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4. AB0982 DOMAINS FOR INCLUSION IN A NOVEL TREATMENT RESPONSE MEASURE FOR SYSTEMIC LUPUS ERYTHEMATOSUS (TRM-SLE): RESULTS OF A MODIFIED DELPHI STUDY

Author

Connelly, K., primary, Koelmeyer, R., additional, Ayton, D., additional, May, J., additional, Gregory, K., additional, Eades, L., additional, Barallon, R., additional, Kandane-Rathnayake, R., additional, Golder, V., additional, Anzum, A., additional, Mydin, M., additional, Akther, M., additional, Friedman, A., additional, Askanase, A., additional, Aranow, C., additional, Vital, E. M., additional, Pons-Estel, G., additional, Brunner, H., additional, Kalunian, K. C., additional, Dantata, K., additional, Arnaud, L., additional, Burke, L., additional, Simon, L., additional, Zuraw, Q., additional, Garces, S., additional, Werth, V., additional, Sun, Y., additional, Tanaka, Y., additional, Lahoud, Y., additional, Cornet, A., additional, Sorrentino, A., additional, Rahman, A., additional, Stevens, A., additional, Barbey, C., additional, Dey, D., additional, Karis, E., additional, Bonfa, E., additional, Noss, E., additional, MD Smith, E., additional, Stojan, G., additional, Andersen, J., additional, Merrill, J., additional, Merola, J. F., additional, Ross Terres, J. A., additional, Buie, J., additional, Maller, J., additional, Costenbader, K., additional, Mosca, M., additional, Hojnik, M., additional, Dall’era, M., additional, Delev, N., additional, Furie, R. A., additional, Van Vollenhoven, R. F., additional, Banerjee, S., additional, and Morand, E., additional

Published
2024
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12. Development of a New International Antiphospholipid Syndrome Classification Criteria Phase I/II Report: Generation and Reduction of Candidate Criteria

Author

Barbhaiya, M., Zuily, S., Ahmadzadeh, Y., Amigo, M. -C., Avcin, T., Bertolaccini, M., Branch, D. W., de Jesus, G., Devreese, K. M. J., Frances, C., Garcia, D., Guillemin, F., Levine, S. R., Levy, R. A., Lockshin, M. D., Ortel, T., Seshan, S. V., Tektonidou, M., Wahl, D., Willis, R., Naden, R., Costenbader, K., Erkan, D., Agmon-Levin, N., Aguilar, C., Alba, P., Alpan, O., Ambrozic, A., Amoura, Z., Andrade, D., Andrade, L., Appenzeller, S., Esen, B. A., Atsumi, T., Berkun, Y., Cabral, A., Canaud, G., Cervera, R., Chen, P., Chighizola, C., Cimaz, R., Cohen, H., Costedoat-Chalumeau, N., Crowther, M., Cuadrado, M. J., de Groot, P. G., de Moerloose, P., Derksen, R., Diz-Kucukkaya, R., Dorner, T., Fortin, P., Giannakopoulos, B., Gomez-Puerta, J. A., Gonzalez, E. B., Inanc, M., Kenet, G., Khamashta, M., Kriegel, M., Krilis, S., Laskin, C., Massicotte, P., Mccarty, G., Meroni, P. L., Mikdashi, J., Myones, B., Pengo, V., Petri, M., Roubey, R., Sammaritano, L., Sanna, G., Sciascia, S., Signorelli, F., Soybilgic, A., Tincani, A., Woller, S., and Yelnik, C.

Subjects
Antiphospholipid Syndrome, Consensus, Delphi Technique, Humans, Predictive Value of Tests, Rheumatology, Severity of Illness Index, CONSENSUS STATEMENT, Potential candidate, AMERICAN-COLLEGE, Article, DISEASE, Reduction (complexity), 03 medical and health sciences, 0302 clinical medicine, Antiphospholipid syndrome, RHEUMATOLOGY/EUROPEAN LEAGUE, Nominal group technique, Medicine and Health Sciences, Hierarchical organization, Medicine, CLINICAL-SIGNIFICANCE, computer.programming_language, 030203 arthritis & rheumatology, RISK, VENOUS THROMBOEMBOLISM, Information retrieval, business.industry, SYSTEMIC-SCLEROSIS, medicine.disease, Phase i ii, MYOCARDIAL-INFARCTION, ANTIBODIES, Report generation, business, computer, Delphi
Abstract

Objective : An international multidisciplinary initiative, jointly supported by the American College of Rheumatology and European Alliance of Associations for Rheumatology, is underway to develop new rigorous classification criteria to identify patients with high likelihood of antiphospholipid syndrome (APS) for research purposes. The present study was undertaken to apply an evidence- and consensus-based approach to identify candidate criteria and develop a hierarchical organization of criteria within domains. Methods : During phase I, the APS classification criteria steering committee used systematic literature reviews and surveys of international APS physician scientists to generate a comprehensive list of items related to APS. In phase II, we reviewed the literature, administered surveys, formed domain subcommittees, and used Delphi exercises and nominal group technique to reduce potential APS candidate criteria. Candidate criteria were hierarchically organized into clinical and laboratory domains. Results : Phase I generated 152 candidate criteria, expanded to 261 items with the addition of subgroups and candidate criteria with potential negative weights. Using iterative item reduction techniques in phase II, we initially reduced these items to 64 potential candidate criteria organized into 10 clinical and laboratory domains. Subsequent item reduction methods resulted in 27 candidate criteria, hierarchically organized into 6 additive domains (laboratory, macrovascular, microvascular, obstetric, cardiac, and hematologic) for APS classification. Conclusion : Using data- and consensus-driven methodology, we identified 27 APS candidate criteria in 6 clinical or laboratory domains. In the next phase, the proposed candidate criteria will be used for real-world case collection and further refined, organized, and weighted to determine an aggregate score and threshold for APS classification.

Published
2021

13. European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria item performance

Author

Aringer, M. Brinks, R. Dörner, T. Daikh, D. Mosca, M. Ramsey-Goldman, R. Smolen, J.S. Wofsy, D. Boumpas, D.T. Kamen, D.L. Jayne, D. Cervera, R. Costedoat-Chalumeau, N. Diamond, B. Gladman, D.D. Hahn, B. Hiepe, F. Jacobsen, S. Khanna, D. Lerstrøm, K. Massarotti, E. McCune, J. Ruiz-Irastorza, G. Sanchez-Guerrero, J. Schneider, M. Urowitz, M. Bertsias, G. Hoyer, B.F. Leuchten, N. Schmajuk, G. Tani, C. Tedeschi, S.K. Touma, Z. Anic, B. Assan, F. Chan, T.M. Clarke, A.E. Crow, M.K. Czirják, L. Doria, A. Graninger, W. Halda-Kiss, B. Hasni, S. Izmirly, P.M. Jung, M. Kumánovics, G. Mariette, X. Padjen, I. Pego-Reigosa, J.M. Romero-Diaz, J. Rúa-Figueroa, I. Seror, R. Stummvoll, G.H. Tanaka, Y. Tektonidou, M.G. Vasconcelos, C. Vital, E.M. Wallace, D.J. Yavuz, S. Meroni, P.L. Fritzler, M.J. Naden, R. Costenbader, K. Johnson, S.R.

Subjects
musculoskeletal diseases, immune system diseases, skin and connective tissue diseases
Abstract

Background/objectives The European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus system showed high specificity, while attaining also high sensitivity. We hereby analysed the performance of the individual criteria items and their contribution to the overall performance of the criteria. Methods We combined the EULAR/ACR derivation and validation cohorts for a total of 1197 systemic lupus erythematosus (SLE) and n=1074 non-SLE patients with a variety of conditions mimicking SLE, such as other autoimmune diseases, and calculated the sensitivity and specificity for antinuclear antibodies (ANA) and the 23 specific criteria items. We also tested performance omitting the EULAR/ACR criteria attribution rule, which defines that items are only counted if not more likely explained by a cause other than SLE. Results Positive ANA, the new entry criterion, was 99.5% sensitive, but only 19.4% specific, against a non-SLE population that included other inflammatory rheumatic, infectious, malignant and metabolic diseases. The specific criteria items were highly variable in sensitivity (from 0.42% for delirium and 1.84% for psychosis to 75.6% for antibodies to double-stranded DNA), but their specificity was uniformly high, with low C3 or C4 (83.0%) and leucopenia 80% for all items, explaining the higher overall specificity of the criteria set. © Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Published
2021

14. Performance of the EULAR/ACR 2019 classification criteria for systemic lupus erythematosus in early disease, across sexes and ethnicities

Author

Johnson, S., Brinks, R., Costenbader, K., Daikh, D., Mosca, M., Ramsey-Goldman, R., Smolen, J. S., Wofsy, D., Boumpas, D., Kamen, D. L., Jayne, D., Cervera, R., Costedoat- Chalumeau, N., Diamond, B., Gladman, D. D., Hahn, B. H., Hiepe, F., Jacobsen, S., Khanna, D., Lerstrom, K., Massarotti, E., Mccune, W. J., Ruiz-Irastorza, G., Sanchez-Guerrero, J., Schneider, M., Urowitz, M. B., Bertsias, G., Hoyer, B. F., Leuchten, N., Tani, C., Tedeschi, S., Touma, Z., Schmajuk, G., Anić, Branimir, Assan, F., Chan, T., Clarke, A. E., Crow, M. K., Czirják, L., Doria, A., Graninger, W., Halda- Kiss, B., Hasni, S., Izmirly, P., Jung, M., Kumanovics, G., Mariette, X., Padjen, Ivan, Pego-Reigosa, J. M., Romero-Diaz, J., Rua- Figueroa, I., Seror, R., Stummvoll, G., Tanaka, Y., Tektonidou, M., Vasconcelos, C., Vital, E., Wallace, D. J., Yavuz, S., Meroni, P. L., Fritzler, M., Naden, R., Dörner, T., and Aringer, M.

Subjects
musculoskeletal diseases, immune system diseases, systemic lupus erythematosus, classification criteria, sexes, ethnicities, skin and connective tissue diseases
Abstract

Background: EULAR/ACR 2019 SLE Classification Criteria were validated in an international cohort. Objectives: To evaluate performance characteristics of SLE classification systems in sex, race/ethnicity, and disease duration subsets. Methods: Sensitivity and specificity of the EULAR/ACR 2019, SLICC 2012 and ACR 1982/1997 criteria were evaluated in the validation cohort. Results: The cohort consisted of female (n=1098), male (n=172), Asian (n=118), Black (n=68), Hispanic (n=124) and White (n=941) patients ; and patients with an SLE duration of 1-3 years (n=196), 3-5 years (n=157), and ≥5 years (n=879). Among patients with 1-3 years disease duration, the EULAR/ACR criteria had better sensitivity than the ACR criteria (97% (95%CI 92-99%) vs 81% (95%CI 72-88%). The new criteria performed well in men (sensitivity 93%, specificity 96%) and women (sensitivity 97%, specificity 94%). The new criteria had better sensitivity than the ACR criteria in White (95% vs 83%), Hispanic (100% vs 86%) and Asian patients (97% vs 77%). Conclusion: The EULAR/ACR 2019 criteria perform well in patients with early disease, and across sexes and ethnicities.

Published
2020

15. PERFORMANCE OF THE EULAR/ACR 2019 CLASSIFICATION CRITERIA FOR SYSTEMIC LUPUS ERYTHEMATOSUS IN EARLY DISEASE, ACROSS SEXES AND ETHNICITIES

Author

Johnson, S. Brinks, R. Costenbader, K. Daikh, D. Mosca, M. Ramsey-Goldman, R. Smolen, J. S. Wofsy, D. Boumpas, D. Kamen, D. L. Jayne, D. Cervera, R. and Costedoat-Chalumeau, N. Diamond, B. Gladman, D. D. Hahn, B. H. Hiepe, F. Jacobsen, S. Khanna, D. Lerstrom, K. and Massarotti, E. Mccune, W. J. Ruiz-Irastorza, G. and Sanchez-Guerrero, J. Schneider, M. Urowitz, M. B. Bertsias, G. Hoyer, B. F. Leuchten, N. Tani, C. Tedeschi, S. and Touma, Z. Schmajuk, G. Anic, B. Assan, F. Chan, T. and Clarke, A. E. Crow, M. K. Czirjak, L. Doria, A. and Graninger, W. Halda-Kiss, B. Hasni, S. Izmirly, P. Jung, M. Kumanovics, G. Mariette, X. Padjen, I. Pego-Reigosa, J. M. Romero-Diaz, J. Rua-Figueroa, I. Seror, R. and Stummvoll, G. Tanaka, Y. Tektonidou, M. Vasconcelos, C. and Vital, E. Wallace, D. J. Yavuz, S. Meroni, P. L. and Fritzler, M. Naden, R. Doerner, T. Aringer, M.

Published
2020

16. Global patient perspective on top challenges in lupus care and research participation.

Author

Werth V., Bloch L., Bruce I.N., Costenbader K., Dickerson B., Dorner T., Getz K., Kao A., Manzi S., Morand E.F., Raymond S., Rovin B.H., Schanberg L., Von Feldt J., Hanrahan L., Zook D., Tse K., Pena Y., Arntsen K., Bae S.C., Werth V., Bloch L., Bruce I.N., Costenbader K., Dickerson B., Dorner T., Getz K., Kao A., Manzi S., Morand E.F., Raymond S., Rovin B.H., Schanberg L., Von Feldt J., Hanrahan L., Zook D., Tse K., Pena Y., Arntsen K., and Bae S.C.

Abstract

Background: The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus initiative to identify, prioritize and address top barriers in lupus drug development, clinical care and access to care. The Lupus Foundation of America convenes ALPHA with Tufts Center for the Study of Drug Development and a Global Advisory Committee of lupus experts representing clinician-scientists, industry and patients. Objective(s): Collect global patient input to determine alignment with the lupus clinician-scientist community on prior published consensus of top lupus barriers. Method(s): A 23-question online Qualtrics survey was developed to identify challenges across lupus diagnosis, clinical care and research participation. The survey, available in English, Spanish, Korean and simplified Chinese, was fielded in November 2019 to people with lupus and caregivers of children <18 with lupus. SPSS 26 and SAS 9.4 were used for descriptive statistics and sub-analysis. Result(s): Analysis included only consented responses with >= 68% survey completion (n=3,447) received across 83 countries. 95% were female with a mean age of 45. Respondents reported being White (57%), Black or of African descent (14%), Hispanic or Latino (18%) and Asian (10%). 65% resided in the US while 35% resided in countries outside of the US. 97% were people with lupus while 3% were caregivers to children <18 with lupus. Highest ranked challenges were similar globally and across children and adults: medication side effects, lack of treatment options and high out-of-pocket costs. Managing side effects ranked significantly higher (p<.05) outside of the US (48%) compared to US (40%). 50% of caregivers reported managing side effects as the top challenge for children compared to 43% of adults (p<.05). Research participation was low (24%) and lower among children (16%). The top reason for not participating in a clinical trial was not being asked by their doctor. Conclusion(s): This global survey re

Published
2020

25. AB1338-HPR GLOBAL PATIENT PERSPECTIVE ON TOP CHALLENGES IN LUPUS CARE AND RESEARCH PARTICIPATION

Author

Tse, K., primary, Peña, Y., additional, Arntsen, K., additional, Bae, S. C., additional, Bloch, L., additional, Bruce, I. N., additional, Costenbader, K., additional, Dickerson, B., additional, Dörner, T., additional, Getz, K., additional, Kao, A., additional, Manzi, S., additional, Morand, E. F., additional, Raymond, S., additional, Rovin, B. H., additional, Schanberg, L., additional, Werth, V., additional, Von Feldt, J., additional, Zook, D., additional, and Hanrahan, L., additional

Published
2020
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26. THU0271 PERFORMANCE OF THE EULAR/ACR 2019 CLASSIFICATION CRITERIA FOR SYSTEMIC LUPUS ERYTHEMATOSUS IN EARLY DISEASE, ACROSS SEXES AND ETHNICITIES

Author

Johnson, S., primary, Brinks, R., additional, Costenbader, K., additional, Daikh, D., additional, Mosca, M., additional, Ramsey-Goldman, R., additional, Smolen, J. S., additional, Wofsy, D., additional, Boumpas, D., additional, Kamen, D. L., additional, Jayne, D., additional, Cervera, R., additional, Costedoat-Chalumeau, N., additional, Diamond, B., additional, Gladman, D. D., additional, Hahn, B. H., additional, Hiepe, F., additional, Jacobsen, S., additional, Khanna, D., additional, Lerstrom, K., additional, Massarotti, E., additional, Mccune, W. J., additional, Ruiz-Irastorza, G., additional, Sanchez-Guerrero, J., additional, Schneider, M., additional, Urowitz, M. B., additional, Bertsias, G., additional, Hoyer, B. F., additional, Leuchten, N., additional, Tani, C., additional, Tedeschi, S., additional, Touma, Z., additional, Schmajuk, G., additional, Anic, B., additional, Assan, F., additional, Chan, T., additional, Clarke, A. E., additional, Crow, M. K., additional, Czirják, L., additional, Doria, A., additional, Graninger, W., additional, Halda-Kiss, B., additional, Hasni, S., additional, Izmirly, P., additional, Jung, M., additional, Kumanovics, G., additional, Mariette, X., additional, Padjen, I., additional, Pego-Reigosa, J. M., additional, Romero-Diaz, J., additional, Rua-Figueroa, I., additional, Seror, R., additional, Stummvoll, G., additional, Tanaka, Y., additional, Tektonidou, M., additional, Vasconcelos, C., additional, Vital, E., additional, Wallace, D. J., additional, Yavuz, S., additional, Meroni, P. L., additional, Fritzler, M., additional, Naden, R., additional, Dörner, T., additional, and Aringer, M., additional

Published
2020
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34. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus

Author

Aringer, M. Costenbader, K. Daikh, D. Brinks, R. Mosca, M. Ramsey-Goldman, R. Smolen, J.S. Wofsy, D. Boumpas, D.T. Kamen, D.L. Jayne, D. Cervera, R. Costedoat-Chalumeau, N. Diamond, B. Gladman, D.D. Hahn, B. Hiepe, F. Jacobsen, Sø. Khanna, D. Lerstrøm, K. Massarotti, E. McCune, J. Ruiz-Irastorza, G. Sanchez-Guerrero, J. Schneider, M. Urowitz, M. Bertsias, G. Hoyer, B.F. Leuchten, N. Tani, C. Tedeschi, S.K. Touma, Z. Schmajuk, G. Anic, B. Assan, F. Chan, T.M. Clarke, A.E. Crow, M.K. Czirják, L. Doria, A. Graninger, W. Halda-Kiss, B. Hasni, S. Izmirly, P.M. Jung, M. Kumánovics, G. Mariette, X. Padjen, I. Pego-Reigosa, J.M. Romero-Diaz, J. Rúa-Figueroa Fernández, Í. Seror, R. Stummvoll, G.H. Tanaka, Y. Tektonidou, M.G. Vasconcelos, C. Vital, E.M. Wallace, D.J. Yavuz, S. Meroni, P.L. Fritzler, M.J. Naden, R. Dörner, T. Johnson, S.R.

Subjects
immune system diseases, skin and connective tissue diseases
Abstract

Objective To develop new classification criteria for systemic lupus erythematosus (SLE) jointly supported by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Methods This international initiative had four phases. (1) Evaluation of antinuclear antibody (ANA) as an entry criterion through systematic review and meta-regression of the literature and criteria generation through an international Delphi exercise, an early patient cohort and a patient survey. (2) Criteria reduction by Delphi and nominal group technique exercises. (3) Criteria definition and weighting based on criterion performance and on results of a multi-criteria decision analysis. (4) Refinement of weights and threshold scores in a new derivation cohort of 1001 subjects and validation compared with previous criteria in a new validation cohort of 1270 subjects. Results The 2019 EULAR/ACR classification criteria for SLE include positive ANA at least once as obligatory entry criterion; followed by additive weighted criteria grouped in seven clinical (constitutional, haematological, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and three immunological (antiphospholipid antibodies, complement proteins, SLE-specific antibodies) domains, and weighted from 2 to 10. Patients accumulating ≥10 points are classified. In the validation cohort, the new criteria had a sensitivity of 96.1% and specificity of 93.4%, compared with 82.8% sensitivity and 93.4% specificity of the ACR 1997 and 96.7% sensitivity and 83.7% specificity of the Systemic Lupus International Collaborating Clinics 2012 criteria. Conclusion These new classification criteria were developed using rigorous methodology with multidisciplinary and international input, and have excellent sensitivity and specificity. Use of ANA entry criterion, hierarchically clustered and weighted criteria reflect current thinking about SLE and provide an improved foundation for SLE research. © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Published
2019

38. Global consensus building and prioritization of major challenges in lupus diagnosis, care, treatment and research.

Author

Dorner T., Kao A.H., Manzi S., Morand E., Raymond S., Rovin B.H., Schanberg L.E., Werth V.P., Getz K., Von Feldt J., Tse K., Daly R.P., Hanrahan L., Anderson A., Arntsen K., Bae S.-C., Bruce I.N., Costenbader K., Dorner T., Kao A.H., Manzi S., Morand E., Raymond S., Rovin B.H., Schanberg L.E., Werth V.P., Getz K., Von Feldt J., Tse K., Daly R.P., Hanrahan L., Anderson A., Arntsen K., Bae S.-C., Bruce I.N., and Costenbader K.

Abstract

Background/Purpose: The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus initiative seeking to identify and prioritize top barriers in lupus impacting diagnosis, care, treatment and research, with the goal of improving rates of accurate and timely diagnosis, increasing access to care, and improving short and long-term patient outcomes. This abstract presents Phase I consensus building and prioritization process methodology, and findings of initial project activities. Method(s): The Lupus Foundation of America and its research partner, Tufts Center for the Study of Drug Development, assembled a Global Advisory Committee (GAC) of 13 lupus experts across 5 countries to provide input and support throughout the effort. A mixed methods approach is being used to elicit concepts seen as major barriers in lupus diagnosis, care, treatment and research, then consolidate and confirm those selected as most urgent. First, a brief web survey was distributed to each GAC member to begin concept elicitation. Identified items were then ranked during a GAC meeting, and will be presented through an in-depth semi-structured interview among 22 stakeholders representing industry, academia, regulatory bodies, patient/advocacy groups, clinicians, and researchers. Finally, an online survey among 200-500 individuals will further validate and demonstrate consensus around top barriers in a broader audience for this Phase I initiative. Result(s): GAC member response rate was 85% for the concept elicitation exercise. Findings are shown in Figure 1. 15 main concepts were identified, with substantial discussion on lupus heterogeneity, lupus as a spectrum of diseases, and the importance of biomarkers in trial design and understanding of the disease. Categorization and prioritization of these concepts is seen in Figure 2. Notably, all GAC members cited issues surrounding disease definition and diagnosis as the most significant burden in lupus. Half also cited clini

Published
2019

39. Global consensus building and prioritisation of fundamental lupus challenges: The ALPHA project.

Author

Schanberg L.E., Rovin B., Von Feldt J.M., Costenbader K., Werth V.P., Manzi S., Raymond S., Tse K., Pena Y., Anderson A., Arntsen K., Bae S.-C., Bruce I., Dorner T., Getz K., Hanrahan L., Kao A., Morand E., Schanberg L.E., Rovin B., Von Feldt J.M., Costenbader K., Werth V.P., Manzi S., Raymond S., Tse K., Pena Y., Anderson A., Arntsen K., Bae S.-C., Bruce I., Dorner T., Getz K., Hanrahan L., Kao A., and Morand E.

Abstract

Objective Lupus is a complex, heterogeneous autoimmune disease that has yet to see significant progress towards more timely diagnosis, improved treatment options for short-Term and long-Term outcomes, and appropriate access to care. The Addressing Lupus Pillars for Health Advancement (ALPHA) project is the first step in establishing global consensus and developing concrete strategies to address the challenges limiting progress. Methods A Global Advisory Committee of 13 individuals guided the project and began barrier identification. Seventeen expert interviews were conducted to further characterise key barriers. Transcripts were analysed using Nvivo and a codebook was created containing a list of thematic a nodes' (topics) and their descriptions. Findings were used to develop a final survey instrument that was fielded to a diverse, international stakeholder audience to achieve broad consensus. Results Expert interviews identified lupus heterogeneity as the primary barrier hindering advancement. Subsequent barriers were categorised into three areas: (1) Drug development. (2) Clinical care. (3) Access and value. The global survey received 127 completed responses from experts across 20 countries. Respondents identified barriers as high priority including the lack of biomarkers for clinical and drug development use, flawed clinical trial design, lack of access to clinicians familiar with lupus, and obstacles to effective management of lupus due to social determinants of care. Respondents also identified 30 autoimmune conditions that may be lupus-related based on overlapping features, shared autoantibodies and pathophysiology. Conclusions ALPHA is a comprehensive initiative to identify and prioritise the continuum of challenges facing people with lupus by engaging a global audience of lupus experts. It also explored views on lupus as a spectrum of related diseases. Conclusions from this effort provide a framework to generate actionable approaches to the identified high-p

Published
2019

44. Dietary patterns and risk of systemic lupus erythematosus in women.

Author

Tedeschi, S K, Barbhaiya, M, Sparks, J A, Karlson, E W, Kubzansky, L D, Roberts, A L, Willett, W C, Lu, B, and Costenbader, K H

Subjects
SYSTEMIC lupus erythematosus, SYSTEMIC risk (Finance), BODY mass index, PRINCIPAL components analysis, GLUCOSE metabolism, LIPID metabolism
Abstract

Objective: Dietary intake is a complex exposure and a potential risk factor for systemic lupus erythematosus (SLE) due to its impact on lipid and glucose metabolism, oxidative stress, and the intestinal microbiome. We aimed to test whether a prudent dietary pattern is associated with a lower risk of SLE, and whether a Western dietary pattern is associated with a higher risk of SLE. Methods: We prospectively investigated two dietary patterns and SLE risk among women in the Nurses' Health Study (NHS, 1984–2014) and Nurses' Health Study II (NHSII, 1991–2015). Food frequency questionnaires were completed every four years. Congruent with prior work in NHS and NHSII, we derived two separate dietary patterns (prudent and Western) using principal component analysis within each cohort. Incident SLE was confirmed by the American College of Rheumatology's 1997 criteria. We estimated hazard ratios (HR) and 95% confidence intervals (CI) for SLE by dietary pattern quartiles using Cox models adjusted for time-varying covariates. Models were performed separately in each cohort and results were meta-analyzed. Stratified analyses tested the association of dietary patterns with anti-dsDNA positive SLE and anti-dsDNA negative SLE. Results: We confirmed 82 NHS incident SLE cases and 98 NHSII SLE cases during 3,833,054 person-years of follow-up. A higher (healthier) prudent dietary pattern score was not associated with SLE risk (meta-analyzed HRQ4 versus Q1 0.84 [95% CI 0.51, 1.38]). Women with higher (less healthy) Western dietary pattern scores did not have a significantly increased risk for SLE (meta-analyzed HRQ4 versus Q1 1.35 [95% CI 0.77, 2.35]). Results were similar after further adjustment for body mass index. Incident anti-dsDNA positive SLE and anti-dsDNA negative SLE were not associated with either dietary pattern. Conclusion: We did not observe a relationship between prudent or Western dietary pattern score and risk of SLE. [ABSTRACT FROM AUTHOR]

Published
2020
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48. OP0002 Multicriteria decision analysis for developing new classification criteria for systemic lupus erythematosus

Author

Tedeschi, S, primary, Johnson, S, additional, Boumpas, D, additional, Daikh, D, additional, Diamond, B, additional, Dorner, T, additional, Jacobsen, S, additional, Kamen, D, additional, McCune, W, additional, Mosca, M, additional, Ramsey-Goldman, R, additional, Ruiz-Irastorza, G, additional, Schneider, M, additional, Smolen, J, additional, Urowitz, M, additional, Wofsy, D, additional, Aringer, M, additional, Naden, R, additional, and Costenbader, K, additional

Published
2017
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50. AB0512 Use of Nominal Group Technique To Facilitate Item Reduction for Sle Classification Criteria Development: Table 1.

Author

Johnson, S., primary, Khanna, D., additional, Cervera, R., additional, Costedoat-Chalumeau, N., additional, Gladman, D.D., additional, Hahn, B.H., additional, Hiepe, F., additional, Sanchez-Guerrero, J., additional, Massarotti, E., additional, Boumpas, D., additional, Costenbader, K., additional, Daikh, D., additional, Jayne, D., additional, Dorner, T., additional, Kamen, D., additional, Mosca, M., additional, Ramsey-Goldman, R., additional, Smolen, J.S., additional, Wofsy, D., additional, and Aringer, M., additional

Published
2016
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