https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/408 2026-07-03T22:01:26Z https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/210380 Title: Association between gastroesophageal reflux disease and incident bronchiectasis: a nationwide representative population-based study in Korea Authors: Yoon, Jiyoung; Yoon, Jai Hoon; Lee, Heajung; Lee, Jun Su; Moon, Seong Mi; Choi, Hayoung; Yang, Bumhee; Lee, Hyun Abstract: Introduction: A close association between gastroesophageal reflux disease (GERD) and chronic respiratory diseases has been suggested. However, limited information is available on whether GERD is associated with an increased incidence of bronchiectasis. Methods: Using a nationwide representative claims database, we identified adults with GERD (GERD cohort) and propensity score-matched controls without GERD (matched controls) between 2004 and 2012. Both cohorts were followed until the date of bronchiectasis diagnosis, date of death, or December 31, 2015. Cox proportional hazard regression analyses were used to evaluate the risk of bronchiectasis between groups. Using the GERD cohort, we also evaluated factors associated with bronchiectasis. Results: During the median follow-up of 9.5 years (interquartile range: 6.33–12.17 years), the cumulative incidence of bronchiectasis was significantly higher in the GERD cohort than in matched controls (418.59 person-years vs. 291.68 person-years; P < 0.01), with a hazard ratio (HR) of 1.43 (95% confidence interval [CI] = 1.13–1.55). Besides, the risk of bronchiectasis increased as GERD severity increased (HR = 1.24, 95% CI = 1.12–1.38 for mild GERD group and HR = 1.48, 95% CI = 1.35–1.62 for severe GERD group). Among the GERD cohort, factors associated with increased risk bronchiectasis were older age (the highest adjusted hazard ratio [aHR] = 8.46, 95% CI = 4.84–14.80 for individuals aged 70 years or older versus individuals aged 20–29), underweight (aHR = 1.79, 95% CI = 1.35–2.37), chronic obstructive pulmonary disease (aHR = 1.33, 95% CI = 1.06–1.67), asthma (aHR = 1.51, 95% CI = 1.25–1.82), and peptic ulcer disease (aHR = 1.26, 95% CI = 1.09–1.46). Conclusion: GERD is associated with an increased risk of bronchiectasis. Older age, underweight, coexisting airway diseases, and peptic ulcer disease were risk factors for developing bronchiectasis in GERD. 2026-12-01T00:00:00Z https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/212760 Title: Treatment patterns, treat-to-target goals and clinical outcomes of patients with active lupus nephritis: real-world evidence from a multicentre cohort study Authors: Kent, Joanna; Xu, Xiaomeng; Ramnarain, Arushi; Louthrenoo, Worawit; Golder, Vera; Hamijoyo, Laniyati; Luo, Shue-Fen; Wu, Yeong-Jian Jan; Chen, Yi-Hsing; Bae, Sang-Cheol; Cho, Jiacai; Lateef, Aisha; Chan, Shirley; Lau, Chak Sing; Navarra, Sandra; Zamora, Leonid; Yao, Haihong; Sockalingam, Sargunan; Basnayake, B.M.D.B.; Hao, Yanjie; Zhang, Zhuoli; Chan, Madelynn; Xu, Chuanhui; Katsumata, Yasuhiro; Kikuchi, Jun; Kaneko, Yuko; Takeuchi, Tsutomu; Oon, Shereen; O’Neill, Sean; Hassett, Geraldine; Goldblatt, Fiona; Poh, Yih Jia; Sapsford, Mark; Tugnet, Nicola; Ng, Kristine Pek Ling; Tee, Cherica; Tee, Michael; Miyazaki, Yusuke; Ohkubo, Naoaki; Tanaka, Yoshiya; Nikpour, Mandana; Hoi, Alberta; Rojas, Aldo A Navarro; Morand, Eric; Kandane-Rathnayake, Rangi Abstract: Background: Lupus nephritis (LN) is a common and severe manifestation of systemic lupus erythematosus (SLE). We sought to evaluate treatment patterns, treat-to-target state attainment, and outcomes of patients with active LN on non-biologic, conventional therapy, in a large real-world cohort from the Asia–Pacific region. Methods: Adult patients enrolled in a multinational lupus cohort were studied for evidence of active LN, defined based on the SLE Disease Activity Index-2000 (SLEDAI-2K)-proteinuria threshold (> 0.5 g/24 h or > 0.05g/mmol), ≥ 2 visits of data, and no exposure to biologics. The subset of these patients who had kidney biopsy-confirmed LN was retrospectively determined. Attainment of treatment goals, including modified versions of complete renal response (mCRR) and primary efficacy renal response (mPERR), lupus low disease activity state (LLDAS) and DORIS remission (REM), and organ damage accrual, were assessed over time following the first visit with proteinuria. Results: One thousand one hundred eighty patients were studied for a median 2.7 [IQR 1.0, 5.0] years, 435 (37%) of whom had biopsies (Class III/IV = 242 (56%)). mCRR, mPERR, LLDAS, and REM were attained at least once during follow-up by 46%, 55%, 60%, and 46% of patients, respectively. mCRR and mPERR attainment was highest at year 2, while LLDAS and REM attainment gradually increased over time. New organ damage accrued in 11% of patients by year 1, increasing to 33% by year 5. Conclusion: In a multinational cohort of patients with active LN receiving non-biologic conventional therapy, the attainment of renal responses, LLDAS, and REM was low, while damage accrual was prevalent. 2026-12-01T00:00:00Z https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/212516 Title: Efficacy of neoadjuvant FOLFIRINOX in resectable pancreatic cancer (NeoFOL-R): study protocol for an international, multicenter, prospective, randomized controlled trial Authors: Jung, Hye-Sol; Choi, Julian; Park, Se Jun; Han, Youngmin; Cho, Young Jae; Yoon, Jeesun; Oh, Do-Youn; Yoon, Yoo-Seok; Kim, Jin Won;  Lim, Chang-Sup; Park, Jin Hyun; Choi, In Sil; Hong, Tae Ho; Kim, Hyung Sun; Jeung, Hei-Cheul; Ahn, Keun Soo; Kim, Jin Young; Yu, Young-Dong; Kim, Ju Won; Hwang, Ho Kyoung; Lee, Choong-Kun; Choi, Hye Jin; Jung, Yun Kyung; Park, Kwonoh; Yoon, Jai Hoon; Han, In Woong; Hong, Jung Yong; Seo, Hyung Il; Do Yang, Jae; Jeon, So-Yeon; Yang, Seok Jeong; Chon, Hong Jae; Kwon, Wooil; Park, Joon Seong; Shan, Yan-Shen; Lee, Myung Ah; Jang, Jin-Young Abstract: Background Recent randomized controlled trials (RCTs) regarding the outcomes of neoadjuvant chemotherapy for patients with resectable pancreatic cancer (PC) reported inconsistent results. As the survival rate of FOLFIRINOX was found to be superior to that of gemcitabine, interest in the efficacy of neoadjuvant chemotherapy with FOLFIRINOX for resectable PC is growing. In this study, we aimed to investigate the efficacy of neoadjuvant FOLFIRINOX in patients with resectable PC. Methods This international (South Korea, Australia, and Taiwan), multicenter, phase 3, RCT will include 609 patients with resectable pancreatic ductal adenocarcinoma and ECOG performance 0-1. Resectable PC is defined as no arterial contact and no tumour contact with the superior mesenteric vein/portal vein or <= 180 degrees contact without vein contour irregularity. Neoadjuvant FOLFIRINOX consisted of oxaliplatin (85 mg/m(2)), administered intravenously over 2 h, followed by leucovorin (400 mg/m(2)) over 2 h and irinotecan (180 mg/m(2)) over 90 min, administered concurrently. Subsequently, an intravenous bolus infusion of 5-FU (400 mg/m(2)) and a continuous infusion of 5-FU (2400 mg/m(2)) over 46 h, repeated every 2 weeks for 6 cycles. Adjuvant therapy with modified FOLFIRINOX (mFOLFIRINOX) included oxaliplatin (85 mg/m(2)), irinotecan (150 mg/m(2)), leucovorin (400 mg/m(2)), and fluorouracil (2400 mg/m(2)) over 46 h and repeated every 2 weeks, with six cycles in the neoadjuvant group and 12 cycles in the upfront surgery group. The primary endpoint is a two-year survival rate by intention-to-treat. Secondary outcomes are overall survival, disease-free survival, resection rate, R0 resection rate, lymph node negative rate, recurrence rate, response rate. When calculating with a significance level of 5% and a statistical power of 80%, 171 events (deaths) are needed. Considering the 5-year participant enrollment period and a minimum of a 2-year follow-up period, 518 patients were required to observe 171 events. A total of 609 patients were required when the dropout rate was calculated as 15%. Discussion The NeoFOL-R trial investigates the efficacy of perioperative versus adjuvant FOLFIRINOX for patients with resectable PC. The study is ongoing, starting in February 2024 in South Korea, Australia, and Taiwan. Trial registration NCT 05529940. Registered in September 2022. KCT0008360 (Korean Clinical Trial Database). Registered in April 2022. 2026-12-01T00:00:00Z https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/212764 Title: Bias due to interval censored outcomes in a study of flare risk after hydroxychloroquine taper/cessation in systemic lupus erythematosus Authors: Kaddoura, Rima; Bernatsky, Sasha; Beauchamp, Marie-Eve; Guerra, Steve Ferreira; Almeida-Brasil, Celline C.; Hanly, John G.; Urowitz, Murray; Clarke, Ann E.; Ruiz-Irastorza, Guillermo; Gordon, Caroline; Ramsey-Goldman, Rosalind; Petri, Michelle A.; Ginzler, Ellen M.; Wallace, Daniel J.; Bae, Sang-Cheol; Romero-Diaz, Juanita; Dooley, Mary-Anne; Peschken, Christine; Isenberg, David; Manzi, Susan; Jacobsen, Soren; Lim, S. Sam; Nived, Ola; Jönsen, Andreas; Kamen, Diane L.; Aranow, Cynthia; Sánchez-Guerrero, Jorge; Gladman, Dafna D.; Fortin, Paul R.; Alarcón, Graciela S.; Merrill, Joan T.; Kalunian, Kenneth; Ramos-Casals, Manuel; Zoma, Asad .A.; Askanase, Anca D.; Khamashta, Munther; Bruce, Ian N.; Inanc, Murat; Lukusa, Luck; Abrahamowicz, Michal Abstract: Objective This study attempted to quantify the bias expected due to partly interval-censored (IC) outcomes in the estimated association between hydroxychloroquine (HCQ) taper/cessation and time to disease flare among individuals with systemic lupus erythematosus (SLE). Methods Using data-driven simulations, we estimated bias expected due to IC using real-world data from the Systemic Lupus International Collaborating Clinics inception cohort. The time-varying exposure of interest was a binary indicator of HCQ tapering/cessation. The composite outcome was lupus flare, defined as lupus hospitalizations or increases in disease activity or medication dose. The two latter components were IC, as they were recorded only at annual assessment, without a precise date. For the unknown IC event times, a “true” event time was randomly generated from a uniform distribution of the time between two assessments. Each simulated sample was analyzed separately imputing unknown event times (for IC outcomes) either at the midpoint or endpoint of the interval between the two adjacent yearly assessments. Results of multivariable Cox proportional hazards models, adjusted for demographics, drugs, and clinical variables, using either “true” or imputed IC event times were compared. Results The 1543 SLE patients were followed for a median of 42.2 months. During follow-up, 396 participants tapered/stopped HCQ and 1187 experienced a flare. The adjusted uncorrected hazard ratio was 1.51 (95% confidence interval: 1.30, 1.75) and 1.40 (95% confidence interval: 1.21, 1.62) for midpoint and endpoint imputations, respectively. Data-driven simulations showed that imputation of IC event times resulted in a small but systematic bias toward the null that was consistently larger for endpoint than for midpoint imputation. Conclusions IC events induced bias toward the null in the estimated association between HCQ taper/cessation and lupus flares. Data-driven simulations are useful for quantitative bias analyses in complex situations, as they allow accounting for relevant characteristics of a particular real-world dataset. 2026-07-01T00:00:00Z