Comparative Cost-Effectiveness of Tofacitinib With Continuing Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs for Active Rheumatoid Arthritis in South Korea.

INTRODUCTION: The objective of this study was to evaluate the cost-effectiveness of initiating treatment with tofacitinib and subsequently incorporating it into a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) treatment sequence and to compare the cost-effectiveness of this sequence with that of continuing csDMARDs alone in patients with active rheumatoid arthritis (RA). METHODS: A cohort-based Markov model was used to evaluate the cost-effectiveness of two tofacitinib treatment sequences compared with that of continuing the csDMARD treatment sequence over a lifetime. Of the two tofacitinib sequences, the first consisted of initial tofacitinib treatment followed by biologic DMARDs (bDMARDs) and the second consisted of csDMARD treatments followed by tofacitinib. A third treatment sequence, continuing the csDMARD treatment sequence before starting bDMARDs, was used as a comparator. Efficacy was assessed using the American College of Rheumatology (ACR) response rates (ACR 20, ACR 50, and ACR 70) after 6 months, which were converted to changes in the health assessment questionnaire-disability index (HAQ-DI) score. Utility was estimated by mapping from the HAQ-DI score, costs were analyzed from a Korean societal perspective, and outcomes were considered in terms of quality-adjusted life-years (QALYs). One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. RESULTS: The incremental cost-effectiveness ratios over a lifetime for starting with tofacitinib and incorporating tofacitinib into the csDMARD treatment sequence versus continuing csDMARDs only were US$14,537 per QALY and US$7,086 per QALY, respectively. One-way sensitivity analysis and probabilistic sensitivity analysis confirmed the robustness of these results. CONCLUSION: Starting with tofacitinib and incorporating it into a csDMARDs treatment sequence is cost-effective compared to continuing csDMARDs alone in patients with RA.

Dose Reduction of Tumor Necrosis Factor Inhibitor and its Effect on Medical Costs for Patients with Ankylosing Spondylitis.

INTRODUCTION: Tumor necrosis factor inhibitors (TNFis) may be administered at a reduced dose to patients with ankylosing spondylitis (AS) for various reasons. However, in practice, there is insufficient evidence of how the dose reduction of TNFi is implemented and the amount of medical costs it reduces. In this study, we investigated treatment patterns among patients with AS who were administered various TNFis. The effect on medical costs related to AS was also investigated using Korea's insurance claims database. METHODS: From the insurance claims database of the Health Insurance Review & Assessment Service in South Korea, patients with AS newly treated with TNFis (etanercept, adalimumab, golimumab, and infliximab) between July 1, 2013, and June 30, 2016, were enrolled. Patients treated with the TNFis were followed up for 2 years. Treatment patterns (continuation and discontinuation of TNFi) and dose reduction (< 50% of recommended dose) in patients who continued treatment were analyzed and compared among the TNFi groups using the Chi-square test. Healthcare costs between the dose reduction and maintenance groups were compared using general linear modeling. RESULTS: Of 1352 patients, 764 (56.51%) continued using TNFis for 2 years, and 17.8% of these were administered reduced doses. TNFi dose reduction was the most frequent in 36 (24.83%) patients using etanercept, followed by those using adalimumab (21.97%), golimumab (11.70%), and infliximab (11.98%) (p = 0.0028). For each TNFi group, the total healthcare cost significantly decreased, that is, by 24.85% for adalimumab, 31.80% for etanercept, 26.34% for golimumab, and 35.52% for infliximab (p < 0.0001). CONCLUSIONS: TNFi dose reduction was identified in 17.8% of the patients with AS, and the patterns were different for each TNFi. Additionally, the dose reductions significantly reduced the medical costs associated with AS, that is, from 24.85 to 35.52% of the total medical expenditure.

Characterization of variable presentations of diabetic ketoacidosis based on blood ketone levels and major society diagnostic criteria: a new view point on the assessment of diabetic ketoacidosis.

AIM: We aimed to evaluate the clinical utility of blood ketone measurement and to test the performance of the diagnostic criteria for diabetic ketoacidosis (DKA) issued by the American Diabetes Association, the Joint British Diabetes Societies, and the American Association of Clinical Endocrinologists and the American College of Endocrinology. METHODS: This retrospective analysis included 278 patients with suspected DKA who were hospitalized at 4 university hospitals and aged ≥16 years with a blood glucose level of >200 mg/dL and a blood ketone level of ≥1.0 mmol/L as well as other biochemical data. The patients were categorized into four subgroups (ketosis, typical DKA, atypical DKA, and DKA + lactic acidosis). Atypical DKA in each analysis was defined by our supplementary criteria if the biochemical data did not meet each set of diagnostic criteria from the aforementioned societies. RESULTS: Blood ketone levels in patients with diabetic ketosis and those with DKA varied widely, 1.05-5.13 mmol/L and 1.02-15.9 mmol/L, respectively. Additionally, there were significant discrepancies between the guidelines in the diagnosis of DKA. Thus, the proportion of patients with atypical DKA ranged from 16.5% to 42.4%. Notably, the in-hospital mortality was comparable between patients with typical and atypical DKA, with a very high mortality in patients with DKA + lactic acidosis (blood lactate >5 mmol/L). CONCLUSIONS: Our results showed that considering variable presentations of DKA, blood ketone data need to be interpreted cautiously along with other biochemical data and suggested that a new system is required to better characterize DKA.

Sodium-glucose co-transporter-2 inhibitors and the risk of ketoacidosis in patients with type 2 diabetes mellitus: A nationwide population-based cohort study.

AIMS: To estimate the risk of diabetic ketoacidosis (DKA) associated with sodium-glucose co-transporter-2 (SGLT2) inhibitor treatment compared with the risk associated with dipeptidyl-peptidase-4 (DPP-4) inhibitor treatment. METHODS: A nationwide population-based cohort study using claims data from the Korean Health Insurance Review and Assessment Service from January 1, 2013 to June 30, 2017 was performed. A total of 56 325 patients who were started on SGLT2 inhibitors were included in this study and were matched with same number of patients who were started on DPP-4 inhibitors using propensity score matching. Kaplan-Meier curves and Cox proportional hazards regression analyses were used to estimate the risk of hospitalization for DKA. RESULTS: The risk of hospitalization for DKA was not increased in SGLT2 inhibitor users vs DPP-4 inhibitor users (hazard ratio [HR] 0.956, 95% confidence interval [CI] 0.581-1.572; P = .996). The incidence rate of hospitalization for DKA during the first 30 days after initiation of the SGLT2 inhibitor was 2.501 cases per 1000 person-years, which was higher than the rate during 3 years (0.614 cases per 1000 person-years). SGLT2 inhibitor use was associated with a higher HR in patients with diabetic microvascular complications (HR 2.044, 95% CI 0.900-4.640; P = .088) and in patients taking diuretics (HR 3.648, 95% CI 0.720-18.480; P = .118), although these associations were not statistically significant. CONCLUSION: We found that SGLT2 inhibitor treatment did not increase the risk of DKA compared with DPP-4 inhibitor treatment. Our findings suggest that patients prescribed diuretics or those with microvascular complications may have a greater tendency to be hospitalized for DKA.

Effect of socio-economic status on the prevalence of diabetes.

PURPOSE: As Korean society has become industrialized and westernized, the prevalence of diabetes has increased rapidly. Environmental factors, especially socio-economic status (SES), may account for the increased prevalence of diabetes. We evaluated the associations between the prevalence of diabetes and SES as reflected by household income and education level. MATERIALS AND METHODS: This study was based on data obtained from the fifth Korea National Health and Nutrition Examination Survey, conducted in 2010-2012. Diabetes referred to a fasting plasma glucose ≥126 mg/dL in the absence of known diabetes, previous diagnosis of diabetes made by a physician, and/or current use of oral hypoglycemic agents or insulin. RESULTS: Household income and education level were inversely associated with the prevalence of diabetes among individuals aged 30 years or older. These associations were more prominent in females aged 30-64 years. According to household income, the odds ratio (OR) [95% confidence interval (CI)] for the lowest quartile group versus the highest quartile group was 4.96 (2.87-8.58). According to education level, the OR (95% CI) for the lowest quartile group versus the highest quartile group was 8.02 (4.47-14.4). CONCLUSION: Public policies for the prevention and management of diabetes should be targeted toward people of lower SES, especially middle-aged females.

Clinical and economic outcomes in medication-adherent and -nonadherent patients with type 2 diabetes mellitus in the Republic of Korea.

BACKGROUND: The prevalence and social burden of type 2 diabetes mellitus (T2DM) is increasing. Medication adherence is necessary for positive outcomes in patients with T2DM. OBJECTIVE: This study evaluated the association between medication adherence and clinical/economic outcomes in patients with T2DM in the Republic of Korea over a 3-year period. METHODS: This study used data from the Korean National Diabetes Program at 5 hospitals. Medication possession ratios of ≥90% and <90% were used to define adherent and nonadherent groups, respectively. The degree of glycemic control, changes in blood pressure and lipid profiles, and health care costs were compared. RESULTS: Of the 608 patients, 472 were medication adherent and 136 were nonadherent. The adherent patients displayed improved fasting blood glucose and hemoglobin A1c during the study. Diastolic blood pressure and total cholesterol were lower at 36 months, and lower low-density lipoprotein cholesterol was noted at baseline and 24 months. The total health care costs were $1861, $2060, and $1924, respectively, versus $1617, $1751, and $1602 during the 3-year study period for the adherent group versus the nonadherent group, respectively (P = 0.316, 0.627, and 0.172, respectively), whereas the outpatient drug costs were $1143, $1176, and $1162 in the adherent group versus $925, $778, and $914 in the nonadherent group (P = 0.002, P < 0.001, and P = 0.001). CONCLUSIONS: The adherent patients displayed better glycemic control and lipid profiles. Medication-related expenses were higher in the adherent group, but overall health care costs, including hospitalization costs, were similar between the 2 groups.