Suchergebnisse

Biosimilars are new drugs, highly similar copies of biological medicines, equally effective and safe but at lower prices. The aim of this brief review is to provide the current status of biosimilars approved in the European Union for dermatological use. We used PubMed for literature search up to June 2018. The keyword 'biosimilars' was searched and 1,691 items were found. From the 1,691 studies, we included 34 articles in our review. Biologics, biosimilars and generics are different types of drugs. Biosimilars are complex molecules produced by a difficult manufacturing process, and changes in product quality may affect its safety and efficacy. Now, there are 9 biosimilar medicines approved by European Medicines Agency (EMA) for plaque psoriasis and hidradenitis suppurativa: Amgevita, Solymbic, Cyltezo, Imraldi, Benepali, Erelzi, Flixabi, Inflectra and Remsima, and the number is increasing. In 2005, EMA issued the first guidelines for approval of biosimilars. Next-generation biologics, called 'biobetters', have the same target or mechanism of action as previously approved biologics, but they have structural changes and an improved formulation. The debate over the future of biosimilars is far from being finished. The explosive development of biological therapy and the emergence of biosimilars represent a significant success in the effort to provide advanced healthcare to patients all over the world.

Clear cell acanthoma represent a benign solitary epidermal tumor of the clear glycogen containing epithelial cells, which is quite common in dermatologic practice. The etiology of this tumor formation is not known exactly at the moment. Clinically, the lesion appears as a single reddish papule or papule-nodule and the characteristic of this lesion is represented by a peripheral scaling collarette. Although solitary lesions represent the most common form of presentation of the acanthoma with clear cells, less than thirtieth cases of multiple clear cell acanthoma, from two up to four hundred lesions, have been described in the medical literature to date. The diagnosis based on clinical features frequently needs to be supported using a dermoscopy exam and, in most cases, a histopathology exam is required. The treatment consists is complete removal (standard surgical excision, cryotherapy, electrofulguration alone, carbon dioxide laser or shave removal or curettage followed by electrofulguration). For the cases with multiple lesions, cryotherapy, or topical 5- fluorouracil are preferred. We present the case of a 62-year-old male patient, presented to our Dermatology Department for multiple asymptomatic rounded papules and multiple exophytic nodular tumor formations (approximate fifteen), on the lower extremities, which had occurred approximately two years previously and gradually increased in number.

Psoriasis is a chronic inflammatory disease, with multisystemic implications and genetic predisposition, characterized by the development of erythematous, scaling plaques on the skin. Management of moderate to severe psoriasis vulgaris may involve a biological treatment that suppresses the immune system. Because of this, the patients with psoriasis on an immunosuppressive treatment are theoretically at an increased risk of infections, including SARS-CoV2 infection. SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) is responsible for the current pandemic. In Romania, COVID-19 (Coronavirus Disease 19) was first reported on February 26, 2020, by confirming the first patient with SARS-CoV-2 by RT-PCR method. COVID-19 progression was divided into three phases: early infection, pulmonary phase, and hyperinflammatory phase. Although the inhibition of pro-inflammatory cytokines by biologic therapy is detrimental in the viral phase, it seems to be beneficial in the hyperinflammatory phase, by protecting the patients with psoriasis in progressing towards extra-pulmonary manifestations and death. Analyzing the evolution of the 8 cases of patients from our dermatology department – Colentina Clinical Hospital, with generalized psoriasis vulgaris on biologic immunosuppressive treatment and SARS-CoV-2 infection, we observed that they did not develop a more severe form of COVID-19 than the general population. Patients on biologic immunosuppressive treatment are more susceptible to the development of infections, including by SARS-CoV-2, but it was found that the biologic therapy can protect against a more severe type of COVID-19.

Psoriasis is a chronic, immune-mediated inflammatory disease that significantly affects a patient's quality of life. Several systemic complications can influence disease progression and response to treatment. Biological therapy is considered the most effective therapeutic option in treating moderate to severe forms of psoriasis. The success of therapy may depend on its persistence, also known as drug survival. The dermatologist needs to be aware of comorbidities and factors that influence the persistence or discontinuation of biological treatment to make appropriate treatment decisions. We have identified several studies on the persistence of biologic therapy or drug survival in patients with psoriasis and summarized some of the most important issues known to date. In several recently published studies, the survival of ustekinumab is better than TNF‐α inhibitors but lower than ixekizumab. Notably, the studies were performed on a limited number of patients and follow-up time. Moreover, secukinumab appears to have a shorter drug survival than other biological agents, especially in patients with biological experience. A real indicator of therapeutic success could be a high quality of life. Female gender and obesity have been consistently highlighted among the predictors of treatment discontinuation, while psoriatic arthritis could be a predictor of persistence and maintenance of biological therapy. We are currently aiming to improve the therapy for patients treated with biological agents to reduce the pressure on the national public health system.

With recent advances in the understanding of psoriatic disease, it is increasingly considered a systemic inflammatory
condition rather than limited to the skin and joints. A variety of biologics are available today for the treatment of psoriasis, but
with them, characteristics such as rapidity of onset, long-term efficacy, safety profile, and effects on comorbidities differ. We
designed an observational, non-interventional, retrospective study of patients with severe psoriasis receiving biologic treatment
with IL-17 inhibitors and aimed to investigate the correlations between etiopathogenic factors and the efficacy and persistence
of these therapies in a group of psoriasis patients from Romania. Study results show that patients treated with ixekizumab had
better persistence and high adherence compared to those treated with secukinumab. In this study, ixekizumab demonstrated
lower risks of non-persistence, discontinuation, and switching and a higher likelihood of high adherence compared with
secukinumab. This study contributes to the understanding of the persistence of anti-IL17 biologic therapies in psoriasis and the
factors that may influence it.

BACKGROUND: Comprehensive and comparable estimates of health spending in each country are a key input for health policy and planning, and are necessary to support the achievement of national and international health goals. Previous studies have tracked past and projected future health spending until 2040 and shown that, with economic development, countries tend to spend more on health per capita, with a decreasing share of spending from development assistance and out-of-pocket sources. We aimed to characterise the past, present, and predicted future of global health spending, with an emphasis on equity in spending across countries. METHODS: We estimated domestic health spending for 195 countries and territories from 1995 to 2016, split into three categories-government, out-of-pocket, and prepaid private health spending-and estimated development assistance for health (DAH) from 1990 to 2018. We estimated future scenarios of health spending using an ensemble of linear mixed-effects models with time series specifications to project domestic health spending from 2017 through 2050 and DAH from 2019 through 2050. Data were extracted from a broad set of sources tracking health spending and revenue, and were standardised and converted to inflation-adjusted 2018 US dollars. Incomplete or low-quality data were modelled and uncertainty was estimated, leading to a complete data series of total, government, prepaid private, and out-of-pocket health spending, and DAH. Estimates are reported in 2018 US dollars, 2018 purchasing-power parity-adjusted dollars, and as a percentage of gross domestic product. We used demographic decomposition methods to assess a set of factors associated with changes in government health spending between 1995 and 2016 and to examine evidence to support the theory of the health financing transition. We projected two alternative future scenarios based on higher government health spending to assess the potential ability of governments to generate more resources for health. FINDINGS: Between 1995 and 2016, health spending grew at a rate of 4·00% (95% uncertainty interval 3·89-4·12) annually, although it grew slower in per capita terms (2·72% [2·61-2·84]) and increased by less than $1 per capita over this period in 22 of 195 countries. The highest annual growth rates in per capita health spending were observed in upper-middle-income countries (5·55% [5·18-5·95]), mainly due to growth in government health spending, and in lower-middle-income countries (3·71% [3·10-4·34]), mainly from DAH. Health spending globally reached $8·0 trillion (7·8-8·1) in 2016 (comprising 8·6% [8·4-8·7] of the global economy and $10·3 trillion [10·1-10·6] in purchasing-power parity-adjusted dollars), with a per capita spending of US$5252 (5184-5319) in high-income countries, $491 (461-524) in upper-middle-income countries, $81 (74-89) in lower-middle-income countries, and $40 (38-43) in low-income countries. In 2016, 0·4% (0·3-0·4) of health spending globally was in low-income countries, despite these countries comprising 10·0% of the global population. In 2018, the largest proportion of DAH targeted HIV/AIDS ($9·5 billion, 24·3% of total DAH), although spending on other infectious diseases (excluding tuberculosis and malaria) grew fastest from 2010 to 2018 (6·27% per year). The leading sources of DAH were the USA and private philanthropy (excluding corporate donations and the Bill & Melinda Gates Foundation). For the first time, we included estimates of China's contribution to DAH ($644·7 million in 2018). Globally, health spending is projected to increase to $15·0 trillion (14·0-16·0) by 2050 (reaching 9·4% [7·6-11·3] of the global economy and $21·3 trillion [19·8-23·1] in purchasing-power parity-adjusted dollars), but at a lower growth rate of 1·84% (1·68-2·02) annually, and with continuing disparities in spending between countries. In 2050, we estimate that 0·6% (0·6-0·7) of health spending will occur in currently low-income countries, despite these countries comprising an estimated 15·7% of the global population by 2050. The ratio between per capita health spending in high-income and low-income countries was 130·2 (122·9-136·9) in 2016 and is projected to remain at similar levels in 2050 (125·9 [113·7-138·1]). The decomposition analysis identified governments' increased prioritisation of the health sector and economic development as the strongest factors associated with increases in government health spending globally. Future government health spending scenarios suggest that, with greater prioritisation of the health sector and increased government spending, health spending per capita could more than double, with greater impacts in countries that currently have the lowest levels of government health spending. INTERPRETATION: Financing for global health has increased steadily over the past two decades and is projected to continue increasing in the future, although at a slower pace of growth and with persistent disparities in per-capita health spending between countries. Out-of-pocket spending is projected to remain substantial outside of high-income countries. Many low-income countries are expected to remain dependent on development assistance, although with greater government spending, larger investments in health are feasible. In the absence of sustained new investments in health, increasing efficiency in health spending is essential to meet global health targets. FUNDING: Bill & Melinda Gates Foundation. ; Bill & Melinda Gates Foundation ; Sí

Importance: Cancer and other noncommunicable diseases (NCDs) are now widely recognized as a threat to global development. The latest United Nations high-level meeting on NCDs reaffirmed this observation and also highlighted the slow progress in meeting the 2011 Political Declaration on the Prevention and Control of Noncommunicable Diseases and the third Sustainable Development Goal. Lack of situational analyses, priority setting, and budgeting have been identified as major obstacles in achieving these goals. All of these have in common that they require information on the local cancer epidemiology. The Global Burden of Disease (GBD) study is uniquely poised to provide these crucial data. Objective: To describe cancer burden for 29 cancer groups in 195 countries from 1990 through 2017 to provide data needed for cancer control planning. Evidence Review: We used the GBD study estimation methods to describe cancer incidence, mortality, years lived with disability, years of life lost, and disability-adjusted life-years (DALYs). Results are presented at the national level as well as by Socio-demographic Index (SDI), a composite indicator of income, educational attainment, and total fertility rate. We also analyzed the influence of the epidemiological vs the demographic transition on cancer incidence. Findings: In 2017, there were 24.5 million incident cancer cases worldwide (16.8 million without nonmelanoma skin cancer [NMSC]) and 9.6 million cancer deaths. The majority of cancer DALYs came from years of life lost (97%), and only 3% came from years lived with disability. The odds of developing cancer were the lowest in the low SDI quintile (1 in 7) and the highest in the high SDI quintile (1 in 2) for both sexes. In 2017, the most common incident cancers in men were NMSC (4.3 million incident cases); tracheal, bronchus, and lung (TBL) cancer (1.5 million incident cases); and prostate cancer (1.3 million incident cases). The most common causes of cancer deaths and DALYs for men were TBL cancer (1.3 million deaths and 28.4 million DALYs), liver cancer (572000 deaths and 15.2 million DALYs), and stomach cancer (542000 deaths and 12.2 million DALYs). For women in 2017, the most common incident cancers were NMSC (3.3 million incident cases), breast cancer (1.9 million incident cases), and colorectal cancer (819000 incident cases). The leading causes of cancer deaths and DALYs for women were breast cancer (601000 deaths and 17.4 million DALYs), TBL cancer (596000 deaths and 12.6 million DALYs), and colorectal cancer (414000 deaths and 8.3 million DALYs). Conclusions and Relevance: The national epidemiological profiles of cancer burden in the GBD study show large heterogeneities, which are a reflection of different exposures to risk factors, economic settings, lifestyles, and access to care and screening. The GBD study can be used by policy makers and other stakeholders to develop and improve national and local cancer control in order to achieve the global targets and improve equity in cancer care.

Importance Cancer and other noncommunicable diseases (NCDs) are now widely recognized as a threat to global development. The latest United Nations high-level meeting on NCDs reaffirmed this observation and also highlighted the slow progress in meeting the 2011 Political Declaration on the Prevention and Control of Noncommunicable Diseases and the third Sustainable Development Goal. Lack of situational analyses, priority setting, and budgeting have been identified as major obstacles in achieving these goals. All of these have in common that they require information on the local cancer epidemiology. The Global Burden of Disease (GBD) study is uniquely poised to provide these crucial data. Objective To describe cancer burden for 29 cancer groups in 195 countries from 1990 through 2017 to provide data needed for cancer control planning. Evidence Review We used the GBD study estimation methods to describe cancer incidence, mortality, years lived with disability, years of life lost, and disability-adjusted life-years (DALYs). Results are presented at the national level as well as by Socio-demographic Index (SDI), a composite indicator of income, educational attainment, and total fertility rate. We also analyzed the influence of the epidemiological vs the demographic transition on cancer incidence. Findings In 2017, there were 24.5 million incident cancer cases worldwide (16.8 million without nonmelanoma skin cancer [NMSC]) and 9.6 million cancer deaths. The majority of cancer DALYs came from years of life lost (97%), and only 3% came from years lived with disability. The odds of developing cancer were the lowest in the low SDI quintile (1 in 7) and the highest in the high SDI quintile (1 in 2) for both sexes. In 2017, the most common incident cancers in men were NMSC (4.3 million incident cases); tracheal, bronchus, and lung (TBL) cancer (1.5 million incident cases); and prostate cancer (1.3 million incident cases). The most common causes of cancer deaths and DALYs for men were TBL cancer (1.3 million deaths and 28.4 million DALYs), liver cancer (572 000 deaths and 15.2 million DALYs), and stomach cancer (542 000 deaths and 12.2 million DALYs). For women in 2017, the most common incident cancers were NMSC (3.3 million incident cases), breast cancer (1.9 million incident cases), and colorectal cancer (819 000 incident cases). The leading causes of cancer deaths and DALYs for women were breast cancer (601 000 deaths and 17.4 million DALYs), TBL cancer (596 000 deaths and 12.6 million DALYs), and colorectal cancer (414 000 deaths and 8.3 million DALYs). Conclusions and Relevance The national epidemiological profiles of cancer burden in the GBD study show large heterogeneities, which are a reflection of different exposures to risk factors, economic settings, lifestyles, and access to care and screening. The GBD study can be used by policy makers and other stakeholders to develop and improve national and local cancer control in order to achieve the global targets and improve equity in cancer

The content is solely the responsibility of the authors and does not necessarily represent the official views of the funders. Data for this research was provided by MEASURE Evaluation, funded by the United States Agency for International Development (USAID). Views expressed do not necessarily reflect those of USAID, the US Government, or MEASURE Evaluation. The Palestinian Central Bureau of Statistics granted the researchers access to relevant data in accordance with licence no. SLN2014-3-170, after subjecting data to processing aiming to preserve the confidentiality of individual data in accordance with the General Statistics Law-2000. The researchers are solely responsible for the conclusions and inferences drawn upon available data. ; Background Assessments of age-specific mortality and life expectancy have been done by the UN Population Division, Department of Economics and Social Affairs (UNPOP), the United States Census Bureau, WHO, and as part of previous iterations of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD). Previous iterations of the GBD used population estimates from UNPOP, which were not derived in a way that was internally consistent with the estimates of the numbers of deaths in the GBD. The present iteration of the GBD, GBD 2017, improves on previous assessments and provides timely estimates of the mortality experience of populations globally. Methods The GBD uses all available data to produce estimates of mortality rates between 1950 and 2017 for 23 age groups, both sexes, and 918 locations, including 195 countries and territories and subnational locations for 16 countries. Data used include vital registration systems, sample registration systems, household surveys (complete birth histories, summary birth histories, sibling histories), censuses (summary birth histories, household deaths), and Demographic Surveillance Sites. In total, this analysis used 8259 data sources. Estimates of the probability of death between birth and the age of 5 years and between ages 15 and 60 years are generated and then input into a model life table system to produce complete life tables for all locations and years. Fatal discontinuities and mortality due to HIV/AIDS are analysed separately and then incorporated into the estimation. We analyse the relationship between age-specific mortality and development status using the Socio-demographic Index, a composite measure based on fertility under the age of 25 years, education, and income. There are four main methodological improvements in GBD 2017 compared with GBD 2016: 622 additional data sources have been incorporated; new estimates of population, generated by the GBD study, are used; statistical methods used in different components of the analysis have been further standardised and improved; and the analysis has been extended backwards in time by two decades to start in 1950. Findings Globally, 18·7% (95% uncertainty interval 18·4–19·0) of deaths were registered in 1950 and that proportion has been steadily increasing since, with 58·8% (58·2–59·3) of all deaths being registered in 2015. At the global level, between 1950 and 2017, life expectancy increased from 48·1 years (46·5–49·6) to 70·5 years (70·1–70·8) for men and from 52·9 years (51·7–54·0) to 75·6 years (75·3–75·9) for women. Despite this overall progress, there remains substantial variation in life expectancy at birth in 2017, which ranges from 49·1 years (46·5–51·7) for men in the Central African Republic to 87·6 years (86·9–88·1) among women in Singapore. The greatest progress across age groups was for children younger than 5 years; under-5 mortality dropped from 216·0 deaths (196·3–238·1) per 1000 livebirths in 1950 to 38·9 deaths (35·6–42·83) per 1000 livebirths in 2017, with huge reductions across countries. Nevertheless, there were still 5·4 million (5·2–5·6) deaths among children younger than 5 years in the world in 2017. Progress has been less pronounced and more variable for adults, especially for adult males, who had stagnant or increasing mortality rates in several countries. The gap between male and female life expectancy between 1950 and 2017, while relatively stable at the global level, shows distinctive patterns across super-regions and has consistently been the largest in central Europe, eastern Europe, and central Asia, and smallest in south Asia. Performance was also variable across countries and time in observed mortality rates compared with those expected on the basis of development. Interpretation This analysis of age-sex-specific mortality shows that there are remarkably complex patterns in population mortality across countries. The findings of this study highlight global successes, such as the large decline in under-5 mortality, which reflects significant local, national, and global commitment and investment over several decades. However, they also bring attention to mortality patterns that are a cause for concern, particularly among adult men and, to a lesser extent, women, whose mortality rates have stagnated in many countries over the time period of this study, and in some cases are increasing. ; Research reported in this publication was supported by the Bill & Melinda Gates Foundation, the University of Melbourne, Public Health England, the Norwegian Institute of Public Health, St. Jude Children's Research Hospital, the National Institute on Aging of the National Institutes of Health (award P30AG047845), and the National Institute of Mental Health of the National Institutes of Health (award R01MH110163). ; Peer reviewed