614 results on '"Ginzler, Ellen"'
Search Results
202. Clinical manifestations of systemic lupus erythematosus, measures of disease activity, and long-term complications.
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Ginzler, Ellen M. and Antoniadis, lleana
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- 1992
203. Dyslipoproteinemia in pediatric systemic lupus erythematosus.
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Ilowite, Norman T., Samuel, Paul, Ginzler, Ellen, and Jacobson, Marc S.
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- 1988
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204. Low plasma androgens in women with systemic lupus erythematosus.
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Lahita, Robert G., Bradlow, H. Leon, Ginzler, Ellen, Pang, Songya, and New, Maria
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- 1987
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205. Abnormal Antidiuretic Hormone Secretion in Patients with Systemic Lupus erythematosus.
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Trachtman, Howard, Ginzler, Ellen, Tejani, Amir, Rao, Madu, Herrod, Lew, and Finberg, Laurence
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- 1987
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206. Effects of Prasterone on Bone Mineral Density in Women with Active Systemic Lupus Erythematosus Receiving Chronic Glucocorticoid Therapy
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Sánchez-Guerrero, Jorge, Fragoso-Loyo, Hilda, Neuwelt, C., Wallace, Daniel, Ginzler, Ellen, Sherrer, Yvonne, McIlwain, Harris, Freeman, Pamela, Aranow, Cynthia, Petri, Michelle, Deodhar, Atul, Blanton, Ellen, Manzi, Susan, Kavanaugh, Arthur, Lisse, Jeffrey, Ramsey-Goldman, Rosalind, McKay, James, Kivitz, Alan, Mease, Philip, Winkler, Anne, Kahl, Leslie, Lee, Albert, Furie, Richard, Strand, C., Lou, Lillian, Ahmed, Mumtaz, Quarles, Betty, and Schwartz, Kenneth
- Abstract
To assess prevention of bone mineral density (BMD) loss and durability of the response during treatment with prasterone in women with systemic lupus erythematosus (SLE) receiving chronic glucocorticoids. METHODS: 155 patients with SLE received 200 mg/day prasterone or placebo for 6 months in a double-blind phase. Subsequently, 114 patients were re-randomized to receive 200 or 100 mg/day prasterone for 12 months in an open-label phase. Primary efficacy endpoints were changes in BMD at the lumbar spine (L-spine) from baseline to Month 6 and maintenance of BMD from Month 6 to 18 for patients who received prasterone during the double-blind phase. RESULTS: In the double-blind phase, there was a trend for a small gain in BMD at the L-spine for patients who received 200 mg/day prasterone for 6 months versus a loss in the placebo group (mean ± SD, 0.003 ± 0.035 vs -0.005 ± 0.053 g/cm2, respectively; p = 0.293 between groups). In the open-label phase, there was dose-dependent increase in BMD at the L-spine at Month 18 between patients who received 200 versus 100 mg/day prasterone (p = 0.021). For patients who received 200 mg/day prasterone for 18 months, the L-spine BMD gain was 1.083 ± 0.512% (p = 0.042). There was no overall change in BMD at the total hip over 18 months with 200 mg/day prasterone treatment. The safety profile reflected the weak androgenic properties of prasterone. CONCLUSION: This study suggests prasterone 200 mg/day may offer mild protection against bone loss in women with SLE receiving glucocorticoids. (ClinicalTrials.gov Identifiers NCT00053560 and NCT00082511)
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- 2008
207. Effects of Prasterone on Bone Mineral Density in Women with Systemic Lupus Erythematosus Receiving Chronic Glucocorticoid Therapy
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Mease, Philip, Ginzler, Ellen, Gluck, Oscar, Schiff, Michael, Goldman, Allan, Greenwald, Maria, Cohen, Stanley, Egan, Rita, Quarles, Betty, and Schwartz, Kenneth
- Abstract
OBJECTIVE: To assess the effects of treatment with prasterone (dehydroepiandrosterone) on bone mineral density (BMD) in female patients with mild to moderate systemic lupus erythematosus (SLE) receiving chronic treatment with glucocorticoids. METHODS: Fifty-five female patients with SLE who had received prednisone (or glucocorticoid equivalent) ≤ 10 mg/day for ≥ 6 months were treated for 1 year with either prasterone 200 mg/day (n = 24) or placebo (n = 31) in this randomized, double blind trial. Prasterone or placebo was added to each patient's one or more concomitant standard SLE medications, including glucocorticoids, nonsteroidal antiinflammatory drugs, antimalarials, methotrexate, azathioprine, and other immunosuppressives, which were to be maintained at fixed doses for the duration of the study. RESULTS: BMD was significantly improved in patients who received prasterone compared to placebo. At the lumbar spine, there was a mean (SEM) gain in BMD of 1.7 ± 0.8% in the prasterone group compared to a mean loss in BMD of –1.1 ± 0.5% in the placebo group (p = 0.003 between groups). For the total hip, mean gain was 2.0 ± 0.9% in the prasterone group vs a mean loss of –0.3 ± 0.4% in the placebo group (p = 0.013 between groups). In the prasterone treatment group, the mean gains from baseline at both lumbar spine and hip were statistically significant. CONCLUSION: Prasterone treatment prevented BMD loss and significantly increased BMD at both the lumbar spine and total hip in female patients with SLE receiving exogenous glucocorticoids.
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- 2005
208. Is ethnicity linked to the severity of SLE manifestations?
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Kabani, Naureen and Ginzler, Ellen M.
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SYSTEMIC lupus erythematosus , *ETHNICITY , *ETHNIC groups , *DISEASE management , *DISEASE prevalence , *SEVERITY of illness index - Abstract
Epidemiological data on the prevalence and severity of specific manifestations of systemic lupus erythematosus (SLE) among different ethnic groups are now emerging. The use of rigorous epidemiological methods should enable a better understanding of these features of SLE in different ethnic groups, which could influence disease management. [ABSTRACT FROM AUTHOR]
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- 2019
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209. The rate and pattern of organ damage in late onset systemic lupus erythematosus.
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Maddison, Peter, Farewell, Vernon, Isenberg, David, Aranow, Cynthia, Bae, Sang-Cheol, Barr, Susan, Buyon, Jill, Fortin, Paul, Ginzler, Ellen, Gladman, Dafna, Hanly, John, Manzi, Susan, Nived, Ola, Petri, Michelle, Ramsey-Goldman, Rosalind, and Sturfelt, Gunnar
- Abstract
OBJECTIVE: To compare the extent and type of damage in patients with late onset and earlier onset systemic lupus erythematosus (SLE) using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). METHODS: A total of 86 SLE patients with disease onset after the age of 54 years were matched for center, sex, and ethnic origin with 155 SLE patients with disease onset before the age of 40 years. SDI scores were obtained at one year and 5 years after the diagnosis of SLE. Analysis was based on conditional logistic regression. RESULTS: SDI scores were higher in the late onset group than in younger patients at both one [mean 0.7 (range 0-3) vs 0.3 (range 0-3); p < 0.001] and 5 years [mean 1.6 (range 0-8) vs 0.9 (range 0-7); p < 0.001] after diagnosis. There was also a difference in the pattern of organ damage. While damage to the skin, kidneys, and central nervous system occurred with similar frequency, late onset disease was characterized by significantly more cardiovascular (OR 14.13, p < 0.001), ocular (OR 9.38, p = 0.001), and musculoskeletal (OR 2.68, p = 0.016) damage and malignancy (OR 7.04, p = 0.046). CONCLUSION: The occurrence of organ damage assessed by the SDI is greater in patients with late onset SLE than in younger patients and, by this criterion, lupus cannot be judged to be more benign in this age group. Also, the pattern of damage is different, but whether this reflects age per se or the effect of the disease in the elderly remains to be established.
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- 2002
210. Aortitis and aortic thrombus in systemic lupus erythematosus.
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Silver, A. S., Shao, C. Y., and Ginzler, Ellen M.
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AORTA ,BLOOD circulation ,VASCULAR diseases ,AORTIC aneurysms ,ARTERIES ,SYSTEMIC lupus erythematosus - Abstract
Aortitis is an uncommon complication of systemic lupus erythematosus (SLE). Most cases of lupus-associated aortitis have been described in conjunction with aortic aneurysms or aortic dissection and have been documented either at autopsy or during surgery to repair a dissection. We describe an unusual case of aortitis associated with an aortic thrombus in a young man with SLE. [ABSTRACT FROM AUTHOR]
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- 2006
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211. Monoclonal IgG Anticoagulants Delaying Fibrin Aggregation in Two Patients With Systemic Lupus Erythematosus (SLE)
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Galanakis, Dennis K., Ginzler, Ellen M., and Fikrig, Senih M.
- Abstract
There is paucity of information regarding the prolonged plasma thrombin time known to occur in some patients with systemic lupus erythematosus. Detailed investigations of plasma from two such patients disclosed that IgG accounted for this defect in each case. IgG isolated from plasma of either patient possessed the property of delaying fibrin aggregation and prolonging the clotting times of fibrinogen. Preincubation of IgG from either patient with anti-IgG or anti-Fab (rabbit) serum abolished this anticoagulant property. Moreover, the anticoagulant IgG from the first patient was neutralized with anti–κ chain and anti-IgG3, that from the second patient with anti-λ chain and anti-IgG, serum. These anticoagulants were also dissimilar with respect to their interactions with fibrin(ogen). IgG from the first patient had no anticoagulant activity against fibrin(ogen) species lacking intact Aαchains. IgG from the second patient displayed undiminished anticoagulant effect on such fibrin(ogen) species. We conclude that each anticoagulant interacted with a distinct region(s) on the fibrinogen molecule and that these interactions affect or involve sites that participate in the fibrin self-assembly process.
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- 1978
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212. Treatment of Systemic Lupus Erythematosus
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GINZLER, ELLEN M.
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- 1978
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213. Etiologic Considerations in Systemic Lupus Erythematosus
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GINZLER, ELLEN M.
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- 1978
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214. Progression of Mesangial and Focal to Diffuse Lupus Nephritis
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Ginzler, Ellen M., Nicastri, Anthony D., Chen, Chun-Kuo, Friedman, Eli A., Diamond, Herbert S., and Kaplan, David
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- 1974
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215. Effect of Frentizole on Mitogen-Induced Blastogenesis in Human Lymphocytes
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Meisel, Allen, Bush, Maurice, Ginzler, Ellen, and Diamond, Herbert
- Abstract
Frentizole is a new immunoregulatory agent developed as an alternative to cytotoxic agents. In human lymphocytes, Frentizole inhibits the response to various phytomitogens without decreasing cell viability. Frentizole (500 ng/ml) inhibited thymidine incorporation into DNA most effectively when added to lymphocyte cultures at the same time as the addition of the mitogen. Frentizole (500 ng/ml) markedly inhibited the response to Con A (% inhibition, (58%) to PHA (30%) and to PWM (39%). Inhibition of thymidine incorporation was dose dependent with 125 ng/ml of Frentizole sufficient to inhibit significantly the response of all three mitogens. Frentizole (62.5 ng/ml) maximally inhibited uridine incorporation, and inhibition of uridine incorporation was independent of the phytomitogen employed. Increasing concentrations of Frentizole were found to have no effect on thymidine or uridine incorporation into unstimulated normal lymphocytes.
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- 1979
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216. Outcome and Prognosis in Systemic Lupus Erythematosus
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Ginzler, Ellen M. and Schorn, Karen
- Abstract
We have attempted to assess the factors associated with prognosis in SLE, and to document the temporal changes in outcome, related not only to improvements in survival but to the emergence of an increased prevalence of morbidity, related to disease manifestations, complications of treatment, and co-morbid conditions.
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- 1988
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217. Systemic Lupus Erythematosus in the Older Age Group: Computer Analysis
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DIMANT, JACOB, GINZLER, ELLEN M., SCHLESINGER, MICHAEL, DIAMOND, HERBERT S., and KAPLAN, DAVID
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ABSTRACT: A computer analysis was made of the data from a prospective study of the clinical course of systemic lupus erythematosus (SLE) in 234 patients followed for an average of 46 months. All fulfilled four ARA criteria for the diagnosis of SLE. Sixteen of the 234 patients were aged 51 or older. They were compared with the 218 younger SLE patients to determine the influence of age on the signs and symptoms of the disease, the organ systems involved, the laboratory data, amount and duration of corticosteroid or azathioprine therapy, and the prognosis. The older group showed more discoid lupus, photosensitivity and pulmonary fibrosis than did the younger group, but a similar incidence of malar rash, alopecia, arthritis, arthralgia, myalgia and serositis, and a lower incidence of oral ulcers, Raynaud's phenomenon, cutaneous vasculitis, neuropsychiatric manifestations, leukopenia, hypocomplementemia and profuse proteinuria. The older patients needed a lower dosage of corticosteroids, and a shorter course of azathioprine therapy. These findings suggest a milder form of SLE with better response to therapy in the older age group.
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- 1979
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218. Cerebrovascular Events in Systemic Lupus Erythematosus: Results From an International Inception Cohort Study
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Hanly, John G, Li, Qiuju, Su, Li, 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, Gladman, Dafna D, Bruce, Ian N, Petri, Michelle, Ginzler, Ellen M, Dooley, MA, Steinsson, Kristjan, Ramsey-Goldman, Rosalind, Zoma, Asad A, Manzi, Susan, Nived, Ola, Jonsen, Andreas, Khamashta, Munther A, Alarcón, Graciela S, Chatham, Winn, Van Vollenhoven, Ronald F, Aranow, Cynthia, Mackay, Meggan, Ruiz-Irastorza, Guillermo, Ramos-Casals, Manuel, Lim, S Sam, Inanc, Murat, Kalunian, Kenneth C, Jacobsen, Soren, Peschken, Christine A, Kamen, Diane L, Askanase, Anca, Theriault, Chris, and Farewell, Vernon
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Adult ,Male ,Cerebrovascular Disorders ,Young Adult ,Quality of Life ,Humans ,Lupus Erythematosus, Systemic ,Female ,Prospective Studies ,Middle Aged ,skin and connective tissue diseases ,3. Good health - Abstract
OBJECTIVE: To determine the frequency, characteristics, and outcomes of cerebrovascular events (CerVEs), as well as clinical and autoantibody associations in a multiethnic/racial inception cohort of patients with systemic lupus erythematosus (SLE). METHODS: A total of 1,826 patients were assessed annually for 19 neuropsychiatric (NP) events, including 5 types of CerVEs: 1) stroke, 2) transient ischemia, 3) chronic multifocal ischemia, 4) subarachnoid/intracranial hemorrhage, and 5) sinus thrombosis. Global disease activity (Systemic Lupus Erythematosus Disease [SLE] Activity Index 2000), damage scores (SLE International Collaborating Clinics/American College of Rheumatology Damage Index), and Short Form 36 (SF-36) scores were collected. Time to event, linear and logistic regressions, and multistate models were used as appropriate. RESULTS: CerVEs were the fourth most frequent NP event: 82 of 1,826 patients had 109 events; of these events, 103 were attributed to SLE, and 44 were identified at the time of enrollment. The predominant events were stroke (60 of 109 patients) and transient ischemia (28 of 109 patients). CerVEs were associated with other NP events attributed to SLE, non-SLE-attributed NP events, African ancestry (at US SLICC sites), and increased organ damage scores. Lupus anticoagulant increased the risk of first stroke and sinus thrombosis and transient ischemic attack. Physician assessment indicated resolution or improvement in the majority of patients, but patients reported sustained reduction in SF-36 summary and subscale scores following a CerVE. CONCLUSION: CerVEs, the fourth most frequent NP event in SLE, are usually attributable to lupus. In contrast to good physician-reported outcomes, patients reported a sustained reduction in health-related quality of life following a CerVE.
219. Economic Evaluation of Damage Accrual in an International SLE Inception Cohort
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Barber, Megan, Bruce, Ian N., Urowitz, Murray, Hanly, John G., Su, Li, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha, Wallace, Daniel J., Merrill, Joan T., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Petri, Michelle, Dooley, Mary Anne, Fortin, Paul R., Gladman, Dafna D., Sanchez-Guerrero, Jorge, Steinsson, Kristjan, Ramsey-Goldman, Rosalind, Khamashta, M., Aranow, Cynthia, Alarcon, Graciela S., Fessler, Barri J., Manzi, Susan, Nived, Ola, Jonsen, Andreas, Zoma, Asad, Vollenhoven, Ronald F., Manuel Ramos-Casals, Ruiz-Irastorza, Guillermo, Lim, S. Sam, Kalunian, Kenneth C., Inanc, Murat, Kamen, Diane L., Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Buyon, Jill P., Theriault, Chris, Farewell, Vernon, and Clarke, Ann E.
220. Mood Disorders in Systemic Lupus Erythematousus (SLE): Results from an International, Inception Cohort Study
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Hanly, John G., Su, Li, Urowitz, Murray, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha R., Clarke, Ann E., Wallace, Daniel J., Merrill, Joan T., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Fortin, Paul, Gladman, Dafna D., Sanchez-Guerrero, Jorge, Petri, Michelle A., Bruce, Ian, Dooley, Mary Anne, Ramsey-Goldman, Rosalind, Aranow, Cynthia, Alarcon, Graciela S., Fessler, Barri J., Steinsson, Kristjan, Nived, Ola, Sturfelt, Gunnar K., Manzi, Susan, Khamashta, Munther A., Vollenhoven, Ronald F., Zoma, Asad, Ramos-Casals, Manuel, Guillermo Ruiz-Irastorza, Lim, S. Sam, Stoll, Thomas, Inanc, Murat, Kalunian, Kenneth C., Kamen, Diane L., Maddison, Peter, Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Buyon, Jill P., Theriault, Chris, Thompson, Kara, and Farewell, Vernon
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Clinical Sciences ,Immunology ,Public Health and Health Services ,Arthritis & Rheumatology
221. Incidence and Predictors of Atherosclerotic Vascular Events in a Multicentre Inception SLE Cohort
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Urowitz, Murray, Gladman, Dafna, Su, Jiandong, Farewell, Vernon, Sanchez-Guerrero, Jorge, Romero-Diaz, Juanita, Bae, Sang-Cheol, Fortin, Paul, Nived, Ola, Clarke, Ann E., Bernatsky, Sasha, Gordon, Caroline, Hanly, John, Wallace, Daniel J., Isenberg, David A., Rahman, Anisur, Merrill, Joan, Ginzler, Ellen M., Alarcon, Graciela, Petri, Michelle, Bruce, Ian, Khamashta, Munther A., Aranow, Cynthia, Manzi, Susan, Dooley, M. A., Ramsey-Goldman, Rosalind, Jonsen, Andreas, Steinsson, Kristjan, Zoma, Asad, Guillermo Ruiz-Irastorza, Lim, S. Sam, Kalunian, Kenneth C., Inanc, Murat, Vollenhoven, Ronald, Ramos, Manuel, Kamen, Diane, Jacobsen, Soren, Peschken, Christine, Askanase, Anca, and Stoll, Thomas
222. Prediction of Organ Damage Accrual in Systemic Lupus Erythematosus Using a Frailty Index
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Legge, Alexandra, Kirkland, Susan, Rockwood, Kenneth, Andreou, Pantelis, Bae, Sang-Cheol, Gordon, Caroline, Romero-Diaz, Juanita, Sanchez-Guerrero, Jorge, Wallace, Daniel J., Bernatsky, Sasha, Clarke, Ann E., Merrill, Joan, Ginzler, Ellen M., Fortin, Paul, Gladman, Dafna, Urowitz, Murray, Bruce, Ian, Isenberg, David A., Rahman, Anisur, Alarcon, Graciela, Petri, Michelle, Khamashta, Munther A., Dooley, M. A., Ramsey-Goldman, Rosalind, Manzi, Susan, Steinsson, Kristjan, Zoma, Asad A., Aranow, Cynthia, Mackay, Meggan, Guillermo Ruiz-Irastorza, Lim, S. Sam, Inanc, Murat, Vollenhoven, Ronald F., Jonsen, Andreas, Nived, Ola, Ramos-Casals, Manuel, Kamen, Diane, Kalunian, Kenneth C., Jacobsen, Soren, Peschken, Christine, Askanase, Anca, and Hanly, John G.
223. Clinical associations of the metabolic syndrome in systemic lupus erythematosus: data from an international inception cohort
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Romero-Diaz, Juanita, Fortin, Paul R., Kalunian, Kenneth C., Isenberg, David A., Manzi, Susan, Bae, Sang Cheol, Ramsey-Goldman, Rosalind, Inanc, Murat, Sanchez-Guerrero, Jorge, MacKay, Meggan, Lunt, Mark, Dooley, Mary Anne, Van Vollenhoven, Raymond F., Merrill, Joan T., Fessler, Barri J., Kamen, Diane L., Steinsson, Kristjan, Sturfelt, Gunnar K., Hanly, John G., Wallace, Daniel J., Rahman, Anisur, Khamashta, Munther A., Aranow, Cynthia, Clarke, Ann E., Nived, Ola, Bruce, Ian N., Gordon, Caroline, Gladman, Dafna D., Petri, Michelle, Parker, Ben, Lim, Sam, Peschken, Christine A., Alarcón, Graciela S., Ramos-Casals, Manuel, Ruiz-Irastorza, Guillermo, Urowitz, Murray B., Zoma, Asad A., Ginzler, Ellen M., and Bernatsky, Sasha
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3. Good health - Abstract
BackgroundThe metabolic syndrome (MetS) may contribute to increased cardiovascular risk in systemic lupus erythematosus (SLE). We aimed to examine the association of demographic factors, lupus phenotype and therapy exposure with the presence of MetS.MethodsThe Systemic Lupus International Collaborating Clinics Registry for Atherosclerosis inception cohort enrolled recently diagnosed (
224. The Initial Presentation of Cerebrovascular Disease Attributed to Lupus Is Most Frequent Early in the Disease Course: Results from an International, Inception Cohort Study
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Hanly, John G., Li, Qiuju, Su, Li, Urowitz, Murray, Romero-Diaz, Juanita, Gordon, C., Bae, Sang-Cheol, Bernatsky, Sasha R., Clarke, Ann, Wallace, Daniel J., Merrill, Joan T., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Petri, Michelle, Bruce, Ian N., Dooley, Mary Anne, Fortin, Paul, Gladman, Dafna D., Sanchez-Guerrero, Jorge, Steinsson, Kristjan, Ramsey-Goldman, Rosalind, Khamashta, Munther, Aranow, Cynthia, Alarcon, Graciela S., Fessler, Barri J., Manzi, Susan, Nived, Ola, Sturfelt, Gunnar K., Zoma, Asad, Vollenhoven, Ronald F., Ramos-Casals, Manuel, Guillermo Ruiz-Irastorza, Lim, S. Sam, Kalunian, Kenneth C., Inanc, Murat, Kamen, Diane L., Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Theriault, Chris, and Farewell, Vernon
225. Mood Disorders in Systemic Lupus Erythematosus: Results From an International Inception Cohort Study
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Hanly, John G, Su, Li, Urowitz, Murray B, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha, Clarke, Ann E, Wallace, Daniel J, Merrill, Joan T, Isenberg, David A, Rahman, Anisur, Ginzler, Ellen M, Petri, Michelle, Bruce, Ian N, Dooley, MA, Fortin, Paul, Gladman, Dafna D, Sanchez-Guerrero, Jorge, Steinsson, Kristjan, Ramsey-Goldman, Rosalind, Khamashta, Munther A, Aranow, Cynthia, Alarcón, Graciela S, Fessler, Barri J, Manzi, Susan, Nived, Ola, Sturfelt, Gunnar K, Zoma, Asad A, Van Vollenhoven, Ronald F, Ramos-Casals, Manuel, Ruiz-Irastorza, Guillermo, Lim, S Sam, Kalunian, Kenneth C, Inanc, Murat, Kamen, Diane L, Peschken, Christine A, Jacobsen, Soren, Askanase, Anca, Theriault, Chris, Thompson, Kara, and Farewell, Vernon
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Adult ,Male ,Internationality ,Mood Disorders ,Incidence ,Black People ,Hispanic or Latino ,Middle Aged ,White People ,3. Good health ,Cohort Studies ,Asian People ,Disease Progression ,Quality of Life ,Humans ,Lupus Erythematosus, Systemic ,Regression Analysis ,Female ,Prospective Studies ,Autoantibodies - Abstract
OBJECTIVE: To examine the frequency, characteristics, and outcome of mood disorders, as well as clinical and autoantibody associations, in a multiethnic/racial, prospective inception cohort of patients with systemic lupus erythematosus (SLE). METHODS: Patients were assessed annually for mood disorders (4 types, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) and 18 other neuropsychiatric events. Global disease activity scores (SLE Disease Activity Index 2000 [SLEDAI-2K]), damage scores (Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI]), and Short Form 36 subscales, mental and physical component summary scores were collected. Time to event, linear and ordinal regressions, and multi-state models were used as appropriate. RESULTS: Among the 1,827 patients with SLE, 88.9% were female, and 48.9% were Caucasian. The mean ± SD age of the patients was 35.1 ± 13.3 years, disease duration was 5.6 ± 4.8 months, and the length of followup was 4.7 ± 3.5 years. During the course of the study, 863 (47.2%) of the 1,827 patients had 1,627 neuropsychiatric events. Mood disorders occurred in 232 (12.7%) of 1,827 patients, and 98 (38.3%) of 256 mood disorder events were attributed to SLE. The estimated cumulative incidence of any mood disorder after 10 years was 17.7% (95% confidence interval 15.1, 20.2%). A greater risk of mood disorder was associated with concurrent neuropsychiatric events (P ≤ 0.01), and a lower risk was associated with Asian race/ethnicity (P = 0.01) and treatment with immunosuppressive drugs (P = 0.003). Mood disorders were associated with lower mental health and mental component summary scores but not with the SLEDAI-2K, SDI, or lupus autoantibodies. Among the 232 patients with depression, 168 (72.4%) were treated with antidepressants. One hundred twenty-six (49.2%) of 256 mood disorders resolved in 117 (50.4%) of 232 patients. CONCLUSION: Mood disorders, the second most frequent neuropsychiatric event in patients with SLE, have a negative impact on health-related quality of life and improve over time. The lack of association with global SLE disease activity, cumulative organ damage, and lupus autoantibodies emphasizes the multifactorial etiology of mood disorders and a role for non-lupus-specific therapies.
226. Risk Factors for Cerebrovascular Events in Systemic Lupus Erythematosus: Results from an International, Inception Cohort Study
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Hanly, John G., Li, Qiuju, Su, Li, Urowitz, Murray, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha, Clarke, Ann E., Wallace, Daniel J., Merrill, Joan T., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Fortin, Paul R., Gladman, D., Sanchez-Guerrero, Jorge, Petri, Michelle, Bruce, Ian N., Dooley, Mary Anne, Ramsey-Goldman, Rosalind, Aranow, Cynthia, Alarcon, Graciela S., Steinsson, Kristjan, Sturfelt, Gunnar K., Nived, Ola, Manzi, Susan, Khamashta, M., Vollenhoven, Ronald F., Zoma, Asad, Guillermo Ruiz-Irastorza, Lim, S. Sam, Inanc, Murat, Kalunian, Kenneth C., Kamen, Diane L., Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Theriault, Chris, Farewell, Vernon, and Ramos-Casals, Manuel
227. The Prevalence of Anti-DFS70 Antibodies in an International Inception Cohort of Systemic Lupus Erythematosus
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Choi, May, Hanly, John G., Urowitz, Murray, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha, Wallace, Daniel J., Merrill, Joan T., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Fortin, Paul R., Gladman, Dafna, Sanchez-Guerrero, Jorge, Petri, Michelle, Bruce, Ian N., Dooley, Mary Anne, Ramsey-Goldman, Rosalind, Aranow, Cynthia, Alarcon, Graciela S., Steinsson, Kristjan, Nived, Ola, Sturfelt, Gunnar K., Manzi, Susan, Khamashta, Munther, Vollenhoven, Ronald F., Zoma, Asad, Ruiz-Irastorza, Guillermo, Lim, S. Sam, Stoll, Thomas, Inanc, Murat, Kalunian, Kenneth C., Kamen, Diane L., Maddison, Peter, Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Buyon, Jill P., Chatham, W. Winn, Manuel Ramos-Casals, Pierre, Yvan St, Clarke, Ann E., and Fritzler, Marvin J.
228. Outcome of Lupus Nephritis and Impact on Health Related Quality of Life: Results from an International, Prospective, Inception Cohort Study
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Hanly, John G., O Keeffe, Aidan, Su, Li, Urowitz, Murray B., Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha R., Clarke, Ann E., Wallace, Daniel J., Merrill, Joan T., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Fortin, Paul, Gladman, Dafna D., Sanchez-Guerrero, Jorge, Petri, Michelle A., Bruce, Ian, Dooley, Mary Anne, Ramsey-Goldman, Rosalind, Aranow, Cynthia, Alarcon, Graciela S., Fessler, Barri, Steinsson, Kristjan, Nived, Ola, Sturfelt, Gunnar, Manzi, Susan, Khamashta, Munther A., Vollenhoven, Ronald F., Zoma, Asad, Ramos-Casals, Manuel, Guillermo Ruiz-Irastorza, Lim, S. Sam, Stoll, Thomas, Inanc, Murat, Kalunian, Kenneth C., Kamen, Diane L., Maddison, Peter, Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Buyon, Jill P., Theriault, Chris, Thompson, Kara, and Farewell, Vernon
229. Glucocorticosteroid Usage and Major Organ Damage in Patients with Systemic Lupus Erythematosus - Meta-analyses of Observational Studies Published Between 1979 and 2018
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Anselm Mak, Cheung, Mike W. L., Wai Yee Joanna Leong, Bhushan Dharmadhikari, Nien Yee Kow, Michelle Petri, Susan Manzi, Ann Clarke, Cynthia Aranow, Laurent Arnaud, Anca Askanase, Sang-Cheol Bae, Sasha Bernatsky, Ian Bruce, Jill Buyon, Winn Chatham, W., Nathalie Costedoat-Chalumeau, Dooley, M. A., Paul Fortin, Ginzler, Ellen M., Dafna Gladman, Caroline Gordon, Hanly, John G., Murat Inanc, Isenberg, David A., Søren Jacobsen, Judith James, Andreas Jönsen, Kalunian, Kenneth C., Diane Kamen, Sam Lim, S., Eric Morand, Christine Peschken, Pons-Estel, Bernardo A., Anisur Rahman, Rosalind Ramsey-Goldman, Juanita Romero-Diaz, Guillermo Ruiz-Irastorza, Jorge Sanchez-Guerrero, Kristjan Steinsson, Elisabet Svenungsson, Murray Urowitz, Ronald van Volllenhoven, Evelyn Vinet, Alexandre Voskuyl, Wallace, Daniel J., and Graciela Alarcón
230. Economic Evaluation of Lupus Nephritis in an International Inception Cohort: Comparing the Hospitalization, Medication, Dialysis, and Procedure Costs of Those with and without Nephritis
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Barber, Megan, Hanly, John G., O Keeffe, Aidan, Su, Li, Urowitz, Murray, St Pierre, Yvan, Romero-Diaz, Juanita, Gordon, C., Bae, Sang-Cheol, Bernatsky, Sasha, Wallace, Daniel J., Merrill, Joan T., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Fortin, Paul R., Gladman, Dafna D., Sanchez-Guerrero, Jorge, Petri, Michelle, Bruce, Ian N., Dooley, Mary Anne, Ramsey-Goldman, Rosalind, Aranow, Cynthia, Alarcon, Graciela S., Chatham, W. Winn, Steinsson, Kristjan, Nived, Ola, Sturfelt, Gunnar K., Manzi, Susan, Khamashta, Munther, Vollenhoven, Ronald F., Zoma, Asad, Ramos-Casals, Manel, Guillermo Ruiz-Irastorza, Lim, S. Sam, Stoll, Thomas, Inanc, Murat, Kalunian, Kenneth C., Kamen, Diane L., Maddison, Peter, Peschken, Christine A., Jacobsen, Soren, Askanase, Anca, Buyon, Jill P., Theriault, Chris, Thompson, Kara, Farewell, Vernon, and Clarke, Ann E.
231. Cancer in an SLE Inception Cohort: Smoking May out-Perform Tumor Markers As a Risk Predictor
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Bernatsky, Sasha, Urowitz, Murray, Hanly, John G., Clarke, Ann E., Fritzler, Marvin J., Gordon, Caroline, Romero-Diaz, Juanita, Alarcon, Graciela S., Bae, Sang-Cheol, Petri, Michelle, Merrill, Joan T., Wallace, Daniel J., Fortin, Paul R., Gladman, Dafna D., Isenberg, David A., Rahman, Anisur, Manzi, Susan, Nived, Ola, Sturfelt, Gunnar K., Peschken, Christine A., Sanchez-Guerrero, Jorge, Guillermo Ruiz-Irastorza, Aranow, Cynthia, Vollenhoven, Ronald F., Zoma, Asad, Steinsson, Kristjan, Khamashta, Munther A., Ginzler, Ellen M., Askanase, Anca, Kalunian, Kenneth C., Dooley, Mary Anne, Lim, S. Sam, Kamen, Diane L., Jacobsen, Soren, Ramos-Casals, Manuel, Inanc, Murat, Lee, Jennifer L. F., and Ramsey-Goldman, Rosalind
232. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort
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Bruce, Ian N, O'Keeffe, Aidan G, Farewell, Vern, Hanly, John G, Manzi, Susan, Su, Li, Gladman, Dafna D, Bae, Sang-Cheol, Sanchez-Guerrero, Jorge, Romero-Diaz, Juanita, Gordon, Caroline, Wallace, Daniel J, Clarke, Ann E, Bernatsky, Sasha, Ginzler, Ellen M, Isenberg, David A, Rahman, Anisur, Merrill, Joan T, Alarcón, Graciela S, Fessler, Barri J, Fortin, Paul R, Petri, Michelle, Steinsson, Kristjan, Dooley, Mary Anne, Khamashta, Munther A, Ramsey-Goldman, Rosalind, Zoma, Asad A, Sturfelt, Gunnar K, Nived, Ola, Aranow, Cynthia, Mackay, Meggan, Ramos-Casals, Manuel, Van Vollenhoven, Ronald F, Kalunian, Kenneth C, Ruiz-Irastorza, Guillermo, Lim, Sam, Kamen, Diane L, Peschken, Christine A, Inanc, Murat, and Urowitz, Murray B
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Inflammation ,Adult ,Male ,Health Status ,Kaplan-Meier Estimate ,Middle Aged ,Systemic Lupus Erythematosus ,3. Good health ,Cohort Studies ,Young Adult ,Outcomes research ,Disease Progression ,Ethnicity ,Quality of Life ,Corticosteroids ,Humans ,Lupus Erythematosus, Systemic ,Female ,Longitudinal Studies ,Prospective Studies ,Proportional Hazards Models - Abstract
BACKGROUND AND AIMS: We studied damage accrual and factors determining development and progression of damage in an international cohort of systemic lupus erythematosus (SLE) patients. METHODS: The Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort recruited patients within 15 months of developing four or more 1997 American College of Rheumatology (ACR) criteria for SLE; the SLICC/ACR damage index (SDI) was measured annually. We assessed relative rates of transition using maximum likelihood estimation in a multistate model. The Kaplan-Meier method estimated the probabilities for time to first increase in SDI score and Cox regression analysis was used to assess mortality. RESULTS: We recruited 1722 patients; mean (SD) age 35.0 (13.4) years at cohort entry. Patients with damage at enrolment were more likely to have further worsening of SDI (SDI 0 vs ≥1; p
233. Outcomes After Hydroxychloroquine Reduction or Discontinuation in a Multinational Inception Cohort of Systemic Lupus
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Almeida-Brasil, Celline, Hanly, John, Urowitz, Murray, Clarke, Ann, Ramsey-Goldman, Rosalind, Gordon, Caroline, Petri, Michelle, Ginzler, Ellen M., Wallace, Daniel J., Bae, Sang-Cheol, Romero-Diaz, Juanita, Dooley, Mary Ann, Peschken, Christine A., Isenberg, David, Rahman, Anisur, Manzi, Susan, Jacobsen, Soren, Lim, S. Sam, Vollenhoven, Ronald, Nived, Ola, Jonsen, Andreas, Kamen, Diane, Aranow, Cynthia, Guillermo Ruiz-Irastorza, Sanchez-Guerrero, Jorge, Gladman, Dafna, Fortin, Paul, Alarcon, Graciela, Merrill, Joan, Kalunian, Kenneth, Ramos-Casals, Manuel, Steinsson, Kristjan, Zoma, Asad, Askanase, Anca, Khamashta, Munther, Bruce, Ian, Inanc, Murat, and Bernatsky, Sasha
234. Is ANA-status at Disease Inception Associated with Long-term Damage Accrual and Direct and Indirect Health Care Costs in the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort?
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Choi, May, Barber, Megan, Fritzler, Marvin, Hanly, John G., Urowitz, Murray, St-Pierre, Yvan, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha, Wallace, Daniel J., Isenberg, David A., Rahman, Anisur, Ginzler, Ellen M., Petri, Michelle, Bruce, Ian, Fortin, Paul, Gladman, Dafna, Sanchez-Guerrero, Jorge, Ramsey-Goldman, Rosalind, Khamashta, Munther A., Aranow, Cynthia, Mackay, Meggan, Alarcon, Graciela, Manzi, Susan, Nived, Ola, Jonsen, Andreas, Zoma, Asad, Vollenhoven, Ronald, Ramos-Casals, Manuel, Guillermo Ruiz-Irastorza, Lim, S. Sam, Kalunian, Kenneth C., Inanc, Murat, Kamen, Diane, Peschken, Christine, Jacobsen, Soren, Askanase, Anca, Farewell, Vernon, and Clarke, Ann E.
235. Retinal Toxicity in a Multinational Inception Cohort of Systemic Lupus Patients on Hydroxychloroquine
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Almeida-Brasil, Celline, Hanly, John, Urowitz, Murray, Clarke, Ann, Ramsey-Goldman, Rosalind, Gordon, Caroline, Petri, Michelle, Ginzler, Ellen M., Wallace, Daniel J., Bae, Sang-Cheol, Romero-Diaz, Juanita, Dooley, Mary Ann, Peschken, Christine A., Isenberg, David, Rahman, Anisur, Manzi, Susan, Jacobsen, Soren, Lim, S. Sam, Vollenhoven, Ronald, Nived, Ola, Jonsen, Andreas, Kamen, Diane, Aranow, Cynthia, Guillermo Ruiz-Irastorza, Sanchez-Guerrero, Jorge, Gladman, Dafna, Fortin, Paul, Alarcon, Graciela, Merrill, Joan, Kalunian, Kenneth, Ramos-Casals, Manuel, Steinsson, Kristjan, Zoma, Asad, Askanase, Anca, Khamashta, Munther, Bruce, Ian, Inanc, Murat, and Bernatsky, Sasha
236. Economic Evaluation of Lupus Nephritis in the Systemic Lupus International Collaborating Clinics Inception Cohort Using a Multistate Model Approach
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Barber, Megan RW, Hanly, John G, Su, Li, Urowitz, Murray B, St Pierre, Yvan, Romero-Diaz, Juanita, Gordon, Caroline, Bae, Sang-Cheol, Bernatsky, Sasha, Wallace, Daniel J, Isenberg, David A, Rahman, Anisur, Ginzler, Ellen M, Petri, Michelle, Bruce, Ian N, Fortin, Paul R, Gladman, Dafna D, Sanchez-Guerrero, Jorge, 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, S Sam, Kalunian, Kenneth C, Inanc, Murat, Kamen, Diane L, Peschken, Christine A, Jacobsen, Soren, Askanase, Anca, Theriault, Chris, Farewell, Vernon, and Clarke, Ann E
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Adult ,Cohort Studies ,Male ,Young Adult ,Models, Economic ,Humans ,Female ,Health Care Costs ,Middle Aged ,urologic and male genital diseases ,Lupus Nephritis ,3. Good health - Abstract
OBJECTIVE: Little is known about the long-term costs of lupus nephritis (LN). The costs were compared between patients with and without LN using multistate modeling. METHODS: Patients from 32 centers in 11 countries were enrolled in the Systemic Lupus International Collaborating Clinics inception cohort within 15 months of diagnosis and provided annual data on renal function, hospitalizations, medications, dialysis, and selected procedures. LN was diagnosed by renal biopsy or the American College of Rheumatology classification criteria. Renal function was assessed annually using the estimated glomerular filtration rate (GFR) or estimated proteinuria. A multistate model was used to predict 10-year cumulative costs by multiplying annual costs associated with each renal state by the expected state duration. RESULTS: A total of 1,545 patients participated; 89.3% were women, the mean ± age at diagnosis was 35.2 ± 13.4 years, 49% were white, and the mean followup duration was 6.3 ± 3.3 years. LN developed in 39.4% of these patients by the end of followup. Ten-year cumulative costs were greater in those with LN and an estimated glomerular filtration rate (GFR) 60 ml/minute) or with LN and estimated proteinuria >3 gm/day ($84,040 versus $20,499 if no LN and estimated proteinuria
237. Peripheral Nervous System Disease in Systemic Lupus Erythematosus: Results From an International Inception Cohort Study
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Hanly, John G, Li, Qiuju, Su, Li, 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, MA, Steinsson, Kristjan, Ramsey-Goldman, Rosalind, Zoma, Asad A, Manzi, Susan, Nived, Ola, Jonsen, Andreas, Khamashta, Munther A, Alarcón, Graciela S, Svenungsson, Elisabet, Van Vollenhoven, Ronald F, Aranow, Cynthia, Mackay, Meggan, Ruiz-Irastorza, Guillermo, Ramos-Casals, Manuel, Lim, S Sam, Inanc, Murat, Kalunian, Kenneth C, Jacobsen, Soren, Peschken, Christine A, Kamen, Diane L, Askanase, Anca, Theriault, Chris, and Farewell, Vernon
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Adult ,Male ,Lupus Vasculitis, Central Nervous System ,Mononeuropathies ,Age Factors ,Peripheral Nervous System Diseases ,Middle Aged ,Severity of Illness Index ,Cranial Nerve Diseases ,3. Good health ,Cohort Studies ,Young Adult ,Multivariate Analysis ,Humans ,Lupus Erythematosus, Systemic ,Female ,Proportional Hazards Models - Abstract
OBJECTIVE: To determine the frequency, clinical characteristics, associations, and outcomes of different types of peripheral nervous system (PNS) disease in a multiethnic/multiracial, prospective inception cohort of systemic lupus erythematosus (SLE) patients. METHODS: Patients were evaluated annually for 19 neuropsychiatric (NP) events including 7 types of PNS disease. SLE disease activity, organ damage, autoantibodies, and patient and physician assessment of outcome were measured. Time to event and linear regressions were used as appropriate. RESULTS: Of 1,827 SLE patients, 88.8% were female, and 48.8% were white. The mean ± SD age was 35.1 ± 13.3 years, disease duration at enrollment was 5.6 ± 4.2 months, and follow-up was 7.6 ± 4.6 years. There were 161 PNS events in 139 (7.6%) of 1,827 patients. The predominant events were peripheral neuropathy (66 of 161 [41.0%]), mononeuropathy (44 of 161 [27.3%]), and cranial neuropathy (39 of 161 [24.2%]), and the majority were attributed to SLE. Multivariate Cox regressions suggested longer time to resolution in patients with a history of neuropathy, older age at SLE diagnosis, higher SLE Disease Activity Index 2000 scores, and for peripheral neuropathy versus other neuropathies. Neuropathy was associated with significantly lower Short Form 36 (SF-36) physical and mental component summary scores versus no NP events. According to physician assessment, the majority of neuropathies resolved or improved over time, which was associated with improvements in SF-36 summary scores for peripheral neuropathy and mononeuropathy. CONCLUSION: PNS disease is an important component of total NPSLE and has a significant negative impact on health-related quality of life. The outcome is favorable for most patients, but our findings indicate that several factors are associated with longer time to resolution.
238. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.
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Rovin, Brad H, Teng, Y K Onno, Ginzler, Ellen M, Arriens, Cristina, Caster, Dawn J, Romero-Diaz, Juanita, Gibson, Keisha, Kaplan, Joshua, Lisk, Laura, Navarra, Sandra, Parikh, Samir V, Randhawa, Simrat, Solomons, Neil, and Huizinga, Robert B
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LUPUS nephritis , *RENAL biopsy , *SYSTEMIC lupus erythematosus , *ADULTS , *GLOMERULAR filtration rate , *GLUCOCORTICOIDS , *MYCOPHENOLIC acid , *CYCLOSPORINE , *TREATMENT effectiveness , *RANDOMIZED controlled trials , *BLIND experiment , *IMMUNOSUPPRESSIVE agents , *STATISTICAL sampling , *CREATININE , *THERAPEUTICS - Abstract
Background: Voclosporin, a novel calcineurin inhibitor approved for the treatment of adults with lupus nephritis, improved complete renal response rates in patients with lupus nephritis in a phase 2 trial. This study aimed to evaluate the efficacy and safety of voclosporin for the treatment of lupus nephritis.Methods: This multicentre, double-blind, randomised phase 3 trial was done in 142 hospitals and clinics across 27 countries. Patients with a diagnosis of systemic lupus erythematosus with lupus nephritis according to the American College of Rheumatology criteria, and a kidney biopsy within 2 years that showed class III, IV, or V (alone or in combination with class III or IV) were eligible. Patients were randomly assigned (1:1) to oral voclosporin (23·7 mg twice daily) or placebo, on a background of mycophenolate mofetil (1 g twice daily) and rapidly tapered low-dose oral steroids, by use of an interactive web response system. The primary endpoint was complete renal response at 52 weeks defined as a composite of urine protein creatinine ratio of 0·5 mg/mg or less, stable renal function (defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1·73 m2 or no confirmed decrease from baseline in eGFR of >20%), no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or for 7 or more days during weeks 44 through 52, just before the primary endpoint assessment. Safety was also assessed. Efficacy analysis was by intention-to-treat and safety analysis by randomised patients receiving at least one dose of study treatment. The trial is registered with ClinicalTrials.gov, NCT03021499.Findings: Between April 13, 2017, and Oct 10, 2019, 179 patients were assigned to the voclosporin group and 178 to the placebo group. The primary endpoint of complete renal response at week 52 was achieved in significantly more patients in the voclosporin group than in the placebo group (73 [41%] of 179 patients vs 40 [23%] of 178 patients; odds ratio 2·65; 95% CI 1·64-4·27; p<0·0001). The adverse event profile was balanced between the two groups; serious adverse events occurred in 37 (21%) of 178 in the voclosporin group and 38 (21%) of 178 patients in the placebo group. The most frequent serious adverse event involving infection was pneumonia, occurring in 7 (4%) patients in the voclosporin group and in 8 (4%) patients in the placebo group. A total of six patients died during the study or study follow-up period (one [<1%] patient in the voclosporin group and five [3%] patients in the placebo group). None of the events leading to death were considered by the investigators to be related to the study treatments.Interpretation: Voclosporin in combination with MMF and low-dose steroids led to a clinically and statistically superior complete renal response rate versus MMF and low-dose steroids alone, with a comparable safety profile. This finding is an important advancement in the treatment of patients with active lupus nephritis.Funding: Aurinia Pharmaceuticals. [ABSTRACT FROM AUTHOR]- Published
- 2021
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239. Reply
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Lahita, Robert G., primary, Bradlow, H. Leon, additional, Pang, Songya, additional, New, Maria, additional, and Ginzler, Ellen, additional
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- 1988
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240. Prevalence of concomitant rheumatologic diseases and autoantibody specificities among racial and ethnic groups in SLE patients.
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Denvir, Brendan, Carlucci, Philip M., Corbitt, Kelly, Buyon, Jill P., Belmont, H. Michael, Gold, Heather T., Salmon, Jane E., Askanase, Anca, Bathon, Joan M., Geraldino-Pardilla, Laura, Ali, Yousaf, Ginzler, Ellen M., Putterman, Chaim, Gordon, Caroline, Barbour, Kamil E., Helmick, Charles G., Parton, Hilary, and Izmirly, Peter M.
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SYSTEMIC lupus erythematosus , *ANTIPHOSPHOLIPID syndrome , *KERATOCONJUNCTIVITIS , *IMMUNOGLOBULINS , *RHEUMATISM , *COMORBIDITY - Abstract
Objective: Leveraging the Manhattan Lupus Surveillance Program (MLSP), a population-based registry of cases of systemic lupus erythematosus (SLE) and related diseases, we investigated the proportion of SLE with concomitant rheumatic diseases, including Sjögren’s disease (SjD), antiphospholipid syndrome (APLS), and fibromyalgia (FM), as well as the prevalence of autoantibodies in SLE by sex and race/ethnicity. Methods: Prevalent SLE cases fulfilled one of three sets of classification criteria. Additional rheumatic diseases were defined using modified criteria based on data available in the MLSP: SjD (anti-SSA/Ro positive and evidence of keratoconjunctivitis sicca and/or xerostomia), APLS (antiphospholipid antibody positive and evidence of a blood clot), and FM (diagnosis in the chart). Results: 1,342 patients fulfilled SLE classification criteria. Of these, SjD was identified in 147 (11.0%, 95% CI 9.2–12.7%) patients with women and nonLatino Asian patients being the most highly represented. APLS was diagnosed in 119 (8.9%, 95% CI 7.3–10.5%) patients with the highest frequency in Latino patients. FM was present in 120 (8.9%, 95% CI 7.3–10.5) patients with non-Latino White and Latino patients having the highest frequency. Anti-dsDNA antibodies were most prevalent in non-Latino Asian, Black, and Latino patients while anti-Sm antibodies showed the highest proportion in non-Latino Black and Asian patients. Anti-SSA/Ro and anti-SSB/La antibodies were most prevalent in non-Latino Asian patients and least prevalent in non-Latino White patients. Men were more likely to be anti-Sm positive. Conclusion: Data from the MLSP revealed differences among patients classified as SLE in the prevalence of concomitant rheumatic diseases and autoantibody profiles by sex and race/ethnicity underscoring comorbidities associated with SLE. [ABSTRACT FROM AUTHOR]
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- 2024
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241. Association Between Severe Nonadherence to Hydroxychloroquine and Systemic Lupus Erythematosus Flares, Damage, and Mortality in 660 Patients From the SLICC Inception Cohort.
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Nguyen, Yann, Blanchet, Benoît, Urowitz, Murray B., Hanly, John G., Gordon, Caroline, Bae, Sang‐Cheol, Romero‐Diaz, Juanita, Sanchez‐Guerrero, Jorge, Clarke, Ann E., Bernatsky, Sasha, 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., and Dooley, Mary Anne
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DISEASE progression , *CONFIDENCE intervals , *SERUM , *HYDROXYCHLOROQUINE , *PATIENT compliance , *SYSTEMIC lupus erythematosus , *PREDNISONE , *IMMUNOSUPPRESSIVE agents , *LOGISTIC regression analysis , *ODDS ratio , *LONGITUDINAL method , *PROPORTIONAL hazards models - Abstract
Objective: The goals of this study were to assess the associations of severe nonadherence to hydroxychloroquine (HCQ), objectively assessed by HCQ serum levels, and risks of systemic lupus erythematosus (SLE) flares, damage, and mortality rates over five years of follow‐up. Methods: The Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort is an international multicenter initiative (33 centers throughout 11 countries). The serum of patients prescribed HCQ for at least three months at enrollment were analyzed. Severe nonadherence was defined by a serum HCQ level <106 ng/mL or <53 ng/mL for HCQ doses of 400 or 200 mg/day, respectively. Associations with the risk of a flare (defined as a Systemic Lupus Erythematosus Disease Activity Index 2000 increase ≥4 points, initiation of prednisone or immunosuppressive drugs, or new renal involvement) were studied with logistic regression, and associations with damage (first SLICC/American College of Rheumatology Damage Index [SDI] increase ≥1 point) and mortality with separate Cox proportional hazard models. Results: Of the 1,849 cohort participants, 660 patients (88% women) were included. Median (interquartile range) serum HCQ was 388 ng/mL (244–566); 48 patients (7.3%) had severe HCQ nonadherence. No covariates were clearly associated with severe nonadherence, which was, however, independently associated with both flare (odds ratio 3.38; 95% confidence interval [CI] 1.80–6.42) and an increase in the SDI within each of the first three years (hazard ratio [HR] 1.92 at three years; 95% CI 1.05–3.50). Eleven patients died within five years, including 3 with severe nonadherence (crude HR 5.41; 95% CI 1.43–20.39). Conclusion: Severe nonadherence was independently associated with the risks of an SLE flare in the following year, early damage, and five‐year mortality. [ABSTRACT FROM AUTHOR]
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- 2023
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242. Population-based prevalence and incidence estimates of mixed connective tissue disease from the Manhattan Lupus Surveillance Program.
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Hasan, Ghadeer, Ferucci, Elizabeth D, Buyon, Jill P, Belmont, H Michael, Salmon, Jane E, Askanase, Anca, Bathon, Joan M, Geraldino-Pardilla, Laura, Ali, Yousaf, Ginzler, Ellen M, Putterman, Chaim, Gordon, Caroline, Helmick, Charles G, Parton, Hilary, and Izmirly, Peter M
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PUBLIC health surveillance , *REPORTING of diseases , *CONFIDENCE intervals , *NOSOLOGY , *CONNECTIVE tissue diseases , *HUMAN services programs , *DISEASE prevalence , *RESEARCH funding - Abstract
Objective Epidemiological data for MCTD are limited. Leveraging data from the Manhattan Lupus Surveillance Program (MLSP), a racially/ethnically diverse population-based registry of cases with SLE and related diseases including MCTD, we provide estimates of the prevalence and incidence of MCTD. Methods MLSP cases were identified from rheumatologists, hospitals and population databases using a variety of International Classification of Diseases, Ninth Revision codes. MCTD was defined as one of the following: fulfilment of our modified Alarcon-Segovia and Kahn criteria, which required a positive RNP antibody and the presence of synovitis, myositis and RP; a diagnosis of MCTD and no other diagnosis of another CTD; and a diagnosis of MCTD regardless of another CTD diagnosis. Results Overall, 258 (7.7%) cases met a definition of MCTD. Using our modified Alarcon-Segovia and Kahn criteria for MCTD, the age-adjusted prevalence was 1.28 (95% CI 0.72, 2.09) per 100 000. Using our definition of a diagnosis of MCTD and no other diagnosis of another CTD yielded an age-adjusted prevalence and incidence of MCTD of 2.98 (95% CI 2.10, 4.11) per 100 000 and 0.39 (95% CI 0.22, 0.64) per 100 000, respectively. The age-adjusted prevalence and incidence were highest using a diagnosis of MCTD regardless of other CTD diagnoses and were 16.22 (95% CI 14.00, 18.43) per 100 000 and 1.90 (95% CI 1.49, 2.39) per 100 000, respectively. Conclusions The MLSP provided estimates for the prevalence and incidence of MCTD in a diverse population. The variation in estimates using different case definitions is reflective of the challenge of defining MCTD in epidemiologic studies. [ABSTRACT FROM AUTHOR]
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- 2023
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243. Connective tissue diseases: Management of lupus nephritis—new guidelines revealed
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Ginzler, Ellen
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- 2012
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244. Aural symptoms and hearing loss in patients with lupus
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Sperling, Neil M., Tehran, Kevin, Liebling, Anne, and Ginzler, Ellen
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- 1996
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245. American College of Rheumatology White Paper on Antimalarial Cardiac Toxicity.
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Desmarais, Julianna, Rosenbaum, James T., Costenbader, Karen H., Ginzler, Ellen M., Fett, Nicole, Goodman, Susan, O'Dell, James, Pineau, Christian A., Schmajuk, Gabriela, Werth, Victoria P., Link, Mark S., and Kovacs, Richard
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CARDIOTOXICITY , *RHEUMATOLOGY , *CARDIOMYOPATHIES , *VENTRICULAR tachycardia , *ANTIMALARIALS , *HYDROXYCHLOROQUINE , *CHLOROQUINE , *PATIENT safety , *DISEASE risk factors - Abstract
Hydroxychloroquine (HCQ) and chloroquine (CQ) are well‐established medications used in treating systemic lupus erythematosus and rheumatoid arthritis, as well as skin conditions such as cutaneous lupus erythematosus. In rare cases, arrhythmias and conduction system abnormalities, as well as cardiomyopathy, have been reported in association with HCQ/CQ use. Recently, however, the corrected QT interval (QTc)–prolonging potential of these medications, and risk of torsade de pointes (TdP) in particular, have been highlighted in the setting of their experimental use for COVID‐19 infection. This report was undertaken to summarize the current understanding of HCQ/CQ cardiac toxicity, describe QTc prolongation and TdP risks, and discuss areas of priority for future research. A working group of experts across rheumatology, cardiology, and dermatology performed a nonsystematic literature review and offered a consensus‐based expert opinion. Current data clearly indicate that HCQ and CQ are invaluable medications in the management of rheumatic and dermatologic diseases, but they are associated with QTc prolongation by directly affecting cardiac repolarization. Prescribing clinicians should be cognizant of this small effect, especially in patients taking additional medications that prolong the QTc interval. Long‐term use of HCQ/CQ may lead to a cardiomyopathy associated with arrhythmias and heart failure. Risk and benefit assessment should be considered prior to initiation of any medication, and both initial and ongoing risk–benefit assessments are important with regard to prescription of HCQ/CQ. While cardiac toxicity related to HCQ/CQ treatment of rheumatic diseases is rarely reported, it can be fatal. Awareness of the potential adverse cardiac effects of HCQ and CQ can increase the safe use of these medications. There is a clear need for additional research to allow better understanding of the cardiovascular risk and safety profile of these therapies used in the management of rheumatic and cutaneous diseases. [ABSTRACT FROM AUTHOR]
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- 2021
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246. Neuropsychiatric Events in Systemic Lupus Erythematosus: Predictors of Occurrence and Resolution in a Longitudinal Analysis of an International Inception Cohort.
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Hanly, John G., 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., Urowitz, Murray B., Bruce, Ian N., Petri, Michelle, Ginzler, Ellen M., Dooley, M. A., Ramsey‐Goldman, Rosalind, and Manzi, Susan
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GLUCOCORTICOIDS , *MULTIVARIATE analysis , *RACE , *SEX distribution , *DESCRIPTIVE statistics , *SYSTEMIC lupus erythematosus , *DRUG side effects , *HEADACHE , *IMMUNOSUPPRESSIVE agents , *MENTAL illness , *LONGITUDINAL method - Abstract
Objective: To determine predictors of change in neuropsychiatric (NP) event status in a large, prospective, international inception cohort of patients with systemic lupus erythematosus (SLE). Methods: Upon enrollment and annually thereafter, NP events attributed to SLE and non‐SLE causes and physician‐determined resolution were documented. Factors potentially associated with the onset and resolution of NP events were determined by time‐to‐event analysis using a multistate modeling structure. Results: NP events occurred in 955 (52.3%) of 1,827 patients, and 593 (31.0%) of 1,910 unique events were attributed to SLE. For SLE‐associated NP (SLE NP) events, multivariate analysis revealed a positive association with male sex (P = 0.028), concurrent non‐SLE NP events excluding headache (P < 0.001), active SLE (P = 0.012), and glucocorticoid use (P = 0.008). There was a negative association with Asian race (P = 0.002), postsecondary education (P = 0.001), and treatment with immunosuppressive drugs (P = 0.019) or antimalarial drugs (P = 0.056). For non‐SLE NP events excluding headache, there was a positive association with concurrent SLE NP events (P < 0.001) and a negative association with African race (P = 0.012) and Asian race (P < 0.001). NP events attributed to SLE had a higher resolution rate than non‐SLE NP events, with the exception of headache, which had comparable resolution rates. For SLE NP events, multivariate analysis revealed that resolution was more common in patients of Asian race (P = 0.006) and for central/focal NP events (P < 0.001). For non‐SLE NP events, resolution was more common in patients of African race (P = 0.017) and less common in patients who were older at SLE diagnosis (P < 0.001). Conclusion: In a large and long‐term study of the occurrence and resolution of NP events in SLE, we identified subgroups with better and worse prognosis. The course of NP events differs greatly depending on their nature and attribution. [ABSTRACT FROM AUTHOR]
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- 2021
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247. Lower vitamin D is associated with metabolic syndrome and insulin resistance in systemic lupus: data from an international inception cohort.
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Chew, Christine, Reynolds, John A, Lertratanakul, Apinya, Wu, Peggy, Urowitz, Murray, Gladman, Dafna D, Fortin, Paul R, Bae, Sang-Cheol, Gordon, Caroline, Clarke, Ann E, Bernatsky, Sasha, Hanly, John G, Isenberg, David, Rahman, Anisur, Sanchez-Guerrero, Jorge, Romero-Diaz, Juanita, Merrill, Joan, Wallace, Daniel, Ginzler, Ellen, and Khamashta, Munther
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REFERENCE values , *HYPERTENSION , *TRIGLYCERIDES , *GLUCOCORTICOIDS , *CARDIOVASCULAR diseases risk factors , *REGRESSION analysis , *VITAMIN D , *RISK assessment , *HYPERLIPIDEMIA , *METABOLIC syndrome , *DESCRIPTIVE statistics , *VITAMIN D deficiency , *SYSTEMIC lupus erythematosus , *LOGISTIC regression analysis , *HIGH density lipoproteins , *INSULIN resistance , *PHENOTYPES , *LONGITUDINAL method , *DISEASE risk factors , *DISEASE complications - Abstract
Objectives Vitamin D (25(OH)D) deficiency and metabolic syndrome (MetS) may both contribute to increased cardiovascular risk in SLE. We aimed to examine the association of demographic factors, SLE phenotype, therapy and vitamin D levels with MetS and insulin resistance. Methods The Systemic Lupus International Collaborating Clinics (SLICC) enrolled patients recently diagnosed with SLE (<15 months) from 33 centres across 11 countries from 2000. Clinical, laboratory and therapeutic data were collected. Vitamin D level was defined according to tertiles based on distribution across this cohort, which were set at T1 (10–36 nmol/l), T2 (37–60 nmol/l) and T3 (61–174 nmol/l). MetS was defined according to the 2009 consensus statement from the International Diabetes Federation. Insulin resistance was determined using the HOMA-IR model. Linear and logistic regressions were used to assess the association of variables with vitamin D levels. Results Of the 1847 patients, 1163 (63%) had vitamin D measured and 398 (34.2%) subjects were in the lowest 25(OH)D tertile. MetS was present in 286 of 860 (33%) patients whose status could be determined. Patients with lower 25(OH)D were more likely to have MetS and higher HOMA-IR. The MetS components, hypertension, hypertriglyceridemia and decreased high-density lipoprotein (HDL) were all significantly associated with lower 25(OH)D. Increased average glucocorticoid exposure was associated with higher insulin resistance. Conclusions MetS and insulin resistance are associated with lower vitamin D in patients with SLE. Further studies could determine whether vitamin D repletion confers better control of these cardiovascular risk factors and improve long-term outcomes in SLE. [ABSTRACT FROM AUTHOR]
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- 2021
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248. American College of Rheumatology, American Academy of Dermatology, Rheumatologic Dermatology Society, and American Academy of Ophthalmology 2020 Joint Statement on Hydroxychloroquine Use With Respect to Retinal Toxicity.
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Rosenbaum, James T., Costenbader, Karen H., Desmarais, Julianna, Ginzler, Ellen M., Fett, Nicole, Goodman, Susan M., O'Dell, James R., Schmajuk, Gabriela, Werth, Victoria P., Melles, Ronald B., and Marmor, Michael F.
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RHEUMATOLOGY , *DERMATOLOGY , *PHYSICIAN-patient relations , *MEDICAL screening , *HYDROXYCHLOROQUINE , *RETINAL diseases , *DRUG utilization , *MEDICAL prescriptions , *OPHTHALMOLOGY , *MEDICAL societies , *DRUG toxicity , *DISEASE risk factors - Abstract
Four major medical societies involved with hydroxychloroquine (HCQ) therapy concur on the need for common principles and cooperation to minimize the risk of ocular toxicity. At a daily dosage of ≤5 mg/kg/day actual body weight, the risk of retinal toxicity from HCQ is <2% for usage up to 10 years. Widespread adoption of more sensitive testing techniques, such as optical coherence tomography and automated visual fields, by eye care providers will allow the detection of early toxicity and thus preserve the patient's visual function. Baseline testing is advised to rule out confounding disease when a patient is started on HCQ. Annual screening with sensitive tests should begin no more than 5 years after treatment initiation. Providers should be sensitive to the medical value of HCQ, and not stop the drug for uncertain indications. It is important to note that effective communication among prescribing physicians, patients, and eye care providers will optimize the utility and safety of HCQ. [ABSTRACT FROM AUTHOR]
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- 2021
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249. A patient-centered evaluation of a novel medical student-based patient navigation program.
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Wilson, Jeremy, Lau, Derrick, Kristoferson, Eva, Ginzler, Ellen, and Kabani, Naureen
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PATIENTS' attitudes , *MEDICAL students , *PATIENT experience , *PATIENT-centered medical homes , *DISEASE management , *LIKERT scale , *HELPLINES - Abstract
Understand the patient experience of a pilot medical student-based patient navigator (PN) program. (2) Assess areas of improvement for further development as a model for expansion. This was a cross-sectional study assessing patients' subjective experience of medical student navigators for rheumatological conditions. Current student navigators contacted enrolled patients by phone with both structured and free-response questions. 44 of 71 patients completed the questionnaire. 84% reported a satisfaction of ≥ 4 on a 5 point Likert scale. > 80% of patients felt that the program helped them better care for their health, feel more understood by their medical team, and feel cared for by their healthcare team. Medical student navigators were able to assist with most patient requests. Patients enrolled in our medical student PN program expressed high levels of satisfaction and felt better able to access health resources with the help of a navigator. Employing medical students as PNs may serve as a mutually beneficial intervention providing early clinical exposure to students while furthering patient access to care. Other institutions may benefit from similarly structured interventions. • Patient navigators can serve a critical role in the management of chronic diseases, like Lupus. • Patients were highly satisfied with the use of medical student patient navigators. • Medical students gain clinical experience while addressing health disparities. [ABSTRACT FROM AUTHOR]
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- 2024
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250. Prediction of Damage Accrual in Systemic Lupus Erythematosus Using the Systemic Lupus International Collaborating Clinics Frailty Index.
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Legge, Alexandra, Kirkland, Susan, Rockwood, Kenneth, Andreou, Pantelis, Bae, Sang‐Cheol, Gordon, Caroline, Romero‐Diaz, Juanita, Sanchez‐Guerrero, Jorge, Wallace, Daniel J., Bernatsky, Sasha, Clarke, Ann E., Merrill, Joan T., Ginzler, Ellen M., Fortin, Paul R., Gladman, Dafna D., Urowitz, Murray B., Bruce, Ian N., Isenberg, David A., Rahman, Anisur, and Alarcón, Graciela S.
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ANTIMALARIALS , *CONFIDENCE intervals , *GLUCOCORTICOIDS , *HEALTH surveys , *PATIENT aftercare , *IMMUNOSUPPRESSIVE agents , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL appointments , *QUALITY of life , *SYSTEMIC lupus erythematosus , *MULTIPLE regression analysis , *SYMPTOMS , *RESEARCH methodology evaluation , *DESCRIPTIVE statistics , *DISEASE complications ,RESEARCH evaluation - Abstract
Objective: The Systemic Lupus International Collaborating Clinics (SLICC) frailty index (FI) has been shown to predict mortality, but its association with other important outcomes is unknown. We examined the association of baseline SLICC FI values with damage accrual in the SLICC inception cohort. Methods: The baseline visit was defined as the first visit at which both organ damage (SLICC/American College of Rheumatology Damage Index [SDI]) and health‐related quality of life (Short Form 36) were assessed. Baseline SLICC FI scores were calculated. Damage accrual was measured by the increase in SDI between the baseline assessment and the last study visit. Multivariable negative binomial regression was used to estimate the association between baseline SLICC FI values and the rate of increase in the SDI during follow‐up, adjusting for relevant demographic and clinical characteristics. Results: The 1,549 systemic lupus erythematosus (SLE) patients eligible for this analysis were mostly female (88.7%) with a mean ± SD age of 35.7 ± 13.3 years and a median disease duration of 1.2 years (interquartile range 0.9–1.5 years) at baseline. The mean ± SD baseline SLICC FI was 0.17 ± 0.08. Over a mean ± SD follow‐up of 7.2 ± 3.7 years, 653 patients (42.2%) had an increase in SDI. Higher baseline SLICC FI values (per 0.05 increase) were associated with higher rates of increase in the SDI during follow‐up (incidence rate ratio [IRR] 1.19 [95% confidence interval 1.13–1.25]), after adjusting for age, sex, ethnicity/region, education, baseline SLE Disease Activity Index 2000, baseline SDI, and baseline use of glucocorticoids, antimalarials, and immunosuppressive agents. Conclusion: Our findings indicate that the SLICC FI predicts damage accrual in incident SLE, which further supports the SLICC FI as a valid health measure in SLE. [ABSTRACT FROM AUTHOR]
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- 2020
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