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• W4220655780 abstract "According to the National Institutes of Health (NIH), more than 23.5 million people in the United States suffer from confirmed autoimmune diseases, which are a leading cause of disability (NIH Autoimmune Diseases Coordinating Committee, 2005NIH Autoimmune Diseases Coordinating CommitteeProgress in Autoimmune Diseases Research.www.niaid.nih.gov/sites/default/files/adccfinal.pdfDate: 2005Date accessed: September 15, 2021Google Scholar). Recent evidence suggests that the prevalence of autoimmune biomarkers is growing in the United States, with 41 million Americans testing positive (Dinse et al., 2020Dinse G.E. Parks C.G. Weinberg C.R. Co C.A. Wilkerson J. Zeldin D.C. Miller F.W. Increasing Prevalence of Antinuclear Antibodies in the United States.Arthritis & Rheumatology. 2020; 72: 1026-1035Crossref PubMed Scopus (113) Google Scholar). Autoimmune disorders must, therefore, be an increasing priority for health policymakers and researchers. The majority of autoimmune diseases are more prevalent in women, who represent more than 80% of autoimmune patients, suggesting sex is an important biological variable that affects these diseases (Desai and Brinton, 2019Desai M.K. Brinton R.D. Autoimmune disease in women: Endocrine transition and risk across the lifespan.Frontiers in Endocrinology. 2019; 10: 265Crossref PubMed Scopus (103) Google Scholar). Furthermore, the burden of disease is arguably greater in women owing to gender and cultural influences that have psychosocial effects and create expectations of caregiving for children, partners, and parents who may suffer from these chronic conditions (Villasante Fricke and Miteva, 2015Villasante Fricke A. Miteva M. Epidemiology and burden of alopecia areata: a systematic review.Clinical, Cosmetic and Investigational Dermatology. 2015; 8: 397-403PubMed Google Scholar). Much is still unknown as to how and why immune-mediated diseases (broadly involving abnormal activity of the immune system) and autoimmune diseases (characterized by antigen presence) are triggered and why many of them are more prevalent, and often more severe, in women (Desai and Brinton, 2019Desai M.K. Brinton R.D. Autoimmune disease in women: Endocrine transition and risk across the lifespan.Frontiers in Endocrinology. 2019; 10: 265Crossref PubMed Scopus (103) Google Scholar). Skin, as the body's largest organ, can be affected by autoimmune diseases. Because the skin is so visible and important to the body's physiological function, skin diseases and comorbidities can impact a person's physical and mental well-being and carry a large public health burden; despite this, they are relatively understudied (Khatami and San Sebastian, 2009Khatami A. San Sebastian M. Skin disease: A neglected public health problem.Dermatologic Clinics. 2009; 27: 99-101Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar). Gaps in understanding the biological sex differences in disease pathology can further hamper treatment and research efforts. It is, therefore, vital to increase research focus on skin diseases, particularly autoimmune and immune-mediated skin diseases that have complex and chronic health implications for those affected. Three such conditions are alopecia areata (AA), atopic dermatitis (AD), and psoriasis. In the United States, an estimated 700,000 people have AA, a condition that results in hair loss on the scalp, face, and other areas of the body (Benigno et al., 2020Benigno M. Anastassopoulos K. Mostaghimi A. Udall M. Daniel S. Cappelleri J. Peeva E. A large cross-sectional survey study of the prevalence of alopecia areata in the United States.Clinical, Cosmetic and Investigational Dermatology. 2020; 13: 259-266Crossref PubMed Scopus (34) Google Scholar). Although AA occurs equally in men and women, women are more likely to be diagnosed in adolescence or later and with concomitant autoimmune diseases (Aldhouse et al., 2020Aldhouse N.V.J. Kitchen H. Knight S. Macey J. Nunes F.P. Dutronc Y. Wyrwich K.W. “‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata.Journal of Patient-Reported Outcomes. 2020; 4: 1-12Crossref Scopus (30) Google Scholar; Darwin et al., 2018Darwin E. Hirt P.A. Fertig R. Doliner B. Delcanto G. Jimenez J.J. Alopecia areata: Review of epidemiology, clinical features, pathogenesis, and new treatment options.International Journal of Trichology. 2018; 10: 51-60Crossref PubMed Scopus (99) Google Scholar). There is also significant social stigma associated with female hair loss that can influence mental health and poor patient outcomes (Aldhouse et al., 2020Aldhouse N.V.J. Kitchen H. Knight S. Macey J. Nunes F.P. Dutronc Y. Wyrwich K.W. “‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata.Journal of Patient-Reported Outcomes. 2020; 4: 1-12Crossref Scopus (30) Google Scholar; Mostaghimi et al., 2021Mostaghimi A. Napatalung L. Sikirica V. Winnette R. Xenakis J. Zwillich S.H. Gorsh B. Patient perspectives of the social, emotional and functional impact of alopecia areata: A systematic literature review.Dermatology and Therapy. 2021; 11: 867-883Crossref PubMed Scopus (25) Google Scholar; Villasante Fricke and Miteva, 2015Villasante Fricke A. Miteva M. Epidemiology and burden of alopecia areata: a systematic review.Clinical, Cosmetic and Investigational Dermatology. 2015; 8: 397-403PubMed Google Scholar). Furthermore, there are currently no treatments for AA approved by the U.S. Food and Drug Administration, and insurance companies may deny claims for treatments that are perceived as cosmetic and not medically necessary. Approximately 16.5 million people in the United States suffer from AD, which is the most common type of eczema (Fuxench et al., 2019Fuxench Z.C.C. Block J.K. Boguniewicz M. Boyle J. Fonacier L. Gelfand J.M. Ong P.Y. Atopic Dermatitis in America Study: A cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population.Journal of Investigative Dermatology. 2019; 139: 583-590Abstract Full Text Full Text PDF PubMed Scopus (220) Google Scholar). The prevalence of childhood AD is similar and steadily rising in boys and girls; however, among adults, it is more common in women than men. AD can become very burdensome owing to itching, dryness, skin pain, and an increased risk of asthma and allergies (Silverberg et al., 2018Silverberg J.I. Gelfand J.M. Margolis D.J. Boguniewicz M. Fonacier L. Grayson M.H. Fuxench Z.C.C. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study.Annals of Allergy, Asthma & Immunology. 2018; 121: 340-347Abstract Full Text Full Text PDF PubMed Scopus (323) Google Scholar). Further, inadequate management of AD can lead to sleep disturbances and additional psychosocial sequelae. Meanwhile, up to 30% of the estimated 8 million people in the United States with psoriasis will also develop psoriatic arthritis (PsA) (Ritchlin et al., 2017Ritchlin C.T. Colbert R.A. Gladman D.D. Psoriatic arthritis.New England Journal of Medicine. 2017; 376: 957-970Crossref PubMed Scopus (742) Google Scholar). If left untreated, this progressive and inflammatory immune-mediated disease can result in irreversible joint damage. Although the prevalence of psoriasis and PsA are similar between sexes, women experience PsA differently than men—including peripheral polyarthritis and poorer treatment responses and remission—although little is known about why (Queiro et al., 2013Queiro R. Tejón P. Coto P. Alonso S. Alperi M. Sarasqueta C. Ballina J. Clinical differences between men and women with psoriatic arthritis: Relevance of the analysis of genes and polymorphisms in the major histocompatibility complex region and of the age at onset of psoriasis.Clinical and Developmental Immunology. 2013; 2013: 482691Crossref PubMed Scopus (43) Google Scholar). Women are differentially and disproportionately impacted as patients, as caregivers, and sometimes as both, when it comes to autoimmune and immune-mediated skin diseases. Thus, the Society for Women's Health Research has identified a pressing need to address gaps in the study and treatment of these skin diseases. We convened an interdisciplinary working group of clinicians, researchers, patient advocates, and policy professionals to discuss the current state of science regarding sex and gender disparities in AA, AD, and PsA and to explore ways to advance the research agenda, support science-based policy to improve patient outcomes, and increase awareness and understanding of these diseases and their impacts on women's health. The strategies proposed in this discussion involve increasing research investment to elucidate the biological and psychosocial impacts of autoimmune and immune-mediated skin diseases on women's health, and implementing policy solutions that promote and protect access to treatments and clinical care that can allow women, their dependents, and their health care providers to effectively and efficiently manage these chronic conditions. Factors that predispose certain individuals to or trigger the onset of autoimmune and immune-mediated skin diseases are still not understood fully. However, a combination of biological factors and environmental factors (including behavioral factors) have been shown to play a role (Ngo et al., 2014Ngo S.T. Steyn F.J. McCombe P.A. Gender differences in autoimmune disease.Frontiers in Neuroendocrinology. 2014; 35: 347-369Crossref PubMed Scopus (599) Google Scholar). Environmental factors—such as exposure to substances in air, water, and food—and lifestyle exposures to stress are possible reasons that rates of autoimmune skin diseases are increasing in the United States (Desai and Brinton, 2019Desai M.K. Brinton R.D. Autoimmune disease in women: Endocrine transition and risk across the lifespan.Frontiers in Endocrinology. 2019; 10: 265Crossref PubMed Scopus (103) Google Scholar; Silverberg et al., 2018Silverberg J.I. Gelfand J.M. Margolis D.J. Boguniewicz M. Fonacier L. Grayson M.H. Fuxench Z.C.C. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study.Annals of Allergy, Asthma & Immunology. 2018; 121: 340-347Abstract Full Text Full Text PDF PubMed Scopus (323) Google Scholar). Although the overall prevalence for AA, AD, and PsA tends to be equal in men and women, there are biological factors that result in differential expression between the sexes (Queiro et al., 2013Queiro R. Tejón P. Coto P. Alonso S. Alperi M. Sarasqueta C. Ballina J. Clinical differences between men and women with psoriatic arthritis: Relevance of the analysis of genes and polymorphisms in the major histocompatibility complex region and of the age at onset of psoriasis.Clinical and Developmental Immunology. 2013; 2013: 482691Crossref PubMed Scopus (43) Google Scholar). Women often report changes in symptoms during menstruation, pregnancy, and menopause—all circumstances that are driven by female hormones. A better understanding of the biological pathways and environmental triggers will provide keys to developing therapeutic targets to better treat these chronic diseases and mitigate their growing public health burdens. The epidemiology of these conditions should also be studied from a gendered lens that considers the cultural and social determinants that affect autoimmune skin diseases in women (Ngo et al., 2014Ngo S.T. Steyn F.J. McCombe P.A. Gender differences in autoimmune disease.Frontiers in Neuroendocrinology. 2014; 35: 347-369Crossref PubMed Scopus (599) Google Scholar). For example, lower health-related quality of life is common among sufferers of autoimmune skin disease, but societal expectations for dermatological beauty can disproportionately impact women, resulting in greater impairment of social and occupational activities and increased risk of depression and anxiety (Aldhouse et al., 2020Aldhouse N.V.J. Kitchen H. Knight S. Macey J. Nunes F.P. Dutronc Y. Wyrwich K.W. “‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata.Journal of Patient-Reported Outcomes. 2020; 4: 1-12Crossref Scopus (30) Google Scholar; Davis and Callender, 2018Davis D. Callender V. Review of quality of life studies in women with alopecia.International Journal of Women’s Dermatology. 2018; 4: 18-22Crossref PubMed Scopus (52) Google Scholar). Furthermore, women are more likely to be exposed to many of the potential triggers for autoimmune disease, including stressors related to higher burden of domestic duties, chemicals found in cleaning products and makeup, pesticides, solvents, and vitamin D deficiency owing to diet or lower sun exposure (Ngo et al., 2014Ngo S.T. Steyn F.J. McCombe P.A. Gender differences in autoimmune disease.Frontiers in Neuroendocrinology. 2014; 35: 347-369Crossref PubMed Scopus (599) Google Scholar). More research is needed to elucidate hormonal stimulation, drug effects, and psychosocial sequelae of autoimmune and immune-mediated skin diseases in women across the lifespan. Unfortunately, research for many skin diseases is underfunded, despite their considerable disease burdens. An analysis of skin disease research funded by the NIH between 2012 and 2013 relative to 15 corresponding skin conditions identified in a 2010 Global Burden of Disease study indicated that dermatitis (including AD) had the highest disability-adjusted life-years (DALY) ranking among skin diseases assessed, yet was ranked fifth in NIH funding (Hagstrom et al., 2015Hagstrom E.L. Patel S. Karimkhani C. Boyers L.N. Williams H.C. Hay R.J. Dellavalle R.P. Comparing cutaneous research funded by the US National Institutes of Health (NIH) with the US skin disease burden.Journal of the American Academy or Dermatology. 2015; 73: 383-391.e1Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar). AA was funded at number 13, despite its DALY ranking of 11. Furthermore, disparities have been documented in NIH funding for diseases that affect more women than men, regardless of the commensurate burden (Mirin, 2021Mirin A.A. Gender disparity in the funding of diseases by the U.S. National Institutes of Health.Journal of Women’s Health. 2021; 30: 956-963Crossref PubMed Scopus (55) Google Scholar). It is, therefore, imperative that the NIH increase efforts for targeted investment in autoimmune skin disease research and prioritize addressing understudied aspects related to biological sex and genetic ancestry, as well as socioenvironmental exposures and experiences, including sexism, racism, and other forms of discrimination. Funding institutes and researchers should be appropriately trained and held accountable to NIH's Policy on Sex as a Biological Variable to ensure that relevant vertebrate animal and human studies concerning autoimmune and immune-mediated skin diseases incorporate research designs, analyses, and reporting that factor in these critical and evident differences observed between men and women (Arnegard et al., 2020Arnegard M.E. Whitten L.A. Hunter C. Clayton J.A. Sex as a biological variable: A 5-year progress report and call to action.Journal of Womens Health. 2020; 29: 858-864Crossref PubMed Scopus (151) Google Scholar; Libby et al., 2020Libby A.M. McGinnes H.G. Regensteiner J.G. Educating the scientific workforce on sex and gender considerations in research: A national scan of the literature and building interdisciplinary research careers in women’s health programs.Journal of Womens Health. 2020; 29: 876-885Crossref Scopus (4) Google Scholar). The disparities for women with autoimmune and immune-mediated skin diseases extends beyond biological differences and into systems and policies that underappreciate the external influences on gender that disproportionately shift the burden of disease on women. Common considerations for assessing disease burden toward health care policies and coverage include utilizing measures such as DALYs and quality-adjusted life-years (Silverberg et al., 2019Silverberg J.I. Gelfand J.M. Margolis D.J. Boguniewicz M. Fonacier L. Grayson M.H. Simpson E.L. Health Utility Scores of Atopic Dermatitis in US Adults.Journal of Allergy and Clinical Immunology: In Practice. 2019; 7: 1246-1252.e1Abstract Full Text Full Text PDF PubMed Scopus (48) Google Scholar; Villasante Fricke and Miteva, 2015Villasante Fricke A. Miteva M. Epidemiology and burden of alopecia areata: a systematic review.Clinical, Cosmetic and Investigational Dermatology. 2015; 8: 397-403PubMed Google Scholar). Although DALYs, quality-adjusted life-years, and claims data generate invaluable information, researchers and policymakers should not overly rely on these traditional datasets that fail to convey the full scope of costs associated with disease management—financial, physical, and psychosocial. Data regarding AA, AD, and PsA often lack the downstream effects associated with living with these conditions, such as productivity losses, comorbid disease and mental health care, and out-of-pocket costs incurred by patients and caregivers (Li et al., 2019Li S.J. Mostaghimi A. Tkachenko E. Huang K.P. Association of out-of-pocket health care costs and financial burden for patients with alopecia areata.JAMA Dermatology. 2019; 155: 493-494Crossref PubMed Scopus (32) Google Scholar; Lim et al., 2017Lim H.W. Collins S.A.B. Resneck J.S. Bolognia J.L. Hodge J.A. Rohrer T.A. Moyano J.v. The burden of skin disease in the United States.Journal of the American Academy of Dermatology. 2017; 76: 958-972.e2Abstract Full Text Full Text PDF PubMed Scopus (291) Google Scholar; Vanderpuye-Orgle et al., 2015Vanderpuye-Orgle J. Zhao Y. Lu J. Shrestha A. Sexton A. Seabury S. Lebwohl M. Evaluating the economic burden of psoriasis in the United States.Journal of the American Academy of Dermatology. 2015; 72: 961-967.e5Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar). Moreover, disease burden is not fully captured owing to underdiagnosis of these conditions, which is influenced by barriers to access, consideration for skin of color, and provider expertise, as is often the case with PsA (Lebwohl et al., 2015Lebwohl M.G. Kavanaugh A. Armstrong A.W. van Voorhees A.S. US perspectives in the management of psoriasis and psoriatic arthritis: Patient and physician results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey.American Journal of Clinical Dermatology. 2015; 17: 87-97Crossref Scopus (140) Google Scholar). Such gaps in our understanding of these diseases impact policy decisions across the health system that drive research focus and investment, availability and access to treatments and providers, and insurance coverage. It is possible that the burden of disease and care for AA, AD, and PsA have greater impacts in women than men. For example, the stigma associated with flawed skin and female hair loss can be a fundamental cause of health inequities and negative patient outcomes by increasing the risk of social isolation and marginalization, psychological distress, and delayed or avoided treatment (Hatzenbuehler et al., 2013Hatzenbuehler M.L. Phelan J.C. Link B.G. Stigma as a fundamental cause of population health inequalities.American Journal of Public Health. 2013; 103: 813Crossref PubMed Scopus (1486) Google Scholar). Delays in diagnosis for a condition like PsA can lead to permanent joint damage. Therefore, recognizing and mitigating possible reluctance of patients to discuss symptoms with their providers is crucial to timely diagnosis and effective disease management. For women with AA, the psychosocial effects of hair loss are a significant contributor to lower quality of life and higher rates of depression, anxiety, and self-isolation (Aldhouse et al., 2020Aldhouse N.V.J. Kitchen H. Knight S. Macey J. Nunes F.P. Dutronc Y. Wyrwich K.W. “‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata.Journal of Patient-Reported Outcomes. 2020; 4: 1-12Crossref Scopus (30) Google Scholar; Davis and Callender, 2018Davis D. Callender V. Review of quality of life studies in women with alopecia.International Journal of Women’s Dermatology. 2018; 4: 18-22Crossref PubMed Scopus (52) Google Scholar). Women report limiting social interactions, avoiding new romantic or sexual relationships, and changing or limiting exercise routines owing to embarrassment and self-consciousness. All of these actions can impact physical and mental health (Mostaghimi et al., 2021Mostaghimi A. Napatalung L. Sikirica V. Winnette R. Xenakis J. Zwillich S.H. Gorsh B. Patient perspectives of the social, emotional and functional impact of alopecia areata: A systematic literature review.Dermatology and Therapy. 2021; 11: 867-883Crossref PubMed Scopus (25) Google Scholar). Further, autoimmune and immune-mediated skin disease symptoms and comorbidities can cause moderate to severe sleep disturbance, pain, and discomfort, resulting in absenteeism and presenteeism that limit educational or career attainment (Drucker et al., 2017Drucker A.M. Wang A.R. Li W.Q. Sevetson E. Block J.K. Qureshi A.A. The burden of atopic dermatitis: Summary of a report for the national eczema association.Journal of Investigative Dermatology. 2017; 137: 26-30Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar). It is important for care providers and insurance companies to understand that, for these patients, aides such as cranial protheses (wigs) and medications to improve their skin condition are not merely cosmetic, but important medical treatments for the management of the complex and systemic nature of these diseases. Although wigs are sometimes approved for patients with cancer to decrease the burden of hair loss, many patients with AA find it difficult to gain insurer approval for wigs, despite the possibility of this hair loss being sporadic, recurrent, and sometimes permanent (Mesinkovska et al., 2020Mesinkovska N. King B. Mirmirani P. Ko J. Cassella J. Burden of illness in alopecia areata: A cross-sectional online survey study.Journal of Investigative Dermatology Symposium Proceedings. 2020; 20: S62-S68Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar). Wigs can be costly, and inadequate insurance coverage limits access to this treatment that can effectively reduce psychosocial and financial burden on women patients (Li et al., 2019Li S.J. Mostaghimi A. Tkachenko E. Huang K.P. Association of out-of-pocket health care costs and financial burden for patients with alopecia areata.JAMA Dermatology. 2019; 155: 493-494Crossref PubMed Scopus (32) Google Scholar). When insurance policies fail to recognize the holistic patient experience and needs, it results in policies that compound the burden of autoimmune skin diseases. To fully capture the impact of these autoimmune and immune-mediated skin diseases on women and women's health and to leverage appropriate policy solutions, an acknowledgement of their effects on caregivers is warranted. Studies have shown that women tend to deprioritize their health below the health and well-being of others in their social networks (Donelan et al., 2001Donelan K. Falik M. DesRoches C.M. Caregiving: Challenges and implications for women’s health.Women’s Health Issues. 2001; 11: 185-200Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar). As such, even women with chronic conditions may forgo or be less adherent to long-term treatment management, attempt to save costs by choosing less effective options, or attend appointments inconsistently owing to busy schedules. With diseases of this nature, such behavior choices can lead to disease progression or flares. Furthermore, up to 80% of women are the primary health care decision-makers for their family, and women are often the primary caregivers for their children, partners, and elderly relatives (Matoff-Stepp et al., 2014Matoff-Stepp S. Applebaum B. Pooler J. Kavanagh E. Women as health care decision-makers: Implications for health care coverage in the United States.Journal of Health Care for the Poor and Underserved. 2014; 25: 1507-1513Crossref PubMed Scopus (53) Google Scholar). The weight of this responsibility can place significant mental health and financial burdens on women. Women report lost sleep, insomnia, and the need to decrease work hours, take time off, or leave their jobs altogether owing to the demands of caring for family members with chronic illness (Carroll et al., 2005Carroll C.L. Balkrishnan R. Feldman S.R. Fleischer A.B. Manuel J.C. The burden of atopic dermatitis: Impact on the patient, family, and society.Pediatric Dermatology. 2005; 22: 192-199Crossref PubMed Scopus (400) Google Scholar; Drucker et al., 2017Drucker A.M. Wang A.R. Li W.Q. Sevetson E. Block J.K. Qureshi A.A. The burden of atopic dermatitis: Summary of a report for the national eczema association.Journal of Investigative Dermatology. 2017; 137: 26-30Abstract Full Text Full Text PDF PubMed Scopus (391) Google Scholar). Caregiving can be prohibitive for social interactions and recreational activities, such as exercise or volunteering, and result in feelings of isolation and/or guilt (Meintjes and Nolte, 2015Meintjes K. Nolte A. Parents’ experience of childhood atopic eczema in the public health sector of Gauteng.Curationis. 2015; 38: 1215Crossref Scopus (9) Google Scholar). Autoimmune disorders in the United States are estimated to cost $100 billion per year in direct and indirect health care costs, lost productivity and earnings, and associated costs (Rosenblum et al., 2012Rosenblum M. Gratz I. Paw J. Abbas A. Treating human autoimmunity: Current practice and future prospects.Science Translational Medicine. 2012; 4: 125sr1Crossref PubMed Scopus (147) Google Scholar). A report from the American Academy of Dermatology indicated the direct medical costs were $314 million for AD, $737 million for psoriasis, and $986 million for all hair and nail disorders (Lim et al., 2017Lim H.W. Collins S.A.B. Resneck J.S. Bolognia J.L. Hodge J.A. Rohrer T.A. Moyano J.v. The burden of skin disease in the United States.Journal of the American Academy of Dermatology. 2017; 76: 958-972.e2Abstract Full Text Full Text PDF PubMed Scopus (291) Google Scholar). Managing autoimmune and immune-mediated skin diseases can be a complex and life-long process; each patient is unique and responds to treatments differently. Access to high-quality care will empower patients to make unencumbered decisions about their treatment. Care providers and patients report significant challenges to effective disease treatment and management that are directly related to economic and bureaucratic barriers (Lebwohl et al., 2015Lebwohl M.G. Kavanaugh A. Armstrong A.W. van Voorhees A.S. US perspectives in the management of psoriasis and psoriatic arthritis: Patient and physician results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey.American Journal of Clinical Dermatology. 2015; 17: 87-97Crossref Scopus (140) Google Scholar; Silverberg et al., 2018Silverberg J.I. Gelfand J.M. Margolis D.J. Boguniewicz M. Fonacier L. Grayson M.H. Fuxench Z.C.C. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study.Annals of Allergy, Asthma & Immunology. 2018; 121: 340-347Abstract Full Text Full Text PDF PubMed Scopus (323) Google Scholar). Policymakers and payers must prioritize reducing barriers that can render effective treatments inaccessible, such as high costs and difficulties navigating health insurance processes for both providers and patients. Further, insurance companies implement formulary restrictions (e.g., step therapy and prior authorization) that can require patients to cycle through a regimented series of treatments (even if unsuccessful in the past), which can extend physical and psychological burdens on a patient longer than necessary (Park et al., 2017Park Y. Raza S. George A. Agrawal R. Ko J. The effect of formulary restrictions on patient and payer outcomes: a systematic literature review.Journal of Managed Care Specialty Pharmacy. 2017; 23: 893-901Crossref PubMed Scopus (41) Google Scholar). Step therapy requirements should be decreased or eliminated to improve treatment efficiency and access for autoimmune and immune-mediated skin patients. Nonmedical switching and payer-mandated drug substitution are growing practices by which insurers change the coverage of a patient's medication for reasons unrelated to their health or the efficacy of the current medication (Dolinar et al., 2019Dolinar R. Kohn C. Lavernia F. Nguyen E. The non-medical switching of prescription medications.Postgraduate Medicine. 2019; 131: 335-341Crossref PubMed Scopus (21) Google Scholar). Nonmedical switching is usually exercised to control payer costs and increase profits. Particularly for chronic autoimmune and immune-mediated skin diseases that involve complex interactions across multiple organ systems, switching from one drug to another without medical necessity or patient desire can impede treatment or reverse progress. There is evidence that the more a patient switches from one biologic to another, the less effective later treatments can be and overall costs may actually increase (Nguyen et al., 2016Nguyen E. Weeda E.R. Sobieraj D.M. Bookhart B.K. Piech C.T. Coleman C.I. Impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior: A systematic literature review.Current Medical Research and Opinion. 2016; 32: 1281-1290Crossref PubMed Scopus (37) Google Scholar; Weeda et al., 2019Weeda E.R. Nguyen E. Martin S. Ingham M. Sobieraj D.M. Bookhart B.K. Coleman C.I. The impact of non-medical switching among ambulatory patients: An updated systematic literature review.Journal of Market Access & Health Policy. 2019; 7: 1678563Crossref PubMed Scopus (12) Google Scholar). Moreover, nonmedical switching has been associated with increased use of the health care system through emergency department visits and hospitalizations, additional office visits, and laboratory tests. Studies of autoimmune patients have found that up to 85% of patients do not wish to switch their treatment, but 67% ultimately did because their current treatment was rendered unaffordable. More than one-half of these individuals suffered from gaps in treatment during the administrative transition (Teeple et al., 2019Teeple A. Ginsburg S. Howard L. Huff L. Reynolds C. Walls D. Curtis J. Patient attitudes about non-medical switching to biosimilars: Results from an online patient survey in the United States.Current Medical Research and Opinion. 2019; 35: 603-609Crossref PubMed Scopus (38) Google Scholar). Furthermore, both patients and providers considered such changes to payer coverage policies to be an interference in the provider's ability to administer the most effective personalized treatment plan for their patients (Costa et al., 2020Costa O.S. Salam T. Duhig A. Patel A.A. Cameron A. Voelker J. Coleman C.I. Specialist physician perspectives on non-medical switching of prescription medications.Journal of Market Access & Health Policy. 2020; 8: 1738637Crossref PubMed Scopus (7) Google Scholar). Policy solutions are needed to regulate or restrict the use of practices like step therapy and non-medical switching that create barriers to access to care and hinder the shared decision-making process for quality patient care. Autoimmune and immune-mediated skin diseases affect a growing number of individuals in the United States, and AA, AD, and psoriasis (as well as the most common comorbidity, PsA) are three conditions that differentially impact women. Although each disease has its own unique gaps in research and clinical care, they share common threads in the economic and psychosocial burdens imposed upon women living with these chronic diseases. There are key challenges to which policy reform can reduce barriers to access and health disparities related to these conditions. Policy solutions must go beyond basic claims data to holistically review disease burden and consider the added caregiver burden that affects women's health and quality of life. Reform that raises awareness, encourages research and medical collaborations, protects access to personalized medicine approaches to treatment, and promotes shared decision-making will provide women and their families with the necessary framework to effectively manage autoimmune and immune-mediated skin diseases and improve their quality of life." @default.
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• W4220655780 title "Addressing Autoimmune and Immune-mediated Skin Disease Burden in Women" @default.
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