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2. Correction: S100 proteins as potential predictive biomarkers of abatacept response in polyarticular juvenile idiopathic arthritis

Author

Brunner, Hermine I, Schulert, Grant S, Sproles, Alyssa, Thornton, Sherry, Cornejo, Gabriel Vega, Antón, Jordi, Cuttica, Ruben, Henrickson, Michael, Foeldvari, Ivan, Kingsbury, Daniel J, Askelson, Margarita, Liu, Jinqi, Mukherjee, Sumanta, Wong, Robert L, Lovell, Daniel J, Martini, Alberto, Ruperto, Nicolino, and Grom, Alexei A

Published
2024
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3. S100 proteins as potential predictive biomarkers of abatacept response in polyarticular juvenile idiopathic arthritis

Author

Brunner, Hermine I, Schulert, Grant S, Sproles, Alyssa, Thornton, Sherry, Cornejo, Gabriel Vega, Antón, Jordi, Cuttica, Ruben, Henrickson, Michael, Foeldvari, Ivan, Kingsbury, Daniel J, Askelson, Margarita, Liu, Jinqi, Mukherjee, Sumanta, Wong, Robert L, Lovell, Daniel J, Martini, Alberto, Ruperto, Nicolino, and Grom, Alexei A

Published
2024
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7. Acute kidney injury requiring kidney replacement therapy in childhood lupus nephritis: a cohort study of the Pediatric Nephrology Research Consortium and Childhood Arthritis and Rheumatology Research Alliance

Author

Stotter, Brian R., Cody, Ellen, Gu, Hongjie, Daga, Ankana, Greenbaum, Larry A., Duong, Minh Dien, Mazo, Alexandra, Goilav, Beatrice, Boneparth, Alexis, Kallash, Mahmoud, Zeid, Ahmed, Seeherunvong, Wacharee, Scobell, Rebecca R., Alhamoud, Issa, Carter, Caitlin E., Shah, Siddharth, Straatmann, Caroline E., Dixon, Bradley P., Cooper, Jennifer C., Nelson, Raoul D., Levy, Deborah M., Brunner, Hermine I., Verghese, Priya S., and Wenderfer, Scott E.

Published
2023
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8. Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial

Author

Viola, Diego, Spindler, Alberto, Akikusa, Jonathan, Chaitow, Jeffrey, Huemer, Christian, Dehoorne, Joke, Wouters, Carine, Lauwerys, Bernard, Boulanger, Cecile, Saad Magalhães, Claudia, Terreri, Maria, Li, Caifeng, Tang, Xuemei, Feng, Qihua, Yu, Haiguo, Zhou, Zhixuan, Dolezalova, Pavla, Horvath, Rudolf, Herlin, Troels, Glerup, Mia, Quartier Dit Maire, Pierre, Kone Paut, Isabelle, Gervais, Elisabeth, Belot, Alexandre, Name, Investigator, Horneff, Gerd, Minden, Kirsten, Trauzeddel, Ralf, Foeldvari, Ivan, Lutz, Thomas, Helling-Bakki, Astrid, Grulich-Henn, Jürgen, Kümmerle-Deschner, Jasmin, Sawhney, Sujata, Kumar, Sathish, Janarthanan, Mahesh, Amarilyo, Gil, Butbul, Yonatan, Uziel, Yosef, Tirosh, Irit, Harel, Liora, Caorsi, Roberta, Pastore, Serena, Tommasini, Alberto, Alessio, Maria, Breda, Luciana, Cattalini, Marco, Cimaz, Rolando, Giani, Teresa, Simonini, Gabriele, Filocamo, Giovanni, Umebayashi, Hiroaki, Kaneko, Utako, Kawano, Yutaka, Sato, Satoshi, Mori, Masaaki, Shimizu, Masaki, Yamaguchi, Kenichi, Ito, Shuichi, Imagawa, Tomoyuki, Inoue, Natsumi, Yokoyama, Tadafumi, Shabana, Kosuke, Ozeki, Yuka, Kawano, Yoshifumi, Yamasaki, Yuichi, Miyamae, Takako, Vega Cornejo, Gabriel, Rubio Perez, Nadina, Vargas, Edgar, Pacheco-Tena, Cesar, Edmundo Enriquez Sosa, Favio, Smolewska, Elzbieta, Zuber, Zbigniew, Gietka, Piotr, Alexeeva, Ekaterina, Nikishina, Irina, Valieva, Sania, Antón López, Jordi, Murias Loza, Sara, Maria Alcobendas Rueda, Rosa, Calvo Penades, Inmaculada, Grana, Genaro, Lucica Boteanu, Alina, Kasapcopur, Ozgur, Unsal, Erbil, Vaidyanathan Ramanan, Athimalaipet, Lacassagne, Sandrine, Hawley, Daniel, Mahmood, Kamran, Almeida, Beverley, Ramanan, Athimalaipet V, Quartier, Pierre, Okamoto, Nami, Fingerhutová, Šárka, Antón, Jordi, Wang, Zhongkai, Meszaros, Gabriella, Araújo, Joana, Liao, Ran, Keller, Stuart, Brunner, Hermine I, and Ruperto, Nicolino

Published
2023
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9. Preclinical characterization of the Toll-like receptor 7/8 antagonist MHV370 for lupus therapy

Author

Hawtin, Stuart, André, Cédric, Collignon-Zipfel, Géraldine, Appenzeller, Simone, Bannert, Bettina, Baumgartner, Lea, Beck, Damian, Betschart, Claudia, Boulay, Thomas, Brunner, Hermine I., Ceci, Melanie, Deane, Jonathan, Feifel, Roland, Ferrero, Enrico, Kyburz, Diego, Lafossas, Frederique, Loetscher, Pius, Merz-Stoeckle, Christina, Michellys, Pierre, Nuesslein-Hildesheim, Barbara, Raulf, Friedrich, Rush, James S., Ruzzante, Giulia, Stein, Thomas, Zaharevitz, Samantha, Wieczorek, Grazyna, Siegel, Richard, Gergely, Peter, Shisha, Tamas, and Junt, Tobias

Published
2023
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10. Long‐Term Maintenance of Clinical Responses by Individual Patients With Polyarticular‐Course Juvenile Idiopathic Arthritis Treated With Abatacept

Author

Brunner, Hermine I., Tzaribachev, Nikolay, Louw, Ingrid, Calvo Penades, Inmaculada, Avila‐Zapata, Francisco, Horneff, Gerd, Foeldvari, Ivan, Kingsbury, Daniel J., Paz Gastanaga, Maria Eliana, Wouters, Carine, Breedt, Johannes, Wong, Robert, Askelson, Margarita, Zhuo, Joe, Martini, Alberto, Lovell, Daniel J., and Ruperto, Nicolino

Published
2023
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11. Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study

Author

Brunner, Hermine I, primary, Akikusa, Jonathan D, additional, Al-Abadi, Eslam, additional, Bohnsack, John F, additional, Boteanu, Alina Lucica, additional, Chedeville, Gaelle, additional, Cuttica, Ruben, additional, De La Pena, Wendy, additional, Jung, Lawrence, additional, Kasapcopur, Ozgur, additional, Kobusinska, Katarzyna, additional, Schulert, Grant S, additional, Neiva, Claudia, additional, Rivas-Chacon, Rafael, additional, Rizo Rodriguez, Juan Cruz, additional, Vazquez-Del Mercado, Monica, additional, Wagner-Weiner, Linda, additional, Weiss, Jennifer E, additional, Wouters, Carine, additional, Posner, Holly, additional, Wouters, Ann, additional, Chang, Cheng, additional, White, Claire, additional, Kanik, Keith, additional, Liu, Shixue, additional, Martini, Alberto, additional, Lovell, Daniel J, additional, and Ruperto, Nicolino, additional

Published
2024
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12. Pilot study comparing the childhood arthritis and rheumatology research alliance consensus treatment plans for induction therapy of juvenile proliferative lupus nephritis

Author

Cooper, Jennifer C, Rouster-Stevens, Kelly, Wright, Tracey B, Hsu, Joyce J, Klein-Gitelman, Marisa S, Ardoin, Stacy P, Schanberg, Laura E, Brunner, Hermine I, Eberhard, B Anne, Wagner-Weiner, Linda, Mehta, Jay, Haines, Kathleen, McCurdy, Deborah K, Phillips, Thomas A, Huang, Zhen, and von Scheven, Emily

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Autoimmune Disease, Pediatric, Kidney Disease, Comparative Effectiveness Research, Arthritis, Clinical Research, Health Services, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Inflammatory and immune system, Adolescent, Child, Cohort Studies, Consensus, Cyclophosphamide, Feasibility Studies, Female, Glucocorticoids, Guideline Adherence, Humans, Immunosuppressive Agents, Kidney, Lupus Nephritis, Male, Mycophenolic Acid, Pilot Projects, Prospective Studies, Registries, Remission Induction, Rheumatology, Treatment Outcome, Juvenile systemic lupus erythematosus, Lupus nephritis, Mycophenolate, Corticosteroids, CARRA registry investigators, Paediatrics and Reproductive Medicine, Arthritis & Rheumatology, Clinical sciences, Paediatrics
Abstract

BackgroundTo reduce treatment variability and facilitate comparative effectiveness studies, the Childhood Arthritis and Rheumatology Research Alliance (CARRA) published consensus treatment plans (CTPs) including one for juvenile proliferative lupus nephritis (LN). Induction immunosuppression CTPs outline treatment with either monthly intravenous (IV) cyclophosphamide (CYC) or mycophenolate mofetil (MMF) in conjunction with one of three corticosteroid (steroid) CTPs: primarily oral, primarily IV or mixed oral/IV. The acceptability and in-practice use of these CTPs are unknown. Therefore, the primary aims of the pilot study were to demonstrate feasibility of adhering to the LN CTPs and delineate barriers to implementation in clinical care in the US. Further, we aimed to explore the safety and effectiveness of the treatments for induction therapy.MethodsForty-one patients were enrolled from 10 CARRA sites. Patients had new-onset biopsy proven ISN/RPS class III or IV proliferative LN, were starting induction therapy with MMF or IV CYC and high-dose steroids and were followed for up to 24 months. Routine clinical data were collected at each visit. Provider reasons for CTP selection were assessed at baseline. Adherence to the CTPs was evaluated by provider survey and medication logs. Complete and partial renal responses were reported at 6 months.ResultsThe majority of patients were female (83%) with a mean age of 14.7 years, SD 2.8. CYC was used more commonly than MMF for patients with ISN/RPS class IV LN (vs. class III), those who had hematuria, and those with adherence concerns. Overall adherence to the immunosuppression induction CTPs was acceptable with a majority of patients receiving the target MMF (86%) or CYC (63%) dose. However, adherence to the steroid CTPs was poor (37%) with large variability in dosing. Renal response endpoints were exploratory and did not show a significant difference between CYC and MMF.ConclusionsOverall, the immunosuppression CTPs were followed as intended in the majority of patients however, adherence to the steroid CTPs was poor indicating revision is necessary. In addition, our pilot study revealed several sources of treatment selection bias that will need to be addressed in for future comparative effectiveness research.

Published
2018

15. Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label Phase III Study.

Author

Brunner, Hermine I., Pacheco-Tena, César, Louw, Ingrid, Vega-Cornejo, Gabriel, Alexeeva, Ekaterina, Appenzeller, Simone, Chasnyk, Vyacheslav, Griffin, Thomas, Navarrete Suarez, Carmen, Knupp-Oliveira, Sheila, Zeft, Andrew, Aviel, Yonatan Butbul, De Ranieri, Deirdre, Gottlieb, Beth S., Levy, Deborah M., Rabinovich, C. Egla, Silva, Clóvis Artur, Spivakovsky, Yury, Uziel, Yosef, and Ringold, Sarah

Published
2024
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16. Long-term efficacy and safety of subcutaneous tocilizumab in clinical trials of polyarticular or systemic juvenile idiopathic arthritis.

Author

Brunner, Hermine I, Ruperto, Nicolino, Ramanan, Athimalaipet V, Horneff, Gerd, Minden, Kirsten, Penades, Inmaculada Calvo, Alexeeva, Ekaterina, Cleary, Gavin, Stern, Sara M, Kone-Paut, Isabelle, Velázquez, María del Rocío Maldonado, Rabinovich, C Egla, Remesal, Agustin, Silva, Clovis Artur, Nikishina, Irina, Zucchetto, Mauro, Brockwell, Laura, Gordon, Oliver, Nagel, Sandra, and Benedetti, Fabrizio De

Subjects
*THERAPEUTIC use of monoclonal antibodies, *JUVENILE idiopathic arthritis, *PATIENT safety, *RESEARCH funding, *CLINICAL trials, *DESCRIPTIVE statistics, *MONOCLONAL antibodies, *DRUG efficacy, *TOCILIZUMAB, *SUBCUTANEOUS injections, *INTERLEUKINS, *EVALUATION, *CHILDREN
Abstract

Objective To investigate the safety and efficacy of subcutaneous tocilizumab (SC-TCZ) treatment in a long-term extension (LTE) of clinical trials in polyarticular or systemic juvenile idiopathic arthritis (pJIA or sJIA). Methods Patients with pJIA or sJIA from two open-label, 52-week phase 1b core trials of SC-TCZ who had adequate response per investigator assessment entered the LTE and continued SC-TCZ treatment according to body weight–based dosing regimens until commercial availability or up to 5 years. Pharmacokinetics, pharmacodynamics, and efficacy were assessed for up to 3 years, and safety for up to 5 years in the LTE. Results Forty-four patients with pJIA and 38 patients with sJIA entered the LTE. Tocilizumab trough concentrations were maintained within the range expected to provide clinical benefit (mean values: pJIA, ∼10 μg/ml; sJIA, ∼75 μg/ml over 3 years). Pharmacodynamic parameters (interleukin-6, soluble interleukin-6 receptor, erythrocyte sedimentation rate, C-reactive protein) were maintained throughout the LTE at levels achieved in the core trials. Inactive disease per American College of Rheumatology provisional criteria was reported for 90% (17/19) and 53% (8/15) of patients with pJIA and 91% (10/11) and 92% (12/13) of patients with sJIA in the <30 and ≥30 kg body weight groups, respectively. Serious adverse events in the LTE were reported in six patients with pJIA (13.6%; five serious infections) and five patients with sJIA (13.2%; one serious infection). Conclusion Patients with pJIA or sJIA experienced long-term disease control with SC-TCZ treatment. Long-term safety was consistent with the known tocilizumab safety profile. Clinical trial registration clinicaltrials.gov, NCT02165345 [ABSTRACT FROM AUTHOR]

Published
2024
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18. 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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19. Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial

Author

Cuttica, R, Akikusa, J, Chaitow, J, Wouters, C, Oliveira, S, Neiva, CLS, Santiago, M, Silva, CA, Terreri, MT, Magalhaes, C, De Souza, V, Bandeira, M, Chédeville, G, Houghton, K, Vazquez-Del Mercado, M, Rizo Rodriguez, J, Kobusinska, K, Alexeeva, E, Calvo Penades, I, Boteanu, AL, Kasapcopur, O, Poyrazoglu, MH, Erguven, M, Ozen, S, Al-Abadi, E, Bohnsack, J, Carrasco, R, Dare, J, Gottlieb, B, Wahezi, D, Jung, L, Klein-Gitelman, M, Zhang, Y, Wagner-Weiner, L, Tarvin, S, Vehe, RK, Chiraseveenuprapund, P, Rivas-Chacon, R, De La Pena, W, Sagcal-Gironella, ACP, Weiss, JE, Ruperto, Nicolino, Brunner, Hermine I, Synoverska, Olga, Ting, Tracy V, Mendoza, Carlos Abud, Spindler, Alberto, Vyzhga, Yulia, Marzan, Katherine, Grebenkina, Lyudmila, Tirosh, Irit, Imundo, Lisa, Jerath, Rita, Kingsbury, Daniel J, Sozeri, Betul, Vora, Sheetal S, Prahalad, Sampath, Zholobova, Elena, Butbul Aviel, Yonatan, Chasnyk, Vyacheslav, Lerman, Melissa, Nanda, Kabita, Schmeling, Heinrike, Tory, Heather, Uziel, Yosef, Viola, Diego O, Posner, Holly B, Kanik, Keith S, Wouters, Ann, Chang, Cheng, Zhang, Richard, Lazariciu, Irina, Hsu, Ming-Ann, Suehiro, Ricardo M, Martini, Alberto, and Lovell, Daniel J

Published
2021
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21. Transancestral mapping and genetic load in systemic lupus erythematosus.

Author

Langefeld, Carl D, Ainsworth, Hannah C, Cunninghame Graham, Deborah S, Kelly, Jennifer A, Comeau, Mary E, Marion, Miranda C, Howard, Timothy D, Ramos, Paula S, Croker, Jennifer A, Morris, David L, Sandling, Johanna K, Almlöf, Jonas Carlsson, Acevedo-Vásquez, Eduardo M, Alarcón, Graciela S, Babini, Alejandra M, Baca, Vicente, Bengtsson, Anders A, Berbotto, Guillermo A, Bijl, Marc, Brown, Elizabeth E, Brunner, Hermine I, Cardiel, Mario H, Catoggio, Luis, Cervera, Ricard, Cucho-Venegas, Jorge M, Dahlqvist, Solbritt Rantapää, D'Alfonso, Sandra, Da Silva, Berta Martins, de la Rúa Figueroa, Iñigo, Doria, Andrea, Edberg, Jeffrey C, Endreffy, Emőke, Esquivel-Valerio, Jorge A, Fortin, Paul R, Freedman, Barry I, Frostegård, Johan, García, Mercedes A, de la Torre, Ignacio García, Gilkeson, Gary S, Gladman, Dafna D, Gunnarsson, Iva, Guthridge, Joel M, Huggins, Jennifer L, James, Judith A, Kallenberg, Cees GM, Kamen, Diane L, Karp, David R, Kaufman, Kenneth M, Kottyan, Leah C, Kovács, László, Laustrup, Helle, Lauwerys, Bernard R, Li, Quan-Zhen, Maradiaga-Ceceña, Marco A, Martín, Javier, McCune, Joseph M, McWilliams, David R, Merrill, Joan T, Miranda, Pedro, Moctezuma, José F, Nath, Swapan K, Niewold, Timothy B, Orozco, Lorena, Ortego-Centeno, Norberto, Petri, Michelle, Pineau, Christian A, Pons-Estel, Bernardo A, Pope, Janet, Raj, Prithvi, Ramsey-Goldman, Rosalind, Reveille, John D, Russell, Laurie P, Sabio, José M, Aguilar-Salinas, Carlos A, Scherbarth, Hugo R, Scorza, Raffaella, Seldin, Michael F, Sjöwall, Christopher, Svenungsson, Elisabet, Thompson, Susan D, Toloza, Sergio MA, Truedsson, Lennart, Tusié-Luna, Teresa, Vasconcelos, Carlos, Vilá, Luis M, Wallace, Daniel J, Weisman, Michael H, Wither, Joan E, Bhangale, Tushar, Oksenberg, Jorge R, Rioux, John D, Gregersen, Peter K, Syvänen, Ann-Christine, Rönnblom, Lars, Criswell, Lindsey A, Jacob, Chaim O, Sivils, Kathy L, Tsao, Betty P, Schanberg, Laura E, and Behrens, Timothy W

Subjects
Humans, Lupus Erythematosus, Systemic, HLA Antigens, Logistic Models, Case-Control Studies, Mutagenesis, Insertional, Age of Onset, Sequence Deletion, Genetic Load, Multifactorial Inheritance, Polymorphism, Single Nucleotide, African Continental Ancestry Group, American Native Continental Ancestry Group, European Continental Ancestry Group, Hispanic Americans, Lupus Erythematosus, Systemic, Mutagenesis, Insertional, Polymorphism, Single Nucleotide
Abstract

Systemic lupus erythematosus (SLE) is an autoimmune disease with marked gender and ethnic disparities. We report a large transancestral association study of SLE using Immunochip genotype data from 27,574 individuals of European (EA), African (AA) and Hispanic Amerindian (HA) ancestry. We identify 58 distinct non-HLA regions in EA, 9 in AA and 16 in HA (∼50% of these regions have multiple independent associations); these include 24 novel SLE regions (P

Published
2017

23. Revisiting Childhood-Onset Systemic Lupus Erythematosus.

Author

Avar-Aydın, Pınar Özge and Brunner, Hermine I.

Subjects
*NEPHRITIS, *HEART diseases, *IMMUNOSUPPRESSIVE agents, *DISEASE management, *AUTOANTIBODIES, *CUTANEOUS manifestations of general diseases, *MUCOUS membranes, *MUSCULOSKELETAL system diseases, *SYSTEMIC lupus erythematosus, *TREATMENT effectiveness, *AGE factors in disease, *DISEASES, *PATIENT-centered care, *CLINICAL pathology, *QUALITY of life, *NEUROPSYCHOLOGY, *LUNG diseases, *INDIVIDUALIZED medicine, *BLOOD diseases, *KIDNEY diseases, *HEALTH care teams, *GASTROINTESTINAL diseases, *DISEASE complications, *SYMPTOMS, *CHILDREN
Abstract

Childhood-onset systemic lupus erythematosus (cSLE) is a chronic autoimmune disease with a multisystemic involvement diagnosed during childhood. The disease is marked by the production of autoantibodies targeting self-antigens, often before symptoms emerge. The presentation, clinical course, and outcome vary significantly among patients with cSLE. The onset of cSLE can be at any age during childhood while a diagnosis of cSLE before the age of 5 years is rare and raises a suspicion of monogenic lupus. Childhood-onset systemic lupus erythematosus affects various organs and systems, most frequently presenting with mucocutaneous, musculoskeletal, renal, and neuropsychiatric manifestations. Multiple disease flares can be seen during the disease course. Childhood-onset systemic lupus erythematosus causes significant morbidity and mortality. Children and adolescents with cSLE show higher disease activity and damage, and more aggressive immunosuppressive treatments are needed compared to adultonset SLE. Early diagnosis can be difficult due to the insidious onset with nonspecific symptoms. Disease activity and damage measures aim to ensure an accurate evaluation of disease status. A multidisciplinary approach and individualized disease management are important. Disease management is complex including the control of disease activity, the reduction of flares and damage, and a limitation of drug toxicity while improving the health-related quality of life in patients with cSLE. [ABSTRACT FROM AUTHOR]

Published
2024
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25. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry

Author

Lovell, Daniel J, primary, Tzaribachev, Nikolay, additional, Henrickson, Michael, additional, Simonini, Gabriele, additional, Griffin, Thomas A, additional, Alexeeva, Ekaterina, additional, Bohnsack, John F, additional, Zeft, Andrew, additional, Horneff, Gerd, additional, Vehe, Richard K, additional, Staņēviča, Valda, additional, Tarvin, Stacey, additional, Trachana, Maria, additional, del Río, Ana Quintero, additional, Huber, Adam M, additional, Kietz, Daniel, additional, Orbán, Ilonka, additional, Dare, Jason, additional, Foeldvari, Ivan, additional, Quartier, Pierre, additional, Dominique, Alyssa, additional, Simon, Teresa A, additional, Martini, Alberto, additional, Brunner, Hermine I, additional, and Ruperto, Nicolino, additional

Published
2024
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26. Secondary analysis of APPLE study suggests atorvastatin may reduce atherosclerosis progression in pubertal lupus patients with higher C reactive protein

Author

Ardoin, Stacy P, Schanberg, Laura Eve, Sandborg, Christy I, Barnhart, Huiman X, Evans, Greg W, Yow, Eric, Mieszkalski, Kelly L, Ilowite, Norman T, Eberhard, Anne, Imundo, Lisa F, Kimura, Yuki, Levy, Deborah, von Scheven, Emily, Silverman, Earl, Bowyer, Suzanne L, Punaro, L, Singer, Nora G, Sherry, David D, McCurdy, Deborah K, Klein-Gitelman, Marissa, Wallace, Carol, Silver, Richard M, Wagner-Weiner, Linda, Higgins, Gloria C, Brunner, Hermine I, Jung, Lawrence, Soep, Jennifer B, Reed, Ann M, Thompson, Susan D, and investigators, for the APPLE

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Autoimmune Disease, Clinical Research, Atherosclerosis, Clinical Trials and Supportive Activities, Lupus, Cardiovascular, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adolescent, Age Factors, Atorvastatin, Biomarkers, C-Reactive Protein, Carotid Arteries, Carotid Intima-Media Thickness, Cholesterol, LDL, Disease Progression, Double-Blind Method, Female, Heptanoic Acids, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Lupus Erythematosus, Systemic, Male, Prospective Studies, Puberty, Pyrroles, Treatment Outcome, Systemic Lupus Erythematosus, Autoimmune Diseases, APPLE investigators, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

ObjectiveParticipants in the Atherosclerosis Prevention in Paediatric Lupus Erythematosus (APPLE) trial were randomised to placebo or atorvastatin for 36 months. The primary endpoint, reduced carotid intima medial thickness (CIMT) progression, was not met but atorvastatin-treated participants showed a trend of slower CIMT progression. Post-hoc analyses were performed to assess subgroup benefit from atorvastatin therapy.MethodsSubgroups were prespecified and defined by age (> or ≤15.5 years), systemic lupus erythematosus (SLE) duration (> or ≤24 months), pubertal status (Tanner score≥4 as post-pubertal or

Published
2014

30. Cancer risk in childhood-onset systemic lupus

Author

Bernatsky, Sasha, Clarke, Ann E, Labrecque, Jeremy, von Scheven, Emily, Schanberg, Laura E, Silverman, Earl D, Brunner, Hermine I, Haines, Kathleen A, Cron, Randy Q, O’Neil, Kathleen M, Oen, Kiem, Rosenberg, Alan M, Duffy, Ciarán M, Joseph, Lawrence, Lee, Jennifer L, Kale, Mruganka, Turnbull, Elizabeth M, and Ramsey-Goldman, Rosalind

Abstract

Abstract Introduction The aim of this study was to assess cancer incidence in childhood-onset systemic lupus erythematosus (SLE). Methods We ascertained cancers within SLE registries at 10 pediatric centers. Subjects were linked to cancer registries for the observational interval, spanning 1974 to 2009. The ratio of observed to expected cancers represents the standardized incidence ratio (SIR) or relative cancer risk in childhood-onset SLE, versus the general population. Results There were 1020 patients aged

Published
2013

32. Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial

Author

Ramanan, Athimalaipet V, primary, Quartier, Pierre, additional, Okamoto, Nami, additional, Foeldvari, Ivan, additional, Spindler, Alberto, additional, Fingerhutová, Šárka, additional, Antón, Jordi, additional, Wang, Zhongkai, additional, Meszaros, Gabriella, additional, Araújo, Joana, additional, Liao, Ran, additional, Keller, Stuart, additional, Brunner, Hermine I, additional, Ruperto, Nicolino, additional, Viola, Diego, additional, Akikusa, Jonathan, additional, Chaitow, Jeffrey, additional, Huemer, Christian, additional, Dehoorne, Joke, additional, Wouters, Carine, additional, Lauwerys, Bernard, additional, Boulanger, Cecile, additional, Saad Magalhães, Claudia, additional, Terreri, Maria, additional, Li, Caifeng, additional, Tang, Xuemei, additional, Feng, Qihua, additional, Yu, Haiguo, additional, Zhou, Zhixuan, additional, Dolezalova, Pavla, additional, Horvath, Rudolf, additional, Herlin, Troels, additional, Glerup, Mia, additional, Quartier Dit Maire, Pierre, additional, Kone Paut, Isabelle, additional, Gervais, Elisabeth, additional, Belot, Alexandre, additional, Name, Investigator, additional, Horneff, Gerd, additional, Minden, Kirsten, additional, Trauzeddel, Ralf, additional, Lutz, Thomas, additional, Helling-Bakki, Astrid, additional, Grulich-Henn, Jürgen, additional, Kümmerle-Deschner, Jasmin, additional, Sawhney, Sujata, additional, Kumar, Sathish, additional, Janarthanan, Mahesh, additional, Amarilyo, Gil, additional, Butbul, Yonatan, additional, Uziel, Yosef, additional, Tirosh, Irit, additional, Harel, Liora, additional, Caorsi, Roberta, additional, Pastore, Serena, additional, Tommasini, Alberto, additional, Alessio, Maria, additional, Breda, Luciana, additional, Cattalini, Marco, additional, Cimaz, Rolando, additional, Giani, Teresa, additional, Simonini, Gabriele, additional, Filocamo, Giovanni, additional, Umebayashi, Hiroaki, additional, Kaneko, Utako, additional, Kawano, Yutaka, additional, Sato, Satoshi, additional, Mori, Masaaki, additional, Shimizu, Masaki, additional, Yamaguchi, Kenichi, additional, Ito, Shuichi, additional, Imagawa, Tomoyuki, additional, Inoue, Natsumi, additional, Yokoyama, Tadafumi, additional, Shabana, Kosuke, additional, Ozeki, Yuka, additional, Kawano, Yoshifumi, additional, Yamasaki, Yuichi, additional, Miyamae, Takako, additional, Vega Cornejo, Gabriel, additional, Rubio Perez, Nadina, additional, Vargas, Edgar, additional, Pacheco-Tena, Cesar, additional, Edmundo Enriquez Sosa, Favio, additional, Smolewska, Elzbieta, additional, Zuber, Zbigniew, additional, Gietka, Piotr, additional, Alexeeva, Ekaterina, additional, Nikishina, Irina, additional, Valieva, Sania, additional, Antón López, Jordi, additional, Murias Loza, Sara, additional, Maria Alcobendas Rueda, Rosa, additional, Calvo Penades, Inmaculada, additional, Grana, Genaro, additional, Lucica Boteanu, Alina, additional, Kasapcopur, Ozgur, additional, Unsal, Erbil, additional, Vaidyanathan Ramanan, Athimalaipet, additional, Lacassagne, Sandrine, additional, Hawley, Daniel, additional, Mahmood, Kamran, additional, and Almeida, Beverley, additional

Published
2023
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33. Abatacept as Monotherapy and in Combination With Methotrexate in Patients With Juvenile Idiopathic Arthritis: Analysis of 2 Phase III Trials

Author

Ruperto, Nicolino, primary, Lovell, Daniel J., additional, Berman, Alberto, additional, Anton, Jordi, additional, Viola, Diego O., additional, Lauwerys, Bernard, additional, Rama, Maria E., additional, Bohnsack, John, additional, Breedt, Johannes, additional, Fischbach, Michel, additional, Lutz, Thomas, additional, Minden, Kirsten, additional, Ally, Mahmood, additional, Rubio-Pérez, Nadina, additional, Gervais, Elisabeth, additional, Van Zyl, Riana, additional, Wong, Robert, additional, Askelson, Margarita, additional, Martini, Alberto, additional, and Brunner, Hermine I., additional

Published
2023
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35. Race, Income, and Disease Outcomes in Juvenile Dermatomyositis

Author

Abramson, Leslie S., Anderson, Eleanor S., Becker, Mara L., Benham, Heather, Beukelman, Timothy, Blier, Peter R., Brunner, Hermine I., Dean, Joni, Dedeoglu, Fatma, Feldman, Brian M., Ferguson, Polly I., Goldsmith, Donald P., Gottlieb, Beth S., Graham, Thomas B., Griffin, Thomas A., Haftel, Hilary M., Higgins, Gloria C., Hollister, J.R., Hsu, Joyce J., Huttenlocher, Anna, Ilowite, Norman T., Imundo, Lisa F., Jerath, Rita S., Jung, Lawrence K., Kahn, Philip J., Kingsbury, Daniel J., Klein, Kristin E., Klein-Gitelman, Marisa S., Lapidus, Sivia K., Lehman, Thomas J.A., Lindsley, Carol B., Malloy, Michael A., McCurdy, Deborah K., Muscal, Eyal, Olson, Judyann C., O'Neil, Kathleen M., Onel, Karen, Prahalad, Sampath, Punaro, Marilynn G., Rabinovich, C. Egla, Reed, Ann M., Ringold, Sarah, Riordan, Mary Ellen, Robinson, Angela B., Rothman, Deborah, Ruth, Natasha M., Schikler, Kenneth N., Singer, Nora G., Spalding, Steven, Syed, Reema H., Torok, Kathryn S., Tress, Jenna, Vehe, Richard K., Von Scheven, Emily, Walters, Lydia M., Weiss, Jennifer E., Weiss, Pamela, White, Andrew J., Woo, Jennifer M., Yalcindag, Ali, Zemel, Lawrence S., Phillippi, Kathryn, Hoeltzel, Mark, Byun Robinson, Angela, and Kim, Susan

Published
2017
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41. Therapeutics Development in Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA): Extrapolation, Dose Selection and Clinical Trial Design; Workshop Proceedings and Recent Updates

Author

Schanberg, Laura E., primary, Mulugeta, Lily (Yeruk), additional, Akinlade, Bolanle, additional, Brunner, Hermine I., additional, Chen, Jianmeng, additional, Colbert, Robert A., additional, Delgaizo, Vincent, additional, Gastonguay, Marc R., additional, Glaser, Rachel, additional, Imundo, Lisa, additional, Lovell, Daniel J., additional, Leu, Jocelyn H., additional, Mostafa, Nael M., additional, Nelson, Robert M., additional, Nigrovic, Peter A., additional, Nikolov, Nikolay P., additional, Rider, Lisa G., additional, Rothwell, Rebecca, additional, Sahajwalla, Chandrahas, additional, Singh, Renu, additional, Sinha, Vikram, additional, Yancey, Carolyn L., additional, and Yao, Lynne, additional

Published
2023
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45. Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.

Author

Schanberg, Laura E., Mulugeta, Lily, Akinlade, Bolanle, Brunner, Hermine I., Chen, Jianmeng, Colbert, Robert A., Delgaizo, Vincent, Gastonguay, Marc R., Glaser, Rachel, Imundo, Lisa, Lovell, Daniel J., Leu, Jocelyn H., Mostafa, Nael M., Nelson, Robert M., Nigrovic, Peter A., Nikolov, Nikolay P., Rider, Lisa G., Rothwell, Rebecca, Sahajwalla, Chandrahas, and Singh, Renu

Subjects
RHEUMATISM treatment, THERAPEUTICS, HEALTH services accessibility, STAKEHOLDER analysis, ADULT education workshops
Abstract

Objective: Stakeholders met to address persistent challenges facing the development of therapeutics for polyarticular juvenile idiopathic arthritis (pJIA), which result in fewer approved therapies for children with pJIA than adults with rheumatoid arthritis (RA) and long lag times from adult RA approval to pediatric labeling. Ensuring that new medications are authorized in a timely manner to meet the needs of JIA patients worldwide is critically important to multiple stakeholders. Methods: The Food and Drug Administration in collaboration with the University of Maryland Center for Regulatory Science and Innovation held a public workshop entitled "Accelerating Drug Development for pJIA" on October 2, 2019, to address challenges surrounding access to new medications for children and adolescents with pJIA. Regulatory, academic, and industry stakeholders, as well as patient representatives, participated in the workshop, which consisted of 4 sessions, including panel discussions. Results: The workshop facilitated broad public discussion of challenges facing the development of pJIA therapeutics, highlighting areas of need and outlining opportunities to expedite development, while underscoring the necessity of close collaboration between all stakeholders, including patients and families. Conclusion: This report summarizes key aspects of the workshop, including the appropriate application of innovative approaches to the development of pJIA therapeutics, including extrapolation, to address current challenges and provide timely access to newer safe and effective treatments. Long‐term safety assessment is of pressing concern to stakeholders and cannot be fully extrapolated from adult studies but requires consistent postmarketing long‐term follow‐up. [ABSTRACT FROM AUTHOR]

Published
2023
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46. Evaluating the Construct of Damage in Systemic Lupus Erythematosus

Author

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

Published
2022
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47. Alternative Biologic Therapy in Children Failing Conventional TNFα Inhibitors for Refractory, Noninfectious, Chronic Anterior Uveitis

Author

Miraldi Utz, Virginia, primary, Angeles-Han, Sheila T., additional, Mwase, Najima, additional, Cassedy, Amy, additional, Hennard, Theresa, additional, Lovell, Daniel J., additional, Lopper, Sarah, additional, Brunner, Hermine I., additional, Dosunmu, Eniolami O., additional, Grom, Alexei A., additional, Henrickson, Michael, additional, Huggins, Jennifer L., additional, Sisk, Robert A., additional, Ting, Tracy V., additional, and Kaufman, Adam H., additional

Published
2022
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49. 605 The Systemic Lupus Erythematosus International Collaborating Clinics (SLICC), American College of Rheumatology (ACR), and Lupus Foundation of America (LFA) Damage Index Revision – Item Generation Phase

Author

Kundakci, Burak, primary, Clarke, Ann E, additional, Johnson, Sindhu R, additional, Brunner, Hermine I, additional, Cho, Jiacai, additional, Costedoat-Chalumeau, Nathalie, additional, Ginzler, Ellen M, additional, Hanly, John G, additional, Hasan, Abida, additional, Inanç, Murat, additional, Kabani, Naureen, additional, Lima, Kaitlin, additional, Lindoso, Livia, additional, Mak, Anselm, additional, Goldman, Rosalind Ramsey-, additional, Ruiz-Irastorza, Guillermo, additional, Silva, Clovis A, additional, Tamirou, Farah, additional, Trindade, Vitor C, additional, Vinet, Évelyne, additional, Bruce, Ian N, additional, and Barber, Megan RW, additional

Published
2022
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