Browsing by Author "Rosmarin, David"
Now showing 1 - 10 of 10
Results Per Page
Sort Options
Item Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream(Elsevier, 2023-09-13) Howell, Michael D.; Kuo, Fiona I.; Rumberger, Beth; Boarder, Erika; Sun, Kang; Butler, Kathleen; Harris, John E.; Grimes, Pearl; Rosmarin, David; Dermatology, School of MedicineBackground: Efficacy of ruxolitinib cream, a topical Jak1/Jak2 inhibitor, was demonstrated in a phase 2 trial in patients with vitiligo. Objective: This study aimed to characterize circulating inflammatory biomarker profiles in patients who demonstrated ≥50% improvement in facial Vitiligo Area Scoring Index scores by week 24 (group 1) and those who did not (group 2). Design: This was a posthoc analysis of a multicenter, randomized, double-blind, vehicle-controlled, phase 2 study in which screening was conducted between June 7, 2017 and March 21, 2018. Population: Patients aged between 18 and 75 years with vitiligo, including depigmentation affecting ≥0.5% of body surface area on the face and ≥3% of body surface area on nonfacial areas, were eligible. Intervention: Patients applied 1.5% ruxolitinib cream to lesions once or twice daily for 52 weeks. Main outcomes and measures: Patients were grouped by achievement of ≥50% improvement in facial Vitiligo Area Scoring Index at week 24. Proteomic analysis was performed on baseline serum samples. Results: Mean ± standard error facial Vitiligo Area Scoring Index in group 1 (n = 30) versus group 2 (n = 27) improved by 79.9 ± 4.0% versus 1.1 ± 7.3% and 91.9 ± 1.5% versus 25.1 ± 13.4% at weeks 24 and 52, respectively. Broad proteomic analysis revealed 76 proteins (of 1,104 tested) that were differentially expressed between groups 1 and 2 at baseline (P < 0.05). Ten distinct proteins were upregulated in group 1; 64 were elevated in group 2. Conclusion: This analysis identified potential differences between patients who achieved ≥50% improvement in facial Vitiligo Area Scoring Index at 24 weeks and those who did not that require deeper scientific interrogation and may be important in stratifying therapeutic benefit for patients with vitiligo.Item Correction to: Real-World Treatment Patterns in Patients with Vitiligo in the United States(Springer, 2023) Rosmarin, David; Soliman, Ahmed M.; Li, Chao; Dermatology, School of MedicineCorrection to: Dermatol Ther (Heidelb) (2023) 13:2079–2091 10.1007/s13555-023-00983-3 Authors would like to update the middle name of co-author as Ahmed M. Soliman. The original article has been corrected.Item Disease Course, Treatment Patterns and Goals Among Patients with Non-segmental Vitiligo Across Europe and the United States(Springer, 2024) Rosmarin, David; Soliman, Ahmed M.; Marwaha, Simran; Piercy, James; Camp, Heidi S.; Anderson, Peter; Ezzedine, Khaled; Dermatology, School of MedicineIntroduction: There is currently a lack of research regarding disease course and burden as well as treatment patterns and goals in patients with non-segmental vitiligo (NSV). The aim of this analysis was to evaluate disease course, treatment patterns and goals in patients with NSV. Methods: This analysis used secondary data from the Adelphi Real World Vitiligo Disease Specific Programme™ 2021, specifically, a survey of physicians and their adult and adolescent patients with NSV. Physicians categorized patients by the extent of NSV at time of survey completion as mild, moderate or severe/very severe. Physician-reported patient information included demographics, current/previously prescribed NSV therapies, treatment satisfaction and the Vitiligo Noticeability Scale (VNS). Patients completed a survey on treatment satisfaction and the VNS. Treatment pattern data were stratified by disease extent and Fitzpatrick skin type. Results: At survey completion, physicians reported that 38, 50 and 12% of patients (N = 1865) had improving, stable and deteriorating/progressing disease, respectively. Most patients (96%) with mild disease at treatment initiation still had mild disease at the time of survey completion. More than half of patients with moderate disease (62%) or severe/very severe disease (57%) at treatment initiation still had moderate or severe/very severe disease at survey completion. Topical calcineurin inhibitors (TCIs) were the most common treatment in 40% of patients followed by phototherapy in 30%. Patients hoped for re-pigmentation (mild 56%, moderate 62%, severe/very severe 66%), reduction (mild 50%, moderate 56%, severe/very severe 49%) or cessation of affected areas with vitiligo (mild 48%, moderate 54%, severe/very severe 43%). Conclusion: The study findings indicate that a significant proportion of patients with NSV are not improving on current treatments, most commonly TCIs and phototherapy. The results highlight the unmet need for novel and effective therapies to substantially improve re-pigmentation, an important treatment goal for patients with NSV.Item Health-Related Quality of Life Burden Among Adults with Vitiligo: Relationship to Disease Severity and Disease Location(Springer, 2024) Rosmarin, David; Soliman, Ahmed M.; Piercy, James; Marwaha, Simran; Anderson, Peter; Camp, Heidi S.; Dermatology, School of MedicineIntroduction: Vitiligo was historically regarded as a cosmetic disorder; however, it is an autoimmune disease. As a visible condition, it affects patient well-being. We assessed the impact of disease severity, lesion location, and body surface area (BSA) affected on patient health-related quality of life (HRQoL). Methods: Retrospective data were from the Adelphi Real World Vitiligo Disease Specific Programme: a cross-sectional survey of physicians and their patients with vitiligo (10/2021-07/2022). Patient-reported outcomes were assessed by the Vitiligo-Specific Quality of Life Instrument (VitiQoL), Hospital Anxiety and Depression Scale (HADS), and EQ-5D-5L. The Work Productivity and Impairment Questionnaire (WPAI) questionnaire was used to assess disease-related impairment of daily activities. Data were stratified by physician-reported disease severity, presence/absence of vitiligo on the face, and BSA percentage affected. Results: In total, 1388 patients were included. Mean (SD) VitiQoL, HADS depression, and anxiety scores were higher for those with severe disease [40.5 (26.1), 5.2 (4.4), and 6.8 (4.7)] than those with mild [24.8 (18.8), 3.6 (3.8), 4.2 (3.8)] or moderate [27.1 (22.6), 3.8 (4.5), 4.3 (4.4)] disease. Patients with face affected reported higher VitiQoL [30.0 (22.3) versus 23.2 (19.3)], and HADS scores [depression, 4.3 (4.3) versus 3.2 (3.9); anxiety, 5.0 (4.3) versus 3.8 (3.9)] than those without. Patients with ≥ 5% BSA affected had higher VitiQoL, depression and anxiety scores [27.9 (21.8), 4.0 (4.4), and 4.5 (4.2)] than those with 0-5% [24.6 (19.7), 3.4 (3.7), and 4.3 (4.1)]. Patients with severe vitiligo, facial lesions, or ≥ 5% BSA reported higher activity impairment. Mean EQ-5D-5L-utility score was approximately 0.9 regardless of disease severity or total BSA affected. Conclusions: These data demonstrate the impact disease severity can have on HRQoL and daily activities for patients with vitiligo. Lesions that are more severe, on the face, or covering a greater BSA are more often associated with poorer outcomes and activity impairment. These data also highlight the potential insensitivity of commonly used HRQoL measures and a need for more sensitive disease-specific measures.Item Healthcare Resource Use and Costs Among Individuals with Vitiligo and Psychosocial Comorbidities: Retrospective Analysis of an Insured US Population(Dove Press, 2024-08-08) Lofland, Jennifer H.; Darbha, Samyuktha; Naim, Ahmad B.; Rosmarin, David; Dermatology, School of MedicinePurpose: This study aimed to describe healthcare resource utilization and costs among individuals with vitiligo who were diagnosed with ≥1 psychosocial comorbidity, using data from US claims databases. Patients and methods: A retrospective, observational cohort analysis of the IBM MarketScan Commercial and Medicare supplemental claims databases for US individuals with vitiligo aged ≥12 years and a first vitiligo claim between January 1 and December 31, 2018, was undertaken to assess psychosocial burden, including mental and behavioral health comorbidities. Results: Of the 12,427 individuals included in the analysis, nearly 1 in 4 (23.5%) who had vitiligo were also diagnosed with ≥1 psychosocial comorbidity. A greater percentage of these individuals versus those who were not diagnosed with a psychosocial comorbidity had a vitiligo-related prescription claim (50.2% vs 45.4%; P<0.0001), especially for oral corticosteroids (25.4% vs 16.6%; P<0.0001) and low-potency topical corticosteroids (9.0% vs 7.6%; P<0.05). Total vitiligo-related healthcare resource utilization and costs were consistent among individuals with and without psychosocial comorbidity despite significantly (P<0.05) higher vitiligo-related ER visit utilization and expenditure among those with psychosocial comorbidity. Furthermore, individuals diagnosed with vitiligo and ≥1 psychosocial comorbidity had significantly (P<0.0001) greater utilization of all-cause mean prescription claims (25.0 vs 12.8), outpatient services (other than physician and ER visits: 19.5 vs 11.3), outpatient physician visits (10.1 vs 6.4), inpatient stays (0.6 vs 0.1), and ER visits (0.4 vs 0.2) and incurred significantly higher mean (SD) direct medical expenditures ($18,804 [$46,621] vs $9833 [$29,094] per patient per year; P<0.0001). Conclusion: Individuals with vitiligo who were diagnosed with ≥1 psychosocial comorbidity incurred greater total all-cause but not vitiligo-related healthcare resource utilization and expenditures than those without diagnosis of psychosocial comorbidities. Identification of psychosocial comorbidities in individuals with vitiligo may be important for multidisciplinary management of vitiligo to reduce overall burden for individuals with vitiligo.Item Impact on Quality of Life, Health Care Access, and Health Care Utilization of Individuals with Vitiligo: An Analysis of the All of Us Research Program(Springer, 2024-08-22) Crummer, Elliott; Cohen, Joshua T.; Rosmarin, David; Lin, Pei-Jung; Dermatology, School of MedicineVitiligo is an autoimmune skin depigmenting disorder that can negatively impact quality of life. A new FDA approved treatment for vitiligo offers considerable promise, and to maximize benefits strategies to implementation should consider disease burden, healthcare access, and healthcare utilization of individuals with vitiligo. Using the All of Us Research Program's large data set, including survey responses, we investigated these outcomes among participants with and without vitiligo. Our analysis used quality of life, delayed care due to an obstacle, and seeing a doctor in the past year as dichotomized proxies for disease burden, healthcare access, and healthcare utilization. The results show that people with vitiligo are more likely to report worse quality of life but ostensibly greater healthcare access and utilization compared to people without vitiligo. However, these relationships are not significant when adjusted for demographics, socioeconomic characteristics, and comorbidities of vitiligo. Prior research has shown non-Caucasian individuals have worse health outcomes in general, and worse quality of life within the vitiligo population. Our data demonstrated consistent findings; moreover, we found that non-Caucasian individuals with vitiligo had inferior healthcare access and lower health care utilization than Caucasian individuals. Implementation of new treatments for vitiligo should prioritize disadvantaged individuals to improve health equity.Item Once-daily upadacitinib versus placebo in adults with extensive non-segmental vitiligo: a phase 2, multicentre, randomised, double-blind, placebo-controlled, dose-ranging study(Elsevier, 2024-05-31) Passeron, Thierry; Ezzedine, Khaled; Hamzavi, Iltefat; van Geel, Nanja; Schlosser, Bethanee J.; Wu, Xiaoqiang; Huang, Xiaohong; Soliman, Ahmed M.; Rosmarin, David; Harris, John E.; Camp, Heidi S.; Pandya, Amit G.; Dermatology, School of MedicineBackground: Janus kinase (JAK) inhibition is a promising approach for treating vitiligo. We aimed to assess the efficacy and safety of upadacitinib, an oral selective JAK inhibitor, in adults with non-segmental vitiligo. Methods: This was a phase 2, multicentre, randomised, double-blind, placebo-controlled, dose-ranging study completed at 33 clinical centres in the United States, Canada, France, and Japan. Eligible patients were aged 18-65 years with non-segmental vitiligo and had a Facial Vitiligo Area Scoring Index (F-VASI) ≥0.5 and a Total Vitiligo Area Scoring Index (T-VASI) ≥5. Patients were randomly assigned (2:2:2:1:1) using an interactive response technology to receive upadacitinib 6 mg (UPA6), upadacitinib 11 mg (UPA11), upadacitinib 22 mg (UPA22), or placebo (PBO; preassigned to switch to either UPA11 or UPA22 in period 2) once daily for 24 weeks (period 1). For weeks 24-52 (period 2), patients randomly assigned to upadacitinib continued their treatment, and patients receiving PBO switched to their preassigned upadacitinib dose in a blinded fashion. The primary endpoint was the percent change from baseline in F-VASI at week 24. Efficacy was analysed in the intention-to-treat population, and safety was examined in all randomly assigned patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT04927975. Findings: Between June 16, 2021, and June 27, 2022, 185 patients (including 115 [62%] who were female and 70 [38%] who were male) were randomly assigned to UPA6 (n = 49), UPA11 (n = 47), UPA22 (n = 43), or PBO (n = 46). At week 24, the LS mean difference versus PBO in the percent change from baseline in F-VASI was -7.60 (95% CI -22.18 to 6.97; p = 0.3037) for UPA6, -21.27 (95% CI -36.02 to -6.52; p = 0.0051) for UPA11, and -19.60 (95% CI -35.04 to -4.16; p = 0.0132) for UPA22. The LS mean difference versus PBO in the percent change from baseline in T-VASI was -7.45 (95% CI -16.86 to 1.96; p = 0.1198) for UPA6, -10.84 (95% CI -20.37 to -1.32; p = 0.0259) for UPA11 and -14.27 (95% CI -24.24 to -4.30; p = 0.0053) for UPA22. Ongoing treatment with upadacitinib induced continuous skin repigmentation over time without reaching a plateau through week 52. The rates for study drug discontinuation and serious treatment-emergent adverse events (TEAEs) were higher in the UPA22 group than in the UPA11 and UPA6 groups. Eight serious TEAEs, including one death of unknown cause and one case of infiltrating lobular breast carcinoma, were reported through 52 weeks; only two serious TEAEs (coronary artery arteriosclerosis [UPA6 (n = 1)] and non-fatal ischemic stroke [UPA11 (n = 1)]) were deemed by the investigator to have a reasonable possibility of being related to study drug. The one case of breast cancer in the UPA11 group was deemed unrelated to study drug, and the one death of unknown cause in the UPA22 group was reviewed and adjudicated and was deemed to be unrelated to study drug. The most common TEAEs were COVID-19, headache, acne, and fatigue. No new safety signals were observed. Interpretation: Upadacitinib monotherapy led to substantial repigmentation of both facial and total body vitiligo lesions and may offer an effective treatment option for adults with extensive non-segmental vitiligo. Based on these findings, upadacitinib 15 mg is being investigated in adults and adolescents with non-segmental vitiligo in an ongoing phase 3 randomised controlled trial.Item Real-World Treatment Patterns in Patients with Vitiligo in the United States(Springer, 2023) Rosmarin, David; Soliman, Ahmed M.; Li, Chao; Dermatology, School of MedicineIntroduction: Vitiligo is an autoimmune disorder resulting in skin depigmentation, with limited approved treatment options. This study evaluated medication utilization and treatment patterns among patients in the first year following vitiligo diagnosis. Methods: This retrospective analysis of claims data from the Merative® MarketScan Research Databases included patients aged ≥ 12 years newly diagnosed with vitiligo. Patients were identified between October 1, 2016, and April 30, 2021, and had ≥ 12 months of continuous enrollment pre- and post-vitiligo diagnosis. Medication use, treatment line of therapy, time to and number of medication claims, and length of therapy were reported in the 12 months post-vitiligo diagnosis. Results are reported separately for treatment initiators post-vitiligo diagnosis, patients with moderate-to-severe vitiligo, and adolescents (aged 12-17 years). Results: A total of 19,335 patients were included in the analysis, with half (N = 9648, 49.9%) not receiving any treatment during the 12-month follow-up. Switching was minimal among treatment initiators (N = 5845) in the 12 months post-vitiligo diagnosis, with the most frequent first-line treatments being high-potency topical corticosteroids (25.4%), oral corticosteroids (23.1%), and topical calcineurin inhibitors (TCI, 14.7%). Adolescents initiating treatment (N = 486) most frequently received TCI (30.9%) as first-line therapy. Patients with moderate-to-severe vitiligo (N = 3462) were very likely to receive treatment during follow-up, with only 1.5% not receiving treatment. Among patients with no vitiligo treatment prior to diagnosis, time to first medication claim ranged from 51.9 days (standard deviation [SD], 84.0) for TCI to 178.6 days (SD 116.0) for systemic immunosuppressants; mean total days supplied ranged from 14.4 days (SD 27.1) for oral corticosteroids to 121.0 (SD 114.0) for immunosuppressants. Conclusion: In this real-world study, a high proportion of patients did not receive any treatment. Among those receiving treatment, most were unlikely to switch or use a combination of treatments within the first year of vitiligo diagnosis.Item Treatment of palmoplantar keratoderma in a patient with ichthyosis with topical tapinarof(Elsevier, 2024-01-27) Robinson, Sarah N.; Kranseler, Julie S.; Rosmarin, David; Dermatology, School of MedicineItem Use of topical clascoterone for the treatment of hidradenitis suppurativa(Elsevier, 2023-04-15) Cunningham, Kaitlynne N.; Moody, Katherine; Alorainy, May; Rosmarin, David; Dermatology, School of Medicine