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Infect Dis Ther ; 8(2): 285-299, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30771220


INTRODUCTION: Japan has one of the highest prevalence rate of chronic hepatitis C (CHC) in the industrialized world. However, the burden of CHC treatment is poorly understood. Thus, the healthcare resource utilization and costs of treated versus untreated patients, and patients with early versus delayed treatment initiation, were assessed in Japan. METHODS: Adult patients with ≥ 2 CHC diagnoses were identified from the Medical Data Vision hospital claims database (1 April 2008-31 May 2016). The presence or absence of antiviral treatment claims was used to form the treated and untreated cohorts, respectively. Among treated patients, the presence of a cirrhosis-related diagnosis was used as an indicator of delayed treatment. The index date was defined as the date of the first antiviral claim for treated patients and randomized to any date with a medical visit for untreated patients. Annualized total healthcare costs and costs associated with hepatic manifestations (HMs) or extrahepatic manifestations (EHMs) were evaluated from the index date to the last observed medical visit. RESULTS: Of 100,125 patients with CHC, 12,984 were treated (early: 8104, delayed: 4880) and 87,141 were untreated. After adjusting for covariates, untreated patients had ¥613,034 ($5456 USD; ¥1 = $0.0089) higher annual medical costs compared with treated patients (P < 0.001), a difference driven by higher inpatient costs. Between 65% (treated patients) and 70% (untreated patients) of medical costs were EHM-related and between 14% (untreated patients) and 15% (treated patients) were HM-related. Patients in the delayed treatment cohort had ¥114,347 ($1018) higher annual medical costs (P < 0.001) versus those in the early treatment cohort. About 95% of these costs were EHM-related, and 64% were HM-related. CONCLUSION: Withholding or delaying antiviral treatment initiation for Japanese patients with CHC increases the clinical and economic burden associated with HMs and EHMs. FUNDING: AbbVie.

Mod Rheumatol ; 28(1): 39-47, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28704126


OBJECTIVES: The objective of this study is to evaluate the economic impact of adalimumab (ADA) on Japanese rheumatoid arthritis (RA) patients. METHODS: ANOUVEAU was a 48-week multicenter, prospective, observational, single-cohort study. Work-related outcomes including absenteeism, presenteeism, overall work impairment (OWI), and activity impairment (AI) were evaluated using the RA-related work productivity and activity impairment (WPAI/RA). The amount of productivity loss was estimated via multiplication of absenteeism, presenteeism and OWI by the national average occupational wage for paid worker (PW) and part time worker (PTW), and via multiplication of AI by the estimated wage for domestic work for home maker (HM). RESULTS: In this analysis, 1196 patients were included. At week 48, measures of productivity loss due to absenteeism, presenteeism, OWI, and AI were significantly improved by administrating ADA to RA patients in all employment types (PW, PTW, and HM), compared to baseline (p < .01). Productivity loss of Japanese society by RA disease was estimated to be $9.80 billion. The annual decrease in productivity loss through ADA administration to Japanese RA patients was estimated to be $3.76 billion. CONCLUSIONS: The socioeconomic burden of RA is high, but ADA treatment may reduce productivity loss related to RA.

Adalimumab/economia , Antirreumáticos/economia , Artrite Reumatoide/economia , Efeitos Psicossociais da Doença , Absenteísmo , Atividades Cotidianas , Adalimumab/uso terapêutico , Adulto , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Emprego/estatística & dados numéricos , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
Adv Ther ; 34(3): 686-702, 2017 03.
Artigo em Inglês | MEDLINE | ID: mdl-28144917


INTRODUCTION: The Adalimumab Non-interventional Trial for Up-verified Effects and Utility (ANOUVEAU) was a large-scale, multicenter, prospective, observational, single-cohort study that evaluated the effects of adalimumab (ADA) on rheumatoid arthritis (RA)-related work productivity and activity impairment (RA-related WPAI) and disease activity in routine rheumatology care in Japan. METHODS: Patients with RA were categorized as paid workers (PWs, ≥35 h/week), part-time workers (PTWs, <35 h/week), or homemakers (HMs, unemployed) and were administered the WPAI for RA (WPAI/RA) questionnaire. All patients who received ADA were followed for 48 weeks to evaluate safety and effectiveness. RESULTS: Of the 1808 patients analyzed, 825, 243, and 740 patients were PWs, PTWs, and HMs, respectively. WPAI/RA domain scores significantly improved at weeks 12, 24, and 48 in all groups, with maximum improvement observed for PWs (p < 0.05). Additionally, remission rates (according to Disease Activity Score 28, erythrocyte sedimentation rate, Simplified Disease Activity Index, or Health Assessment Questionnaire-Disability Index scores) and EuroQol 5-Dimension 3-Level scores significantly increased from baseline to 48 weeks in all groups (p < 0.0001). Analysis of patient subgroups revealed better WPAI/RA outcomes for patients who were biologic-naïve, treated with concomitant methotrexate, or with RA duration of ≤2 years (p < 0.05). The rate of serious adverse events over 48 weeks of ADA treatment was 5.23%. CONCLUSIONS: Treatment with ADA provided sustained improvement in WPAI and had an acceptable safety profile in patients with RA. FUNDING: AbbVie GK and Eisai Co., Ltd. TRIAL REGISTRATION: identifier, NCT01346488.

Adalimumab , Artrite Reumatoide , Aptidão Física/fisiologia , Desempenho Profissional , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adulto , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Artrite Reumatoide/fisiopatologia , Feminino , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Gravidade do Paciente , Estudos Prospectivos , Indução de Remissão/métodos , Inquéritos e Questionários , Resultado do Tratamento
Adv Ther ; 33(11): 1947-1963, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27664107


INTRODUCTION: Crohn's disease (CD) is a chronic and progressive disease in which the long-term management is important. This study sought to assess treatment persistence and dose escalation in the maintenance phase with adalimumab (ADA) or infliximab (IFX) in a Japanese real-world setting. METHODS: A retrospective analysis was conducted using the Japan Medical Data Center database. CD patients with either ADA or IFX prescriptions between January 2012 and February 2015 were included. Outcomes of interest were (1) failure in the induction phase (defined as switch or discontinuation) and (2) persistence in the maintenance phase (defined as the absence of switch or discontinuation over 12 months since maintenance initiation). RESULTS: Overall, 133 patients (53 ADA; 80 IFX) were included. Of them, treatment failed in 26 patients (19.6%) in the induction phase. During the induction phase, there was a trend towards fewer treatment failures with ADA than IFX (88.7% vs. 75.0%; p = 0.051). Of those who completed induction, 64 patients (33 ADA; 31 IFX) had at least 12 months of valid insurance enrolment after the initiation of maintenance and 13 (5 ADA; 8 IFX) had either switch or discontinuation within 12 months after the initiation of maintenance. Probabilities of switch or discontinuation over 12 months after the maintenance date were 15.2% and 20.9% for ADA and IFX groups, respectively (p-log rank = 0.7764). CONCLUSION: Japanese patients have a high primary response to anti-tumor necrosis factor therapy in the real-world setting, in line with the results of clinical trials. This initial therapeutic advantage can be lost during the maintenance phase, leading to dose escalation, treatment switch, or discontinuation. This study suggests that those events occurred in comparable proportions of patients treated with either ADA or IFX. However, these findings should be considered with caution given the retrospective nature and small size of the study. FUNDING: Abbvie GK, Tokyo, Japan.

Adalimumab , Doença de Crohn , Infliximab , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adulto , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Doença de Crohn/tratamento farmacológico , Doença de Crohn/epidemiologia , Quimioterapia Combinada/métodos , Quimioterapia Combinada/estatística & dados numéricos , Uso de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Revisão da Utilização de Seguros , Japão/epidemiologia , Assistência de Longa Duração/métodos , Assistência de Longa Duração/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
J Med Econ ; 19(12): 1144-1156, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27348464


OBJECTIVE: This study compared the cost-effectiveness of chronic hepatitis C virus (HCV) genotype 1b (GT1b) therapy ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) vs daclatasvir + asunaprevir (DCV/ASV) and no treatment in patients without cirrhosis. Cost-effectiveness analyses (CEAs) that compared OBV/PTV/r against DCV/ASV and sofosbuvir/ledipasvir (SOF/LDV) in Y93H mutation-negative, GT1b patients with and without cirrhosis were also included. METHODS: A health state transition model was developed to capture the natural history of HCV. A CEA over a lifetime horizon was performed from the perspective of the public healthcare payer in Japan. Costs, health utilities, and rates of disease progression were derived from published studies. Sustained virologic response (SVR) rates of OBV/PTV/r and DCV/ASV were extracted from Japanese clinical trials. Analyses were performed for treatment-naïve and -experienced patients. Alternative scenarios and input parameter uncertainty on the results were tested. RESULTS: OBV/PTV/r exhibited superior clinical outcomes vs comparators. For OBV/PTV/r, DCV/ASV, and no treatment, the lifetime risk of decompensated cirrhosis in treatment-naïve patients without cirrhosis was 0.4%, 1.4%, and 9.2%, and hepatocellular carcinoma was 6.5%, 11.4%, and 49.9%, respectively. Quality-adjusted life years (QALYs) were higher in treatment-naïve and -experienced patients without cirrhosis treated with OBV/PTV/r (16.41 and 16.22) vs DCV/ASV (15.83 and 15.66) or no treatment (11.34 and 11.23). In treatment-naïve and -experienced patients without cirrhosis, the incremental cost-effectiveness ratios (ICERs) of OBV/PTV/r vs DCV/ASV were JPY 1,684,751/QALY and JPY 1,836,596/QALY, respectively; OBV/PTV/r was dominant compared with no treatment. In scenario analysis, including GT1b patients with and without cirrhosis who were Y93H mutation-negative, the ICER of OBV/PTV/r vs DCV/ASV was below the Japanese willingness-to-pay threshold of JPY 5 million/QALY, while the ICER of SOF/LDV vs OBV/PTV/r was above this threshold; thus, OBV/PTV/r was cost-effective. CONCLUSION: OBV/PTV/r appears to be a cost-effective treatment for chronic HCV GT1b infection against DCV/ASV. OBV/PTV/r dominates no treatment in patients without cirrhosis.

Anilidas/economia , Anilidas/uso terapêutico , Antivirais/economia , Carbamatos/economia , Carbamatos/uso terapêutico , Análise Custo-Benefício , Genótipo , Hepacivirus/efeitos dos fármacos , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Compostos Macrocíclicos/economia , Compostos Macrocíclicos/uso terapêutico , Ritonavir/economia , Ritonavir/uso terapêutico , Quimioterapia Combinada , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Modelos Econômicos