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 vitiligoassociated burden of disease. Protocol Registration PROSPERO (CRD42020162223).

Primary restless legs syndrome (RLS) was not associated with new-onset cardiovascular disease (CVD) or coronary artery disease (CAD) but was associated with a slight increased risk of hypertension. In contrast, secondary RLS was associated with an increased risk of CVD, CAD, and hypertension.

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Objective To evaluate the efficacy of fremanezumab in patients with chronic migraine (CM) and moderate to severe depression. Background Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene–related peptide, has been approved for the preventive treatment of migraine in adults. CM and depression are highly comorbid. Methods The 12‐week, Phase 3 HALO trial randomized patients with CM to fremanezumab quarterly (675 mg/placebo/placebo), fremanezumab monthly (675/225/225 mg), or placebo. Post hoc analyses evaluated the effects of fremanezumab in patients with moderate to severe depression (baseline 9‐item Patient Health Questionnaire sum score ≥10) on monthly number of headache days of at least moderate severity; monthly migraine days; Patient Global Impression of Change (PGIC); 6‐item Headache Impact Test (HIT‐6) scores; and depression. Results For the 219/1121 (19.5%) patients with moderate to severe depression at baseline, fremanezumab was associated with a significant reduction in monthly number of headache days of at least moderate severity for active treatment versus placebo (least‐squares mean change ± standard error for quarterly dosing: −5.3 ± 0.77; for monthly dosing: −5.5 ± 0.72; and for placebo: −2.2 ± 0.81; both p < 0.001). More patients achieved a ≥50% reduction in headache days of at least moderate severity with fremanezumab (quarterly: 31/78 [39.7%]; monthly: 39/96 [40.6%]) than placebo (9/67 [13.4%]; both p < 0.001). Compared with placebo, fremanezumab improved PGIC and HIT‐6 scores. Conclusions Fremanezumab demonstrated efficacy in the preventive treatment of CM and reduced headache impact in patients with comorbid depression.

Background Vitiligo, an autoimmune disorder characterised by skin depigmentation, is associated with reduced quality of life (QoL). Vitiligo may be under‐reported, in part because of misconceptions that it is a cosmetic disease. Objectives This survey sought to characterise vitiligo prevalence and explore the relationship between sociodemographic and clinical characteristics with QoL in a population‐based, multinational study. Methods Participants aged ≥18 years were recruited via an online panel in Europe, Japan and the USA to answer questions regarding skin disorders they may have experienced. Those reporting vitiligo (diagnosed or undiagnosed) or vitiligo signs (experiencing loss of skin colour but unaware of vitiligo and not diagnosed) were included in the analyses of vitiligo prevalence. Participants who self‐reported physician‐diagnosed vitiligo were given a broader survey to characterise disease progression, management and QoL (as measured with the Vitiligo‐specific QoL [VitiQoL] instrument). Results The total estimated vitiligo prevalence among 35 694 survey participants (Europe, n = 18 785; USA, n = 8517; Japan, n = 8392) was 1.3% (diagnosed, 0.6%; undiagnosed, 0.4%; vitiligo signs, 0.3%). Among 219 patients formally diagnosed with vitiligo (Europe, n = 150; USA, n = 48; Japan, n = 21), total VitiQoL scores were associated with age (P = 0.00017), disease extent (P < 0.0001), disease progression (P < 0.0001), disease management (P < 0.0001) and time since diagnosis (P = 0.0015). Behaviour scores varied based on skin phototype (P = 0.024) and ethnicity (P = 0.048). Higher total VitiQoL scores were reported in patients with head lesions (P = 0.027) and those with head and hand and/or wrist lesions (P = 0.018). Substantial high concern (rated 8–10 on an 11‐point Likert scale) for lesions was found across all body areas and varied with geographical region. Conclusions The vitiligo prevalence rate may be higher than previously reported, with a substantial proportion attributed to people who have not received a formal diagnosis. Among formally diagnosed patients with vitiligo, QoL was most severely impacted by more progressive and higher extent of disease.

Patients in the United States receive multiple forms of written drug information with their prescription medicines. This study solicited consumers' preferences about formatting of information, their motivation to read drug information, and their ability to navigate and understand the information. A 3 × 3 study design was used in which 3 prototypes for 3 prescription drugs, ORTHO TRI-CYCLEN (norgestimate/ethinyl estradiol), COUMADIN (warfarin sodium), and PARNATE (tranylcypromine sulfate), were evaluated. The prototypes included 2 novel formats ("new" and "bubble") and the "current" format that patients now commonly receive with their prescriptions. A total of 105 consumers participated in the study. Consumers correctly answered more questions about the medicine when presented with a new (70%-95%) or a bubble prototype (83%-92%) than with the current format (53%-74%). All attributes scored higher with both prototypes compared with the current format. However, in terms of overall preference, consumers favored the new prototype and indicated that they would be more motivated to read it. Consumers also reported that simple icons assisted them in finding important information. The new and bubble prototypes were favored by participants more than the current format. Key attributes preferred by consumers must be considered as new formats for patient medication information are developed.

303 Background: Most patients (pts) with cholangiocarcinoma (CCA) are diagnosed with advanced disease and are ineligible for surgery. FGFR2 fusions/rearrangements are oncogenic drivers and are present almost exclusively in pts with intrahepatic CCA (iCCA; 10–16% of pts); however, little is known about the effects of FGFR2 status on response to systemic chemotherapy. Memorial Sloan Kettering (MSK) obtains genomic sequencing data from almost all iCCA pts treated at the institution. This provides a unique, rich database from which genomic profiling data can be overlaid with clinical data to facilitate a meaningful understanding of pt outcomes, and to suggest potential therapeutic options. This retrospective analysis evaluated progression free survival (PFS) and overall survival (OS) in pts receiving standard systemic chemotherapy (CXT) for iCCA harboring FGFR2 fusions/rearrangements ( FGFR2 +), or harboring wild-type FGFR2 ( FGFR2wt). Methods: Clinical and genomic data were obtained from the MSK database for all iCCA pts to determine disease history and exposure to prior lines (PL) of CXT in the advanced setting. Only pts with complete data for PL of CXT were analyzed. Median PFS and OS were calculated using the Kaplan-Meier method. OS was calculated from diagnosis until death; PFS was calculated from first dose of first line of CXT until progression, death, last visit, relevant dates of later CXT lines; pts with unconfirmed outcomes were censored at last known follow-up date. Results: One-hundred-thirty-two pts were included in this analysis (median age at diagnosis: 62.0 y; 54.5% female; FGFR2+, n = 15; FGFR2wt, n = 115; other FGFR2 alterations, n = 2). Among pts receiving first-line CXT, median PFS was 7.1 months (95% CI: 5.0–8.3) for all pts (n = 124), 6.2 months (2.0–16.8) for FGFR2+ pts (n = 15), and 7.2 months (5.0–8.3) for FGFR2wt pts (n = 107). Among pts with ≥2 PL of CXT (n = 90), median PFS on second-line chemotherapy was 5.6 months (95% CI: 2.8–10.3) for FGFR2+ pts, and 3.7 months (2.6–5.6) for FGFR2wt pts. Median OS was numerically longer in FGFR2+ pts compared with FGFR2wt pts (31.3 months [95% CI: 5.8–not estimable] vs 21.8 months [16.7–26.6]). Conclusions: Among pts receiving standard systemic chemotherapy for iCCA, median PFS was similar in pts harboring FGFR2+ vs FGFR2wt receiving first-line chemotherapy, and relatively longer in pts harboring FGFR2+ receiving second-line chemotherapy. Median OS was longer in FGFR2+ vs FGFR2wt pts. Compared with recently published data in molecularly unselected CCA pts (Lowery. Cancer. 2019; 125: 4426), PFS was similar in pts receiving first-line chemotherapy, and slightly longer for second-line chemotherapy. Data interpretation is limited by the retrospective nature of this analysis of investigator-reported data, the study size, and by the possibility that the analysis population may not reflect the general population of pts with CCA.

PURPOSE Oncogenic fibroblast growth factor receptor (FGFR) gene alterations have been described in patients with cholangiocarcinoma (CCA). This post hoc analysis assessed progression-free survival (PFS) in patients who had received first- or second-line systemic therapy for advanced/metastatic CCA before enrollment in the phase II FIGHT-202 study (ClinicalTrials.gov identifier: NCT02924376 ). PATIENTS AND METHODS Patients with locally advanced or metastatic CCA with FGFR2 fusions/rearrangements (n = 107), other FGF/FGFR alterations (n = 20), or no FGF/FGFR alterations (n = 18) and documented disease progression after at least one systemic cancer therapy before enrollment in FIGHT-202 were assessed. Prior therapy and disease response data were collated from electronic case report forms. PFS was calculated for each prior line of systemic cancer therapy. RESULTS Among patients with FGFR2 fusions/rearrangements, other FGF/ FGFR alterations, and no FGF/ FGFR alterations, respectively, the median PFS with prior first-line systemic therapy was 5.5 months (95% CI, 4.0 to 8.0; n = 102), 4.4 months (2.7 to 7.1; n = 19), and 2.8 months (1.6 to 11.3; n = 16); the median PFS with prior second-line systemic therapy was 4.2 months (3.0 to 5.3; n = 39), 3.0 months (1.1 to 9.9; n = 8), and 5.9 months (2.4 to 12.5; n = 6). The median PFS was 7.0 months (4.9 to 11.1) for patients with FGFR2 fusions/rearrangements (n = 65) with second-line pemigatinib received during the FIGHT-202 trial. CONCLUSION In patients with CCA and FGFR2 fusions or rearrangements, second-line treatment with pemigatinib may be associated with longer PFS compared with second-line treatment with systemic therapy received before study enrollment; however, a prospective controlled trial is required to confirm this. The results support the therapeutic potential of pemigatinib previously demonstrated in FIGHT-202.