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3. Association of systemic lupus erythematosus standard of care immunosuppressants with glucocorticoid use and disease outcomes: a multicentre cohort study

Author

de Luca Montes, Ricardo Azêdo, Huq, Molla, Godfrey, Timothy, Oon, Shereen, Calderone, Alicia, Kandane-Rathnayake, Rangi, Louthrenoo, Worawit, Luo, Shue-Fen, Jan Wu, Yeong-Jian, Golder, Vera, Lateef, Aisha, Navarra, Sandra V., Zamora, Leonid, Hamijoyo, Laniyati, Sockalingam, Sargunan, An, Yuan, Li, Zhanguo, Katsumata, Yasuhiro, Harigai, Masayoshi, Chan, Madelynn, Goldblatt, Fiona, O’Neill, Sean, Lau, Chak Sing, Cho, Jiacai, Hoi, Alberta, Karyekar, Chetan S., Morand, Eric F., and Nikpour, Mandana

Published
2024
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4. Smith-specific regulatory T cells halt the progression of lupus nephritis

Author

Eggenhuizen, Peter J., Cheong, Rachel M. Y., Lo, Cecilia, Chang, Janet, Ng, Boaz H., Ting, Yi Tian, Monk, Julie A., Loh, Khai L., Broury, Ashraf, Tay, Elean S. V., Shen, Chanjuan, Zhong, Yong, Lim, Steven, Chung, Jia Xi, Kandane-Rathnayake, Rangi, Koelmeyer, Rachel, Hoi, Alberta, Chaudhry, Ashutosh, Manzanillo, Paolo, Snelgrove, Sarah L., Morand, Eric F., and Ooi, Joshua D.

Published
2024
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5. A Randomized, Placebo‐Controlled Phase III Extension Trial of the Long‐Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus

Author

Kalunian, Kenneth C, Furie, Richard, Morand, Eric F, Bruce, Ian N, Manzi, Susan, Tanaka, Yoshiya, Winthrop, Kevin, Hupka, Ihor, Zhang, Lijin, Werther, Shanti, Abreu, Gabriel, Hultquist, Micki, Tummala, Raj, Lindholm, Catharina, and Al‐Mossawi, Hussein

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Lupus, Autoimmune Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Inflammatory and immune system, Humans, Treatment Outcome, COVID-19, Antibodies, Monoclonal, Humanized, Lupus Erythematosus, Systemic, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

ObjectiveTo explore long-term safety and tolerability of anifrolumab 300 mg compared with placebo in patients with systemic lupus erythematosus (SLE) who completed a Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP) trial and enrolled in the placebo-controlled 3-year long-term extension (LTE) study (ClinicalTrials.gov identifier: NCT02794285).MethodsIn the blinded LTE study, patients continued anifrolumab 300 mg, switched from anifrolumab 150 mg to 300 mg, or were re-randomized from placebo to receive either anifrolumab 300 mg or to continue placebo, administered every 4 weeks. Primary comparisons in the LTE study were between patients who received anifrolumab 300 mg or placebo throughout the TULIP and LTE studies. For rare safety events, comparisons included patients who received any anifrolumab dose during TULIP or LTE. When exposure differed, exposure-adjusted incidence rates (EAIRs) per 100 patient-years were calculated.ResultsIn the LTE study, EAIRs of serious adverse events (SAEs) were 8.5 with anifrolumab compared with 11.2 with placebo; likewise, EAIRs of AEs leading to treatment discontinuation were 2.5 versus 3.2, respectively. EAIRs of non-opportunistic serious infections were comparable between groups (3.7 with anifrolumab versus 3.6 with placebo). Exposure-adjusted event rates of COVID-related AEs, including asymptomatic infections, were 15.5 with anifrolumab compared with 9.8 with placebo. No COVID-related AEs occurred in fully vaccinated individuals. EAIRs of malignancy and major acute cardiovascular events were low and comparable between groups. Anifrolumab was associated with lower cumulative glucocorticoid use and greater mean improvement in the SLE Disease Activity Index 2000, compared with placebo.ConclusionThis LTE study represents the longest placebo-controlled clinical trial performed in SLE to date. No new safety findings were identified in the LTE study, supporting the favorable benefit-risk profile of anifrolumab for patients with moderate-to-severe SLE receiving standard therapy.

Published
2023

7. Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials

Author

Bruce, Ian N, Furie, Richard A, Morand, Eric F, Manzi, Susan, Tanaka, Yoshiya, Kalunian, Kenneth C, Merrill, Joan T, Puzio, Patricia, Maho, Emmanuelle, Kleoudis, Christi, Albulescu, Marius, Hultquist, Micki, and Tummala, Raj

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Lupus, Clinical Research, Autoimmune Disease, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Inflammatory and immune system, Alprostadil, Antibodies, Monoclonal, Humanized, Glucocorticoids, Humans, Lupus Erythematosus, Systemic, Severity of Illness Index, Treatment Outcome, Autoimmune Diseases, Biological Therapy, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

ObjectivesIn the anifrolumab systemic lupus erythematosus (SLE) trial programme, there was one trial (TULIP-1) in which BILAG-based Composite Lupus Assessment (BICLA) responses favoured anifrolumab over placebo, but the SLE Responder Index (SRI(4)) treatment difference was not significant. We investigated the degree of concordance between BICLA and SRI(4) across anifrolumab trials in order to better understand drivers of discrepant SLE trial results.MethodsTULIP-1, TULIP-2 (both phase 3) and MUSE (phase 2b) were randomised, 52-week trials of intravenous anifrolumab (300 mg every 4 weeks, 48 weeks; TULIP-1/TULIP-2: n=180; MUSE: n=99) or placebo (TULIP-1: n=184, TULIP-2: n=182; MUSE: n=102). Week 52 BICLA and SRI(4) outcomes were assessed for each patient.ResultsMost patients (78%-85%) had concordant BICLA and SRI(4) outcomes (Cohen's Kappa 0.6-0.7, nominal p

Published
2022

8. Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials

Author

Vital, Edward M, Merrill, Joan T, Morand, Eric F, Furie, Richard A, Bruce, Ian N, Tanaka, Yoshiya, Manzi, Susan, Kalunian, Kenneth C, Kalyani, Rubana N, Streicher, Katie, Abreu, Gabriel, and Tummala, Raj

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Lupus, Clinical Research, Clinical Trials and Supportive Activities, Autoimmune Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Inflammatory and immune system, Antibodies, Monoclonal, Humanized, Biomarkers, Double-Blind Method, Female, Glucocorticoids, Humans, Interferon Type I, Lupus Erythematosus, Systemic, Male, Treatment Outcome, biological therapy, lupus erythematosus, systemic, therapeutics, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

ObjectivesTo characterise the efficacy and safety of anifrolumab in patients with systemic lupus erythematosus (SLE) according to interferon gene signature (IFNGS), demographic and clinical subgroups.MethodsWe performed post hoc analyses of pooled data from the 52-week phase III TULIP-1/TULIP-2 placebo-controlled trials of intravenous anifrolumab in moderate-to-severe SLE. Outcomes were assessed in predefined subgroups: IFNGS (high/low), age, sex, body mass index, race, geographic region, age of onset, glucocorticoid use, disease activity and serological markers.ResultsIn pooled data, patients received anifrolumab 300 mg (360/726) or placebo (366/726); 82.6% were IFNGS-high. IFNGS-high patients had greater baseline disease activity and were more likely to have abnormal serological markers versus IFNGS-low patients. In the total population, a greater proportion of patients treated with anifrolumab versus placebo achieved British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at week 52 (difference 16.6%; nominal p

Published
2022

9. Association of sustained lupus low disease activity state with improved outcomes in systemic lupus erythematosus: a multinational prospective cohort study

Author

Golder, Vera, Kandane-Rathnayake, Rangi, Li, Ning, Louthrenoo, Worawit, Chen, Yi-Hsing, Cho, Jiacai, Lateef, Aisha, Hamijoyo, Laniyati, Luo, Shue Fen, Wu, Yeong-Jian, Navarra, Sandra V, Zamora, Leonid, Li, Zhanguo, Sockalingam, Sargunan, Katsumata, Yasuhiro, Harigai, Masayoshi, Hao, Yanjie, Zhang, Zhuoli, Basnayake, Duminda, Chan, Madelynn, Kikuchi, Jun, Takeuchi, Tsutomu, Bae, Sang-Cheol, Goldblatt, Fiona, Oon, Shereen, O'Neill, Sean, Ng, Kristine, Law, Annie, Tugnet, Nicola, Kumar, Sunil, Tee, Cherica, Tee, Michael, Ohkubo, Naoaki, Tanaka, Yoshiya, Lau, Chak Sing, Hoi, Alberta, Nikpour, Mandana, and Morand, Eric F

Published
2024
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10. Towards a novel clinical outcome assessment for systemic lupus erythematosus: first outcomes of an international taskforce

Author

Connelly, Kathryn, Eades, Laura E., Koelmeyer, Rachel, Ayton, Darshini, Golder, Vera, Kandane-Rathnayake, Rangi, Gregory, Kate, Brunner, Hermine, Burke, Laurie, Arnaud, Laurent, Askanase, Anca, Aranow, Cynthia, Vital, Ed, Pons-Estel, Guillermo, Dantata, Khadija, Andersen, Jeanette, Cornet, Alain, Buie, Joy, Sun, Ying, Tanaka, Yoshiya, Simon, Lee, Lahoud, Youmna, Friedman, Alan, Kalunian, Kenneth, Zuraw, Qing, Werth, Victoria, Garces, Sandra, and Morand, Eric F.

Published
2023
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12. Impact of low disease activity, remission, and complete remission on flares following tapering of corticosteroids and immunosuppressive therapy in patients with systemic lupus erythematous: a multinational cohort study

Author

Cho, Jiacai, Shen, Liang, Huq, Molla, Kandane-Rathnayake, Rangi, Golder, Vera, Louthrenoo, Worawit, Chen, Yi-Hsing, Hamijoyo, Laniyati, Luo, Shue-Fen, Wu, Yeong-Jian J, Zamora, Leonid, Li, Zhanguo, Sockalingam, Sargunan, Katsumata, Yasuhiro, Harigai, Masayoshi, Hao, Yanjie, Zhang, Zhuoli, Basnayake, Duminda, Chan, Madelynn, Kikuchi, Jun, Takeuchi, Tsutomu, Bae, Sang-Cheol, Oon, Shereen, O'Neill, Sean, Goldblatt, Fiona, Ng, Kristine Pek Ling, Law, Annie, Tugnet, Nicola, Kumar, Sunil, Tee, Cherica, Tee, Michael, Ohkubo, Naoaki, Tanaka, Yoshiya, Navarra, Sandra V, Lau, Chak Sing, Hoi, Alberta, Morand, Eric F, Nikpour, Mandana, and Lateef, Aisha

Published
2023
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13. Plain Language Summary of the PAISLEY study: deucravacitinib as a treatment for people with systemic lupus erythematosus

Author

Morand, Eric F., primary, Pike, Marilyn, additional, Merrill, J, additional, F van Vollenhoven, Ronald, additional, Werth, Victoria P, additional, Hobar, Coburn, additional, Delev, Nikolay, additional, Shah, Vaishali, additional, Sharkey, Brian, additional, Wegman, Thomas, additional, Catlett, Ian, additional, Banerjee, Subhashis, additional, and Singhal, Shalabh, additional

Published
2024
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14. Type I interferon blockade with anifrolumab in patients with systemic lupus erythematosus modulates key immunopathological pathways in a gene expression and proteomic analysis of two phase 3 trials

Author

Baker, Tina, primary, Sharifian, Hoda, additional, Newcombe, Paul J, additional, Gavin, Patrick G, additional, Lazarus, Mark N, additional, Ramaswamy, Madhu, additional, White, Wendy I, additional, Ferrari, Nicola, additional, Muthas, Daniel, additional, Tummala, Raj, additional, Morand, Eric F, additional, Furie, Richard, additional, Vital, Edward M, additional, Chamberlain, Chris, additional, Platt, Adam, additional, Al-Mossawi, Hussein, additional, Brohawn, Philip Z, additional, and Csomor, Eszter, additional

Published
2024
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15. Lupus low disease activity state and remission and risk of mortality in patients with systemic lupus erythematosus: a prospective, multinational, longitudinal cohort study

Author

Kandane-Rathnayake, Rangi, Golder, Vera, Louthrenoo, Worawit, Chen, Yi-Hsing, Cho, Jiacai, Lateef, Aisha, Hamijoyo, Laniyati, Luo, Shue-Fen, Wu, Yeong-Jian J, Navarra, Sandra V, Zamora, Leonid, Li, Zhanguo, Sockalingam, Sargunan, Katsumata, Yasuhiro, Harigai, Masayoshi, Hao, Yanjie, Zhang, Zhuoli, Basnayake, B M D B, Chan, Madelynn, Kikuchi, Jun, Takeuchi, Tsutomu, Bae, Sang-Cheol, Oon, Shereen, O'Neill, Sean, Goldblatt, Fiona, Ng, Kristine Pek Ling, Law, Annie, Tugnet, Nicola, Kumar, Sunil, Tee, Cherica, Tee, Michael, Ohkubo, Naoaki, Tanaka, Yoshiya, Yu, DaeYoung, Karyekar, Chetan S, Sing Lau, Chak, Monk, Julie A, Nikpour, Mandana, Hoi, Alberta, and Morand, Eric F

Published
2022
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16. Associations of improvement in laboratory tests with clinical outcomes in patients with active systemic lupus erythematosus: a multinational longitudinal cohort study

Author

Connelly, Kathryn, Kandane-Rathnayake, Rangi, Hoi, Alberta, Louthrenoo, Worawit, Hamijoyo, Laniyati, Cho, Jiacai, Lateef, Aisha, Fen Luo, Shue, Wu, Yeong-Jian J, Li, Zhanguo, Navarra, Sandra, Zamora, Leonid, Sockalingam, Sargunan, Hao, Yanjie, Zhang, Zhuoli, Katsumata, Yasuhiro, Harigai, Masayoshi, Oon, Shereen, Chan, Madelynn, Chen, Yi-Hsing, Bae, Sang-Cheol, O'Neill, Sean, Goldblatt, Fiona, Kikuchi, Jun, Takeuchi, Tsutomu, Ling Ng, Kristine Pek, Tugnet, Nicola, Basnayake, B M D B, Ohkubo, Naoaki, Tanaka, Yoshiya, Sing Lau, Chak, Nikpour, Mandana, Golder, Vera, and Morand, Eric F

Published
2022
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17. Evaluating the Construct of Damage in Systemic Lupus Erythematosus

Author

Johnson, Sindhu R., Gladman, Dafna D., Brunner, Hermine I., Isenberg, David, Clarke, Ann E., Barber, Megan R. W., Arnaud, Laurent, Fortin, Paul R., Mosca, Marta, Voskuyl, Alexandre E., Manzi, Susan, Aranow, Cynthia, Askanase, Anca, Alarcón, Graciela S., Bae, Sang‐Cheol, Costedoat‐Chalumeau, Nathalie, English, Jessica A., Pons‐Estel, Guillermo J., Pons‐Estel, Bernardo A., Gilman, Rebecca, Ginzler, Ellen M., Hanly, John G., Jacobsen, Soren, Kalunian, Kenneth, Kamen, Diane L., Lambalgen, Chynace, Legge, Alexandra, Lim, S. Sam, Mak, Anselm, Morand, Eric F., Peschken, Christine A., Petri, Michelle, Rahman, Anisur, Ramsey‐Goldman, Rosalind, Reynolds, John A., Romero‐Diaz, Juanita, Ruiz‐Irastorza, Guillermo, Sanchez‐Guerrero, Jorge, Svenungsson, Elisabet, Touma, Zahi, Urowitz, Murray, Vinet, Evelyne, van Vollenhoven, Ronald F., Waldhauser, Heather, Wallace, Daniel J., Zoma, Asad, and Bruce, Ian N.

Published
2023
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18. Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study

Author

Appenzeller, Simone, Aranow, Cynthia, Askanase, Anca, Avcin, Tadej, Bae, Sang-Cheol, Bertsias, George, Bonfa, Eloisa, Cairoli, Ernesto, Cardiel, Mario H, Cervera, Ricard, Chasset, François, Chizzolini, Carlo, Clarke, Ann E, Conti, Fabrizio, Costedoat-Chalumeau, Nathalie, Czirják, László, Doria, Andrea, Dörner, Thomas, Espinosa, Gerard, Fischer-Betz, Rebecca, Garcìa, Mercedes, Gladman, Dafna D, González, Luis A, Gunnarsson, Iva, Hamijoyo, Laniyati, Hanly, John G, Hasni, Sarfaraz A, Houssiau, Frédéric A, Inanç, Murat, Inês, Luís S, Isenberg, David, Jacobsen, Soren, Jan Wu, Yeong-Jian, Kaneko, Yuko, Katsumata, Yasuhiro, Lau, Chak S, Legge, Alexandra C, Lerang, Karoline, Limper, Maarten, Louthrenoo, Worawit, Luo, Shue-Fen, Marinho, António, Massardo, Loreto, Mathian, Alexis, Mosca, Marta, Nikpour, Mandana, Pego-Reigosa, José M, Peschken, Christine A, Pons-Estel, Bernardo A, Pons-Estel, Guillermo J, Rahman, Anisur, Rednic, Simona, Ribi, Camillo, Ruiz-Irastorza, Guillermo, Sato, Emilia I, Saxena, Amit, Schneider, Matthias, Sebastiani, Gian Domenico, Strand, Vibeke, Svenungsson, Elisabet, Tanaka, Yoshiya, Tazi Mezalek, Zoubida, Tee, Michael L, Tincani, Angela, Touma, Zahi, Troldborg, Anne, Vasconcelos, Carlos, Vinet, Évelyne, Vital, Edward M, Voskuyl, Alexandre E, Voss, Anne, Wallace, Daniel, Ward, Michael, Zamora, Leonid D, Piga, Matteo, Chessa, Elisabetta, Morand, Eric F, Ugarte-Gil, Manuel F, Tektonidou, Maria, van Vollenhoven, Ronald, Petri, Michelle, and Arnaud, Laurent

Published
2022
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22. ‘Not at target’: prevalence and consequences of inadequate disease control in systemic lupus erythematosus—a multinational observational cohort study

Author

Kandane-Rathnayake, Rangi, Louthrenoo, Worawit, Hoi, Alberta, Luo, Shue-Fen, Wu, Yeong-Jian J., Chen, Yi-Hsing, Cho, Jiacai, Lateef, Aisha, Hamijoyo, Laniyati, Navarra, Sandra V., Zamora, Leonid, Sockalingam, Sargunan, An, Yuan, Li, Zhanguo, Katsumata, Yasuhiro, Harigai, Masayoshi, Hao, Yanjie, Zhang, Zhuoli, Kikuchi, Jun, Takeuchi, Tsutomu, Basnayake, B. M. D. B., Chan, Madelynn, Ng, Kristine Pek Ling, Tugnet, Nicola, Kumar, Sunil, Oon, Shereen, Goldblatt, Fiona, O’Neill, Sean, Gibson, Kathryn A., Ohkubo, Naoaki, Tanaka, Yoshiya, Bae, Sang-Cheol, Lau, Chak Sing, Nikpour, Mandana, Golder, Vera, and Morand, Eric F.

Published
2022
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24. Genetic contributions to lupus nephritis in a multi-ethnic cohort of systemic lupus erythematous patients

Author

Lanata, Cristina M, Nititham, Joanne, Taylor, Kimberly E, Chung, Sharon A, Torgerson, Dara G, Seldin, Michael F, Pons-Estel, Bernardo A, Tusié-Luna, Teresa, Tsao, Betty P, Morand, Eric F, Alarcón-Riquelme, Marta E, and Criswell, Lindsey A

Subjects
Biological Sciences, Biomedical and Clinical Sciences, Genetics, Epidemiology, Health Sciences, Lupus, Clinical Research, Human Genome, Autoimmune Disease, Kidney Disease, Aetiology, 2.1 Biological and endogenous factors, Inflammatory and immune system, Adult, Cohort Studies, Female, Humans, Lupus Nephritis, Male, Middle Aged, Models, Genetic, Polymorphism, Single Nucleotide, Risk Factors, General Science & Technology
Abstract

ObjectiveAfrican Americans, East Asians, and Hispanics with systemic lupus erythematous (SLE) are more likely to develop lupus nephritis (LN) than are SLE patients of European descent. The etiology of this difference is not clear, and this study was undertaken to investigate how genetic variants might explain this effect.MethodsIn this cross-sectional study, 1244 SLE patients from multiethnic case collections were genotyped for 817,810 single-nucleotide polymorphisms (SNPs) across the genome. Continental genetic ancestry was estimated utilizing the program ADMIXTURE. Gene-based testing and pathway analysis was performed within each ethnic group and meta-analyzed across ethnicities. We also performed candidate SNP association tests with SNPs previously established as risk alleles for SLE, LN, and chronic kidney disease (CKD). Association testing and logistic regression models were performed with LN as the outcome, adjusted for continental ancestries, sex, disease duration, and age.ResultsWe studied 255 North European, 263 South European, 238 Hispanic, 224 African American and 264 East Asian SLE patients, of whom 606 had LN (48.7%). In genome-wide gene-based and candidate SNP analyses, we found distinct genes, pathways and established risk SNPs associated with LN for each ethnic group. Gene-based analyses showed significant associations between variation in ZNF546 (p = 1.0E-06), TRIM15 (p = 1.0E-06), and TRIMI0 (p = 1.0E-06) and LN among South Europeans, and TTC34 (p = 8.0E-06) was significantly associated with LN among Hispanics. The SNP rs8091180 in NFATC1 was associated with LN (OR 1.43, p = 3.3E-04) in the candidate SNP meta-analysis with the highest OR among African-Americans (OR 2.17, p = 0.0035).ConclusionDistinct genetic factors are associated with the risk of LN in SLE patients of different ethnicities. CKD risk alleles may play a role in the development of LN in addition to SLE-associated risk variants. These findings may further explain the clinical heterogeneity of LN risk and response to therapy observed between different ethnic groups.

Published
2018

25. Comparison Of Attainment And Protective Effects Of Lupus Low Disease Activity State In Patients With Newly Diagnosed Versus Established SLE.

Author

Golder, Vera, primary, Kandane-Rathnayake, Rangi, additional, Louthrenoo, Worawit, additional, Chen, Yi-Hsing, additional, Cho, Jiacai, additional, Lateef, Aisha, additional, Hamijoyo, Laniyati, additional, Luo, Shue-Fen, additional, Wu, Yeong-Jian J., additional, Navarra, Sandra V., additional, Zamora, Leonid, additional, Li, Zhanguo, additional, Sockalingam, Sargunan, additional, Katsumata, Yasuhiro, additional, Harigai, Masayoshi, additional, Hao, Yanjie, additional, Zhang, Zhuoli, additional, Basnayake, BMDB, additional, Chan, Madelynn, additional, Kikuchi, Jun, additional, Takeuchi, Tsutomu, additional, Bae, Sang-Cheol, additional, Oon, Shereen, additional, O'Neill, Sean, additional, Goldblatt, Fiona, additional, Ng, Kristine (Pek Ling), additional, Law, Annie, additional, Tugnet, Nicola, additional, Kumar, Sunil, additional, Tee, Cherica, additional, Tee, Michael, additional, Ohkubo, Naoaki, additional, Tanaka, Yoshiya, additional, Lau, Chak Sing, additional, Nikpour, Mandana, additional, Hoi, Alberta, additional, and Morand, Eric F., additional

Published
2024
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28. Risk of flare and damage accrual after tapering glucocorticoids in modified serologically active clinically quiescent patients with systemic lupus erythematosus: a multinational observational cohort study

Author

Katsumata, Yasuhiro, primary, Inoue, Eisuke, additional, Harigai, Masayoshi, additional, Cho, Jiacai, additional, Louthrenoo, Worawit, additional, Hoi, Alberta, additional, Golder, Vera, additional, Lau, Chak Sing, additional, Lateef, Aisha, additional, Chen, Yi-Hsing, additional, Luo, Shue-Fen, additional, Wu, Yeong-Jian Jan, additional, Hamijoyo, Laniyati, additional, Li, Zhanguo, additional, Sockalingam, Sargunan, additional, Navarra, Sandra, additional, Zamora, Leonid, additional, Hao, Yanjie, additional, Zhang, Zhuoli, additional, Chan, Madelynn, additional, Oon, Shereen, additional, Ng, Kristine, additional, Kikuchi, Jun, additional, Takeuchi, Tsutomu, additional, Goldblatt, Fiona, additional, O’Neill, Sean, additional, Tugnet, Nicola, additional, Law, Annie Hui Nee, additional, Bae, Sang-Cheol, additional, Tanaka, Yoshiya, additional, Ohkubo, Naoaki, additional, Kumar, Sunil, additional, Kandane-Rathnayake, Rangi, additional, Nikpour, Mandana, additional, and Morand, Eric F, additional

Published
2024
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33. Burden of systemic lupus erythematosus in clinical practice: baseline data from the SLE Prospective Observational Cohort Study (SPOCS) by interferon gene signature

Author

Arnaud, Laurent, primary, Furie, Richard, additional, Morand, Eric F, additional, Aringer, Martin, additional, Peschken, Christine, additional, Desta, Barnabas, additional, Rapsomaniki, Eleni, additional, Hedberg, Jonatan, additional, Knagenhjelm, Jacob, additional, Seo, Caroline, additional, Grünfeld Eén, Tina, additional, Sorrentino, Alessandro, additional, Tummala, Raj, additional, Stirnadel-Farrant, Heide A, additional, and Ding, Bo, additional

Published
2023
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35. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update

Author

Fanouriakis, Antonis, primary, Kostopoulou, Myrto, additional, Andersen, Jeanette, additional, Aringer, Martin, additional, Arnaud, Laurent, additional, Bae, Sang-Cheol, additional, Boletis, John, additional, Bruce, Ian N, additional, Cervera, Ricard, additional, Doria, Andrea, additional, Dörner, Thomas, additional, Furie, Richard A, additional, Gladman, Dafna D, additional, Houssiau, Frederic A, additional, Inês, Luís Sousa, additional, Jayne, David, additional, Kouloumas, Marios, additional, Kovács, László, additional, Mok, Chi Chiu, additional, Morand, Eric F, additional, Moroni, Gabriella, additional, Mosca, Marta, additional, Mucke, Johanna, additional, Mukhtyar, Chetan B, additional, Nagy, György, additional, Navarra, Sandra, additional, Parodis, Ioannis, additional, Pego-Reigosa, José M, additional, Petri, Michelle, additional, Pons-Estel, Bernardo A, additional, Schneider, Matthias, additional, Smolen, Josef S, additional, Svenungsson, Elisabet, additional, Tanaka, Yoshiya, additional, Tektonidou, Maria G, additional, Teng, YK Onno, additional, Tincani, Angela, additional, Vital, Edward M, additional, van Vollenhoven, Ronald F, additional, Wincup, Chris, additional, Bertsias, George, additional, and Boumpas, Dimitrios T, additional

Published
2023
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37. Evaluation of remission definitions for systemic lupus erythematosus: a prospective cohort study

Author

Golder, Vera, Kandane-Rathnayake, Rangi, Huq, Molla, Louthrenoo, Worawit, Luo, Shue Fen, Wu, Yeong-Jian Jan, Lateef, Aisha, Sockalingam, Sargunan, Navarra, Sandra V, Zamora, Leonid, Hamijoyo, Laniyati, Katsumata, Yasuhiro, Harigai, Masayoshi, Chan, Madelynn, O’Neill, Sean, Goldblatt, Fiona, Lau, Chak Sing, Li, Zhan Guo, Hoi, Alberta, Nikpour, Mandana, and Morand, Eric F

Published
2019
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38. Lupus low disease activity state as a treatment endpoint for systemic lupus erythematosus: a prospective validation study

Author

Golder, Vera, Kandane-Rathnayake, Rangi, Huq, Molla, Nim, Hieu T, Louthrenoo, Worawit, Luo, Shue Fen, Wu, Yeong-Jian Jan, Lateef, Aisha, Sockalingam, Sargunan, Navarra, Sandra V, Zamora, Leonid, Hamijoyo, Laniyati, Katsumata, Yasuhiro, Harigai, Masayoshi, Chan, Madelynn, O'Neill, Sean, Goldblatt, Fiona, Lau, Chak Sing, Li, Zhan Guo, Hoi, Alberta, Nikpour, Mandana, and Morand, Eric F

Published
2019
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39. Contributors

Author

Ahearn, Joseph M., primary, Alarcón-Riquelme, Marta E., additional, Almaani, Salem J., additional, Anolik, Jennifer H., additional, Aranow, Cynthia, additional, Bacalao, Maria A., additional, Barilla-LaBarca, Maria-Louise, additional, Barnas, Jennifer L., additional, Barturen, Guillermo, additional, Bermas, Bonnie L., additional, Bernatsky, Sasha, additional, Bruce, I.N., additional, Bucala, Richard, additional, Buyon, Jill P., additional, Carnero-Montoro, Elena, additional, Clarke, Ann E., additional, Clowse, Megan E.B., additional, Concha, Josef Symon S., additional, Dellaripa, Paul, additional, Diamond, Betty, additional, Doyle, Tracy J., additional, Fernando, Michelle M.A., additional, Fisk, John D., additional, Furie, Richard, additional, Gordon, Caroline, additional, Greiling, Teri M., additional, Han, Shuhong, additional, Hanly, John G., additional, Hile, Grace A., additional, Horowitz, Diane, additional, Isenberg, David, additional, Izmirly, Peter, additional, Jacobs, Barbara, additional, James, Judith A., additional, Kahlenberg, J. Michelle, additional, Kalunian, Kenneth C., additional, Kang, Insoo, additional, Kaplan, Mariana J., additional, Khamashta, Munther A., additional, Kim, Mimi, additional, Knight, Jason S., additional, Koumpouras, Fotios, additional, Kriegel, Martin A., additional, La Cava, Antonio, additional, Ladouceur, Alexandra, additional, Lahita, Robert G., additional, Lee, Iris Jung-Won, additional, Lessard, Christopher J., additional, Lewandowski, Laura B., additional, Liang, Yun, additional, Liu, Chau-Ching, additional, Mackay, Meggan, additional, Madaio, Michael P., additional, Marder, Galina, additional, Matteson, Eric L., additional, McCoy, Sara, additional, McMahon, Maureen, additional, Meffre, Eric, additional, Mejia-Vilet, Juan, additional, Merrill, Joan, additional, Morand, Eric F., additional, Moreira Pinto, Sara, additional, Nakabo, Shuichiro, additional, Northcott, Melissa, additional, Omisade, Antonina, additional, Ortel, Thomas L., additional, Perl, Andras, additional, Ramsey-Goldman, Rosalind, additional, Reeves, Westley H., additional, Reyes-Thomas, Joyce, additional, Reynolds, J.A., additional, Richardson, Bruce, additional, Rodriguez, Juan Vicente, additional, Rovin, Brad H., additional, Rudinskaya, Alla, additional, Ruiz-Irastorza, Guillermo, additional, Saxena, Amit, additional, Schanberg, Laura E., additional, Sharma, Tarun S., additional, Skaggs, Brian, additional, Somers, Emily C., additional, Stohl, William, additional, Talabi, Mehret Birru, additional, Tessneer, Kandice L., additional, Tsao, Betty P., additional, Ugarte, Amaia, additional, Volpe, Bruce T., additional, Vyse, Timothy J., additional, Wainwright, Benjamin J., additional, Ward, Michael M., additional, Wasko, Mary Chester M., additional, Werth, Victoria P., additional, Wise, Leanna, additional, Zhuang, Haoyang, additional, and Zuo, Yu, additional

Published
2021
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43. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update.

Author

Fanouriakis, Antonis, Kostopoulou, Myrto, Andersen, Jeanette, Aringer, Martin, Arnaud, Laurent, Bae, Sang- Cheol, Boletis, John, Bruce, Ian N., Cervera, Ricard, Dörner, Andrea Doria Thomas, Furie, Richard A., Gladman, Dafna D., Houssiau, Frederic A., Inês, Luís Sousa, Jayne, David, Kouloumas, Marios, Kovács, László, Mok, Chi Chiu, Morand, Eric F., and Moroni, Gabriella

Published
2024
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44. Identifying lupus Patient Subsets Through Immune Cell Deconvolution of Gene Expression Data in Two Atacicept Phase II Studies

Author

Studham, Matthew, primary, Vazquez‐Mateo, Cristina, additional, Samy, Eileen, additional, Haselmayer, Philipp, additional, Aydemir, Aida, additional, Rolfe, P. Alexander, additional, Merrill, Joan T., additional, Morand, Eric F., additional, DeMartino, Julie, additional, Kao, Amy, additional, and Townsend, Robert, additional

Published
2023
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46. LP-183 Enpatoran: preclinical evidence supporting glucocorticoid dose reduction and phase II study design in patients with SLE and/or CLE (WILLOW)

Author

Morand, Eric F, primary, Werth, Victoria P, additional, Bender, Andrew, additional, Deshpande, Aditee, additional, Deshmukh, Ankita, additional, Vaidyanathan, Bharat, additional, Vazquez-mateo, Cristina, additional, Przetak, Melinda, additional, Moreau, Flavie, additional, Khursheed, Mukhy, additional, Roy, Sanjeev, additional, and Pearson, David R, additional

Published
2023
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47. LP-184 Rationale and design of two phase 3, Randomized, double-blind, placebo-controlled studies of the efficacy and safety of litifilimab in adults with active systemic lupus erythematosus: TOPAZ-1 and TOPAZ-2

Author

vollenhoven, Ronald FVan, primary, Furie, Richard A, additional, Morand, Eric F, additional, Kalunian, Kenneth, additional, Dall’era, Maria, additional, Goode-sellers, Stacey, additional, Joshi, Puja, additional, Kong, George, additional, Wang, Ting, additional, Wei, Xing, additional, Lahoud, Youmna, additional, and Barbey, Catherine, additional

Published
2023
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48. Baricitinib for systemic lupus erythematosus

Author

Morand, Eric F., Vital, Edward M., Petri, Michelle, van Vollenhoven, Ronald, Wallace, Daniel J., Mosca, Marta, Furie, Richard A., Silk, Maria E., Dickson, Christina L., Meszaros, Gabriella, Jia, Bochao, Crowe, Brenda, de la Torre, Inmaculada, Dörner, Thomas, Rheumatology, AII - Inflammatory diseases, Clinical Immunology and Rheumatology, and AMS - Musculoskeletal Health

Subjects
General Medicine
Abstract

Background: Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. The objective of this trial was to evaluate the efficacy and safety of baricitinib in patients with active SLE in a 52-week phase 3 study. Methods: In a multicentre, double-blind, randomised, placebo-controlled, parallel-group, phase 3 study, SLE-BRAVE-I, patients (aged ≥18 years) with active SLE receiving stable background therapy were randomly assigned 1:1:1 to baricitinib 4 mg, 2 mg, or placebo once daily for 52 weeks with standard of care. Glucocorticoid tapering was encouraged but not required per protocol. The primary endpoint was the proportion of patients reaching an SLE Responder Index (SRI)-4 response at week 52 in the baricitinib 4 mg treatment group compared with placebo. The primary endpoint was assessed by logistic regression analysis with baseline disease activity, baseline corticosteroid dose, region, and treatment group in the model. Efficacy analyses were done on a modified intention-to-treat population, comprising all participants who were randomly assigned and received at least one dose of investigational product. Safety analyses were done on all randomly assigned participants who received at least one dose of investigational product and who did not discontinue from the study for the reason of lost to follow-up at the first post-baseline visit. This study is registered with ClinicalTrials.gov, NCT03616912. Findings: 760 participants were randomly assigned and received at least one dose of baricitinib 4 mg (n=252), baricitinib 2 mg (n=255), or placebo (n=253). A significantly greater proportion of participants who received baricitinib 4 mg (142 [57%]; odds ratio 1·57 [95% CI 1·09 to 2·27]; difference with placebo 10·8 [2·0 to 19·6]; p=0·016), but not baricitinib 2 mg (126 [50%]; 1·14 [0·79 to 1·65]; 3·9 [–4·9 to 12·6]; p=0·47), reached SRI-4 response compared with placebo (116 [46%]). There were no significant differences between the proportions of participants in either baricitinib group reaching any of the major secondary endpoints compared with placebo, including glucocorticoid tapering and time to first severe flare. 26 (10%) participants receiving baricitinib 4 mg had serious adverse events, 24 (9%) participants receiving baricitinib 2 mg, and 18 (7%) participants receiving placebo. The safety profile of baricitinib in participants with SLE was consistent with the known baricitinib safety profile. Interpretation: The primary endpoint in this study was met for the 4 mg baricitinib group. However, key secondary endpoints were not. No new safety signals were observed. Funding: Eli Lilly and Company.

Published
2023

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