PN treated with dupilumab as early as 1 month and continued over the 6 months post treatment.

Objective: Vulvar lichen planus (VLP), especially erosive VLP (EVLP), seriously affects women’s physiological function and quality of life. A retrospective analysis of erosive vulvar lichen planus (EVLP) was performed to raise awareness on this chronic, deforming, and painful vulvar disease.Methods: This observational retrospective study involved 40 patients with EVLP among 1,368 patients with vulvar disease from 2017 to 2020. The patients’ vulvar clinical features and extravulvar mucosal involvement were investigated. The patients’ pain and quality of life were evaluated with the numeric rating scale and the Dermatology Life Quality Index (DLQI), respectively. Clinical characteristics were reported using frequencies and proportions for categorical variables. Continuous variables are expressed as mean ± standard deviation. The association between NRS score for pain and DLQI score was analyzed by Pearson’s correlation test.Results: EVLP accounted for 2.9% (40/1,368) of all cases of vulvar disease, and the median age at onset was 42 years. Erosion mostly occurred on the labia minora and introitus. Half (20/40) of the patients had extravulvar mucosal involvement. Seventeen (42.5%) patients had oral lichen planus, and seven (17.5%) patients were diagnosed with vulvovaginal-gingival syndrome. The numeric rating scale score showed that 47.5% (19/40) of patients experienced mild pain, whereas 12.5% (5/40) described the pain as severe. Thirty-one patients (77.5%, 31/40) had dyspareunia, and nine patients had aggravated pain after sexual intercourse. The mean DLQI score was 9.1 ± 6.0, with 37.5% (15/40) of patients indicating that EVLP had severely affected their lives. The numeric rating scale score for pain was significantly correlated with the DLQI score (P = 0.007).Conclusion: EVLP can affect the quality of women’s lives and cause severe deformations and painful architectural changes. The description of the characteristics of EVLP in this report will benefit the diagnosis and early treatment of this disease.

Introduction: Dupilumab is a monoclonal antibody approved in the United States (US) for patients aged ≥18 years with prurigo nodularis (PN). This analysis evaluated the real-world initial impact of dupilumab therapy on symptoms and treatment satisfaction among US adults with PN. Methods: RELIEVE-PN is an ongoing longitudinal prospective patient survey study assessing the real-world effectiveness of dupilumab in the treatment of adult patients with PN. Adults with PN were recruited through the US dupilumab patient support program and surveyed before (baseline) and 1 month after dupilumab initiation. PN symptoms over the last 7 days were assessed using the worst-itch numeric rating scale (WI-NRS), average-itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS (range 0 [no symptom] to 10 [most severe symptom] for all). Treatment satisfaction with current therapy was evaluated using a 7-point Likert scale from “extremely satisfied” to “extremely dissatisfied”. Results: Of 84 patients (mean age, 57.5 years; 79.8% female; 83.3% White) completing the baseline survey and initiating dupilumab, 62 (mean age, 56.4 years; 77.4% female; 83.9% White) completed the Month 1 survey. At baseline, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning/tingling NRS were 7.70 (2.24), 6.45 (2.25), 5.06 (2.87), and 5.51 (3.02), respectively. By month 1, mean (SD) WI-NRS, average itch NRS, skin pain NRS, and skin burning or stinging/tingling NRS improved to 5.56 (2.89), 4.35 (2.23), 3.40 (2.46), and 3.76 (2.60), respectively (p<0.001 for all). Additionally, significantly more patients reported they were satisfied with current PN treatment(s) at 1 month after dupilumab treatment initiation vs prior to starting dupilumab (77.4% vs 13.1%; p<0.001). Conclusion: Early results from the RELIEVE-PN study demonstrate improvement in symptoms and patient satisfaction with therapy as early as 1-month from treatment initiation of dupilumab. Further comparative research is needed to confirm these findings. Acknowledgment: Research was funded by Sanofi and Regeneron Pharmaceuticals Inc.

Abstract Background Atopic dermatitis (AD) is a chronic inflammatory skin disease with high global prevalence and profound negative impact on the quality of life of children and adults. RELIEVE-AD, a prospective, longitudinal cohort study, included adults with moderate-to-severe AD who initiated dupilumab in real-world clinical practice. Results from RELIEVE-AD showed significant improvements in patient-reported disease control, quality of life, and treatment satisfaction in the overall study population that were sustained through 3 years of dupilumab treatment. Objective To report on response to dupilumab treatment over time at the individual patient-level in adults with moderate-to-­severe AD, using 3-year data from RELIEVE-AD. Methods RELIEVE-AD is a single-arm, prospective, observational study of adults with moderate-to-severe AD prescribed dupilumab and enrolled in the US dupilumab patient support program, who agreed to participate in online surveys at baseline and Months 1, 2, 3, 6, 9, 12, and 30–36. Post hoc analysis of the RELIEVE-AD 3yr data, describing changes from baseline through all post-dupilumab initiation time points at individual patient level, using Sankey plots to assess variability of individual patient response over time for the following patient-reported outcomes: Atopic Dermatitis Control Tool (ADCT) total score-based disease control status, AD-related health status, and AD treatment satisfaction. Results Of 698 patients who completed the baseline survey, 425 completed the Months 30–36 survey. Disease control (as measured by the ADCT) increased rapidly from 5.9% at baseline to 61.0% at Month 1, further increasing to 80.7% at Months 30–36. Patients reported improved AD-related health status at Month 30–36, with 70.9% reporting “Excellent” or “Very Good”, compared to 2.8% at baseline. At Months 30–36, 86.8% of patients reported being “Extremely Satisfied/Very Satisfied/Somewhat Satisfied” with their AD treatment, compared to 17.7% at baseline. All endpoints were significant vs baseline (P < 0.001). Sankey plots of the three outcomes indicated that the majority of patients maintained response over time after achieving the initial response. Conclusion The majority of patients who completed the survey reported benefits of dupilumab, such as AD control, treatment satisfaction, and health status, which remained stable or significantly improved during long-term treatment up to 36 months.

Hui-Wei, Shi; Wen-Jia, Zhang; Yan, Zhao; Min, Yang; Ying, Gao; Shuang, Zhang; Yong-Gang, Sui; Jie, Qian; Jian-Jun, Li; Na-Qiong, WuAuthor Information

In order to retrospectively analyse the multi -site involvement pattern of erosive lichen planus patients, we retrospectively reported the clinical and medical data of three patients with erosive lichen planus which involving their vulva, vagina, gingiva, and ear canal. We confirmed the existence of otic lichen planus, and found that it is more common in patients with vulvovaginal-gingival syndrome of erosive lichen planus. Therefore, we propose 'vulvovaginal-gingival-otic syndrome' to further describe this rare compound pattern of lichen planus.

Objective To analyze special histopathological characteristics of melanocytic nevi and their associations with age, gender, anatomical locations and pathological subtypes. Methods Clinical and histopathological data were collected from 1 011 patients with melanocytic nevi, who visited Beijing Hospital from January 2005 to January 2019, and analyzed retrospectively. Statistical analysis was carried out by using chi-square test for comparing enumeration data, and t test for comparing measurement data. Results Among the 1 011 patients with melanocytic nevi, the age at the clinic visit was 40.90 ± 19.19 years, and there were 289 males and 722 females. Lesional (biopsy) sites included the trunk (402 cases, 39.8%) , face and neck (268 cases, 26.5%) , extremities (138 cases, 13.6%) , hands and feet (133 cases, 13.2%) , scalp (53 cases, 5.2%) and vulva (17 cases, 1.7%) . Pathological subtypes included intradermal nevus (580 cases, 57.4%) , compound nevus (333 cases, 32.9%) and junctional nevus (98 cases, 9.7%) . Among special histopathological characteristics, neuralization and adipose cell hyperplasia were observed in 172 (17.0%) and 155 (15.3%) cases respectively, and the prevalence of neuralization and adipose cell hyperplasia was significantly higher in female patients than in male patients, higher in elderly patients than in young patients, and higher on the scalp than on the other sites (all P < 0.05) ; vascular proliferation was observed in 313 (31.0%) cases, and more commonly occurred on the scalp than on the other sites (P < 0.05) ; nevus cells distributed along the hair follicles/sebaceous glands were observed in 502 (49.7%) cases, and more commonly seen on the face and neck than on the other sites (P < 0.05) ; nevus cell lysis occurred in 203 (20.1%) cases, and fissures were observed in 384 (38.0%) . All the above histopathological characteristics were more frequently observed in the intradermal nevus subtype than in the compound nevus subtype (all P < 0.05) . Nevus cells distributed along the blood vessels were observed in 20 (2.0%) cases, and more commonly seen on the extremities than on the trunk, hands and feet (P < 0.05) , as well as in the compound nevus subtype than in the intradermal nevus subtype (P < 0.05) . Conclusions There are many special histopathological characteristics in melanocytic nevi, such as neuralization, adipose cell hyperplasia, vascular proliferation, and nevus cells distributed along the hair follicles/sebaceous glands, which are associated with patients′ age, gender, lesional locations and histopathological subtypes. Key words: Nevus, pigmented; Age of onset; Melanocytic nevus; Histopathological characteristics; Histopathological subtype