Comparison of Real-World Outcomes of Infliximab versus Adalimumab in Biologic-Naïve Korean Patients with Ulcerative Colitis: A Population-Based Study

PURPOSE: Data on the comparative effectiveness of infliximab (IFX) or adalimumab (ADA) in patients with ulcerative colitis (UC) are extremely limited, especially in the Asian population. We compared clinically important outcomes [colectomy, UC-related emergency room (ER) visits, UC-related hospitalizations, and need for corticosteroids] for these two biologics in biologic-naïve Korean patients with UC. MATERIALS AND METHODS: Using National Health Insurance claims, we collected data on patients who were diagnosed with UC and exposed to IFX or ADA between 2010 and 2016. RESULTS: A total of 862 new users of biologics were included, of whom 630 were treated with IFX and 232 were treated with ADA. Over a median follow-up of 1.8 years after starting biologic therapy, there were no significant differences in the risk of colectomy [adjusted hazard ratio (aHR), 1.87; 95% confidence interval (CI), 0.30-11.63], ER visits (aHR, 1.58; 95% CI, 0.79-3.16), hospitalizations (aHR, 0.83; 95% CI, 0.59-1.17), and corticosteroid use (aHR, 1.16; 95% CI, 0.76-1.78) between IFX and ADA users. These results were stable even when only patients who used biologics for ≥6 months were analyzed. Additionally, these results were unchanged in patients treated with biologic monotherapy or combination therapy with immunomodulators. CONCLUSION: In this nationwide population-based study, there was no significant difference in the risk of colectomy, ER visits, hospitalizations, and corticosteroid use between IFX and ADA users. Our findings indicate that IFX and ADA have comparable effectiveness in biologic-naïve Korean patients with UC.ope

Cancer Risk in Patients with Intestinal Behçet’s Disease: A Nationwide Population-Based Study

Background/Aims: The relationship between intestinal Behçet's disease (BD) and cancer remains unclear. We conducted a nationwide, population-based study to determine the risk of cancer in patients with intestinal BD. Methods: Using the National Health Insurance claims records, we collected data on 365 patients who had been diagnosed with intestinal BD between 2011 and 2014. Standardized incidence ratios (SIRs) of overall and site-specific cancers in patients with intestinal BD in comparison with the general population were calculated. Results: Among 167 men with intestinal BD, four cases of cancer were observed; among 191 women with BD, eight cases of cancer were observed. The risk of all cancers was significantly higher in women with intestinal BD than in women of the general population (SIR, 4.27; 95% confidence interval [CI], 1.84 to 8.41). However, in men with intestinal BD, the risk of all cancers was not significantly higher than that in men of the general population (SIR, 2.08; 95% CI, 0.57 to 5.33). The risk of hematologic cancer was significantly higher in both men and women with intestinal BD than in their counterparts in the general population (SIR, 23.90; 95% CI, 2.89 to 86.32 in men; SIR, 34.47; 95% CI, 4.17 to 124.51 in women). In particular, patients with intestinal BD showed a higher risk of leukemia and myelodysplastic syndrome than the general population. Conclusions: Patients with intestinal BD demonstrated a higher risk of hematologic cancer, especially leukemia, than the general population. Furthermore, women with intestinal BD showed a higher risk of all cancers.ope

Comparison of Long-term Outcomes of Infliximab versus Adalimumab in 1,488 Biologic-Naive Korean Patients with Crohn's Disease

Background/aims: Data on the comparative effectiveness of infliximab (IFX) or adalimumab (ADA) in patients with Crohn's disease (CD) are rare, particularly for Asian patients. We compared the key clinical outcomes (surgery, hospitalization, and corticosteroid use) of use of these two drugs in biologic-naive Korean patients with CD. Methods: Using National Health Insurance claims, we collected data on patients who were diagnosed with CD and exposed to IFX or ADA between 2010 and 2016. Results: We included 1,488 new users of biologics (1,000 IFX users and 488 ADA users). Over a median follow-up period of 2.1 years after starting biological therapy, no significant differences were found between IFX and ADA users in the risks for surgery (ADA vs IFX: adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 0.81 to 1.84), hospitalization (aHR, 1.02; 95% CI, 0.81 to 1.28), and corticosteroid use (aHR, 0.82; 95% CI, 0.56 to 1.19). These results were unchanged even when only patients who used biologics for over 6 months were analyzed (aHR [95% CI]: surgery, 1.31 [0.82 to 2.11]; hospitalization, 1.02 [0.80 to 1.30]; corticosteroid use, 0.80 [0.54 to 1.18]). Additionally, these results were unchanged in patients treated with biologics as monotherapy or in combination with immunomodulators. Conclusions: In this nationwide population-based study, no significant difference was found in the long-term effectiveness of IFX and ADA in the real-world setting of biologic-naive Korean patients with CD. In the absence of trials to directly compare IFX and ADA, our study indicates that the selection of one of these two biologics can be determined by patient and/or physician preference.ope

Use of serotonin reuptake inhibitors and risk of subsequent bone loss in a nationwide population-based cohort study

This study examined whether the use of SRIs is associated with an increased risk of bone loss using a nested case-control design with a nationwide population-based cohort in Korea. Using the Korean National Health Screening Cohort, subjects newly diagnosed with osteoporosis or osteopenia (n = 55,799) were matched with controls (n = 278,995) at a ratio of 1:5. We stratified the participants by their time-dependent use of SRIs and sex and controlled for various confounders, including lifestyle habits, laboratory data, and comorbidities. Conditional logistic regression showed that both recent and former users of SRIs had an increased risk of subsequent bone loss compared with non-users: men [recent users: odds ratio (OR) 1.35, 95% confidential interval (CI) 1.20, 1.53; former-users: OR 1.10, 95% CI 1.01, 1.20]; women (recent users: OR 1.38, 95% CI 1.28-1.48; former-users: OR 1.07, 95% CI 1.02, 1.21). The use of SRIs was associated with an increased risk of bone loss in both men and women. In particular, the association was stronger in recent users. These findings provide population-level evidence for the risk of bone loss associated with SRI exposure and highlight the importance of monitoring the bone health of SRI users.ope

Acute Ischemic Stroke in the Patients with Inflammatory Arthritis: An Analysis of Data from National Health Insurance Service

Background: Inflammation is an important mechanism in stroke. To a considerable extent, the pathophysiology of inflammatory arthritis is influenced by inflammatory cells and cytokines. We compared the risk of stroke between patients with inflammatory arthritis and matched controls, using data from the National Health Insurance Service. Methods: Using a combination of primary diagnosis and V codes for rare incurable diseases, we defined the patients with ankylosing spondylitis, seropositive rheumatoid arthritis, and psoriatic arthritis and enteropathic spondyloarthropathy. The control group was defined by 1:5 propensity score-matching for each disease. Newly developed stroke was identified in the patients with the primary diagnosis of (I60-64) and 1) brain imaging or 2) a prescription of stroke medication or related intervention. Results: The occurrence of stroke was more frequently associated with seropositive rheumatoid arthritis in both the patient population and the seropositive rheumatoid arthritis control group (hazard ratio 1:11, 95% CI 1.02-1.20, P=0.012). In this study, the frequency of stroke occurrence was not associated with the diagnosis of ankylosing spondylitis nor psoriatic arthritis or enteropathic spondyloarthropathy. Furthermore, the use of biologic agents was not associated with the occurrence of stroke, using multivariable analyses in the three different types of inflammatory arthritis and their respective control groups. Conclusion: Seropositive rheumatoid arthritis was a predictor of frequent stroke occurrences. The patients with seropositive rheumatoid arthritis must be cautious with regard to the occurrence of a comorbid stroke. Further studies with long-term follow-ups of clinical outcomes are warranted to explain the underlying correlation between inflammatory arthritis and the risk of stroke.ope

Cancer risk in Korean patients with Behçet's disease: A nationwide population-based study.

BACKGROUND: Various immune-mediated diseases are associated with increased malignancy risks. However, the relationship between Behçet's disease (BD) and cancer remains unclear. We conducted a nationwide, population-based study to determine the risk of cancer in patients with BD. METHODS: Using National Health Insurance claims records, we collected data from 2402 patients diagnosed with BD between 2013 and 2014. Standardized incidence ratios (SIRs) of overall and site-specific cancers in patients with BD in comparison with the general population were calculated. RESULTS: The risks of overall cancer (SIR, 3.54; 95% confidence interval, 2.35-5.11 in men and 2.17; 1.58-2.92 in women) and solid cancer (3.10; 1.94-4.69 in men and 2.13; 1.52-2.90 in women) were greater in patients with BD than in the general population. There were significantly increased risks for these solid cancers: colorectal (4.26; 1.38-9.94), liver (4.00; 1.09-10.25), bone/articular cartilage (55.66; 1.41-310.14), prostate (7.05; 1.45-20.60), and brain/central nervous system (28.32; 3.43-102.31) in men; and the lips/oral cavity/pharynx (13.97, 1.69-50.47), liver (12.78; 5.14-26.33), lungs (4.35; 1.18-11.13), other female genital organs (53.57; 1.36-298.49), and eyes (128.26; 3.24-714.59) in women. Patients with BD had a greater risk of myelodysplastic syndrome (MDS) than the general population did (65.72; 7.96-237.41 in men and 53.86; 11.11-157.40 in women), but not of hematological cancer. CONCLUSIONS: Compared to the general population, Korean patients with BD had greater risks of overall cancer, some solid cancers, and MDS, but not of hematological cancer.ope

Do police officers and firefighters have a higher risk of disease than other public officers? A 13-year nationwide cohort study in South Korea

OBJECTIVES: The work of public officers involves repeated and long-term exposure to heavy workloads ; high job strain and workplace violence ; all of which negatively impact physical and mental health. This study aimed to evaluate and compare the incidences of diseases among different categories of public officers in Korea ; in order to further understand the health risks associated with these occupations. DESIGN: A cohort study using the National Health Insurance data. PARTICIPANTS: We collated claims data between 2002 and 2014 for 860 221 public officers. PRIMARY AND SECONDARY OUTCOME MEASURES: Age-standardised rates were calculated using the direct standardisation method ; and HRs were calculated using the Cox proportional hazard regression models. RESULTS: Overall ; we found that police officers and firefighters had a higher incidence of a range of diseases when compared with national and regional government officers (NRG). The most prominent HRs were observed among police officers for angina pectoris (HR: 1.52 ; 95% CI 1.49 to 1.54) ; acute myocardial infarction (HR: 1.84 ; 95% CI 1.77 to 1.92) and cerebrovascular disease (HR: 1.36 ; 95% CI 1.31 to 1.40). Firefighters were more susceptible to physical ailments and were at a significantly higher risk for traumatic stress disorders (HR: 1.40 ; 95% CI 1.26 to 1.56) than NRGs. CONCLUSION: Compared withNRGs ; police officers had higher HRs for all measured diseases ; except for traumatic stress disorders. While firefighters had higher HRs for almost all diseases examined ; public education officers had a higher HR for traumatic stress disorders ; when compared with NRGs.ope

Comparison of developing tuberculosis following tumor necrosis factor inhibition and interleukin-6 inhibition in patients with rheumatoid arthritis: a nationwide observational study in South Korea, 2013-2018

Background: Tumor necrosis factor (TNF) inhibitors increase the risk of tuberculosis (TB) in patients with rheumatoid arthritis (RA). This study compared the incidence of TB after treatment with TNF inhibitors and tocilizumab in patients with RA, separately in those who were treated for latent tuberculosis infection (LTBI) and those without evidence of LTBI. Methods: This study included patients with RA who initiated TNF inhibitors and tocilizumab between December 2013 and August 2018. Patient data were collected from the nationwide database of the Health Insurance Review and Assessment service in South Korea. The incidence of TB was compared among different biologic drugs in patients with or without LTBI treatment. Results: Of 4736 patients, 1168 were treated for LTBI and 48 developed TB (554.9 per 100,000 person-years). When compared based on etanercept, infliximab showed a higher risk of TB (adjusted incidence rate ratio 2.71, 95% confidence interval 1.05-7.01), especially in patients without evidence of LTBI. Other TNF inhibitors and tocilizumab showed a comparable incidence of TB, regardless of treatment for LTBI. There was no significant difference in TB incidence after biologic therapy between patients with and without LTBI treatment (627.9/100,000 vs. 529.5/100,000 person-years). In patients treated for LTBI, no differential risk of TB was observed among biologic drugs. Conclusions: The incidence of TB was not significantly different among biologic drugs in the current era, except for infliximab in patients who were not treated for LTBI. Treatment of LTBI might alleviate the drug-specific risk of TB in patients with RA.ope

Characteristics and Treatment Patterns of Patients with Advanced Soft Tissue Sarcoma in Korea

PURPOSE: A soft tissue sarcoma (STS) is a rare type of cancer, accounting for 1% of adult solid cancers. The aim of the present study is to determine the incidence of localized and advanced STS in Korean patients, their treatment patterns, and the survival of patients by disease status. Materials and Methods: The STS patient cohort was defined using National Health Insurance Service medical data from 2002 to 2015. Incidence, distribution, anatomical location of tumors, survival rates (Kaplan-Meyer survival function) and treatment patterns were analyzed by applying different algorithms to the STS cohort containing localized and advanced STS cases. RESULTS: A total of 7,813 patients were diagnosed with STS from 2007 to 2014, 4,307 were localized STS and 3,506 advanced STS cases. The total incidence of STS was 2.49 per 100,000 person- years: 1.37 per 100,000 person-years for localized STS and 1.12 per 100,000 person-years for advanced STS. The 5-year survival rate after diagnosis was 56.4% for all STS, 82.4% for localized, and 27.2% for advanced STS. Half of the advanced STS patients (49.98%) received anthracycline-containing chemotherapy as initial treatment after diagnosis. CONCLUSION: This study provides insights into localized and advanced STS epidemiology, treatment patterns and outcomes in Korea, which could be used as fundamental data in improving clinical outcomes of STS patients in the future.ope

Impact of early anti-TNF use on clinical outcomes in Crohn's disease: a nationwide population-based study

Background/aims: The optimal timing for initiation of anti-tumor necrosis factor (TNF) therapy in Crohn's disease (CD) is still debated. Little is known about the clinical outcomes of early versus late administration of anti-TNF agents, especially in Asian CD patients. We aimed to evaluate the impact of early anti-TNF therapy on clinical outcomes in Korean CD patients. Methods: Using the Korean National Health Insurance Claims database, we collected data on patients diagnosed with CD who received anti-TNF therapy for more than 6 months between 2010 and 2016. Early initiation of anti-TNF therapy was defined as those starting infliximab or adalimumab therapy within 1 year of diagnosis. The following outcomes were assessed using a Cox proportional hazard model: abdominal surgery, CD-related emergency room (ER) visit, CD-related hospitalization, and new corticosteroid use. Results: Among 1,207 patients, 609 were early initiators of anti-TNF. Late anti-TNF initiation (> 1 year after diagnosis) was associated with increased risk of surgery (adjusted hazard ratio [aHR], 1.64; 95% confidence interval [CI], 1.05 to 2.55) and tended to be associated with increased risk of ER visit (aHR, 1.38; 95% CI, 0.99 to 1.94). However, there were no significant differences in the risk of hospitalization and corticosteroid use between early and late initiators. Conclusion: Early anti-TNF therapy among Korean CD patients within 1 year of diagnosis was associated with better clinical outcomes than late therapy, such as lower surgery and ER visit rates. Our results suggest that aggressive medical intervention in the early stages of CD may potentially change the course of this disease.ope