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: Despite the increasing prevalence of anorexia nervosa (AN) in Asia, standardized treatments are lacking in South Korea.This study examined the feasibility and effectiveness of evidence-based psychological treatments for AN in Korean children and adolescents. Methods: This retrospective study included outpatients diagnosed with AN, aged <18 years, who received either family-based treatment (FBT; n=102) or specialist supportive clinical management (SSCM; n=43). Feasibility was measured using dropout rates, and effectiveness was assessed using outcome variables, including changes in body mass index (BMI) and eating disorder (ED) pathology, using an intention-to-treat approach. Results: The mean dropout rate was 41%, and the mean BMI increase was 2.76 kg/m2 . Overall, there were no differences between the treatment groups in terms of the dropout rate or outcomes, except for the frequency of starvation. SSCM group exhibited greater reductions in starvation frequency (F(1,139)=4.80, p=0.030, ηp2 =0.034) with a small effect size. Lower BMI and higher ED psychopathology atbaseline were associated with a greater BMI increase at the end of treatment. Conclusion These results suggest that both FBT and SSCM are feasible and effective for Korean children and adolescents with AN. Notably, SSCM may be more effective in individuals who frequently starved. Further controlled trials are needed to examine the effectiveness and improve treatment retention by incorporating cultural considerations.

Objective: International treatment guidelines recommend psychotherapy as the first-line treatment for anorexia nervosa (AN). Adaptation of Western evidence-based treatments to different cultures through personalization has become increasingly important, but evidence remains limited. This study examined the feasibility and effectiveness of AN outpatient psychotherapies in Korea. Methods: A total of 160 adult patients diagnosed with AN (mean age = 25.3 years) were recruited from an eating disorder (ED) clinic in Korea. They received one of the following psychotherapy programs: motivational enhancement therapy with nutrition (MET with nutrition) (n = 47); Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) augmented by New Maudsley Model for Collaborative Care (NMCC) (n = 20); or Specialist Supportive Clinical Management (SSCM) (n = 93). Treatments were administered face-to-face by trained therapists, following protocols tailored to each individual. Demographic and ED‐related clinical data were collected through standardized interviews and questionnaires at baseline and at the end of treatment. Results: Overall dropout rate was 40.3%, with a lower rate observed in MANTRA augmented by NMCC and SSCM than MET with nutrition. All three psychotherapies increased body mass index (BMI), with minimal group differences.Individuals with lower baseline BMI and those who attended more sessions experienced greater BMI increases across all psychotherapies. Conclusion Psychotherapies for AN were feasible and showed promise in terms of effectiveness among Korean patients.Despite comparable BMI increases, the therapies led by experienced therapists and with greater personalization had lower dropout rates. Further studies using randomized controlled trials are needed while controlling for variables outside treatments.

Objective: This study investigated the clinical features and personality traits of pediatric and adult patients with avoidant/restrictive food intake disorder (ARFID) and anorexia nervosa-restricting type (RAN) in a Korean hospital cohort, and the distinct characteristics of ARFID in a non-Western sample. Methods: This retrospective cohort study included 392 Korean outpatients with ARFID (n=68) or RAN (n=324) at an eating disorders clinic. Clinical characteristics including eating and general psychopathology, and personality traits based on the five-factor model and behavior inhibition/activation systems were assessed. The eating and general psychopathology and personality traits of pediatric and adult patients with ARFID were retrospectively investigated alongside those of pediatric and adult RAN patients. Results: Patients with ARFID had an earlier onset age, a longer illness duration, and lower levels of eating and general psychopathology compared to those with RAN. ARFID patients also reported lower levels of neuroticism and behavioral inhibition. Pediatric ARFID patients showed less severe general psychopathology than adult patients with ARFID, while personality traits were consistent across age groups. However, pediatric RAN patients demonstrated higher dietary restraint and lower levels of general psychopathology compared to adult patients. Conclusion This study highlights distinct psychopathology and personality traits between ARFID and RAN. These findings emphasize the importance of age-specific interventions for ARFID. Compared to pediatric patients, adult patients with ARFID require interventions targeting psychological difficulties. The results underscore the need to improve recognition of ARFID in Korea.

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.