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Introduction: This study reports psychometric testing of the facial and total Vitiligo Area Scoring Index quantitative clinical instruments (F-VASI [range: 0–3], T-VASI [range: 0–100], respectively) using data from two phase 3 randomized, vehicle-controlled studies of ruxolitinib cream (TRuE-V1/TRuE-V2), the largest vitiligo trials conducted to date. Because VASI assessment is required by regulatory authorities, we evaluated the psychometric properties of the VASI instruments and confirmed thresholds for clinically meaningful change. Methods: The TRuE-V1/TRuE-V2 full analysis set population included 652 patients (≥ 12 years old with nonsegmental vitiligo affecting ≤ 10% total body surface area, F-VASI ≥ 0.5, and T-VASI ≥ 3 at baseline). Data collected using the facial and total Patient Global Impression of Change–Vitiligo (PaGIC-V) and Physician's Global Vitiligo Assessment (PhGVA) scales were used as anchors to assess F-VASI and T-VASI for reliability, validity, sensitivity to change, and clinically meaningful change. Results: Median F-VASI and T-VASI scores were 0.70 and 6.76, respectively, at baseline, decreasing to 0.48 and 4.80 at week 24. Test–retest reliability was excellent between screening and baseline for F-VASI (intraclass correlation coefficient [ICC]: 0.943) and T-VASI (ICC: 0.945). Among stable patients per PaGIC-V and PhGVA, reliability was moderate to good for both F-VASI (ICC: 0.891 and 0.739, respectively) and T-VASI (ICC: 0.768 and 0.686). F-VASI and T-VASI differentiated well among PhGVA categories mild/moderate/severe at baseline and week 24. Both VASI instruments detected changes assessed by correlations with PaGIC-V scores at week 24 (F-VASI, r = 0.610; T-VASI, r = 0.512) and changes in PhGVA scores from baseline to week 24 (F-VASI, r = 0.501; T-VASI, r = 0.344). Thresholds for clinically meaningful improvement per PaGIC-V and PhGVA were 0.38–0.60 for F-VASI and 1.69–3.88 for T-VASI. Conclusions: Data from the TRuE-V1/TRuE-V2 studies confirmed that F-VASI and T-VASI are reliable, valid, and responsive to change, with defined clinically meaningful change from baseline in patients with nonsegmental vitiligo. Trial Registration: The original studies were registered at ClinicalTrials.gov: NCT04052425/NCT04057573. Plain Language Summary: Vitiligo is a skin disease that causes patches of white (depigmented) skin and affects 0.5–2.0% of people worldwide. People with vitiligo often say that restoring color to white patches of skin (repigmentation) is important. Ruxolitinib cream is approved in the USA and Europe for topical treatment of vitiligo in adults and adolescents based on results from the phase 3 TRuE-V1 and TRuE-V2 studies. In these studies, applying ruxolitinib cream twice daily up to 52 weeks resulted in substantial repigmentation, as assessed by the facial and total Vitiligo Area Scoring Index (F-VASI/T-VASI). We aimed to confirm which changes in F-VASI/T-VASI scores represented meaningful improvement for doctors and people with vitiligo. We compared changes in VASI scores with results from two other tools used to assess vitiligo. One tool was based on doctor assessment (Physician's Global Vitiligo Assessment [PhGVA]); the other was based on patient assessment (Patient Global Impression of Change–Vitiligo [PaGIC-V]). The analysis included clinical trial data for 652 people with vitiligo. After 6 months of treatment, median F-VASI and T-VASI scores decreased considerably, indicating improvement in repigmentation. We saw higher VASI scores for disease considered more severe per the PhGVA and PaGIC-V. Changes in VASI scores largely aligned with changes in PhGVA and PaGIC-V scores. We found that F-VASI and T-VASI are reliable tools to assess vitiligo and confirmed that improvement of 0.38–0.60 for F-VASI and 1.69–3.88 for T-VASI scores represent meaningful repigmentation in people with vitiligo on up to 10% of their bodies. [ABSTRACT FROM AUTHOR]

Background: First-line standard-of-care therapy for advanced cholangiocarcinoma is gemcitabine plus cisplatin; there is no established second-line systemic therapy. Fibroblast growth factor receptor (FGFR)-2 fusions/rearrangements can be oncogenic drivers, occurring almost exclusively in intrahepatic cholangiocarcinoma, but little is known about whether FGFR2 status affects the response to systemic chemotherapy.Objective: We aimed to evaluate the effects of FGFR2 status on survival outcomes in patients receiving systemic therapy for intrahepatic cholangiocarcinoma.Methods: In this retrospective analysis, patients treated with systemic therapy at Memorial Sloan Kettering Cancer Center for intrahepatic cholangiocarcinoma were categorized into three cohorts: FGFR2 fusions; other FGFR2 alterations; no FGFR2 alterations. Endpoints were overall survival and progression-free survival per therapy line.Results: In total, 132 patients with intrahepatic cholangiocarcinoma were included (FGFR2 fusions, n = 15; other FGFR2 alterations, n = 2 [data not reported]; no FGFR2 alterations, n = 115). First-line therapy was platinum based in 93% of patients; 80% received platinum/pyrimidine-based second-line therapy. For patients with FGFR2 fusions and no FGFR2 alterations, respectively, median overall survival from diagnosis was 31.3 months (95% confidence interval [CI] 5.8-not estimable months) [n = 9] and 21.7 months (95% CI 16.1-26.6) [n = 109]; median progression-free survival in first-line therapy was 6.2 months (95% CI 2.0-16.8) [n = 15] and 7.2 months (95% CI 5.0-8.3) [n = 107], and median progression-free survival in second-line therapy was 5.6 months (95% CI 2.8-10.3) [n = 8] and 3.7 months (95% CI 2.6-5.6) [n = 81].Conclusions: Patients with intrahepatic cholangiocarcinoma and FGFR2 fusions may have a better prognosis than those without FGFR2 alterations in terms of overall survival, and progression-free survival on second-line, but not first-line systemic therapy. Progression-free survival improvement on second-line chemotherapy may imply an important impact of prior chemotherapy as first line. [ABSTRACT FROM AUTHOR]

Background: Patients with vitiligo experience reduced quality of life. Objective: To comprehensively describe the available evidence for psychosocial burden in vitiligo. Methods: A systematic review of observational studies and clinical trials identified using PubMed, EMBASE, Scopus, and the Cochrane databases was performed through 1 March, 2021, to assess psychosocial comorbidities in vitiligo. Two independent reviewers performed an assessment of articles and extracted data for qualitative synthesis. Results: Included studies (N = 168) were published between 1979 and 1 March, 2021; 72.6% were published since 2010. Disorders including or related to depression (41 studies, 0.1–62.3%) and anxiety (20 studies, 1.9–67.9%) were the most commonly reported. The most prevalent psychosocial comorbidities were feelings of stigmatization (eight studies, 17.3–100%), adjustment disorders (12 studies, 4–93.9%), sleep disturbance (seven studies, 4.6–89.0%), relationship difficulties including sexual dysfunction (ten studies, 2.0–81.8%), and avoidance or restriction behavior (12.5–76%). The prevalence of most psychosocial comorbidities was significantly higher vs healthy individuals. Factors associated with a significantly higher burden included female sex, visible or genital lesions, age < 30 years (particularly adolescents), and greater body surface area involvement, among others. The most commonly reported patient coping strategy was lesion concealment. Limitations: Available studies were heterogeneous and often had limited details; additionally, publication bias is possible. Conclusions: The results of this systematic review show that vitiligo greatly affects psychosocial well-being. The extent of psychosocial comorbidities supports the use of multidisciplinary treatment strategies and education to address the vitiligo-associated burden of disease. Protocol Registration: PROSPERO (CRD42020162223). [ABSTRACT FROM AUTHOR]

The article presents a study on subjects with migraine, asthma, or chronic obstructive pulmonary disease (COPD) and their attitude towards reading medication guides. Topics include patients that use medications like Advair and Treximet, the study used a survey whose results which shows that majority of subjects read their guides, but only once and not thoroughly, and patients did not read medication guides during refills, and the factors of age, simple formats, and medication guide content.

This article presents a study on consumers' preferences about formatting of information, their motivation to read drug information and their ability to understand the information. Two novel formats were used in the study, namely the new and bubble formats, and the current format that patients commonly receive with their prescriptions. The study showed that consumers prefer the new and bubble formats.

Purpose Of Review: Deaths associated to tramadol, a synthetic opioid, are rising globally. Herein, we characterize prescription patterns of tramadol relative to other opioids in the USA from 2012 to 2015, by geographic region and physician specialty.Recent Findings: Data on opioid was obtained using Truven Health Analytics MarketScan for the years 2012-2015. Inclusion criteria included subjects living in the USA with ages from 12 to 64 years. Patterns of prescription of tramadol were contrasted with other prescription opioids including hydrocodone, codeine, oxycodone, oxymorphone, methadone, and fentanyl. Between 2012 and 2015, prescriptions for tramadol increased by 22.8%. The absolute rate of prescription varies considerably per region, with tramadol representing nearly 20% of opioid prescriptions in the South, which, in turn, represents nearly 50% of all prescriptions in the USA. Significant differences were seen when comparing prescribers of tramadol with other opioids (p < 0.0001). Tramadol was more frequently prescribed by family practice (40% vs. 32%) and internal medicine physicians (19% vs. 16%). Family medicine, internal medicine, and non-physician prescribers responded by 67.2% of all tramadol prescriptions in 2015. The proportion of patients receiving tramadol from non-physician prescribers increased by 56% between 2012 and 2015 (p < 0.001) IOM. Tramadol prescriptions rates have continuously increased both nationally and throughout all US regions. Important differences exist among regions and physician specialties. These results may be helpful in the creation of regional policies to monitor reasons for this increase and to avoid excessive use of tramadol. [ABSTRACT FROM AUTHOR]