Risk of Cardiovascular Events in Schizophrenic Patients Treated with Paliperidone Palmitate Once-Monthly Injection (PP1M): A Population-Based Retrospective Cohort Study in Taiwan.

BACKGROUND: Schizophrenia is one of the leading causes of disability. Paliperidone palmitate once-monthly injection (PP1M) was developed to provide consistent drug delivery and improve medication adherence for maintenance treatment. It is well known that patients with schizophrenia have higher cardiovascular risks, however little is known about the cardiovascular risks of patients with schizophrenia treated with PP1M in Asia. OBJECTIVE: This study aimed to estimate the incidence of cardiovascular events after initiating PP1M treatment and evaluate the cardiovascular risk associations compared with oral second-generation antipsychotics (SGAs). METHODS: Data from Taiwan's National Health Insurance Research Database were used to identify a cohort of adult patients with schizophrenia who received any SGAs from 1 March 2012 to 31 December 2018. Patients who initiated PP1M treatment were enrolled for descriptive analysis of incidence rates. PP1M patients were propensity matched 1:1 to patients initiating a new oral SGA, for comparative analysis based on demographics, clinical characteristics and treatment history at baseline, in three-step matching procedures, following the prevalent new-user design to enhance comparability. Follow-up ended at the end of the treatment episode of index drug, death, last record available, or end of the study (31 December 2019). Study endpoints included serious cardiovascular events (including severe ventricular arrhythmia and sudden death), expanded serious cardiovascular events (which further included acute myocardial infarction and ischemic stroke), and cardiovascular hospitalizations. Risks of study endpoints between matched cohorts were compared using Cox regression. RESULTS: Overall, 11,023 patients initiating PP1M treatment were identified (49.5% were females; mean age of 43.2 [12.2] years). Overall incidences for serious cardiovascular events, expanded serious cardiovascular events, and cardiovascular hospitalizations were 3.92, 7.88 and 51.96 per 1000 person-years, respectively. In matched cohort analysis (N = 10,115), the hazard ratios (HRs) between initiating PP1M and a new oral SGA for serious cardiovascular events, expanded serious cardiovascular events, and cardiovascular hospitalizations were 0.86 (95% confidence interval [CI] 0.55-1.36), 0.88 (95% CI 0.63-1.21), and 0.78 (95% CI 0.69-0.89), respectively. CONCLUSION: This study reported the population-based incidence of cardiovascular events in schizophrenic patients initiating PP1M treatment. PP1M was not associated with increased risks of serious cardiovascular events but was potentially associated with lower risks of cardiovascular hospitalizations compared with oral SGAs.

Higher cumulative dose of topical corticosteroids is associated with osteoporosis and major osteoporotic fracture: A nationwide case-control study.

BACKGROUND: Connections between long-term use of topical corticosteroids (TCSs) of varying potency and osteoporosis and major osteoporotic fracture (MOF) are unclear. Susceptibility to adverse bone effects of TCSs in different sex, age and ethnic groups is unknown too. OBJECTIVES: To demonstrate the association between cumulative dose of TCSs of varying potency and osteoporosis and MOF in Taiwanese population, with stratified analysis of sex and age. METHODS: We conducted a nationwide case-control study and obtained data from Taiwan National Health Insurance Research Database. Cumulative TCS doses in different exposure periods were calculated, and the potency of TCSs was converted to prednisolone equivalent. Adjusted odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for osteoporosis and MOF associated with TCS use. RESULTS: From 2017 to 2020, 129,682 osteoporosis cases and 34,999 MOF cases were selected and randomly matched with 518,728 and 139,996 controls by sex and age. We found clear dose-response relationships between long-term TCS exposure and osteoporosis and MOF. For example, compared to no TCS use, adjusted ORs of osteoporosis were 1.216 (95% CI 1.189-1.243), 1.260 (95% CI, 1.241-1.280) and 1.341 (95% CI, 1.314-1.369) for exposure to low, medium and high cumulative TCS doses, respectively, over 5 years. Adjusted ORs of MOF were 1.118 (95% CI 1.069-1.170), 1.191 (95% CI, 1.156-1.227) and 1.288 (95% CI, 1.238-1.340) for exposure to low, medium and high cumulative TCS doses, respectively, over 5 years. Stratified analysis showed women had higher ORs of osteoporosis and MOF compared to men. Younger people (<50 years) had highest OR of osteoporosis compared to other age groups. CONCLUSIONS: Higher cumulative TCS dose was associated with increased risk of osteoporosis and MOF. Long-term use of TCSs should be cautious, especially in susceptible populations such as women and young people.

Risk of bullous pemphigoid and pemphigus in patients on chronic dialysis: A nationwide population-based cohort study.

Bullous pemphigoid has a high incidence among dialysis patients. However, whether or not chronic dialysis is an independent risk factor of bullous pemphigoid remains unclear. We aimed to investigate the effect of chronic dialysis on the development of bullous pemphigoid and pemphigus. We performed a retrospective cohort study using records from Taiwan's National Health Insurance Research Database between 2008 and 2019. We identified a dialysis cohort that included patients on chronic hemodialysis and peritoneal dialysis, and the hazard ratios (HRs) for bullous pemphigoid and pemphigus were compared with those of a sex-, age-, and index-matched cohort, then the results were adjusted for various confounding factors. Among 93 538 patients on chronic dialysis and 93 538 patients in the control group, 287 and 139 developed incident bullous pemphigoid, and 45 and 35 developed incident pemphigus after a median follow-up of 3.7 and 5.6 years, respectively. The incidence rates of bullous pemphigoid in the dialysis patients and the control group were 74.2 and 25.2 per 100 000 person-years, respectively (difference between groups, P < 0.0001). The incidence rates of pemphigus in the dialysis patients and the control group were 11.6 and 6.3 per 100 000 person-years, respectively (difference between groups, P < 0.01). Cox proportional hazard adjustment showed the HR for bullous pemphigoid in dialysis patients was 2.12 (95% confidence interval [CI] 1.64-2.74, P < 0.0001) compared with the control group. Dialysis patients aged <75 years had an even higher risk of bullous pemphigoid development (5- to 8-fold) than the control group. The adjusted HR for pemphigus was not elevated in dialysis patients (adjusted HR 1.52, 95% CI 0.87-2.67, P = 0.14). Chronic dialysis is an independent risk factor for developing bullous pemphigoid, but not a risk factor for pemphigus. Physicians should be aware of the predisposition of chronic dialysis patients to bullous pemphigoid.

Healthcare resource utilization and costs associated with generalized myasthenia gravis: a retrospective matched cohort study using the National Health Insurance Research Database in Taiwan.

Background: We estimated healthcare resource utilization (HRU) and costs in patients with generalized myasthenia gravis (gMG) in Taiwan. Methods: This retrospective population-based, matched cohort study used the National Health Insurance Research Database to identify prevalent patients with gMG (cases) in 2019. In total, 2537 cases were matched (1:4) by age, sex, and urbanization level to 10148 randomly selected patients without gMG (comparators). A generalized linear regression model predicted the frequency of HRU and costs among service users. Costs attributable to gMG were obtained by subtracting all-cause HRU costs incurred by comparators from cases. Results: The mean age of all patients was 54.99 years and 55.97% were female. Compared with comparators, cases had significantly higher rates of hypertension (33.03%/24.26%), diabetes mellitus (18.92%/11.37%), malignancies (16.00%/4.08%), cardiovascular disease (11.35%/8.12%), thyroid-related conditions (5.99%/1.16%), respiratory illness/disorders (4.38%/1.22%), and neurotic disorders (4.65%/2.6%). Amongst users of healthcare resources, cases had a mean 10 additional outpatient visits, 0.62 inpatient stays, and 0.49 emergency room visits in 2019 compared with comparators (p < 0.0001 for all). The mean (standard deviation) difference in all-cause healthcare costs between cases and comparators was NT$ 94997 (76431) [US$ 3133 (2521)], and was significantly higher for all categories (outpatient, inpatient, emergency room, drugs; p < 0.0001 for all). Among employed persons, 13.18%/7.59% of cases/comparators changed employment status during the study (p < 0.0001). Conclusion: gMG presents a substantial burden on HRU and healthcare costs in Taiwan. A high attrition rate from full-time employment suggests additional societal costs. Improved treatments are needed to alleviate the burden of disease on individuals, healthcare systems, and economies.

Treatment Retention Rates of 3-monthly Paliperidone Palmitate and Risk Factors Associated with Discontinuation: A Population-based Cohort Study.

Objective: Limited evidence exists regarding real-world 3-monthly paliperidone palmitate (PP3M) treatment retention and associated factors. Methods: We conducted a retrospective, nationwide cohort study using the Taiwan National Health Insurance Research Database between October 2017 and December 2019. Adult patients with schizophrenia initiated on PP3M were enrolled. The primary outcomes were time to PP3M discontinuation, time to psychiatric hospitalization, and the proportions of patients receiving the next PP3M dose within 120 days among first-, second-, and third-dose completers. Key covariates included prior PP1M duration and adequate PP3M initiation. Results: The PP3M treatment retention rates were 79.7%, 66.3%, and 52.5% after 6, 12, and 24 months, respectively, with 86.4%, 90.6%, and 90.0% of respective first-, second-, and third-dose completers receiving the next PP3M dose. Adequate PP3M initiation and prior PP1M treatment duration > 180 days were associated with favorable PP3M treatment retention. In multivariate analyses, PP1M durations of 180-360 days (adjusted relative risk [aRR], 1.76) or < 180 days (aRR, 2.79) were associated with PP3M discontinuation at the second dose. Inadequate PP3M initiation was associated with discontinuation at the third dose (aRR, 2.18). Patients fully adherent to PP3M treatment in the first year had a higher probability of being free from psychiatric hospitalization (86.7% at 2 years), compared with those partially adherent or non-adherent to PP3M in the first year. Conclusion: Prior PP1M duration and adequate PP3M initiation are major factors affecting PP3M treatment retention. Higher PP3M treatment retention is associated with a lower risk of psychiatric hospitalization.

The growing burden of generalized myasthenia gravis: a population-based retrospective cohort study in Taiwan.

Background: The prevalence of myasthenia gravis is increasing in many countries, including Asia. As treatment options expand, population-based information about the disease burden can inform health technology assessments. Methods: We conducted a population-based retrospective cohort study using the Taiwan National Healthcare Insurance Research database and Death Registry to describe the epidemiology, disease burden and treatment patterns of generalized myasthenia gravis (gMG) from 2009 to 2019. Episodes of hepatitis B virus (HBV) infection or reactivation were explored. Results: The number of patients with gMG increased from 1,576 in 2009 to 2,638 in 2019 and the mean (standard deviation) age from 51.63 (17.32) to 55.38 (16.29) years. The female:male ratio was 1.3:1. Frequently reported co-morbidities were hypertension (32-34% of patients), diabetes mellitus (16-21%) and malignancies (12-17%). The prevalence of patients with gMG increased annually from 6.83/100,000 population in 2009 to 11.18/100,000 population in 2019 (p < 0.0001). There was no temporal trend in all-cause fatality rates (range 2.76-3.79/100 patients annually) or gMG incidence rates (2.4-3.17/100,000 population annually). First-line treatment was with pyridostigmine (82%), steroids (58%), and azathioprine (11%). There was minimal change in treatment patterns over time. Among 147 new HBV infections, 32 (22%) received ≥4 weeks of antiviral therapy suggesting chronic infection. The HBV reactivation rate was 7.2%. Conclusion: The epidemiology of gMG in Taiwan is evolving rapidly, with higher prevalence rates and increasing involvement of older age-groups suggesting a growing burden of disease and associated healthcare costs. HBV infection or reactivation may pose a previously unrecognized recognized risk for patients with gMG receiving immunosuppressants.

Association Between the Use of Topical Calcineurin Inhibitors and the Risk of Cancer Among Patients with Atopic Dermatitis: A Nationwide, Population-Based, Retrospective Cohort Study.

IMPORTANCE: The cancer risks associated with treatment with topical calcineurin inhibitors (TCIs) in patients with atopic dermatitis (AD) remain controversial, and limited evidence exists regarding the cancer risks among patients with AD treated with TCIs in Asian populations. OBJECTIVES: This study identified the association between TCI use and the risks of developing all cancers, lymphoma, skin cancers, and other cancers. DESIGN: This study was a nationwide, population-based, retrospective cohort study. SETTING: Taiwan's National Health Insurance Research Database. PARTICIPANTS: Patients diagnosed at least twice with ICD-9 code 691 or at least one time with ICD-9 codes 691 or 692.9 within 1 year between 1 January 2003 and 31 December 2010 were included and followed until 31 December 2018. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated using the Cox proportional hazard ratio model. EXPOSURES: Patients using tacrolimus or pimecrolimus were identified in the National Health Insurance Research Database and compared with patients using topical corticosteroids (TCSs). MAIN OUTCOMES AND MEASURES: The main outcomes were hazard ratios (HRs) of cancer diagnoses and associated outcomes obtained from the Taiwan Cancer Registry database. RESULTS: After propensity score (PS) matching, the final cohort included 195,925 patients with AD, including 39,185 who were initial TCI users and 156,740 who were TCS users. Propensity score matching was performed according to age, sex, index year, and Charlson Comorbidity Index using a ratio of 1:4. Except for leukemia, HR and 95% CI showed no significant associations between TCI use and the risk of developing all cancer, lymphoma, skin cancers, and other cancers. Sensitivity analysis showed that the lag time HRs for every cancer subtype continued to show no significant association between TCI use and cancer risk, except for leukemia. CONCLUSIONS AND RELEVANCE: Our study found no evidence to support an association between TCI use and the risks of almost all cancers compared with TCS use in patients with AD, but physicians should be aware of potentially higher risks of leukemia with TCI use. This study represents the first population-based study focused on the cancer risk of TCI use among patients with AD in an Asian population.

Change of employment status in patients with depression - A longitudinal study using national claims data.

Depression increases an individual's risk of work disability, sick leave, unemployment, and early retirement. This population-based study identified 3673 depressive patients utilizing national claim data from Taiwan and aimed to investigate changes in employment status among depressive patients, compared to matched controls, with the longest observation of up to 12 years. This study found depressive patients had an adjusted hazard ratio of 1.24 for changing to non-income earners compared to controls. Moreover, younger age, lower payroll bracket, urbanity, and geographical area were associated with increased risk among patients with depression. Despite these increased risks, most depressive patients remained employed.

Economic Burden of Atopic Dermatitis in Taiwan.

Atopic dermatitis is a prevalent inflammatory skin disease that manifests clinically as pruritus and eczema. Severe forms of atopic dermatitis can be chronic and relapsing or associated with other dermatological complications and comorbidities, resulting in lifelong impacts across multiple aspects for patients. This study was conducted to calculate the atopic dermatitis-related economic burden in Taiwan. First, the out-of- pocket costs incurred by 200 patients with atopic dermatitis were estimated using a specifically designed questionnaire. Secondly, work impairment was converted into quantifiable costs. The costs reimbursed by the Taiwan National Health Insurance (NHI), which were estimated in our previous work, were included in the final calculation. The atopic dermatitis-related economic burden for patients in Taiwan in 2018 was estimated as (2018 New Taiwan dollars; NT$) 37.90 billion, which is 0.207% of Taiwan's gross domestic product. This substantial economic burden suggests an existing need for more effective and equitable treatment for atopic dermatitis.

A population-based cohort study of the epidemiology of light-chain amyloidosis in Taiwan.

The incidence rate of AL (light-chain) amyloidosis is not known in Asia. We conducted a retrospective cohort study using the Taiwan National Healthcare Insurance Research database and Death Registry to estimate incidence and all-cause case fatality rates, and characteristics of patients with AL amyloidosis in Taiwan. All patients with confirmed, newly diagnosed AL amyloidosis from 01-Jan-2016 until 31-Dec-2019 were enrolled and followed up until dis-enrolment, death or study end (31-Dec-2019). There were 841 patients with newly diagnosed AL amyloidosis with median age of 61.4 years and 58.7% were men. At diagnosis, cardiac, renal and liver-related diseases were present in 28.54%, 23.19% and 2.14% of patients, respectively. AL amyloidosis age-adjusted annual incidence was 5.73 per million population in 2016 and 5.26 per million population in 2019. All-cause case fatality ranged from 1.7 to 2.9% over the study period and was highest (~10%) in patients ≥ 80 years. Survival was significantly lower in patients with co-morbid cardiac, renal, or liver-related diseases which could indicate organ involvement. The incidence of AL amyloidosis in Taiwan appears to be similar to Western countries. The poor prognosis in patients with co-morbid diseases highlights the need for earlier diagnosis.

Patient Characteristics, Treatment Patterns, Healthcare Resource Utilization, and Costs of Targeted Therapy-Eligible Atopic Dermatitis Patients in Taiwan-A Real-World Study.

INTRODUCTION: The objective of this study was to conduct a retrospective analysis to understand the patient profile, treatment patterns, healthcare resource utilization, and cost of atopic dermatitis (AD) of patients eligible for targeted therapy in Taiwan. METHODS: A retrospective, claims-based analysis was undertaken using Taiwan's National Health Insurance Research Database from 01 January 2014 to 31 December 2017. Patients aged ≥ 2 years and with at least one diagnosis code for AD during 2015 were identified. Patients with comorbid autoimmune diseases were excluded. Enrolled AD patients were categorized using claims-based treatment algorithms by disease severity and their eligibility for targeted therapy treatment. A cohort of targeted therapy-eligible patients was formed, and a matched cohort using patients not eligible for targeted therapy was derived using propensity score matching based on age, gender, and the Charlson Comorbidity Index (CCI). Treatment patterns, resource utilization, and costs were measured during a 1-year follow-up period. RESULTS: A total of 377,423 patients with AD were identified for this study. Most patients had mild AD (84.5%; n = 318,830) with 11.9% (n = 45,035) having moderate AD, and 3.6% (n = 13,558) having severe AD. Within the 58,593 moderate-to-severe AD patients, 1.5% (n = 897) were included in the targeted therapy-eligible cohort. The matched cohort consisted of 3558 patients. During the 1-year follow-up period, targeted therapy-eligible patients utilized antihistamines (85.5%), topical treatments (80.8%), and systemic anti-inflammatories (91.6%) including systemic corticosteroids (51.4%) and azathioprine (59.1%). During the first year of follow-up, targeted therapy-eligible patients (70.5%; 7.01 [SD = 8.84] visits) had higher resource utilization rates and frequency of AD-related outpatient visits compared with the matched cohort (40.80%; 1.85 [SD = 4.71] visits). Average all-cause direct costs during 1-year follow-up were $2850 (SD = 3629) and $1841 (SD = 6434) for the eligible targeted therapy and matched cohorts, respectively. AD-related costs were 17.7% ($506) of total costs for the targeted therapy eligible cohort and 2.2% ($41) for the matched cohort. CONCLUSIONS: AD patients eligible for targeted therapy in Taiwan experienced high resource and economic burden compared with their non-targeted-therapy-eligible counterparts.

Treatment patterns and healthcare utilization of patients with treatment-resistant depression estimated using health insurance database: A population-based study from Taiwan.

BACKGROUND: Determining the proportion of patients with treatment-resistant depression (TRD) among patients with unipolar depression receiving adequate pharmacological treatment (pharmaceutically treated depression [PTD]) is clinically important and may affect health care utilization. In Taiwan, these issues can be assessed by analyzing population-based data. METHODS: The present study included data from the Taiwan National Health Insurance Research Database from 2010 to 2017. Among patients with depression, PTD was defined by the receipt of at least one adequate antidepressant treatment, and TRD was defined as receiving a third adequate antidepressant treatment after failure to respond to two prior treatments. Time of progression from PTD to TRD was estimated via the Kaplan-Meier function. A propensity-matched case-comparison cohort approach was used to compare resource utilization between patients with non-TRD PTD and TRD. RESULTS: TRD was defined in 11.2 % of patients with unipolar depression and 37.1 % of PTD patients. The time of progression from PTD to TRD was approximately 1 year. Most TRD patients were women, middle-aged, and treated in general practice clinics. Antidepressant monotherapy, followed by antidepressant with augmentation, was the most common treatment strategy applied to TRD patients. Medical utilization was significantly higher in patients with TRD than those with non-TRD PTD across most aspects. LIMITATIONS: TRD was defined based on pharmacological treatment patterns, as the reasons for changes in antidepressant regimens were not available. CONCLUSION: Approximately one-third of patients with PTD developed TRD, often soon after receiving adequate pharmacological treatment. Patients with TRD used more medical resources than patients with non-TRD PTD.

Evaluation of risk adjustment performance of diagnosis-based and medication-based comorbidity indices in patients with chronic obstructive pulmonary disease.

OBJECTIVES: This study assessed risk adjustment performance of six comorbidity indices in two categories of comorbidity measures: diagnosis-based comorbidity indices and medication-based ones in patients with chronic obstructive pulmonary disease (COPD). METHODS: This was a population-based retrospective cohort study. Data used in this study were sourced from the Taiwan National Health Insurance Research Database. The study population comprised all patients who were hospitalized due to COPD for the first time in the target year of 2012. Each qualified patient was individually followed for one year starting from the index date to assess two outcomes of interest, medical expenditures within one year after discharge and in-hospital mortality of patients. To assess how well the added comorbidity measures would improve the fitted model, we calculated the log-likelihood ratio statistic G2. Subsequently, we compared risk adjustment performance of the comorbidity indices by using the Harrell c-statistic measure derived from multiple logistic regression models. RESULTS: Analytical results demonstrated that that comorbidity measures were significant predictors of medical expenditures and mortality of COPD patients. Specifically, in the category of diagnosis-based comorbidity indices the Elixhauser index was superior to other indices, while the RxRisk-V index was a stronger predictor in the framework of medication-based codes, for gauging both medical expenditures and in-hospital mortality by utilizing information from the index hospitalization only as well as the index and prior hospitalizations. CONCLUSIONS: In conclusion, this work has ascertained that comorbidity indices are significant predictors of medical expenditures and mortality of COPD patients. Based on the study findings, we propose that when designing the payment schemes for patients with chronic diseases, the health authority should make adjustments in accordance with the burden of health care caused by comorbid conditions.

Persistence and Adherence to Biologics in Patients with Psoriasis in Taiwan: A New Biologics User Cohort Study.

Background: Biologics are used to treat moderate-to-severe psoriasis, and persistence to biologics may reflect clinical effectiveness. Limited information describing how biologics are used in patients with moderate-to-severe psoriasis in Asian countries is available. We conducted a population-based, retrospective, new user cohort study using the National Health Insurance Research Database (NHIRD) in Taiwan to assess treatment persistence and adherence to biologics. Methods: Adults with a diagnosis of psoriasis between 01 January 2015 and 31 December 2017 were identified in the NHIRD (ICD-9-CM 696.1; ICD-10 L40.0). New users were patients who initiated treatment with etanercept, adalimumab, ustekinumab or secukinumab between 01 January 2015 and 31 December 2017. All eligible patients were followed until 31 December 2018, death or disenrollment. Kaplan-Meier analysis was conducted to estimate persistence of treatment for index biologics. A Cox-proportional hazard regression model was used to compare risks of biologic discontinuation between biologic groups. Adjustments for potential confounding factors (age, gender and Charlson comorbidity index score) were made in the Cox model. Results: There were 1,397 new biologic users with psoriasis during the study period. The ratio men:women was approximately 4:1. Mean age of patients ranged from 44.6 to 47.7 years across exposure groups. The 1-year/2-years persistence rates were 94.2%/84.9% for ustekinumab, 96.2%/not calculated (due to too few patients at year 2) for secukinumab, 66.0%/29.9% for etanercept, and 59.8%/40.3% for adalimumab. The risk of discontinuation was significantly lower in patients initiating ustekinumab compared with adalimumab (hazard ratio adjusted for age, sex and co-morbidities 0.289, 95%CI 0.247-0.339, p < 0.0001). Drug survival was significantly higher for ustekinumab compared with adalimumab and etanercept (log-rank test p < 0.0001). The proportions of patients with 1-year/2-years medication possession ratios of ≥80% were 95.3%/92.0% for ustekinumab, 98.1%/not calculated for secukinumab, 89.4%/83.1% for etanercept, and 70.8%/59.4% for adalimumab. Limitations: Clinical improvement and response to treatment data were not available. Conclusion: There was relatively high persistence amongst biologic users with psoriasis in Taiwan. There is a trend towards greater persistence of ustekinumab compared to other biologics, the magnitude of which depends on the treatment gap used for its calculation. This study provides real-world evidence that may facilitate optimal treatment choice.

Correlation between anxiety and depression risk and atopic dermatitis severity in Taiwan: A cross-sectional study.

BACKGROUND: Limited studies on atopic dermatitis (AD) have investigated the possible covariance of sociodemographic factors with the Hospital Anxiety and Depression Scale (HADS). OBJECTIVE: This study aimed to examine the possible covariance between AD severity and HADS scores of patients in Taiwan. METHODS: Patients with AD from a medical center and 2 regional hospitals in Taiwan were enrolled in this cross-sectional study from April 2018 to April 2019. AD severity was measured using the "scoring atopic dermatitis" index, and anxiety and depression were screened based on HADS. RESULTS: A total of 200 patients were included. After correcting for sociodemographic variables, significantly more borderline (≥8) and abnormal (≥11) cases of anxiety/depression (P < .05) were noted in patients with moderate-to-severe AD. LIMITATIONS: First, the cross-sectional study design cannot show causality. Second, baseline data, including a history of underlying cancer or previous psychiatric disorder, were not obtained in the questionnaire and may confound the HADS scores. Finally, a standardized psychiatric clinical interviews study design should be used for higher accuracy in the assessment of psycho-comorbidities. CONCLUSION: Higher anxiety and depression risks were noted in patients with moderate-to-severe AD. Except for psychosomatic symptoms, all kinds of anxiety and depression symptoms occurred more frequently in patients with moderate-to-severe AD.

Healthcare utilization and costs of atopic dermatitis in Taiwan.

BACKGROUND: Atopic dermatitis (AD) is a common chronic skin disease. Only relatively scant studies from Asian countries have attempted to quantify AD-associated healthcare utilization and costs by using population-based databases. This study aims to evaluate the AD-associated annual healthcare utilization and costs in Taiwan. METHODS: A retrospective matched-cohort study was conducted by matching the AD cases with controls at a 1:4 (cases:controls) ratio, with the data for both the cases and controls being sourced from the 2017 National Health Insurance Research Database (NHIRD). The AD patients were stratified by disease severity based on their treatments. Differences in the regression-adjusted frequency of care and costs between the cases and controls were compared using t-tests by the severity level of AD. RESULTS: The incremental frequency of outpatient visits per year increased with AD severity (9.60, 11.28, and 16.23 for mild, moderate, and severe cases, respectively). However, the frequency of inpatient care and emergency room visits per year showed no consistent pattern associated with disease severity. The incremental total costs per year were NT$9,511.64, NT$9,705.20, and NT$15,762.09 for mild, moderate, and severe cases, respectively, and the outpatient and drug costs accounted for 46.65%-54.82% and 17.01%-31.20% of the total costs, respectively. CONCLUSION: AD was found to impose significant healthcare costs, with estimated total cost burdens of NT$3.61 billion in 2017, which is 0.314% of Taiwan's national health expenditure and 0.020% of Taiwan's gross domestic product.

Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis.

BACKGROUND: To ascertain the efficacy, safety, and immunogenicity from existing evidence via conducting a meta-analysis of randomized controlled trials between biosimilar and originator insulins. METHODS: The PubMed, Cochrane Library, EMBASE, and ClinicalTrails.gov were searched to identify head-to-head randomized controlled trials (RCTs) that directly compare the efficacy and safety of biosimilar insulin and its originator. Efficacy was assessed by change of HbA1C, fasting plasma glucose (laboratory or self-monitoring of blood glucose (SMBG)), and change all mean of 7 points- or 8 points- SMBG. Safety was assessed by change in proportion hypoglycemia and serious hypoglycemia. The occurrence of anti-insulin antibodies (AIAs) was also evaluated. RESULTS: Fourteen RCTs with 6188 patients from different countries were included. Data were pooled using a random-effects model and were expressed as the mean difference (MD), odds ratio (OR), and 95% confidence interval (CI). In efficacy, Insulin biosimilar products showed similar in change of HbA1C at weeks 26 and 52, the MD were 0.03 (95% CI - 0.02 to 0.07, p = 0.28), and 0.05 (95% CI - 0.05 to 0.15, p = 0.36), respectively. The proportion of HbA1C less than 7% at endpoint, the OR were 1.04 (95% CI 0.89 to 1.20, p = 0.64). The change of fasting plasma glucose (laboratory or SMBG) mmol/L in 24-52 weeks and change all mean of 7 points-/8 points- SMBG mmol/L in 24-52 weeks, the MD were 0.02 (95% CI - 0.20 to 0.24, p = 0.87) and - 0.34 (95% CI - 1.35 to 0.67, p = 0.51), respectively. In occurrence of hypoglycemia (≥ 1 events) and severe hypoglycemia, the OR were 0.96 (95% CI 0.85 to 1.09, p = 0.52) and 1.06 (95% CI 0.85 to 1.31, p = 0.62). The AIA was 1.02 (95% CI 0.90 to 1.16, p = 0.76). Analysis stratified by type of diabetes and duration of insulin. There was no significant difference between the biosimilar and their reference group in a different type of diabetes and different duration of insulin. CONCLUSIONS: Insulin biosimilar showed comparable characteristics with the reference drug in terms of efficacy, safety, immunogenicity, through comprehensive and specific conventional meta-analysis.