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52. Severe eosinophilic asthma in Chinese C‐BIOPRED asthma cohort.

Author

Zhang, Qingling, Fu, Xiuhua, Wang, Changzheng, Shen, Huahao, Zhu, Lei, Shi, Guochao, Qiu, Zhongmin, Wen, Zhongguang, Gu, Wei, Luo, Wei, Zhao, Lina, Chen, Yunqin, Lim, Sam, Xiao, Chang, Kang, Jian, Zhang, Yunhui, Huang, Mao, Xu, Jinfu, Huang, Kewu, and Li, Qiang

Subjects
ASTHMA, WHEEZE, EOSINOPHILIA, HYPERTONIC saline solutions
Abstract

Thus, using SEC, a very high proportion of patients with severe asthma of up to 76.8% would have severe eosinophilic asthma, which is higher than in other severe asthma cohorts7-9 of Caucasian populations. Keywords: blood eosinophil count; cigarette smoking; exacerbations; fractional exhaled nitric oxide; severe asthma EN blood eosinophil count cigarette smoking exacerbations fractional exhaled nitric oxide severe asthma 1 7 7 03/03/22 20220201 NES 220201 Dear Editor, In China, asthma affects 45.7 million adults with a prevalence of 4.2%,1 while that of severe asthma ranges from 3.4% to 8.3% among asthmatic patients.2-4 There is scarce information on the characteristics and biomarker expression, and the different phenotypes of severe asthma. Therefore, severe asthma patients have more symptoms, more exacerbations, more airflow obstruction, and more nasal polyps even if they are on high-dose asthma medication regimens, including oral corticosteroids. [Extracted from the article]

Published
2022
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54. Neuropsychiatric events in systemic lupus erythematosus:A longitudinal analysis of outcomes in an international inception cohort using a multistate model approach

Author

Hanly, John G., Urowitz, Murray B., Gordon, Caroline, Bae, Sang Cheol, Romero-Diaz, Juanita, Sanchez-Guerrero, Jorge, Bernatsky, Sasha, Clarke, Ann E., Wallace, Daniel J., Isenberg, David A., Rahman, Anisur, Merrill, Joan T., Fortin, Paul R., Gladman, Dafna D., Bruce, Ian N., Petri, Michelle, Ginzler, Ellen M., Dooley, Mary Anne, Ramsey-Goldman, Rosalind, Manzi, Susan, Jönsen, Andreas, Alarcón, Graciela S., Van Vollenhoven, Ronald F., Aranow, Cynthia, MacKay, Meggan, Ruiz-Irastorza, Guillermo, Lim, Sam, Inanc, Murat, Kalunian, Kenneth C., Jacobsen, Søren, Peschken, Christine A., Kamen, Diane L., Askanase, Anca, Farewell, Vernon, Hanly, John G., Urowitz, Murray B., Gordon, Caroline, Bae, Sang Cheol, Romero-Diaz, Juanita, Sanchez-Guerrero, Jorge, Bernatsky, Sasha, Clarke, Ann E., Wallace, Daniel J., Isenberg, David A., Rahman, Anisur, Merrill, Joan T., Fortin, Paul R., Gladman, Dafna D., Bruce, Ian N., Petri, Michelle, Ginzler, Ellen M., Dooley, Mary Anne, Ramsey-Goldman, Rosalind, Manzi, Susan, Jönsen, Andreas, Alarcón, Graciela S., Van Vollenhoven, Ronald F., Aranow, Cynthia, MacKay, Meggan, Ruiz-Irastorza, Guillermo, Lim, Sam, Inanc, Murat, Kalunian, Kenneth C., Jacobsen, Søren, Peschken, Christine A., Kamen, Diane L., Askanase, Anca, and Farewell, Vernon

Abstract

Objectives: Using a reversible multistate model, we prospectively examined neuropsychiatric (NP) events for attribution, outcome and association with health-related quality of life (HRQoL), in an international, inception cohort of systemic lupus erythematosus (SLE) patients. Methods: Annual assessments for 19 NP events attributed to SLE and non-SLE causes, physician determination of outcome and patient HRQoL (short-form (SF)-36 scores) were measured. Time-to-event analysis and multistate modelling examined the onset, recurrence and transition between NP states. Results: NP events occurred in 955/1827 (52.3%) patients and 592/1910 (31.0%) unique events were attributed to SLE. In the first 2 years of follow-up the relative risk (95% CI) for SLE NP events was 6.16 (4.96, 7.66) and non-SLE events was 4.66 (4.01, 5.43) compared with thereafter. Patients without SLE NP events at initial assessment had a 74% probability of being event free at 10 years. For non-SLE NP events the estimate was 48%. The majority of NP events resolved over 10 years but mortality was higher in patients with NP events attributed to SLE (16%) versus patients with no NPSLE events (6%) while the rate was comparable in patients with non-SLE NP events (7%) compared with patients with no non-SLE events (6%). Patients with NP events had lower SF-36 summary scores compared with those without NP events and resolved NP states (p<0.001). Conclusions: NP events occur most frequently around the diagnosis of SLE. Although the majority of events resolve they are associated with reduced HRQoL and excess mortality. Multistate modelling is well suited for the assessment of NP events in SLE.

Published
2020

71. Osteopontin versus disease activity and damage accrual in recent-onset systemic lupus erythematosus: Results from the Systemic Lupus International Collaborating Clinics Inception Cohort

Author

Wirestam, Lina, Enocsson, Helena, Skogh, Thomas, Padyukov, Leonid, Jönsen, Andreas, Urowitz, Murray, Gladman, Dafna, Romero-Diaz, Juanita, Bae, Sang-Cheol, Fortin, Paul R, Sanchez-Guerrero, Jorge, Clarke, Ann, Bernatsky, Sasha, Gordon, Caroline, Hanly, John G, Wallace, Daniel, Isenberg, David, Rahman, Anisur, Merrill, Joan, Ginzler, Ellen, Alarcón, Graciela S, Chatham, W Winn, Petri, Michelle, Khamashta, Munther, Aranow, Cynthia, Mackay, Meggan, Dooley, Mary Anne, Manzi, Susan, Ramsey-Goldman, Rosalind, Nived, Ola, Steinsson, Kristjan, Zoma, Asad, Ruiz-Irastorza, Guillermo, Lim, Sam, Kalunian, Ken, Inanc, Murat, van Vollenhoven, Ronald, Ramos-Casals, Manuel, Kamen, Diane L, Jacobsen, SØren, Peschken, Christine, Askanase, Anca, Stoll, Thomas, Bruce, Ian N, Wetterö, Jonas, and Sjöwall, Christopher

Subjects
Adult, Male, Asia, Internationality, Adolescent, Enzyme-Linked Immunosorbent Assay, Severity of Illness Index, Article, Young Adult, Sex Factors, stomatognathic system, Reference Values, Humans, Lupus Erythematosus, Systemic, skin and connective tissue diseases, Child, Aged, Age Factors, Middle Aged, Europe, Cross-Sectional Studies, Logistic Models, Multivariate Analysis, North America, Disease Progression, Female, Osteopontin, Biomarkers, Follow-Up Studies
Abstract

In cross-sectional studies, elevated osteopontin (OPN) levels have been proposed to reflect, and/or precede, progressive organ damage and disease severity in systemic lupus erythematosus (SLE). We aimed, in a cohort of patients with recent-onset SLE, to determine whether raised serum OPN levels precede damage and/or are associated with disease activity or certain disease phenotypes.We included 344 patients from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort who had 5 years of followup data available. All patients fulfilled the 1997 American College of Rheumatology (ACR) criteria. Baseline sera from patients and from age- and sex-matched population-based controls were analyzed for OPN using ELISA. Disease activity and damage were assessed at each annual followup visit using the SLE Disease Activity Index 2000 (SLEDAI-2K) and the SLICC/ACR damage index (SDI), respectively.Compared to controls, baseline OPN was raised 4-fold in SLE cases (p0.0001). After relevant adjustments in a binary logistic regression model, OPN levels failed to significantly predict global damage accrual defined as SDI ≥ 1 at 5 years. However, baseline OPN correlated with SLEDAI-2K at enrollment into the cohort (r = 0.27, p0.0001), and patients with high disease activity (SLEDAI-2K ≥ 5) had raised serum OPN (p0.0001). In addition, higher OPN levels were found in patients with persistent disease activity (p = 0.0006), in cases with renal involvement (p0.0001) and impaired estimated glomerular filtration rate (p = 0.01).The performance of OPN to predict development of organ damage was not impressive. However, OPN associated significantly with lupus nephritis and with raised disease activity at enrollment, as well as over time.

Published
2019

75. Neuropsychiatric events in systemic lupus erythematosus: a longitudinal analysis of outcomes in an international inception cohort using a multistate model approach

Author

Hanly, John G, primary, Urowitz, Murray B, additional, Gordon, Caroline, additional, Bae, Sang-Cheol, additional, Romero-Diaz, Juanita, additional, Sanchez-Guerrero, Jorge, additional, Bernatsky, Sasha, additional, Clarke, Ann E, additional, Wallace, Daniel J, additional, Isenberg, David A, additional, Rahman, Anisur, additional, Merrill, Joan T, additional, Fortin, Paul R, additional, Gladman, Dafna D, additional, Bruce, Ian N, additional, Petri, Michelle, additional, Ginzler, Ellen M, additional, Dooley, Mary Anne, additional, Ramsey-Goldman, Rosalind, additional, Manzi, Susan, additional, Jönsen, Andreas, additional, Alarcón, Graciela S, additional, van Vollenhoven, Ronald F, additional, Aranow, Cynthia, additional, Mackay, Meggan, additional, Ruiz-Irastorza, Guillermo, additional, Lim, Sam, additional, Inanc, Murat, additional, Kalunian, Kenneth C, additional, Jacobsen, Søren, additional, Peschken, Christine A, additional, Kamen, Diane L, additional, Askanase, Anca, additional, and Farewell, Vernon, additional

Published
2020
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76. STAT6 expression in T cells, alveolar macrophages and bronchial biopsies of normal and asthmatic subjects

Author

Tomita Katsuyuki, Caramori Gaetano, Ito Kazuhiro, Sano Hiroyuki, Lim Sam, Oates Timothy, Cosio Borja, Chung K Fan, Tohda Yuji, Barnes Peter J, and Adcock Ian M

Subjects
Airway epithelial cells, Alveolar macrophages, Asthma, STAT6, T-cells, Th2 cells, Therapeutics. Pharmacology, RM1-950
Abstract

Abstract Background Asthma is characterised by increased numbers of Th2-like cells in the airways and IgE secretion. Generation of Th2 cells requires interleukin (IL)-4 and IL-13 acting through their specific receptors and activating the transcription factor, signal transducer and activator of transcription 6 (STAT6). STAT6 knockout mice fail to produce IgE, airway hyperresponsiveness and bronchoalveolar lavage eosinophilia after allergen sensitisation, suggesting a critical role for STAT6 in allergic responses. Methods We have investigated the expression of STAT6 in peripheral blood T-lymphocytes, alveolar macrophages and bronchial biopsies from 17 normal subjects and 18 mild-moderate steroid-naïve stable asthmatic patients. Results STAT6 expression was variable and was detected in T-lymphocytes, macrophages and bronchial epithelial cells from all subjects with no difference between normal and stable asthmatic subjects. Conclusions STAT6 expression in different cells suggests that it may be important in regulating the expression of not only Th2-like cytokines in T cells of man, but may also regulate STAT-inducible genes in alveolar macrophages and airway epithelial cells.

Published
2012
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77. Is low dose inhaled corticosteroid therapy as effective for inflammation and remodeling in asthma? A randomized, parallel group study

Author

Baraket Melissa, Oliver Brian GG, Burgess Janette K, Lim Sam, King Gregory G, and Black Judith L

Subjects
asthma, corticosteroids, airway hyperresponsiveness, alveolar macrophage, airway inflammation, airway remodeling, Diseases of the respiratory system, RC705-779
Abstract

Abstract Background While most of the clinical benefits of inhaled corticosteroid (ICS) therapy may occur at low doses, results of dose-ranging studies are inconsistent. Although symptom/lung function response to low and high dose ICS medication is comparable, it is uncertain whether low dose ICSs are as effective as high dose in the treatment of inflammation and remodeling. Methods 22 mild or moderate asthmatic adult subjects (corticosteroid free for > 2 months) participated in a randomized, parallel group study to compare effects of fluticasone propionate (FP) 200 mcg/day and 1000 mcg/day. Alveolar macrophage (AM)-derived cytokines and basement membrane thickness (BMT) were measured at baseline and after 7 weeks treatment while symptoms, spirometry, exhaled nitric oxide (eNO) and airway hyperresponsiveness (AHR) to mannitol at baseline and 6 weeks. Results FP improved spirometry, eNO, symptoms and AHR with no difference between low and high dose FP. Both high and low dose FP reduced GM-CSF, TNF-alpha and IL-1ra, with no change in BMT and with no differences between low and high dose FP. Conclusions 200 μg/day of FP was as effective as 1000 μg/day in improving asthma control, airway inflammation, lung function and AHR in adults in the short term. Future studies should examine potential differential effects between low and high dose combination therapy (ICS/long acting beta agonist) on inflammation and airway remodeling over longer treatment periods.

Published
2012
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78. Characteristics of severe asthma in China with one year follow-up: the C-BIOPRED study

Author

Zhang, Qingling, primary, Fu, Xiuhua, additional, Zhu, Lei, additional, Gu, Wei, additional, Kang, Jian, additional, Shi, Guochao, additional, Qiu, Zhongmin, additional, Shen, Huahao, additional, Wang, Changzheng, additional, Zhao, Lina, additional, Chen, Yunqin, additional, Lim, Sam, additional, Xiao, Chang, additional, Chung, Kai Fan, additional, and Zhong, Nanshan, additional

Published
2019
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87. Low aspirin use and high prevalence of pre-eclampsia risk factors among pregnant women in a multinational SLE inception cohort

Author

Medicina, Medikuntza, Mendel, Arielle, Bernatsky, Sasha B., Hanly, John G., Urowitz, Murray B., Clarke, Ann Elaine, Romero Díaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Wallace, Daniel J., Merrill, Joan T., Buyon, Jill P., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Petri, Michelle, Dooley, Mary Anne, Fortin, Paul R., Gladman, Dafna D., Steinsson, Kristjan, Ramsey Goldman, Rosalind, Khamashta, Munther A., Aranow, Cynthia, Mackay, Meggan, Alarcon, Graciela S., Manzi, Susan, Nived, Ola, Jonsen, Andreas, Zoma, Asad A., Ramos Casals, Manuel, Ruiz Irastorza, Guillermo, Lim, Sam, Kalunian, Ken C., Inanc, Murat, Kamen, Diane L., Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Sánchez Guerrero, Jorge, Bruce, Ian N., Costedoat Chalumeau, Nathalie, Vinet, Evelyne, Medicina, Medikuntza, Mendel, Arielle, Bernatsky, Sasha B., Hanly, John G., Urowitz, Murray B., Clarke, Ann Elaine, Romero Díaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Wallace, Daniel J., Merrill, Joan T., Buyon, Jill P., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Petri, Michelle, Dooley, Mary Anne, Fortin, Paul R., Gladman, Dafna D., Steinsson, Kristjan, Ramsey Goldman, Rosalind, Khamashta, Munther A., Aranow, Cynthia, Mackay, Meggan, Alarcon, Graciela S., Manzi, Susan, Nived, Ola, Jonsen, Andreas, Zoma, Asad A., Ramos Casals, Manuel, Ruiz Irastorza, Guillermo, Lim, Sam, Kalunian, Ken C., Inanc, Murat, Kamen, Diane L., Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Sánchez Guerrero, Jorge, Bruce, Ian N., Costedoat Chalumeau, Nathalie, and Vinet, Evelyne

Published
2019

88. Osteopontin and Disease Activity in Patients with Recent-onset Systemic Lupus Erythematosus:Results from the SLICC Inception Cohort

Author

Wirestam, Lina, Enocsson, Helena, Skogh, Thomas, Padyukov, Leonid, Jönsen, Andreas, Urowitz, Murray B, Gladman, Dafna D, Romero-Diaz, Juanita, Bae, Sang-Cheol, Fortin, Paul R, Sanchez-Guerrero, Jorge, Clarke, Ann E, Bernatsky, Sasha, Gordon, Caroline, Hanly, John G, Wallace, Daniel, Isenberg, David A, Rahman, Anisur, Merrill, Joan, Ginzler, Ellen, Alarcón, Graciela S, Chatham, W Winn, Petri, Michelle, Khamashta, Munther, Aranow, Cynthia, Mackay, Meggan, Dooley, Mary Anne, Manzi, Susan, Ramsey-Goldman, Rosalind, Nived, Ola, Steinsson, Kristjan, Zoma, Asad, Ruiz-Irastorza, Guillermo, Lim, Sam, Kalunian, Ken, Inanc, Murat, van Vollenhoven, Ronald, Ramos-Casals, Manuel, Kamen, Diane L, Jacobsen, Søren, Peschken, Christine, Askanase, Anca, Stoll, Thomas, Bruce, Ian N, Wetterö, Jonas, Sjöwall, Christopher, Wirestam, Lina, Enocsson, Helena, Skogh, Thomas, Padyukov, Leonid, Jönsen, Andreas, Urowitz, Murray B, Gladman, Dafna D, Romero-Diaz, Juanita, Bae, Sang-Cheol, Fortin, Paul R, Sanchez-Guerrero, Jorge, Clarke, Ann E, Bernatsky, Sasha, Gordon, Caroline, Hanly, John G, Wallace, Daniel, Isenberg, David A, Rahman, Anisur, Merrill, Joan, Ginzler, Ellen, Alarcón, Graciela S, Chatham, W Winn, Petri, Michelle, Khamashta, Munther, Aranow, Cynthia, Mackay, Meggan, Dooley, Mary Anne, Manzi, Susan, Ramsey-Goldman, Rosalind, Nived, Ola, Steinsson, Kristjan, Zoma, Asad, Ruiz-Irastorza, Guillermo, Lim, Sam, Kalunian, Ken, Inanc, Murat, van Vollenhoven, Ronald, Ramos-Casals, Manuel, Kamen, Diane L, Jacobsen, Søren, Peschken, Christine, Askanase, Anca, Stoll, Thomas, Bruce, Ian N, Wetterö, Jonas, and Sjöwall, Christopher

Abstract

OBJECTIVE: In cross-sectional studies, elevated osteopontin (OPN) levels have been proposed to reflect, and/or precede, progressive organ damage and disease severity in systemic lupus erythematosus (SLE). We aimed, in a cohort of patients with recent-onset SLE, to determine whether raised serum OPN levels precede damage and/or are associated with disease activity or certain disease phenotypes.METHODS: We included 344 patients from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort who had 5 years of followup data available. All patients fulfilled the 1997 American College of Rheumatology (ACR) criteria. Baseline sera from patients and from age- and sex-matched population-based controls were analyzed for OPN using ELISA. Disease activity and damage were assessed at each annual followup visit using the SLE Disease Activity Index 2000 (SLEDAI-2K) and the SLICC/ACR damage index (SDI), respectively.RESULTS: Compared to controls, baseline OPN was raised 4-fold in SLE cases (p < 0.0001). After relevant adjustments in a binary logistic regression model, OPN levels failed to significantly predict global damage accrual defined as SDI ≥ 1 at 5 years. However, baseline OPN correlated with SLEDAI-2K at enrollment into the cohort (r = 0.27, p < 0.0001), and patients with high disease activity (SLEDAI-2K ≥ 5) had raised serum OPN (p < 0.0001). In addition, higher OPN levels were found in patients with persistent disease activity (p = 0.0006), in cases with renal involvement (p < 0.0001) and impaired estimated glomerular filtration rate (p = 0.01).CONCLUSION: The performance of OPN to predict development of organ damage was not impressive. However, OPN associated significantly with lupus nephritis and with raised disease activity at enrollment, as well as over time.

Published
2019

89. Low aspirin use and high prevalence of pre-eclampsia risk factors among pregnant women in a multinational SLE inception cohort

Author

Mendel, Arielle, Bernatsky, Sasha B., Hanly, John G., Urowitz, Murray B., Clarke, Ann Elaine, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang Cheol, Wallace, Daniel J., Merrill, Joan T., Buyon, Jill P., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Petri, Michelle, Dooley, Mary Anne, Fortin, Paul R., Gladman, Dafna D., Steinsson, Kristján, Ramsey-Goldman, Rosalind, Khamashta, Munther A., Aranow, Cynthia, Mackay, Meggan, Alarcón, Graciela S., Manzi, Susan, Nived, Ola, Jönsen, Andreas, Zoma, Asad A., Van Vollenhoven, Ronald F., Ramos-Casals, Manuel, Ruiz-Irastorza, Guillermo, Lim, Sam, Kalunian, Ken C., Inanc, Murat, Kamen, Diane L., Peschken, Christine A., Jacobsen, Søren, Askanase, Anca, Sanchez-Guerrero, Jorge, Bruce, Ian N., Costedoat-Chalumeau, Nathalie, Vinet, Évelyne, Mendel, Arielle, Bernatsky, Sasha B., Hanly, John G., Urowitz, Murray B., Clarke, Ann Elaine, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang Cheol, Wallace, Daniel J., Merrill, Joan T., Buyon, Jill P., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Petri, Michelle, Dooley, Mary Anne, Fortin, Paul R., Gladman, Dafna D., Steinsson, Kristján, Ramsey-Goldman, Rosalind, Khamashta, Munther A., Aranow, Cynthia, Mackay, Meggan, Alarcón, Graciela S., Manzi, Susan, Nived, Ola, Jönsen, Andreas, Zoma, Asad A., Van Vollenhoven, Ronald F., Ramos-Casals, Manuel, Ruiz-Irastorza, Guillermo, Lim, Sam, Kalunian, Ken C., Inanc, Murat, Kamen, Diane L., Peschken, Christine A., Jacobsen, Søren, Askanase, Anca, Sanchez-Guerrero, Jorge, Bruce, Ian N., Costedoat-Chalumeau, Nathalie, and Vinet, Évelyne

Published
2019

90. Increased proinflammatory responses from asthmatic human airway smooth muscle cells in response to rhinovirus infection

Author

King Nicholas JC, Burgess Janette K, Baraket Melissa, Johnston Sebastian L, Oliver Brian GG, Roth Michael, Lim Sam, and Black Judith L

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Abstract Background Exacerbations of asthma are associated with viral respiratory tract infections, of which rhinoviruses (RV) are the predominant virus type. Airway smooth muscle is important in asthma pathogenesis, however little is known about the potential interaction of RV and human airway smooth muscle cells (HASM). We hypothesised that rhinovirus induction of inflammatory cytokine release from airway smooth muscle is augmented and differentially regulated in asthmatic compared to normal HASM cells. Methods HASM cells, isolated from either asthmatic or non-asthmatic subjects, were infected with rhinovirus. Cytokine production was assayed by ELISA, ICAM-1 cell surface expression was assessed by FACS, and the transcription regulation of IL-6 was measured by luciferase activity. Results RV-induced IL-6 release was significantly greater in HASM cells derived from asthmatic subjects compared to non-asthmatic subjects. This response was RV specific, as 5% serum- induced IL-6 release was not different in the two cell types. Whilst serum stimulated IL-8 production in cells from both subject groups, RV induced IL-8 production in only asthmatic derived HASM cells. The transcriptional induction of IL-6 was differentially regulated via C/EBP in the asthmatic and NF-κB + AP-1 in the non-asthmatic HASM cells. Conclusion This study demonstrates augmentation and differential transcriptional regulation of RV specific innate immune response in HASM cells derived from asthmatic and non-asthmatics, and may give valuable insight into the mechanisms of RV-induced asthma exacerbations.

Published
2006
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91. Low aspirin use and high prevalence of pre-eclampsia risk factors among pregnant women in a multinational SLE inception cohort

Author

Mendel, Arielle, primary, Bernatsky, Sasha B, additional, Hanly, John G, additional, Urowitz, Murray B, additional, Clarke, Ann Elaine, additional, Romero-Diaz, Juanita, additional, Gordon, Caroline, additional, Bae, Sang-Cheol, additional, Wallace, Daniel J, additional, Merrill, Joan T, additional, Buyon, Jill P, additional, Isenberg, David A, additional, Rahman, Anisur, additional, Ginzler, Ellen M, additional, Petri, Michelle, additional, Dooley, Mary Anne, additional, Fortin, Paul R, additional, Gladman, Dafna D, additional, Steinsson, Kristján, additional, Ramsey-Goldman, Rosalind, additional, Khamashta, Munther A, additional, Aranow, Cynthia, additional, Mackay, Meggan, additional, Alarcón, Graciela S, additional, Manzi, Susan, additional, Nived, Ola, additional, Jönsen, Andreas, additional, Zoma, Asad A, additional, van Vollenhoven, Ronald F, additional, Ramos-Casals, Manuel, additional, Ruiz-Irastorza, Guillermo, additional, Lim, Sam, additional, Kalunian, Ken C, additional, Inanc, Murat, additional, Kamen, Diane L, additional, Peschken, Christine A, additional, Jacobsen, Søren, additional, Askanase, Anca, additional, Sanchez-Guerrero, Jorge, additional, Bruce, Ian N, additional, Costedoat-Chalumeau, Nathalie, additional, and Vinet, Évelyne, additional

Published
2018
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93. Linaclotide in irritable bowel syndrome with constipation: A Phase 3 randomized trial in China and other regions

Author

Yang, Yunsheng, primary, Fang, Jingyuan, additional, Guo, Xiaozhong, additional, Dai, Ning, additional, Shen, Xizhong, additional, Yang, Youlin, additional, Sun, Jing, additional, Bhandari, Bal Raj, additional, Reasner, David S, additional, Cronin, Jacquelyn A, additional, Currie, Mark G, additional, Johnston, Jeffrey M, additional, Zeng, Peter, additional, Montreewasuwat, Niwat, additional, Chen, George Zhijian, additional, and Lim, Sam, additional

Published
2018
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95. Nitrated nucleosome levels and neuropsychiatric events in systemic lupus erythematosus; a multi-center retrospective case-control study

Author

Medicina, Medikuntza, Ferreira, Isabel, Croca, Sara, Raimondo, Maria Gabriella, Matharu, Manjit, Miller, Sarah, Giles, Ian, Isenberg, David, Ioannou, Yiannis, Hanly, John G., Urowitz, Murray B., Anderson, Nicole, Aranow, Cynthia, Askanase, Anca, Bae, Sang-Cheol, Bernatsky, Sasha, Bruce, Ian N., Buyon, Jill, Clarke, Ann E., Dooley, Mary Anne, Fortin, Paul R., Ginzler, Ellen, Gladman, Dafna, Gordon, Caroline, Inanc, Murat, Jacobsen, Soren, Kalunian, Kenneth, Kamen, Diane, Khamashta, Munther, Lim, Sam, Manzi, Susan, Merrill, Joan, Nived, Ola, Peschken, Christine, Petri, Michelle, Ramsey Goldman, Rosalind, Ruiz Irastorza, Guillermo, Sanchez-Guerrero, Jorge, Steinson, Kristjan, Sturfelt, Gunnar K., Van Vollenhoven, Ronald, Wallace, Daniel J., Zoma, Asad, Rahman, Anisur, Medicina, Medikuntza, Ferreira, Isabel, Croca, Sara, Raimondo, Maria Gabriella, Matharu, Manjit, Miller, Sarah, Giles, Ian, Isenberg, David, Ioannou, Yiannis, Hanly, John G., Urowitz, Murray B., Anderson, Nicole, Aranow, Cynthia, Askanase, Anca, Bae, Sang-Cheol, Bernatsky, Sasha, Bruce, Ian N., Buyon, Jill, Clarke, Ann E., Dooley, Mary Anne, Fortin, Paul R., Ginzler, Ellen, Gladman, Dafna, Gordon, Caroline, Inanc, Murat, Jacobsen, Soren, Kalunian, Kenneth, Kamen, Diane, Khamashta, Munther, Lim, Sam, Manzi, Susan, Merrill, Joan, Nived, Ola, Peschken, Christine, Petri, Michelle, Ramsey Goldman, Rosalind, Ruiz Irastorza, Guillermo, Sanchez-Guerrero, Jorge, Steinson, Kristjan, Sturfelt, Gunnar K., Van Vollenhoven, Ronald, Wallace, Daniel J., Zoma, Asad, and Rahman, Anisur

Abstract

Background: In patients with systemic lupus erythematosus (SLE) there is no serological test that will reliably distinguish neuropsychiatric (NP) events due to active SLE from those due to other causes. Previously we showed that serum levels of nitrated nucleosomes (NN) were elevated in a small number of patients with NPSLE. Here we measured serum NN in samples from a larger population of patients with SLE and NP events to see whether elevated serum NN could be a marker for NPSLE. Methods: We obtained serum samples from patients in the Systemic Lupus International Collaborative Clinics (SLICC) inception cohort. This included 216 patients with NP events and two matched controls with SLE but no NP events for each of these patients. For the NP patients we tested samples taken before, during and after the NP event. Results: Twenty-six patients had events attributed to SLE according to the most stringent SLICC attribution rule. In these patients there was no association between onset of event and elevated serum NN. In 190 patients in whom events were not attributed to SLE by the SLICC rules, median serum NN was elevated at the onset of event (P = 0.006). The predominant clinical features in this group of 190 patients were headache, mood disorders and anxiety. Conclusions: Serum NN levels rise at the time of an NP event in a proportion of patients with SLE. Further studies are needed to determine the value of serum NN as a biomarker for NPSLE.

Published
2017

97. Mo1646 Efficacy and Safety of Linaclotide in Patients With IBS-C: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial in China and Other Regions

Author

Yang, Yunsheng, primary, Fang, Jing-Yuan, additional, Guo, Xiaozhong, additional, Dai, Ning, additional, Shen, Xizhong, additional, Yang, Youlin, additional, Sun, Jing, additional, Reasner, David S., additional, Johnston, Jeffrey, additional, Zeng, Peter, additional, and Lim, Sam, additional

Published
2016
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98. Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine.

Author

Wenhui Lou, Ying Xia, Peng Xiang, Liangqing Zhang, Xiangyou Yu, Sam Lim, Mo Xu, Lina Zhao, Rydholm, Hans, Traxler, Barry, Xinyu Qin, Lou, Wenhui, Xia, Ying, Xiang, Peng, Zhang, Liangqing, Yu, Xiangyou, Lim, Sam, Xu, Mo, Zhao, Lina, and Qin, Xinyu

Subjects
GASTROINTESTINAL hemorrhage treatment, CIMETIDINE, ESOMEPRAZOLE, THERAPEUTICS, RESEARCH, GASTROINTESTINAL hemorrhage, RESEARCH methodology, EVALUATION research, MEDICAL cooperation, CATASTROPHIC illness, COMPARATIVE studies, RANDOMIZED controlled trials, BLIND experiment
Abstract

Objective: To assess the efficacy and safety of esomeprazole in preventing upper gastrointestinal (GI) bleeding in critically ill Chinese patients, using cimetidine as an active comparator.Methods: A pre-specified non-inferiority limit (5%) was used to compare rates of significant upper GI bleeding in this randomized, double-blind, parallel-group, phase 3 study across 27 intensive care units in China. Secondary endpoints included safety and tolerability measures. Patients required mechanical ventilation and had at least one additional risk factor for stress ulcer bleeding. Patients were randomized to receive either active esomeprazole 40 mg, as a 30-min intravenous (IV) infusion twice daily, and an IV placebo cimetidine infusion or active cimetidine 50 mg/h, as a continuous infusion following an initial bolus of 300 mg, and placebo esomeprazole injections, given up to 14 days. Patients were blinded using this double-dummy technique.Results: Of 274 patients, 2.7% with esomeprazole and 4.6% with cimetidine had significant upper GI bleeding (bright red blood in the gastric tube not clearing after lavage or persistent Gastroccult-positive "coffee grounds" material). Non-inferiority of esomeprazole to cimetidine was demonstrated. The safety profiles of both drugs were similar and as expected in critically ill patients.Conclusions: Esomeprazole is effective in preventing upper GI bleeding in critically ill Chinese patients, as demonstrated by the non-inferiority analysis using cimetidine as an active control.Trial Registration: ClinicalTrials.gov identifier NCT02157376. [ABSTRACT FROM AUTHOR]

Published
2018
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