Background: and Purpose Treatments for neuromyelitis optica spectrum disorder (NMOSD) such as eculizumab, ravulizumab, satralizumab, and inebilizumab have significantly advanced relapse prevention, but they remain expensive. Rituximab is an off-label yet popular alternative that offers a cost-effective solution, but its real-world efficacy needs better quantification for guiding the application of newer approved NMOSD treatments (ANTs). This study aimed to determine real-world rituximab failure rates to anticipate the demand for ANTs and aid in resource allocation. Methods: We conducted a nationwide retrospective study involving 605 aquaporin-4-antibody-positive NMOSD patients from 22 centers in South Korea that assessed the efficacy and safety of rituximab over a median follow-up of 47 months. Results: The 605 patients treated with rituximab included 525 (87%) who received continuous therapy throughout the follow-up period (median=47 months, interquartile range=15–87 months). During this period, 117 patients (19%) experienced at least 1 relapse. Notably, 68 of these patients (11% of the total cohort) experienced multiple relapses or at least 1 severe relapse.Additionally, 2% of the patients discontinued rituximab due to adverse events, which included severe infusion reactions, neutropenia, and infections. Conclusions This study has confirmed the efficacy of rituximab in treating NMOSD, as evidenced by an 87% continuation rate among patients over a 4-year follow-up period. Nevertheless, the occurrence of at least one relapse in 19% of the cohort, including 11% who experienced multiple or severe relapses, and a 2% discontinuation rate due to adverse events highlight the urgent need for alternative therapeutic options.

Background: and Purpose Treatments for neuromyelitis optica spectrum disorder (NMOSD) such as eculizumab, ravulizumab, satralizumab, and inebilizumab have significantly advanced relapse prevention, but they remain expensive. Rituximab is an off-label yet popular alternative that offers a cost-effective solution, but its real-world efficacy needs better quantification for guiding the application of newer approved NMOSD treatments (ANTs). This study aimed to determine real-world rituximab failure rates to anticipate the demand for ANTs and aid in resource allocation. Methods: We conducted a nationwide retrospective study involving 605 aquaporin-4-antibody-positive NMOSD patients from 22 centers in South Korea that assessed the efficacy and safety of rituximab over a median follow-up of 47 months. Results: The 605 patients treated with rituximab included 525 (87%) who received continuous therapy throughout the follow-up period (median=47 months, interquartile range=15–87 months). During this period, 117 patients (19%) experienced at least 1 relapse. Notably, 68 of these patients (11% of the total cohort) experienced multiple relapses or at least 1 severe relapse.Additionally, 2% of the patients discontinued rituximab due to adverse events, which included severe infusion reactions, neutropenia, and infections. Conclusions This study has confirmed the efficacy of rituximab in treating NMOSD, as evidenced by an 87% continuation rate among patients over a 4-year follow-up period. Nevertheless, the occurrence of at least one relapse in 19% of the cohort, including 11% who experienced multiple or severe relapses, and a 2% discontinuation rate due to adverse events highlight the urgent need for alternative therapeutic options.

Background: and Purpose Treatments for neuromyelitis optica spectrum disorder (NMOSD) such as eculizumab, ravulizumab, satralizumab, and inebilizumab have significantly advanced relapse prevention, but they remain expensive. Rituximab is an off-label yet popular alternative that offers a cost-effective solution, but its real-world efficacy needs better quantification for guiding the application of newer approved NMOSD treatments (ANTs). This study aimed to determine real-world rituximab failure rates to anticipate the demand for ANTs and aid in resource allocation. Methods: We conducted a nationwide retrospective study involving 605 aquaporin-4-antibody-positive NMOSD patients from 22 centers in South Korea that assessed the efficacy and safety of rituximab over a median follow-up of 47 months. Results: The 605 patients treated with rituximab included 525 (87%) who received continuous therapy throughout the follow-up period (median=47 months, interquartile range=15–87 months). During this period, 117 patients (19%) experienced at least 1 relapse. Notably, 68 of these patients (11% of the total cohort) experienced multiple relapses or at least 1 severe relapse.Additionally, 2% of the patients discontinued rituximab due to adverse events, which included severe infusion reactions, neutropenia, and infections. Conclusions This study has confirmed the efficacy of rituximab in treating NMOSD, as evidenced by an 87% continuation rate among patients over a 4-year follow-up period. Nevertheless, the occurrence of at least one relapse in 19% of the cohort, including 11% who experienced multiple or severe relapses, and a 2% discontinuation rate due to adverse events highlight the urgent need for alternative therapeutic options.

Objectives: Difficulties in interpersonal relationships intensify negative emotions and act as risk and maintenance factors for eating pathology in eating disorders. Rejection sensitivity refers to the tendency to react sensitively to a rejection. Patients with eating disorders experience difficulties in interpersonal relationships because of their high sensitivity to rejection. Cognitive bias modification interpretation (CBM-I) is a treatment developed to correct interpretation bias for social and emotional stimuli. In this review, we searched for research characteristics and trends through a systematic literature analysis of CBM-I for eating disorders. Methods: Five papers that met the selection and exclusion criteria were included in the final literature review and analyzed according to detailed topics (participant characteristics, design, and results). Results: The literature supports the efficacy of the CBM-I in reducing negative interpretation bias and eating disorder psychopathology in patients with eating disorders. CBM-I targets emotional dysregulation in adolescent patients with eating disorders and serves as an additional strengthening psychotherapy to alleviate eating disorder symptoms. Conclusion The current findings highlight the potential of CBM-I as an individualized adjunctive treatment for adolescents with eating disorders and social functioning problems.

Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC) formulation of dapagliflozin and metformin extended release (XR) tablets, relative to the reference formulation (10 mg dapagliflozin/1,000 mg metformin XR FDC tablet) in healthy subjects under fasting (Part A) and fed (Part B) conditions. After giving the dose, serial blood samples were collected for a period of 48 hours. Primary PK parameters (AUC 0-t and C max ) were used to assess bioequivalence between two dapagliflozin/metformin XR (10/1,000 mg) FDC formulations under fed and fasting conditions. Safety and tolerability were also evaluated. Part A and Part B were completed by 32 and 37 subjects, respectively. Bioequivalence of the two FDC formulations of dapagliflozin and metformin XR tablets was established in both the fasted and the fed conditions as the 90% confidence interval of the ratios of adjusted geometric means for AUC 0-t and C max were contained within the predefined range of 0.800–1.250 bioequivalence criteria. Single-dose administration of dapagliflozin and metformin XR was safe and well tolerated as the two FDC formulations. In conclusion, both FDC formulations of dapagliflozin and metformin XR tablets were bioequivalent in fed and fasted subjects. All treatments were well tolerated.

A new fixed-dose combination (FDC) formulation of raloxifene 60 mg and cholecalciferol 800 IU was developed to improve the medication compliance and overall efficacy of raloxifene treatment in postmenopausal osteoporosis patients. The aim of this study was to compare the pharmacokinetics between two tablets of FDC formulation of raloxifene/cholecalciferol and the two products administered concomitantly at respective doses. This randomized, open-label, single-dose, two-treatment, two-way crossover study included 46 volunteers. During each treatment period, subjects received the test formulation (FDC formulation containing raloxifene and cholecalciferol) or the reference formulation (co-administration of raloxifene and cholecalciferol), with a 14-d washout period. Serial blood samples were collected periodically over 96 hours after drug intake. In total, 46 subjects completed the study. The geometric mean ratios and its 90% confidence intervals of the FDC to the single agents for the area under the concentration-time curve from zero to the last quantifiable time point and the maximum plasma concentration met the regulatory criteria for bioequivalence: 1.1364 (1.0584–1.2201) and 1.1010 (0.9945–1.2188) for raloxifene and 1.0266 (0.9591–1.0989) and 1.0354 (0.9816–1.0921) for baseline-corrected cholecalciferol, respectively. Both formulations were well tolerated. No significant differences was observed in the incidence of adverse events between the two treatments. It was concluded that two tablets of the newly developed FDC formulation of raloxifene and cholecalciferol and the corresponding two agents administered concomitantly at respective doses were bioequivalent.

This study compared the pharmacokinetics of a fixed-dose combination (FDC) of candesartan (16 mg) and amlodipine (10 mg) versus coadministration of individual formulations to clarify the bioequivalence of the FDC. In this randomized, open-label, single-dose, 2-treatment, 2-way crossover study, healthy Korean volunteers received a single dose of candesartan (16 mg) with amlodipine (10 mg) as either an FDC or single agents concomitantly administered, with a 2-week washout period. Serial blood samples were collected up to 72 hours after dosing for each treatment period, and plasma concentrations of candesartan and amlodipine were measured using a validated liquid chromatography-tandem mass spectrometry method. A total of 39 subjects completed the study. The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for the area under the plasma concentration-time curve from time 0 to the last measurement (AUC0-t) and the peak plasma concentration (Cmax) for candesartan were 1.0182 (0.9562–1.0841) and 0.9492 (0.8726–1.0324), respectively. The GMR and 90% CI for the AUC0-t and Cmax for amlodipine were 1.0552 (1.0255–1.0857) and 1.0668 (1.0259–1.1094), respectively. In conclusion, the new FDC formulation of candesartan (16 mg) and amlodipine (10 mg) was bioequivalent to the concomitant administration of single agents. A single dose of candesartan/amlodipine as the FDC or as single agents was well tolerated.

OBJECTIVES: The Eating Disorder Examination Questionnaire, version 6.0 (EDE-Q version 6.0) and the Clinical Impairment Assessment Questionnaire (CIA) measure attitudes and behavioral features of eating disorders and impairments secondary to eating disorders, respectively. The aims of this study were to examine the reliability and the validity of the Korean versions of the EDE-Q version 6.0 and the CIA. METHODS: Four hundred nineteen participants (370 female university students and 49 women with eating disorders) completed the EDE-Q version 6.0, the CIA, the Body Shape Questionnaire (BSQ) and the Weight Concern Scale (WCS). RESULTS: Excellent internal consistencies were obtained for the EDE-Q version 6.0 (Cronbach's α=0.92) and the CIA (Cronbach's α=0.91). Exploratory factor analysis of CIA extracted the 3 factors of personal, social, and cognitive impairments, as the original CIA had. The EDE-Q version 6.0 and the CIA were well correlated with the BSQ and the WCS, in respect to their contextually concordant variables. Patients with eating disorders had higher scores both in the EDE-Q 6.0 and the CIA than university women had, supporting good discriminant validity. CONCLUSIONS: The EDE-Q version 6.0 and the Korean versions of the CIA had adequate reliability and validity. These data will help clinicians and researchers to use the EDE-Q and the CIA in diagnosis, prevention and intervention of eating disorders in Korea.
Cognition Disorders ; Diagnosis ; Eating ; Female ; Humans ; Korea ; Reproducibility of Results

OBJECTIVES: Although breakfast is important to nutrition balance, prevention of overeating, and weight control, people in their 20s (males: 55.1%, females: 49.9%) were reported to have the highest rate of skipping breakfast in 2016 Korea Health Statistics. This study aims to examine dietary habits and nutrient intake depending on breakfast frequency among young women in Seoul. METHODS: The subjects were 655 young women in Seoul from August to October 2016, and the survey was performed by using a questionnaire that included general characteristics, dietary habits, and eating behavior. Body composition was determined by bioelectric impedance analysis. Nutritional status was examined by the 24-hour recall method. RESULTS: The participants were classified by breakfast intake frequency; ‘≥ 5 times/week (n=160)’, ‘1–4 times/week (n=327)’, and ‘breakfast skipping (n=168)’. The ‘breakfast skipping’ group had lower frequency and regularity of meals. In addition, the ‘breakfast skipping’ group had a higher frequency of eating-out and late-night meals. There was no difference in total calories between the ‘breakfast skipping’ group and other groups, but the ‘breakfast skipping’ group had significantly low carbohydrate and fiber intakes. The participants showed lower intakes of calories, fiber, vitamin A, vitamin C, niacin, folic acid, calcium, potassium, and zinc in comparison with recommended intakes. Especially, the ‘breakfast skipping’ group had significantly lower fiber, vitamin A, vitamin C, calcium, potassium levels compared to the ‘≥ 5 times/week’ group. For Mean Adequacy Ratio (MAR), the ‘breakfast skipping’ group recorded a ratio of 0.60, which was lower than those of other groups. Index of Nutritional Quality (INQ) including fiber, vitamin C, calcium and phosphorus were significantly lower in the breakfast skipper group, compared to the breakfast eater group. CONCLUSIONS: The ‘breakfast skipping’ group showed low regularity of meals and a high frequency of eating-out and late-night meals. The breakfast regular eater group showed high intake of micronutrients and quality of meals was high in general. Skipping breakfast could lower nutrient intake and quality of meals, which requires attention.
Ascorbic Acid ; Body Composition ; Breakfast ; Calcium ; Electric Impedance ; Feeding Behavior ; Female ; Folic Acid ; Food Habits ; Humans ; Hyperphagia ; Korea ; Meals ; Methods ; Micronutrients ; Niacin ; Nutritional Status ; Nutritive Value ; Phosphorus ; Potassium ; Seoul ; Vitamin A ; Zinc

OBJECTIVES: Although breakfast is important to nutrition balance, prevention of overeating, and weight control, people in their 20s (males: 55.1%, females: 49.9%) were reported to have the highest rate of skipping breakfast in 2016 Korea Health Statistics. This study aims to examine dietary habits and nutrient intake depending on breakfast frequency among young women in Seoul. METHODS: The subjects were 655 young women in Seoul from August to October 2016, and the survey was performed by using a questionnaire that included general characteristics, dietary habits, and eating behavior. Body composition was determined by bioelectric impedance analysis. Nutritional status was examined by the 24-hour recall method. RESULTS: The participants were classified by breakfast intake frequency; ‘≥ 5 times/week (n=160)’, ‘1–4 times/week (n=327)’, and ‘breakfast skipping (n=168)’. The ‘breakfast skipping’ group had lower frequency and regularity of meals. In addition, the ‘breakfast skipping’ group had a higher frequency of eating-out and late-night meals. There was no difference in total calories between the ‘breakfast skipping’ group and other groups, but the ‘breakfast skipping’ group had significantly low carbohydrate and fiber intakes. The participants showed lower intakes of calories, fiber, vitamin A, vitamin C, niacin, folic acid, calcium, potassium, and zinc in comparison with recommended intakes. Especially, the ‘breakfast skipping’ group had significantly lower fiber, vitamin A, vitamin C, calcium, potassium levels compared to the ‘≥ 5 times/week’ group. For Mean Adequacy Ratio (MAR), the ‘breakfast skipping’ group recorded a ratio of 0.60, which was lower than those of other groups. Index of Nutritional Quality (INQ) including fiber, vitamin C, calcium and phosphorus were significantly lower in the breakfast skipper group, compared to the breakfast eater group. CONCLUSIONS: The ‘breakfast skipping’ group showed low regularity of meals and a high frequency of eating-out and late-night meals. The breakfast regular eater group showed high intake of micronutrients and quality of meals was high in general. Skipping breakfast could lower nutrient intake and quality of meals, which requires attention.
Ascorbic Acid ; Body Composition ; Breakfast ; Calcium ; Electric Impedance ; Feeding Behavior ; Female ; Folic Acid ; Food Habits ; Humans ; Hyperphagia ; Korea ; Meals ; Methods ; Micronutrients ; Niacin ; Nutritional Status ; Nutritive Value ; Phosphorus ; Potassium ; Seoul ; Vitamin A ; Zinc