Objective: CT-P13, a biosimilar of infliximab, is widely used for treating ankylosing spondylitis (AS). However, the formation of anti-drug antibodies (ADAs) can reduce its efficacy. This study aimed to identify risk factors associated with high ADA levels in AS patients treated with CT-P13. Methods: A prospective observational study enrolled patients with intravenous CT-P13. Clinical data and disease activity was assessed at baseline, 24 weeks, and 54 weeks after CT-P13 treatment. Blood concentrations of CT-P13 and ADAs were measured at 24 and 54 weeks, and their correlation was investigated. Patients were grouped by ADA levels at 54 weeks. Univariable and multivariable logistic regression identified factors associated with high ADA concentrations. Results: A total of 34 patients was enrolled. Significant decreases in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were observed relative to baseline after 24 weeks of CT-P13 therapy. Serum concentrations of CT-P13 and ADA levels increased following treatment. The median serum CT-P13 concentration was 17.6 [12.8, 22.7] µg/mL at 24 weeks and 23.5 [11.7, 34.2] µg/mL at 54 weeks. ADA levels were 6.7 [6.5, 9.1] AU/mL at 24 weeks and 11.4 [9.0, 28.4] AU/mL at 54 weeks. The serum concentrations of CT-P13 and ADA exhibited a negative correlation. In multivariable analysis, current smoking was associated with high ADA production at 54 weeks. Conclusion Smoking is identified as a significant risk factor for elevated ADAs in AS patients treated with CT-P13. The findings underscore the importance of smoking-cessation strategies in the management of AS patients.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Background and Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. Methods: All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. Results: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. Conclusions The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.

Background and Objectives: The Fractional Flow Reserve and Intravascular UltrasoundGuided Intervention Strategy for Clinical Outcomes in Patients with Intermediate Stenosis (FLAVOUR) trial demonstrated non-inferiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared with intravascular ultrasound (IVUS)-guided PCI. We sought to investigate the cost-effectiveness of FFR-guided PCI compared to IVUS-guided PCI in Korea. Methods: A 2-part cost-effectiveness model, composed of a short-term decision tree model and a long-term Markov model, was developed for patients who underwent PCI to treat intermediate stenosis (40% to 70% stenosis by visual estimation on coronary angiography).The lifetime healthcare costs and quality-adjusted life-years (QALYs) were estimated from the healthcare system perspective. Transition probabilities were mainly referred from the FLAVOUR trial, and healthcare costs were mainly obtained through analysis of Korean National Health Insurance claims data. Health utilities were mainly obtained from the Seattle Angina Questionnaire responses of FLAVOUR trial participants mapped to EQ-5D. Results: From the Korean healthcare system perspective, the base-case analysis showed that FFR-guided PCI was 2,451 U.S. dollar lower in lifetime healthcare costs and 0.178 higher in QALYs compared to IVUS-guided PCI. FFR-guided PCI remained more likely to be cost-effective over a wide range of willingness-to-pay thresholds in the probabilistic sensitivity analysis. Conclusions Based on the results from the FLAVOUR trial, FFR-guided PCI is projected to decrease lifetime healthcare costs and increase QALYs compared with IVUS-guided PCI in intermediate coronary lesion, and it is a dominant strategy in Korea.

Cavernous lymphangiomas, characterized by the cystic enlargement of lymphatic vessels in the dermis and subcutaneous tissue, are rarely reported in the scalp. We present the case of a 6-month-old male infant with occipital scalp swelling, whose ultrasonographic examination identified a multiseptated hypoechoic mass in the subcutaneous layer. Histologically, the tumor exhibited irregular, dilated spaces lined with a single layer of endothelial cells, showing D2-40 positivity. This represents a rare case of pediatric cavernous lymphangioma of the scalp, accompanied by a literature review.

Background/Aims: Exercise is a key component of the management of axial spondyloarthritis (axSpA), providing symptomatic relief and helping prevent ankylosis. However, there is a lack of quantitative studies evaluating daily exercise patterns in patients with axSpA. This study assessed the types, frequency, and duration of exercises performed by these patients through a structured questionnaire. Methods: This cross-sectional study included radiographic axSpA patients who visited a rheumatology clinic between September 2014 and March 2016 and provided informed consent to participate. The survey captured information on four types of exercise: high-intensity exercise, moderate-intensity exercise, strength training, and walking. Disease activity and functional status were evaluated using the Bath ankylosing spondylitis disease activity index (BASDAI) and the Bath ankylosing spondylitis functional index (BASFI), respectively. Results: A total of 645 patients participated in the study. Among them, 25.1% engaged in high-intensity exercise, 36.0% in moderate-intensity exercise, 81.2% in walking, and 32.8% in strength training. The median weekly exercise frequency was 3.0 days (interquartile range [IQR], 2.0-4.0) for high-intensity exercise, 3.0 days (IQR, 2.0-5.0) for moderate-intensity exercise, 5.5 days (IQR, 4.0-7.0) for walking, and 3.0 days (IQR, 2.0-5.0) for strength training. The median daily exercise duration was 60 minutes (IQR, 60-120) for high-intensity exercise, 60 minutes (IQR, 30-90) for moderate-intensity exercise, 30 minutes (IQR, 20-60) for walking, and 30 minutes (IQR, 20-60) for strength training. Comparisons by disease activity showed that BASFI scores were more strongly associated with differences in exercise patterns than BASDAI scores. Conclusion Radiographic axSpA patients predominantly engaged in low-intensity activities, particularly walking, typically for short durations. Given the observed variations in exercise patterns based on disease activity, personalized exercise education and guidance should be prioritized in clinical practice to optimize axSpA management.

Cavernous lymphangiomas, characterized by the cystic enlargement of lymphatic vessels in the dermis and subcutaneous tissue, are rarely reported in the scalp. We present the case of a 6-month-old male infant with occipital scalp swelling, whose ultrasonographic examination identified a multiseptated hypoechoic mass in the subcutaneous layer. Histologically, the tumor exhibited irregular, dilated spaces lined with a single layer of endothelial cells, showing D2-40 positivity. This represents a rare case of pediatric cavernous lymphangioma of the scalp, accompanied by a literature review.

Background/Aims: Exercise is a key component of the management of axial spondyloarthritis (axSpA), providing symptomatic relief and helping prevent ankylosis. However, there is a lack of quantitative studies evaluating daily exercise patterns in patients with axSpA. This study assessed the types, frequency, and duration of exercises performed by these patients through a structured questionnaire. Methods: This cross-sectional study included radiographic axSpA patients who visited a rheumatology clinic between September 2014 and March 2016 and provided informed consent to participate. The survey captured information on four types of exercise: high-intensity exercise, moderate-intensity exercise, strength training, and walking. Disease activity and functional status were evaluated using the Bath ankylosing spondylitis disease activity index (BASDAI) and the Bath ankylosing spondylitis functional index (BASFI), respectively. Results: A total of 645 patients participated in the study. Among them, 25.1% engaged in high-intensity exercise, 36.0% in moderate-intensity exercise, 81.2% in walking, and 32.8% in strength training. The median weekly exercise frequency was 3.0 days (interquartile range [IQR], 2.0-4.0) for high-intensity exercise, 3.0 days (IQR, 2.0-5.0) for moderate-intensity exercise, 5.5 days (IQR, 4.0-7.0) for walking, and 3.0 days (IQR, 2.0-5.0) for strength training. The median daily exercise duration was 60 minutes (IQR, 60-120) for high-intensity exercise, 60 minutes (IQR, 30-90) for moderate-intensity exercise, 30 minutes (IQR, 20-60) for walking, and 30 minutes (IQR, 20-60) for strength training. Comparisons by disease activity showed that BASFI scores were more strongly associated with differences in exercise patterns than BASDAI scores. Conclusion Radiographic axSpA patients predominantly engaged in low-intensity activities, particularly walking, typically for short durations. Given the observed variations in exercise patterns based on disease activity, personalized exercise education and guidance should be prioritized in clinical practice to optimize axSpA management.

Objective: It has been 1 year since the start of the worldwide coronavirus disease-19 (COVID-19) pandemic. This study analyzed the indirect effects of COVID-19 on treating patients with non-infectious diseases by comparing the incidence of complicated appendicitis before and after the pandemic. Methods: The target group included patients aged at least 16 years diagnosed with acute appendicitis between February 23 and July 31, 2020. Patients diagnosed during the same period in 2019 were selected as the control group. The differences in the incidence of complicated appendicitis before and after COVID-19 were investigated, and the association with various variables was analyzed using the odds ratios and 95% confidence intervals (CIs). Results: The study included 120 subjects in 2019 (pre-COVID group) and 119 cases in 2020 (post-COVID group). The pre-COVID group included 25 cases (20.8%) of complicated appendicitis, while the post-COVID group included 48 cases (40.3%). The median time from symptom onset to visit (pre-hospital time) increased from 15 to 22 hours, and the median time from the visit to surgery (in-hospital time) increased from 7 to 11 hours. Multivariate regression analysis of the three variables revealed odds ratios (95% CIs) of pre-hospital time, erythrocyte sedimentation rate, and inclusion in the post-COVID group of 1.02 (1.01-1.02), 2.07 (1.11-3.86), and 2.15 (1.12-4.11), respectively. Conclusion The incidence of complicated appendicitis increased after the COVID-19 pandemic. Therefore, a healthcare system that can minimize the delay in treating non-infectious emergency patients is needed.