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1.
Postepy Dermatol Alergol ; 36(5): 589-594, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31839776

RESUMO

Introduction: Antidrug antibody (ADA) production may be the reason behind secondary inefficacy of anti-TNF-α therapy in psoriasis. Aim: To investigate the production of ADA, serum tumor necrosis factor α (TNF-α) and drug levels as predictors of clinical response in real-life circumstances. Material and methods: Serum drug concentrations (TNFi), the presence of ADAs and serum TNF-α levels were measured in 158 patients by the ELISA method. Clinical response was evaluated by calculating PASI. Their correlation has been statistically analysed. Results: In adalimumab and infliximab treated patients, ADA formation was observed in 18.4% and 33%, respectively, and the serum TNFi concentration was significantly higher in the ADA negative groups. In contrast there was no ADA formation detected among etanercept treated patients. The serum TNFi concentration was significantly lower among non-responders (n = 33). The serum TNF-α level was also measured and the correlation with the concentration of the serum TNFi level was analysed. Having evaluated the results of all patients together, the serum TNFi and TNF-α concentrations showed a significant negative correlation. However, when groups were analysed separately, in case of adalimumab, a significant negative correlation was detected between serum TNFi and TNF-α concentrations. With respect to infliximab, there was no significant correlation, and an inverse correlation was found in the etanercept group. The TNF-α levels and ADA positivity were significantly higher in non-responders. Conclusions: This study revealed the major role of ADAs against TNFi in case of secondary inefficacy in real-life circumstances. ADA levels show a stronger correlation with PASI failure than serum TNFi or TNF-α levels.

2.
Expert Rev Pharmacoecon Outcomes Res ; 19(5): 537-549, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31340686

RESUMO

Introduction: Early biological treatment of rheumatoid arthritis (RA) may reverse the autoimmune response in some patients resulting in favorable long-term outcomes. Although the cost-effectiveness of this strategy has been questioned, biosimilar entries warrant the revision of clinical and pharmaco-economic evidence. Areas covered: We conducted a systematic review of randomized controlled trials (RCTs) published up to 24 May 2018 in Pubmed, EMBASE and Cochrane CENTRAL, comparing infliximab with non-biological therapy in patients with RA naïve to methotrexate. We performed meta-analyses for efficacy outcomes at month 6 and years 1 and 2. Six RCTs were identified, involving 1832 patients. At month 6 ACR70 response and remission, and at year 1 ACR20/ACR70 responses and remission were improved significantly with first-line infliximab versus control. The differences were not significant at year 2. We reviewed cost-utility studies, up to 31 October 2018 in PubMed, Cochrane CENTRAL and the CRD HTA databases. Four studies indicated that first-line use of originator infliximab calculated at 2005-2008 prices was not cost-effective. Expert opinion: We demonstrated the efficacy benefits of first-line infliximab therapy up to 1 year in methotrexate-naïve RA. We highlighted the need for standardized reporting of outcomes and conducting cost-effectiveness analyses of first-line biosimilar therapy in RA.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Infliximab/administração & dosagem , Antirreumáticos/economia , Artrite Reumatoide/economia , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/economia , Análise Custo-Benefício , Farmacoeconomia , Humanos , Infliximab/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento
3.
Eur J Health Econ ; 20(Suppl 1): 119-132, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31104218

RESUMO

BACKGROUND: In the Central and Eastern European region, the British EQ-5D-3L value set is used commonly in quality of life (QoL) studies. Only Poland and Slovenia have country-specific weights. Our study aimed to investigate the impact of value set choice on the evaluation of 18 chronic conditions in Hungary. METHODS: Patients' EQ-5D-3L index scores were calculated using the VAS-based Slovenian and European and the time-trade-off-based Polish and British value sets. We performed pairwise comparisons of mean index values by dimensions, diagnoses and age groups. We evaluated disease burden by comparing index values matched by age and gender in each condition with those of the general population of the CEE region in all four value sets. RESULTS: Altogether, 2421 patients (55% female) were included in our sample with the average age of 55.87 years (SD = 17.75). The average Slovenian, European, Polish and British EQ-5D-3L scores were 0.598 (SD = 0.279), 0.661 (SD = 0.257), 0.770 (SD = 0.261) and 0.644 (SD = 0.279), respectively. We found highly significant differences in most diagnoses, with the greatest difference between the Polish and Slovenian index values in Parkinson's disease (0.265). Systematic pairwise comparison across all conditions and value sets revealed greatest differences between the time-trade-off (TTO) and VAS-based value sets as well as varying sensitivity of the disease burden evaluations of chronic disease conditions to the choice of value sets. CONCLUSIONS: Our results suggest that the choice of value set largely influences the health state utility results in chronic diseases, and might have a significant impact on health policy decisions.


Assuntos
Doença Crônica/psicologia , Qualidade de Vida/psicologia , Inquéritos e Questionários/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Europa (Continente) , Europa Oriental , Feminino , Humanos , Hungria , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença
4.
Eur J Health Econ ; 20(Suppl 1): 155-172, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31104219

RESUMO

BACKGROUND: To date, a multi-country review evaluating the cost-of-illness (COI) studies from the Central and Eastern European (CEE) region has not yet been published. Our main objective was to provide a general description about published COI studies from CEE. METHODS: A systematic search was performed between 1 January 2006 and 1 June 2017 in Medline, EMBASE, The Cochrane Library, CINAHL, and Web of Science to identify all relevant COI studies from nine CEE countries. COI studies reporting costs without any restrictions by age, co-morbidities, or treatment were included. Methodology, publication standards, and cost results were analysed. RESULTS: We identified 58 studies providing 83 country-specific COI results: Austria (n = 9), Bulgaria (n = 16), Croatia (n = 3), the Czech Republic (n = 10), Hungary (n = 24), Poland (n = 11), Romania (n = 3), Slovakia (n = 3), and Slovenia (n = 4). Endocrine, nutritional, and metabolic diseases (18%), neoplasms (12%), infections (11%), and neurological disorders (11%) were the most frequently studied clinical areas, and multiple sclerosis was the most commonly studied disease. Overall, 57 (98%) of the studies explicitly stated the source of resource use data, 45 (78%) the study perspective, 34 (64%) the costing method, and 24 (58%) reported at least one unit costs. Regardless of methodological differences, a positive relationship was observed between costs of diseases and countries' per capita GDP. CONCLUSIONS: Cost-of-illness studies varied considerably in terms of methodology, publication practice, and clinical areas. Due to these heterogeneities, transferability of the COI results is limited across Central and Eastern European countries.


Assuntos
Efeitos Psicossociais da Doença , Doença/economia , Europa (Continente) , Europa Oriental , Humanos , Modelos Econômicos
5.
Eur J Health Econ ; 20(Suppl 1): 31-41, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31111401

RESUMO

BACKGROUND: We aimed to determine the acceptability of non-perfect health states with age using the EQ VAS and analyse the influencing factors. METHODS: We conducted a cross-sectional survey on a convenience sample from the general population (N = 200). Respondents were asked to indicate on the EQ VAS the health states that are still acceptable for ages between 30 and 80 years in 10-year intervals (VAS acceptable health curve, AHCvas). We recorded respondents' current health, health-related lifestyle, demographic background and explored the reference person they imagined when evaluating acceptable health states. We evaluated the AHCvas by estimating linear multilevel models including a random intercept (estimated at age 30) and a random slope for age. RESULTS: AHCvas scores were available for 194 respondents (mean age = 42.8 years, range 19-93, 58% female). For ages of 30, 40, 50, 60, 70 and 80 years, mean AHCvas scores were 93, 87, 80, 73, 65 and 57, respectively. The decline of AHCvas was linear with age. Respondents' age, health status, lifestyle and health-related experiences, as well as their reference point taken (e.g. imagining themselves, others or both during the valuation task) influenced significantly the acceptability of health problems. CONCLUSIONS: When measured with the EQ VAS, health problems were increasingly acceptable with age. Capturing well the individual variability in the assessment of acceptable health states at different ages, the EQ VAS is a useful addition to EQ-5D-3L descriptive system-based measures of acceptable health.


Assuntos
Envelhecimento/fisiologia , Envelhecimento/psicologia , Nível de Saúde , Estilo de Vida , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Hungria , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Fatores Socioeconômicos
6.
Eur J Health Econ ; 20(Suppl 1): 43-55, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31111402

RESUMO

BACKGROUND: The nine-item Shared Decision Making Questionnaire (SDM-Q-9) is one of the most frequently applied instruments for assessing patients' involvement in medical decision-making. Our objectives were to develop a Hungarian version of SDM-Q-9, to evaluate its psychometric properties and to compare its performance between primary and specialised care settings. METHODS: In 2019, a sample of adults (n = 537) representative of the Hungarian general population in terms of age, gender and geographic region completed an online survey with respect to a recent health-related decision. Outcome measures included SDM-Q-9 and Control Preferences Scale-post (CPSpost). Item characteristics, internal consistency reliability and the factor structure of SDM-Q-9 were determined. RESULTS: The overall ceiling and floor effects for SDM-Q-9 total scores were 12.3% and 2.2%, respectively. An excellent internal consistency reliability (Cronbach's alpha 0.925) was demonstrated. Exploratory factor analysis resulted in a one-factor model explaining 63.5% of the variance of SDM-Q-9. A confirmatory factor analysis supported the acceptability of this model. Known-groups validity was confirmed with CPSpost categories; mean SDM-Q-9 total scores were higher in the 'Shared decision' category (72.6) compared to both 'Physician decided' (55.1, p = 0.0002) and 'Patient decided' (57.2, p = 0.0086) categories. In most aspects of validity and reliability, there was no statistically significant difference between primary and specialised care. CONCLUSIONS: The overall good measurement properties of the Hungarian SDM-Q-9 make the questionnaire suitable for use in both primary and specialised care settings. SDM-Q-9 may be useful for health policies targeting the implementation of shared decision-making and aiming to improve efficiency and quality of care in Hungary.


Assuntos
Participação do Paciente , Inquéritos e Questionários/normas , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Análise Fatorial , Feminino , Humanos , Hungria , Masculino , Pessoa de Meia-Idade , Relações Médico-Paciente , Psicometria , Reprodutibilidade dos Testes , Fatores Sexuais , Fatores Socioeconômicos , Adulto Jovem
7.
Eur J Health Econ ; 20(Suppl 1): 17-30, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31111403

RESUMO

BACKGROUND: We aimed to investigate individuals' subjective expectations regarding health and happiness alongside their provisions on life circumstances for older ages. METHODS: A cross-sectional online survey was performed involving a representative sample (N = 1000; mean age 50.9, SD = 15.4; female 54.5%) in Hungary. Subjective expectations on health status (EQ-5D-3L/-5L, GALI, WHO-5), happiness (0-10 VAS), employment status, care time, and forms of care for ages 60, 70, 80, and 90 were surveyed. RESULTS: Current mean EQ-5D-5L was 0.869 (SD = 0.164) and happiness was 6.7 (SD = 2.4). Subjective life expectancy was 80.9 (SD = 11.1), and median expected retirement age was 65. Mean expected EQ-5D-5L for ages 60/70/80/90 was 0.761/0.684/0.554/0.402, and no activity limitations (GALI) were expected by 64%/40%/18%/14%, respectively. Expected happiness score was 6.8/6.7/6.2/5.7, and a decrease in mental well-being (WHO-5) was provisioned. A substantial increase in drug expenses and care time was anticipated, but only 52% thought to have extra income besides pension. The great majority expected to be helped by the family (77%/72%/53%/40%) if needed. Educational level, GALI, and longevity expectations were significant predictors of EQ-5D-5L expectations using a standard 5% significance level of decision. Current happiness was major determinant of expected future happiness. CONCLUSIONS: Individuals expect a significant deterioration of health with age but only a moderate decrease in happiness. Overestimation of future activity limitations suggests a gap between statistical and subjective healthy life expectancy. The majority expects to rely on informal care in the elderly. Raise in retirement age is underestimated. Our results can be used as inputs for economic modelling of labor force participation and ageing.


Assuntos
Envelhecimento/psicologia , Felicidade , Nível de Saúde , Saúde Mental , Qualidade de Vida , Atividades Cotidianas , Adolescente , Adulto , Idoso , Estudos Transversais , Honorários Farmacêuticos , Feminino , Gastos em Saúde , Humanos , Hungria , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , Fatores Socioeconômicos , Adulto Jovem
8.
Eur J Health Econ ; 20(Suppl 1): 91-100, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31102158

RESUMO

BACKGROUND: In patients with Crohn's disease (CD), luminal disease activity paralleled by perianal fistulas may seriously impair health-related quality of life (HRQoL). Health utility values are not available from patients with CD that reflect the health loss associated with both luminal and perianal CD. OBJECTIVE: To generate utilities for luminal and concomitant perianal fistulising CD health states directly from patients and from members of the general public. METHODS: A cross-sectional survey was undertaken enrolling CD patients and a convenience sample of members of the general population. Respondents were asked to evaluate four common CD heath states [severe luminal disease (sCD), mild luminal disease (mCD), severe luminal disease with active perianal fistulas (sPFCD), and mild luminal disease with active perianal fistulas (mPFCD)] by 10-year time trade-off (TTO). In addition, patients assessed their current HRQoL by the TTO method. RESULTS: Responses of 206 patients (40.8% with perianal fistulas) and 221 members of the general population were analysed. Mean ± SD utilities among patients for sPFCD, sCD, mPFCD and mCD states were 0.69 ± 0.33, 0.73 ± 0.31, 0.80 ± 0.29 and 0.87 ± 0.26. Corresponding values in the general public were: 0.59 ± 0.31, 0.65 ± 0.29, 0.80 ± 0.26 and 0.88 ± 0.25. Patients with active perianal fistulas, previous non-resection surgeries, and higher pain intensity scores valued their current health as worse (p < 0.05). CONCLUSIONS: TTO is a feasible method to assess HRQoL in patients with perianal fistulising disease, often not captured by health status questionnaires. Utilities from this study are intended to support the optimization of treatment-related decision making in patients with luminal disease paralleled by active perianal fistulas.


Assuntos
Doenças do Ânus/etiologia , Doença de Crohn/complicações , Fístula do Sistema Digestório/etiologia , Qualidade de Vida/psicologia , Adolescente , Adulto , Fatores Etários , Doenças do Ânus/patologia , Doenças do Ânus/psicologia , Doença de Crohn/patologia , Doença de Crohn/psicologia , Estudos Transversais , Fístula do Sistema Digestório/patologia , Fístula do Sistema Digestório/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Fatores Sexuais , Fatores Socioeconômicos , Adulto Jovem
9.
Eur J Health Econ ; 20(Suppl 1): 141-154, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31102159

RESUMO

BACKGROUND: EQ-5D-3L population data are available only from Hungary, Poland and Slovenia in Central and Eastern Europe (CEE). We aimed to compare the accessible studies and estimate a regional EQ-5D-3L population norm for CEE. METHODS: A combined dataset using patient-level data of 8850 respondents was created. Based on the European Census of 2011, regional population norm estimates were calibrated by gender, age and education for the joint citizenry of 11 CEE countries. RESULTS: EQ-5D-3L health states were available for 6926 and EQ VAS scores for 6569 respondents. Demographic characteristics of the samples reflected the recruitment methods (Hungary: online; Slovenia: postal survey, Poland: personal interviews). Occurrence of problems differed significantly by educational level in all the five dimensions (p < 0.001). The inter-country differences persisted after controlling for demographic variables. The estimated EQ-5D-3L index CEE norms with UK tariffs for age groups 18-24, 25-34, 35-44, 45-54, 55-64, 65-74 and 75 + were 0.911, 0.912, 0.871, 0.817, 0.762, 0.743 and 0.636 for males and 0.908, 0.888, 0.867, 0.788, 0.752, 0.68 and 0.584 for females, respectively. Estimates were provided also using Polish, European and Slovenian value sets. CONCLUSIONS: Besides gender and age, education should be considered during the design and interpretation of quality-of-life studies in CEE. The estimated regional EQ-5D-3L population norm may be used as a benchmark by CEE countries with lack of local dataset. However, the substantial inter-country differences in health status and scarcity of data over age 65 call for harmonized country-specific EQ-5D-3L population norm studies in the CEE region.


Assuntos
Nível de Saúde , Qualidade de Vida , Inquéritos e Questionários/normas , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comparação Transcultural , Escolaridade , Europa Oriental , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Adulto Jovem
10.
Eur J Health Econ ; 20(Suppl 1): 109-117, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31098882

RESUMO

BACKROUND: Guidelines for economic analyses of health care technologies require local input data for reimbursement decisions in the countries of Central and Eastern Europe (CEE). The aim of this study was to systematically review and analyse the available empirical studies using the EQ-5D instrument as a measure of the health-related quality of life (HRQoL) in patients with neurological diseases. METHODS: A systematic literature search was performed up to 1st April 2018 to identify relevant studies in eight selected CEE countries. Original articles reporting on studies of neurological diseases using the EQ-5D instrument were analysed. RESULTS: Thirty-six articles, describing the results of 38 samples of patients and a total of 13,005 patients were included in the review. Most studies were from Hungary (44.4%) and none from Romania or Slovakia. EQ-5D utility scores were reported in 33 (91.7%) articles. In multiple sclerosis (MS) being the most represented disease, the average utility scores ranged from 0.49 in Austria to 0.80 in Poland with a weighted average of 0.69. EQ VAS scores for MS ranged from 39 in Czech Republic to 72.0 in Poland, with weighted average of 59.1. MS patients, together with epilepsy and essential tremor patients, estimated their HRQoL among the highest. CONCLUSIONS: EQ-5D research activity in neurology has been increasing through the years in studied CEE countries. There are clinical areas with the significant social burden, such as a migraine or meningitis, that are completely lacking data, other areas, such as stroke or epilepsy, with very scarce data.


Assuntos
Doenças do Sistema Nervoso/epidemiologia , Doenças do Sistema Nervoso/psicologia , Qualidade de Vida/psicologia , Atividades Cotidianas , Europa (Continente)/epidemiologia , Europa Oriental/epidemiologia , Humanos , Saúde Mental , Dor/epidemiologia , Desempenho Físico Funcional , Autocuidado , Índice de Gravidade de Doença
11.
Eur J Health Econ ; 20(Suppl 1): 101-107, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31098885

RESUMO

BACKGROUND: Pemphigus is a chronic autoimmune blistering disease of the skin and mucosa severely impairing patients' health-related quality of life (HRQoL). To date, no studies have measured subjective well-being in terms of life satisfaction in pemphigus. Our main objective was to evaluate satisfaction with life in patients with pemphigus, and to analyse its relationship with clinical severity and HRQoL. METHODS: A cross-sectional survey was carried out enrolling 77 patients with pemphigus. Subjective well-being was measured using the Satisfaction with Life Scale (SWLS). HRQoL was assessed by the Dermatology Life Quality Index (DLQI) and EQ-5D-5L. Disease severity was measured by Autoimmune Bullous Skin Disorder Intensity Score (ABSIS). RESULTS: Mean ABSIS, DLQI, EQ-5D-5L and SWLS scores of patients were 11.7 (SD 17.3), 5.4 (6.8), 0.84 (0.22) and 4.76 (SD 1.52), respectively. The proportion of patients indicating extreme dissatisfaction, dissatisfaction, slightly below average in life satisfaction, average satisfaction, high satisfaction and very high satisfaction with life was 6 (7.8%), 5 (6.5%), 14 (18.2%), 16 (20.8%), 21 (27.3%) and 15 (19.5%), respectively. Life satisfaction was independent from age, gender, level of education and type of disease. A path analysis revealed that there was no direct relationship between ABSIS and SWLS (beta = - 0.09; p = 0.428); however, the following indirect path was confirmed: ABSIS → DLQI → EQ-5D-5L → SWLS. CONCLUSIONS: Disease severity and HRQoL measures regularly used to assess patients' health status may be complemented with a measure of subjective well-being, such as SWLS, to achieve a more holistic assessment of patients' lives and optimise pemphigus care.


Assuntos
Pênfigo/psicologia , Qualidade de Vida , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pênfigo/patologia , Satisfação Pessoal , Índice de Gravidade de Doença
12.
Eur J Health Econ ; 20(Suppl 1): 133-140, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31098886

RESUMO

BACKGROUND: The recent update of the European Union's (EU) regulation on public procurement has created new opportunity for progress in the purchasing of medical devices by shifting towards focus on value from one purely on price. Patient-reported outcome measures (PROMs) may serve as additional tools for manufacturers to demonstrate value beyond traditional metrics of safety and performance and to differentiate their products in a market of increasing competition. The aim of our study was to investigate the extent to which PROMs are included in registered device studies in the EU and interpret the results in the context of the purchasing of medical devices. METHODS: Twelve device groups were searched in clinical trial registries to determine the frequency distribution of PROMs in related studies. RESULTS: Results indicate that clinical studies of the selected device categories are done predominately in the western EU nations and are increasingly including PROMs. In the United Kingdom 121 (65%) study, out of 186 included PROMs, and in Germany, 92 (52%) out of 178 between 1998 and 2018. Few device studies were done in the Central and Eastern European region, and out of 76 studies 27 (35%) included PROMs. Since there is no requirement to include PROMs in device studies for regulatory purposes, it seems probable that their increasing use is driven by competitive market pressures. CONCLUSION: The trend of increasing use of PROMs might be driven by the demand of purchasers to demonstrate value of devices, but is manifested at different levels in various regions of the EU.


Assuntos
Ensaios Clínicos como Assunto/métodos , Equipamentos e Provisões/economia , Medidas de Resultados Relatados pelo Paciente , Aquisição Baseada em Valor/tendências , Europa (Continente) , Humanos
13.
Adv Ther ; 36(3): 721-745, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30637590

RESUMO

INTRODUCTION: Synthesis of evidence on the long-term use of first-line biologic therapy in patients with early rheumatoid arthritis (RA) is required. We compared the efficacy of up to 5 years' treatment with first-line tumor necrosis factor inhibitors (TNFis) versus other treatment strategies in this population. METHODS: Previous systematic reviews, PubMed and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials (RCTs) involving treatment of methotrexate-naïve RA patients with first-line TNFis. Literature was synthesized qualitatively, and a meta-analysis conducted to evaluate American College of Rheumatology (ACR) responses, clinical remission defined by any standard measure, and Health Assessment Questionnaire Disability Index (HAQ) at Years 2 and/or 5. RESULTS: Ten RCTs involving 4306 patients [first-line TNFi, n = 2234; other treatment strategies (control), n = 2072] were included in the meta-analysis. Three studies were double-blind for the first 2 years, while seven were partly/completely open label during this period. Five studies reported data at Year 5; all were open label at this time point. At Year 2, ACR50 response, ACR70 response and remission rates were significantly improved with first-line TNFi versus control in double-blind RCTs [log-odds ratio (OR) 0.32 [95% confidence interval (CI) 0.02, 0.62; p = 0.035], log-OR 0.48 (95% CI 0.20, 0.77; p = 0.001), and log-OR 0.44 (95% CI 0.13, 0.74; p = 0.005), respectively], but not in open-label studies. No significant between-group differences were observed in mean HAQ at Year 2 in double-blind or open-label RCTs or in ACR response or remission outcomes at Year 5. CONCLUSION: In double-blind studies, 2-year efficacy outcomes were significantly improved with first-line TNFi versus other treatment strategies in patients with MTX-naïve RA. No significant differences in these outcomes were observed when data from open-label RCTs were considered on their own. Further data on the efficacy of TNFi therapy over ≥ 2 years in patients with methotrexate-naïve RA are required. Plain language summary available for this article.

14.
Qual Life Res ; 28(1): 141-152, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30225788

RESUMO

PURPOSE: The EuroQol five-dimension questionnaire (EQ-5D) is the most commonly used instrument to obtain utility values for cost-effectiveness analyses of treatments for Crohn's disease (CD). We aimed to compare the measurement properties of the two adult versions of EQ-5D (EQ-5D-3L and EQ-5D-5L) in patients with CD. METHODS: Between 2016 and 2017, a multicentre cross-sectional survey was carried out. Consecutive outpatients with CD completed the 3L, 5L and EQ visual analogue scale (VAS). Disease severity was graded by the Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI). The 3L and 5L were compared in terms of feasibility, agreement, ceiling effect, redistribution properties, discriminatory power, convergent and known-groups validity. RESULTS: Two-hundred and six patients (54.9% male, mean age 35 ± 11 years) participated in the survey. For 3L, 25 unique health states were observed versus 59 for the 5L. The overall ceiling effect decreased from 29.6% (3L) to 25.5% (5L). Absolute discriminatory power improved (mean Shannon index 0.84 vs. 1.18). The 3L correlated stronger with EQ VAS and CDAI scores, whereas the 5L with PDAI. The 5L demonstrated a better known-groups validity on the basis of age, perianal fistulas, extraintestinal manifestations and disability. CONCLUSIONS: This is the first study to report the impact of CD on quality of life using the EQ-5D-5L questionnaire. The 5L seems to perform better than 3L in terms of feasibility, ceiling effect, discriminatory power and known-groups validity. Understanding the differences in psychometrics between the 3L and 5L is essential as they have substantial implications for financial decision-making about CD treatments.


Assuntos
Doença de Crohn/diagnóstico , Psicometria/métodos , Qualidade de Vida/psicologia , Adulto , Doença de Crohn/patologia , Estudos Transversais , Feminino , Humanos , Masculino , Reprodutibilidade dos Testes , Inquéritos e Questionários
15.
Curr Med Chem ; 26(2): 259-269, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-28393687

RESUMO

Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals. The total projected cost savings are significant. If the achieved budget savings were used to cover more biological therapy, several additional IBD patients could be treated. Currently, the main barriers to the increasing uptake of biosimilars are the few incentives of the key stakeholders, while physicians' and patients' skepticism towards biosimilars seems to be changing. Over the coming years, biosimilars are expected to gain a growing importance in the treatment of IBD, contributing to a better access to treatment, improving population-level health gain and sustainability of health systems. This review summarizes the results of the literature on the economic considerations of biosimilars in IBD and the role of biosimilar infliximab in the treatment of IBD.


Assuntos
Anti-Inflamatórios não Esteroides/economia , Medicamentos Biossimilares/economia , Farmacoeconomia , Doenças Inflamatórias Intestinais/economia , Anti-Inflamatórios não Esteroides/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Análise Custo-Benefício , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Doenças Inflamatórias Intestinais/terapia , Infliximab/economia , Infliximab/uso terapêutico
16.
Orv Hetil ; 159(21): 837-846, 2018 May.
Artigo em Húngaro | MEDLINE | ID: mdl-29779387

RESUMO

INTRODUCTION: The health status and health-related quality of life (HRQoL) of patients with psoriasis in Hungary are understudied. AIM: To assess HRQoL in psoriasis patients, to compare HRQoL of psoriasis patients to that of the general public in Hungary and to identify predictors of HRQoL. METHOD: Between 2012 and 2016, two cross-sectional surveys were carried out among psoriasis patients at two academic dermatology departments. HRQoL was assessed by EQ-5D-3L, EQ Visual Analogue Scale (EQ VAS) and Dermatology Life Quality Index (DLQI). Predictors of HRQoL were analysed by multivariate linear regression. RESULTS: 434 patients were enrolled (mean age 49 years, 65% male, 81% moderate-to-severe psoriasis, 43% treated with biologics). Mean EQ-5D-3L, EQ VAS and DLQI scores were 0.74 ± 0.28, 69.06 ± 20.98 and 6.78 ± 7.38, respectively. Overall, 54%, 43%, 40%, 32% and 15% of patients indicated at least some problems in pain/discomfort, anxiety/depression, mobility, usual activities and self-care. EQ-5D-3L index scores in patients were lower compared to the age- and gender-matched general population in Hungary. The difference was statistically significant for the age groups 25-34 and 45-64 in males, and 18-64 in females (p<0.05). Female gender (p = 0.042), psoriatic arthritis (p<0.001) and palmoplantar psoriasis (p = 0.031) were associated with lower EQ-5D-3L index scores. On the contrary, employed and highly educated patients reported higher EQ-5D-3L index scores (p<0.001). CONCLUSIONS: We were the first to assess HRQoL in psoriasis patients by using EQ-5D questionnaire in Hungary, and more broadly in Central and Eastern Europe. Our findings are useful for cost-effectiveness modelling of psoriasis treatments and decision-making in healthcare. Orv Hetil. 2018; 159(21): 837-846.


Assuntos
Nível de Saúde , Psoríase/psicologia , Qualidade de Vida/psicologia , Índice de Gravidade de Doença , Adulto , Estudos Transversais , Feminino , Humanos , Hungria , Masculino , Pessoa de Meia-Idade , Psoríase/terapia , Análise de Regressão , Inquéritos e Questionários
17.
United European Gastroenterol J ; 6(2): 310-321, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-29511561

RESUMO

Background: In clinical practice, treatment sequences of biologicals are applied for active fistulising Crohn's disease, however underlying health economic analyses are lacking. Objective: The purpose of this study was to analyse the cost-effectiveness of different biological sequences including infliximab, biosimilar-infliximab, adalimumab and vedolizumab in nine European countries. Methods: A Markov model was developed to compare treatment sequences of one, two and three biologicals from the payer's perspective on a five-year time horizon. Data on effectiveness and health state utilities were obtained from the literature. Country-specific costs were considered. Calculations were performed with both official list prices and estimated real prices of biologicals. Results: Biosimilar-infliximab is the most cost-effective treatment against standard care across the countries (with list prices: €34684-€72551/quality adjusted life year; with estimated real prices: €24364-€56086/quality adjusted life year). The most cost-effective two-agent sequence, except for Germany, is the biosimilar-infliximab-adalimumab therapy compared with single biosimilar-infliximab (with list prices: €58533-€133831/quality adjusted life year; with estimated prices: €45513-€105875/quality adjusted life year). The cost-effectiveness of the biosimilar-infliximab-adalimumab-vedolizumab three-agent sequence compared wit biosimilar-infliximab -adalimumab is €87214-€152901/quality adjusted life year. Conclusions: The suggested first-choice biological treatment is biosimilar-infliximab. In case of treatment failure, switching to adalimumab then to vedolizumab provides meaningful additional health gains but at increased costs. Inter-country differences in cost-effectiveness are remarkable due to significant differences in costs.

18.
Kardiol Pol ; 76(5): 860-870, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29350378

RESUMO

BACKGROUND: The measurement of health-related quality of life (HRQoL) by validated generic instruments, such as EQ-5D, has become an increasingly important tool for the assessment of health care in a wide range of diagnoses. AIM: We aimed to systematically review EQ-5D literature on cardiovascular diseases in eight Central and Eastern European (CEE) countries. METHODS: A structured literature search was conducted in MEDLINE, EMBASE, Web of Science, CINAHL, PsycINFO, Cochrane Library, and the EuroQol website up to November 2016. Original cardiovascular-related studies that reported EQ-5D results were included. RESULTS: Of the 36 papers, 17 reported EQ-5D index scores. Most studies were performed in Poland (n = 24, 67%). The most common diagnosis regarding the number of publications and population size was ischaemic heart disease (n = 13, N = 6394), followed by atrial fibrillation (n = 4, N = 1052). The average EQ-5D index scores ranged from 0.61 to 0.88 and from 0.66 to 0.95 for patients before and after cardiac procedure/surgery, respectively (including angioplasty, coronary artery bypass grafting, ablation, surgical correction of septal defects, transcatheter aortic valve implantation [TAVI]). In all studies baseline scores were lower than the repeated assessments after the procedure, with the most substantial improvement of 0.24 in high-risk elderly patients after TAVI. Studies which did not assess invasive treatment reported mean EQ-5D index scores ranging from 0.18 to 0.80. CONCLUSIONS: The number of cardiovascular-related studies reporting HRQoL using EQ-5D has consistently increased in CEE countries over the past decade and is outstanding compared with other clinical fields. The EQ-5D index and EQ VAS scores varied based on the disease severity, patient characteristics, and treatment protocol.


Assuntos
Doenças Cardiovasculares/epidemiologia , Qualidade de Vida , Adulto , Idoso , Idoso de 80 Anos ou mais , Europa Oriental/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
19.
Arch Dermatol Res ; 310(1): 47-55, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29128966

RESUMO

Dermatology Life Quality Index (DLQI) is the most commonly applied measure of health-related quality of life (HRQoL) in psoriasis patients. It is among defining criteria of moderate-to-severe psoriasis and present in treatment guidelines. Our objective was to estimate preference-based HRQoL values (i.e., utilities) for hypothetical health states described by the 10 items of the DLQI in psoriasis patients. Moreover, we compare results to findings of a similar study previously conducted among the general public. A cross-sectional survey was carried out among 238 psoriasis patients. Seven hypothetical DLQI-defined health states with total scores of 6, 11, and 16 (3-3 and 1 states, respectively) were evaluated by time trade-off method. The difference in DLQI scores between hypothetical health states was set at 5 points, as it exceeds the minimal clinically important difference (MCID). Utility scores were found to be homogenous across the seven hypothetical health states (range of means for the 6-point states 0.85-0.91, range of means for the 11-point states 0.83-0.85, and mean of 0.84 for the 16-point state). Overall, mean utilities assessed by psoriasis patients were higher for all seven states compared with the general public (mean difference 0.16-0.28; p < 0.001). In 11 out of the 15 comparisons between health states with DLQI scores differing larger than the MCID, there was no statistically significant difference in utility. Thus, in clinical settings, patients with DLQI scores differing more than the MCID may have identical HRQoL. Improving the definition of moderate-to-severe disease and reconsideration of the DLQI in clinical assessment of psoriasis patients are suggested.


Assuntos
Tomada de Decisão Clínica/métodos , Dermatologia/métodos , Indicadores Básicos de Saúde , Psoríase/diagnóstico , Qualidade de Vida , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Dermatologia/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Psoríase/terapia , Índice de Gravidade de Doença , Adulto Jovem
20.
BMC Geriatr ; 17(1): 233, 2017 10 10.
Artigo em Inglês | MEDLINE | ID: mdl-29017463

RESUMO

BACKGROUND: Subjective expectations regarding future health may influence patients' judgement of current health and treatment effects, as well as adherence to therapies in chronic diseases. We aimed to explore subjective expectations on longevity and future health-related quality of life (HRQOL) of patients with age-related macular degeneration (AMD) treated with antiVEGF injections and analyse the influencing factors. METHODS: Consecutive AMD patients in two ophthalmology centres were included. Demographics, clinical characteristics and informal care utilisation were recorded. Current health was evaluated by the EQ-5D generic health status questionnaire and time trade-off (TTO) methods. Happiness was measured on a visual analogue scale (VAS). Subjective life-expectancy and expected EQ-5D status at ages 70, 80 and 90 were surveyed. T-test was applied to compare subgroups and Pearson correlations were performed to analyse relationships between variables. RESULTS: One hundred twenty two patients were involved (females 62%) with a mean (SD) age of 75.2 (7.9) years and disease duration of 2.9 (2.5) years. The majority were in AREDS-4 state, the better eye's ETDRS was 64.7 (15.4). EQ-5D and TTO revealed moderate deterioration of health (0.66 vs. 0.72, p = 0.131), happiness VAS was 6.3 (2.2). Correlation between EQ-5D and ETDRS was moderate (R = 0.242, p < 0.05) and having both versus one eye in AREDS-4 resulted lower TTO (0.68 vs. 0.83; p = 0.013). Subjective life-expectancy did not differ significantly from statistical life-expectancy and had no significant impact on TTO. The self-estimated mean EQ-5D score was 0.60, 0.40 and 0.24 for ages 70, 80 and 90 which is lower than the population norm of age-groups 65-74, 75-84 and 85+ (0.77, 0.63 and 0.63, respectively). Age, gender, current EQ-5D, need for informal care and happiness were deterministic factors of subjective health expectations. CONCLUSION: AMD patients with antiVEGF treatment have comparable HRQOL as the age-matched general public but expect a more severe deterioration of health with age. Older patients with worse HRQOL have worse subjective expectations. Exploring patients' health expectations provides an opportunity for ophthalmologists to correct misperceptions and improve the quality of AMD care. Further studies should provide evidences on the relationship between subjective expectations and actual health outcomes, and on its impact on patients' AMD-specific health behaviour.


Assuntos
Degeneração Macular/tratamento farmacológico , Qualidade de Vida/psicologia , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Nível de Saúde , Inquéritos Epidemiológicos , Humanos , Expectativa de Vida , Masculino , Pessoa de Meia-Idade
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