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53. Long‐TermMaintenance of Clinical Responses by Individual Patients With Polyarticular‐CourseJuvenile 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

Abstract

To investigate the frequency and trajectories of individual patients with polyarticular‐course juvenile idiopathic arthritis (JIA) achieving novel composite end points on abatacept. Data from a clinical trial of subcutaneous abatacept (NCT01844518) and a post hoc analysis of intravenous abatacept (NCT00095173) in patients with polyarticular‐course JIA were included. Three end points were defined and evaluated: combined occurrence of low disease activity (LDA) measured by the Juvenile Arthritis Disease Activity Score; 50% improvement in American College of Rheumatology criteria for JIA (ACR50); and patient‐reported outcomes. Patient‐reported outcomes included visual analog scale score of minimal pain (pain‐min) and Childhood Health Assessment Questionnaire disability index score of 0 (C‐HAQ DI0). In this post hoc analysis, maintenance of month 13 and 21 end points (LDA+pain‐min, LDA+C‐HAQ DI0, and ACR50+pain‐min) in those who achieved them at month 4 was determined. Composite end points (LDA+pain‐min, LDA+C‐HAQ DI0, and ACR50+pain‐min) were achieved at month 4 (44.7%, 19.6%, and 58.9% of the 219 patients treated with subcutaneous abatacept, respectively). Of those who achieved LDA+pain‐min at month 4, 84.7% (83 of 98) and 65.3% (64 of 98) maintained LDA+pain‐min at months 13 and 21, respectively. The proportions of patients meeting LDA+pain‐min outcomes increased from 44.7% (98 of 219) at month 4 to 54.8% (120 of 219) at month 21. The frequency of patients who met an LDA+C‐HAQ DI score of 0 increased from 19.6% (43 of 219) at month 4 to 28.8% (63 of 219) at month 21. Among individual patients with polyarticular‐course JIA treated with abatacept who achieved 1 of the combined clinical and patient‐reported outcomes composite end points, many maintained them over 21 months of abatacept treatment.

Published
2023
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55. 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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56. Patient‐Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular‐Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two‐Year Results From an International Phase III Study.

Author

Ruperto, Nicolino, Lovell, Daniel J., Berman, Alberto, Ávila‐Zapata, Francisco, Horneff, Gerd, Alessio, Maria, Becker, Mara L., Belot, Alexandre, Burgos‐Vargas, Ruben, Gamir, Maria L., Goldenstein‐Schainberg, Claudia, Scheibel, Iloite M., Terreri, Maria T., Zemel, Lawrence, Zhuo, Joe, Askelson, Margarita, Wong, Robert, Martini, Alberto, and Brunner, Hermine I.

Subjects
JUVENILE idiopathic arthritis, ABATACEPT, JUVENILE diseases, PAIN measurement, TREATMENT effectiveness, INFECTIOUS arthritis, MACROPHAGE activation syndrome
Abstract

Objective: To describe longitudinal changes in patient‐reported outcomes (PROs) in children with polyarticular‐course juvenile idiopathic arthritis (pJIA) treated with subcutaneous abatacept. Methods: Secondary analysis of a single‐arm, open‐label 24‐month study of patients ages 6–17 years and 2–5 years. PROs included Childhood Health Assessment Questionnaire‐Disability Index (CHAQ‐DI), parent global assessment of child well‐being (PaGA), pain assessment, and Activity Limitation Questionnaire (ALQ). Clinical outcomes included 50% or greater improvement in JIA American College of Rheumatology (ACR) criteria, clinically inactive disease, and Juvenile Arthritis Disease Activity Score. Results: For the 6‐ to 17‐year‐old (n = 173) and 2‐ to 5‐year‐old (n = 46) cohorts, respectively, median (Q1, Q3) changes from baseline in CHAQ‐DI at months 4 and 24 were −0.3 (−0.8, 0.0) and −0.5 (−1.0, −0.1), and −0.4 (−0.8, 0.0) and −0.5 (−1.0–−0.1). Median pain scores were below cutoff threshold for clinically relevant pain (<35 mm) by month 1 (6 to 17 years, 32.3 mm; 2 to 5 years, 25.7 mm), reaching a nadir at month 24 (6 to 17 years, 6.0 mm; 2 to 5 years, 2.0 mm). For the 6‐ to 17‐year‐old and 2‐ to 5‐year‐old cohorts, respectively, median PaGA scores were 47.8 (n = 172) and 42.1 (n = 46) at baseline and 6.3 (n = 107) and 2.0 (n = 37) at month 24. In both cohorts, ALQ components improved from baseline to month 4 and were largely maintained to month 24. Clinical outcomes improved through to month 24. Conclusion: Early and sustained PRO improvements were reported in this phase III, open‐label trial of subcutaneous abatacept in patients with pJIA. [ABSTRACT FROM AUTHOR]

Published
2023
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57. 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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58. 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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60. 1106 Stability of novel urinary biomarkers used for lupus

Author

Cody, Ellen, primary, Rose, James, additional, Hopkins, Rebecca, additional, Quinlan-Waters, Megan, additional, Robben, Catherine, additional, Qiu, Tingting, additional, Huang, Bin, additional, Brunner, Hermine, additional, and Devarajan, Prasad, additional

Published
2022
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61. 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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65. 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., primary, Cody, Ellen, additional, Gu, Hongjie, additional, Daga, Ankana, additional, Greenbaum, Larry A., additional, Duong, Minh Dien, additional, Mazo, Alexandra, additional, Goilav, Beatrice, additional, Boneparth, Alexis, additional, Kallash, Mahmoud, additional, Zeid, Ahmed, additional, Seeherunvong, Wacharee, additional, Scobell, Rebecca R., additional, Alhamoud, Issa, additional, Carter, Caitlin E., additional, Shah, Siddharth, additional, Straatmann, Caroline E., additional, Dixon, Bradley P., additional, Cooper, Jennifer C., additional, Nelson, Raoul D., additional, Levy, Deborah M., additional, Brunner, Hermine I., additional, Verghese, Priya S., additional, and Wenderfer, Scott E., additional

Published
2022
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66. Cross-cultural adaptation and initial validation of the Brazilian-Portuguese version of the pediatric automated neuropsychological assessment metrics

Author

de Amorim, Jaqueline Cristina, primary, Kishimoto, Simone Thiemi, additional, Elorza, Cibele Longobardi Cutinhola, additional, Cavaletti, Flávia Alegretti, additional, Marini, Roberto, additional, Silva, Clovis Artur, additional, Saad-Magalhães, Claudia, additional, Fernandes, Paula Teixeira, additional, Brunner, Hermine I., additional, and Appenzeller, Simone, additional

Published
2022
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67. Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial

Author

Brunner, Hermine I, primary, Foeldvari, Ivan, additional, Alexeeva, Ekaterina, additional, Ayaz, Nuray Aktay, additional, Calvo Penades, Inmaculada, additional, Kasapcopur, Ozgur, additional, Chasnyk, Vyacheslav G, additional, Hufnagel, Markus, additional, Żuber, Zbigniew, additional, Schulert, Grant, additional, Ozen, Seza, additional, Rakhimyanova, Adelina, additional, Ramanan, Athimalaipet, additional, Scott, Christiaan, additional, Sozeri, Betul, additional, Zholobova, Elena, additional, Martin, Ruvie, additional, Zhu, Xuan, additional, Whelan, Sarah, additional, Pricop, Luminita, additional, Martini, Alberto, additional, Lovell, Daniel, additional, and Ruperto, Nicolino, additional

Published
2022
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69. Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial

Author

Brunner, Hermine I, Ruperto, Nicolino, Tzaribachev, Nikolay, Horneff, Gerd, Chasnyk, Vyacheslav G, Panaviene, Violeta, Abud-Mendoza, Carlos, Reiff, Andreas, Alexeeva, Ekaterina, Rubio-Pérez, Nadina, Keltsev, Vladimir, Kingsbury, Daniel J, del Rocio Maldonado Velázquez, Maria, Nikishina, Irina, Silverman, Earl D, Joos, Rik, Smolewska, Elzbieta, Bandeira, Márcia, Minden, Kirsten, van Royen-Kerkhof, Annet, Emminger, Wolfgang, Foeldvari, Ivan, Lauwerys, Bernard R, Sztajnbok, Flavio, Gilmer, Keith E, Xu, Zhenhua, Leu, Jocelyn H, Kim, Lilianne, Lamberth, Sarah L, Loza, Matthew J, Lovell, Daniel J, and Martini, Alberto

Published
2018
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72. Patient‐ReportedOutcomes Among Patients Ages Two to Seventeen Years With Polyarticular‐CourseJuvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two‐YearResults From an International Phase IIIStudy

Author

Ruperto, Nicolino, Lovell, Daniel J., Berman, Alberto, Ávila‐Zapata, Francisco, Horneff, Gerd, Alessio, Maria, Becker, Mara L., Belot, Alexandre, Burgos‐Vargas, Ruben, Gamir, Maria L., Goldenstein‐Schainberg, Claudia, Scheibel, Iloite M., Terreri, Maria T., Zemel, Lawrence, Zhuo, Joe, Askelson, Margarita, Wong, Robert, Martini, Alberto, and Brunner, Hermine I.

Abstract

To describe longitudinal changes in patient‐reported outcomes (PROs) in children with polyarticular‐course juvenile idiopathic arthritis (pJIA) treated with subcutaneous abatacept. Secondary analysis of a single‐arm, open‐label 24‐month study of patients ages 6–17 years and 2–5 years. PROs included Childhood Health Assessment Questionnaire‐Disability Index (CHAQ‐DI), parent global assessment of child well‐being (PaGA), pain assessment, and Activity Limitation Questionnaire (ALQ). Clinical outcomes included 50% or greater improvement in JIA American College of Rheumatology (ACR) criteria, clinically inactive disease, and Juvenile Arthritis Disease Activity Score. For the 6‐ to 17‐year‐old (n = 173) and 2‐ to 5‐year‐old (n = 46) cohorts, respectively, median (Q1, Q3) changes from baseline in CHAQ‐DI at months 4 and 24 were −0.3 (−0.8, 0.0) and −0.5 (−1.0, −0.1), and −0.4 (−0.8, 0.0) and −0.5 (−1.0–−0.1). Median pain scores were below cutoff threshold for clinically relevant pain (<35 mm) by month 1 (6 to 17 years, 32.3 mm; 2 to 5 years, 25.7 mm), reaching a nadir at month 24 (6 to 17 years, 6.0 mm; 2 to 5 years, 2.0 mm). For the 6‐ to 17‐year‐old and 2‐ to 5‐year‐old cohorts, respectively, median PaGA scores were 47.8 (n = 172) and 42.1 (n = 46) at baseline and 6.3 (n = 107) and 2.0 (n = 37) at month 24. In both cohorts, ALQ components improved from baseline to month 4 and were largely maintained to month 24. Clinical outcomes improved through to month 24. Early and sustained PRO improvements were reported in this phase III, open‐label trial of subcutaneous abatacept in patients with pJIA.

Published
2023
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75. Clinical measurement of lupus nephritis activity is inferior to biomarker-based activity assessment using the renal activity index for lupus nephritis in childhood-onset systemic lupus erythematosus

Author

Aljaberi, Najla, primary, Wenderfer, Scott E, additional, Mathur, Arjun, additional, Qiu, Tingting, additional, Jose, Steffy, additional, Merritt, Angela, additional, Rose, James, additional, Devarajan, Prasad, additional, Huang, Bin, additional, and Brunner, Hermine, additional

Published
2022
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76. Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis

Author

Ruperto, Nicolino, Brunner, Hermine I, Pacheco-Tena, César, Louw, Ingrid, Vega-Cornejo, Gabriel, Spindler, Alberto J, Kingsbury, Daniel J, Schmeling, Heinrike, Borzutzky, Arturo, Cuttica, Rubén, Inman, C. J., Malievskiy, Victor, Scott, Christiaan, Keltsev, Vladimir, Terreri, Maria Teresa, Viola, Diego Oscar, Xavier, Ricardo M, Fernandes, Taciana A. Pedrosa [UNESP], Velázquez, María Del Rocío Maldonado, Henrickson, Michael, Clark, Michael B, Bensley, Karen A, Li, Xiaoming, Lo, Kim Hung, Leu, Jocelyn H, Hsu, Chyi-Hung, Hsia, Elizabeth C, Xu, Zhenhua, Martini, Alberto, Lovell, Daniel J, Appenzeller, Simone, Oliveira, Sheila, Silva, Clóvis Arthur, Levy, Deborah, Navarrete, Carmen, Aviel, Yonatan Butbul, Uziel, Yosef, Alexeeva, Ekaterina, Chasnyk, Vladimir, Spivakovsky, Yury, Gottlieb, Beth, Rabinovich, Egla, Zeft, Andrew, Griffin, Thomas, De Ranieri, Deirdre, Carrasco, Ruy, IRCCS Ist Giannina Gaslini Clin Pediat & Reumatol, Univ Cincinnati, Univ Autonoma Chihuahua, Panorama Med Ctr, Hosp Mexico Americano, Ctr Med Privado Reumatol, Randall Childrens Hosp Legacy Emanuel, Univ Calgary, Pontificia Univ Catolica Chile, Hosp Pedro de Elizalde, Univ Utah, Bashkir State Med Univ Minist Healthcare Russian, Univ Cape Town, Clin Hosp 5, Universidade Federal de São Paulo (UNIFESP), Inst CAICI, Univ Fed Rio Grande do Sul, Universidade Estadual Paulista (UNESP), Hosp Infantil Mexico Dr Federico Gomez, Cincinnati Childrens Hosp Med Ctr, Janssen Res & Dev LLC, Univ Genoa, PRINTO, University of Cincinnati, Circuito Universitario Campus II, Rheumatology Private Practice, Hospital México Americano, Rheumatology Section, Randall Children's Hospital at Legacy Emanuel, University of Calgary, Pontificia Universidad Católica de Chile, Hospital Pedro de Elizalde, University of Utah, Ministry of Healthcare of Russian Federation, University of Cape Town, Clinical Hospital No. 5, Instituto CAICI, Universidade Federal Do Rio Grande Do sul, Medicina Interna y Reumatologia, Cincinnati Children's Hospital Medical Center, LLC, and Genetica e Scienze Materno-Infantili

Subjects
musculoskeletal diseases, Male, medicine.medical_specialty, Adolescent, Arthritis, Phases of clinical research, Gastroenterology, tumour necrosis factor alpha, Rheumatology, Pharmacokinetics, Internal medicine, medicine, Humans, Pharmacology (medical), Dosing, golimumab, Child, AcademicSubjects/MED00360, Body surface area, business.industry, Area under the curve, Antibodies, Monoclonal, Clinical Science, medicine.disease, Arthritis, Juvenile, Golimumab, Treatment Outcome, Antirheumatic Agents, Child, Preschool, Rheumatoid arthritis, intravenous, juvenile idiopathic arthritis, Administration, Intravenous, Female, business, pharmacokinetics, medicine.drug
Abstract

Made available in DSpace on 2022-04-28T17:22:32Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-10-01 Janssen Research & Development, LLC Objectives. To assess efficacy, pharmacokinetics (PK) and safety of intravenous (i.v.) golimumab in patients with polyarticular-course JIA (pc-JIA). Methods. Children aged 2 to = 2months received 80 mg/m(2) golimumab at weeks 0, 4, then every 8 weeks through week 52 plus MTX weekly through week 28. The primary and major secondary endpoints were PK exposure and model-predicted steady-state area under the curve (AUC(ss)) over an 8-week dosing interval at weeks 28 and 52, respectively. JIA ACR response and safety were also assessed. Results. In total, 127 children were treated with i.v. golimumab. JIA ACR 30, 50, 70, and 90 response rates were 84%, 80%, 70% and 47%, respectively, at week 28 and were maintained through week 52. Golimumab serum concentrations and AUC(ss) were 0.40 mu g/ml and 399 mu g. day/ml at week 28. PK exposure was maintained at week 52. Steady-state trough golimumab concentrations and AUC(ss) were consistent across age categories and comparable to i.v. golimumab dosed 2mg/kg in adults with rheumatoid arthritis. Golimumab antibodies and neutralizing antibodies were detected via a highly sensitive drug-tolerant assay in 31% (39/125) and 19% (24/125) of patients, respectively. Median trough golimumab concentration was lower in antibody-positive vs antibody-negative patients. Serious infections were reported in 6% of patients, including one death due to septic shock. Conclusion. Body surface area-based dosing of i.v. golimumab was well tolerated and provided adequate PK exposure for clinical efficacy in paediatric patients with active pc-JIA. IRCCS Ist Giannina Gaslini Clin Pediat & Reumatol, PRINTO, Genoa, Italy Univ Cincinnati, Cincinnati Childrens Hosp Med Ctr, Div Rheumatol, Cincinnati, OH USA Univ Autonoma Chihuahua, Fac Med, Circuito Univ Campus 2, Chihuahua, Mexico Panorama Med Ctr, Cape Town, South Africa Hosp Mexico Americano, Ctr Reumatol & Autoinmunidad CREA, Guadalajara, Jalisco, Mexico Ctr Med Privado Reumatol, Rheumatol Sect, San Miguel De Tucuman, Tucuman, Argentina Randall Childrens Hosp Legacy Emanuel, Portland, OR USA Univ Calgary, Alberta Childrens Hosp, Cumming Sch Med, Dept Pediat, Calgary, AB, Canada Pontificia Univ Catolica Chile, Sch Med, Dept Pediat Infect Dis & Immunol, Santiago, Chile Hosp Pedro de Elizalde, Rheumatol Sect, Buenos Aires, DF, Argentina Univ Utah, Pediat Rheumatol, Salt Lake City, UT USA Bashkir State Med Univ Minist Healthcare Russian, Fed State Budget Educ Inst Higher Educ, Ufa, Russia Univ Cape Town, Red Cross War Mem Childrens Hosp, Cape Town, South Africa Univ Cape Town, Groote Schuur Hosp, Paediat Rheumatol, Cape Town, South Africa Clin Hosp 5, Pediat Dept, Tolyatti, Russia Univ Fed Sao Paulo, Escola Paulista Med, Pediat, Sao Paulo, Brazil Inst CAICI, Rheumatol, Rosario, Argentina Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, Porto Alegre, RS, Brazil UNESP, Hosp Clin Botucatu Med Univ, Paediat Dept, Botucatu, SP, Brazil Hosp Infantil Mexico Dr Federico Gomez, Med Interna & Reumatol, Mexico City, DF, Mexico Cincinnati Childrens Hosp Med Ctr, Cincinnati, OH 45229 USA Janssen Res & Dev LLC, Spring House, PA USA Janssen Res & Dev LLC, Raritan, NJ USA Univ Genoa, Dipartimento Neurosci Riabilitaz Oftalmol Genet &, Genoa, Italy UNESP, Hosp Clin Botucatu Med Univ, Paediat Dept, Botucatu, SP, Brazil

Published
2021

77. CHILDREN WITH ENTHESITIS-RELATED ARTHRITIS COULD BENEFIT FROM TREATMENTS TARGETED FOR ADULTS WITH SPONDYLOARTHRITIS

Author

Weiss, Pamela F., Fuhlbrigge, Robert C., von Scheven, Emily, Lovell, Daniel J, Colbert, Robert A, and Brunner, Hermine I

Subjects
musculoskeletal diseases, Adult, Antirheumatic Agents, Spondylarthritis, Humans, Spondylarthropathies, Spondylitis, Ankylosing, Child, Article, Arthritis, Juvenile
Abstract

This review will summarize clinical, genetic, and pathophysiologic characteristics that are shared between children with enthesitis-related arthritis (ERA) with axial involvement and adults with nonradiographic (and in some cases radiographic) axial spondyloarthritis (SpA), as well as between children with ERA and primarily peripheral disease manifestations and adults with peripheral SpA. Due to the differences in classification criteria for children with ERA and adults with axial and peripheral SpA, the US Food and Drug Administration (FDA) granted automatic full waivers of studies in children for new medications for "axial spondyloarthropathies including ankylosing spondylitis" up until July 2020. Thus, although current juvenile idiopathic arthritis treatment guidelines recommend the use of biologic disease-modifying antirheumatic drugs as part of the early treatment for patients with ERA, none of the FDA-approved therapies for peripheral SpA or nonradiographic axial SpA (certolizumab pegol, ixekizumab, and secukinumab) have been studied or are labeled for use in children with ERA. Considering the similarities between adult SpA and ERA in terms of etiology, genetics, pathogenesis, and clinical manifestations summarized in this review, medications approved for axial SpA or peripheral SpA should also be studied in children with active ERA involving axial or peripheral joints, respectively, with the intent to achieve labeling for use in children. Considering the current lack of effective FDA-approved therapies for ERA, the FDA should also consider requiring pediatric studies for medications that have already been approved for the treatment of adults with SpA.

Published
2022

78. Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis: results from the PREVENT-JIA trial

Author

Pediatric Immunology, Immuno/reuma patientenzorg, Child Health, Gerss, Joachim, Tedy, Monika, Klein, Ariane, Horneff, Gerd, Miranda-Garcia, Maria, Kessel, Christoph, Holzinger, Dirk, Stanevica, Valda, Swart, Joost F., Cabral, David A., Brunner, Hermine I., Foell, Dirk, Pediatric Immunology, Immuno/reuma patientenzorg, Child Health, Gerss, Joachim, Tedy, Monika, Klein, Ariane, Horneff, Gerd, Miranda-Garcia, Maria, Kessel, Christoph, Holzinger, Dirk, Stanevica, Valda, Swart, Joost F., Cabral, David A., Brunner, Hermine I., and Foell, Dirk

Published
2022

81. American College of Rheumatology Provisional Criteria for Clinically Relevant Improvement in Children and Adolescents With Childhood-Onset Systemic Lupus Erythematosus

Author

Brunner, Hermine I, Holland, Michael J, Beresford, Michael W, Ardoin, Stacy P, Appenzeller, Simone, Silva, Clovis A, Flores, Francisco, Goilav, Beatrice, Aydin, Pinar Ozge Avar, Wenderfer, Scott E, Levy, Deborah M, Ravelli, Angelo, Khubchandani, Raju, Avcin, Tadej, Klein-Gitelman, Marisa S, Ruperto, Nicolino, Feldman, Brian M, Ying, Jun, Battagliotti, Cristina, Brusco, Maria Isabel, Cuttica, Ruben, De Cunto, Carmen, Espada, Graciela, Farfan, Maximiliano, Garay, Stella, Marcantoni, Maria, Marcela, Alvarez, Meiorin, Silvia, Rama, Maria Elena, Russo, Ricardo, Walsh, Carolina Torre, Zamparo, Celso, Adib, Navid, Akikusa, Jonathan, Boros, Christina, Lee, Senq J, Mckay, Damien, Piper, Susan, Joos, Rik, Bica, Blanca, Campos, Leonardo, Cavalcanti, Andre, do Prado, Rogerio, Donner-Maliki, Amanda, Fernandes, Taciana, Fonseca, Adriana, de Almeida, Rozana Gasparello, Guariento, Andressa, Gusman, Catherine, Fiorot, Fernanda Jusan, Oliveira, Sheila Knupp, Len, Claudio, Campos, Lucia M Arruda, Machado, Sandra, Marques, Luciana, de Carvalho, Luciana Martins, Moulin, Rodrigo, Pedroso, Soraya, Pileggi, Gecilmara, Romanelli, Paulo Roberto S, Saad-Magalhaes, Claudia, Sakamoto, Ana, Santos, Maria Carolina, Silva, Marco Felipe, Spelling, Paulo, Sztajnbok, Flavio, Terreri, Maria, Cabral, David, Chedeville, Gaelle, Ellsworth, Janet, Huber, Adam, Tucker, Lori, Houghton, Kristin, Borzutzky, Arturo, Ladino, Mabel, Norambuena, Ximena, Eraso, Ruth, Mosquera, Angela, Velasquez, Monica, Harjacek, Miroslav, Jelusic, Marija, Hermosilla, Cecilia Coto, Dolezalova, Pavla, Nielsen, Susan, Tineo, Carmen, Alegria, Mauricio, Dressler, Frank, Foell, Dirk, Ganser, Gerd, Hinze, Claas, Hufnagel, Markus, Lutz, Thomas, Trauzeddel, Ralf, Boiu, Sorina, Trachana, Maria, Tsitsami, Elena, Cifuentes, Mayra, Orban, Ilonka, Aggarwal, Amita, Sawhney, Sujata, Aviel, Yonatan Butbul, Cimaz, Rolando, Maggio, Maria Cristina, Rumba-Rozenfelde, Ingrid, Hashad, Soad, Lim, Sern Chin, Abud, Carlos, Burgos-Vargas, Ruben, Carreno-Manjarrez, Roberto, Enciso Pelaez, Sandra, Hernandez-Huirache, Hayde, Maldonado Velazquez, Rocio, Orozco, Javier, Rodriguez-Lozano, Ana Luisa, Rojas Pacheco, Omar Ernesto, Suarez Larios, Luz Maria, Vega, Gabriel, Ramirez Miramontes, Julia Veronica, Ruiz Lopez, Ivon Karina, Kamphuis, Sylvia, Schonenberg-Meinema, Dieneke, Concannon, Anthony, Yan, Jaqueline, Jaime, Martha Jarquin, Al Abrawi, Safiya, Vega, Cynthia, Lopez-Benitez, Jorge, Estrella, Amparo Ibanez, Miraval, Tatiana, Dans, Leonia, Kimseng, Karen Joy, Opoka-Winiarska, Violetta, Rutkowska-Sak, Lidia, Smolewska, Elzbieta, Conde, Marta, Guedes, Margarida, del Valle, Enid, Quintero-Del Rio, Ana, Ailioaie, Constantin, Sparchez, Mihaela, Alekseeva, Ekaterina, Keltsev, Vladimir, Al-Mayouf, Sulaiman, Asiri, Abdurhman, Suwairi, Wafaa, Susic, Gordana, Vijatov-Djuric, Gordana, Ang, Elizabeth, Arkachaisri, Thaschawee, Boteanu, Alina-Lucica, Lopez-Robledillo, Juan Carlos, San Ildefonso, Marta Medrano, Modesto, Consuelo, Calvo, Inmaculada, Sotoca-Fernandez, Jorge, Bolt, Isabel, Vilaiyuk, Soamarat, Al-Abadi, Eslam, Baildam, Eileen, Fotis, Lampros, Pain, Clare, Pilkington, Clarissa, Abulaban, Khalid, Barbar-Smiley, Fatima, Binstadt, Bryce, Bohnsack, John, Boneparth, Alexis, Brown, Diane, Chira, Peter, Cron, Randy, Dedeoglu, Fatma, Eberhard, Anne, Gedalia, Abraham, Grom, Alexei, Henrickson, Michael, Hom, Christine, Huggins, Jennifer, Jerath, Rita, Jones, Jordan, Jung, Lawrence, Kingsbury, Daniel, Lai, Jamie, Lovell, Daniel, Nanda, Kabita, Nocton, James, Olson, Judyann, O'Neil, Kathleen, Onel, Karen, Punaro, Lynn, Reiff, Andreas, Rouster-Stevens, Kelly, Ruth, Natasha, Schikler, Ken, Schmidt, Kara Murphy, Schulert, Grant, Shaham, Bracha, Singer, Nora, Smith, Judith, Sundel, Robert, Syverson, Grant, Vega-Fernandez, Patricia, Vehe, Richard, Wagner-Weiner, Linda, Cameto, Juan, Jurado, Rosario, Maldonado, Irama, Org, Paediat Rheumatology Int Trial, Collaborative, Pediat Rheumatology, AII - Inflammatory diseases, Graduate School, Paediatric Infectious Diseases / Rheumatology / Immunology, Brunner, Hermine I., Holland, Michael J., Beresford, Michael W., Ardoin, Stacy P., Appenzeller, Simone, Silva, Clovis A., Flores, Francisco, Goilav, Beatrice, Avar Aydin, Pinar Ozge, Wenderfer, Scott E., Levy, Deborah M., Ravelli, Angelo, Khubchandani, Raju, Avcin, Tadej, Klein-Gitelman, Marisa S., Ruperto, Nicolino, Feldman, Brian M., Ying, Jun, Battagliotti, Cristina, Brusco, Maria Isabel, Cuttica, Rubén, De Cunto, Carmen, Espada, Graciela, Farfan, Maximiliano, Garay, Stella, Marcantoni, Maria, Marcela, Alvarez, Meiorin, Silvia, Rama, Maria Elena, Russo, Ricardo, Torre Walsh, Carolina, Zamparo, Celso, Adib, Navid, Akikusa, Jonathan, Boros, Christina, Lee, Senq J., Mckay, Damien, Piper, Susan, Joos, Rik, Bica, Blanca, Campos, Leonardo, Cavalcanti, André, do Prado, Rogerio, Donner-Maliki, Amanda, Fernandes, Taciana, Fonseca, Adriana, Gasparello de Almeida, Rozana, Guariento, Andressa, Gusman, Catherine, Jusan Fiorot, Fernanda, Knupp Oliveira, Sheila, Len, Claudio, Arruda Campos, Lucia M., Machado, Sandra, Marques, Luciana, Martins de Carvalho, Luciana, Moulin, Rodrigo, Pedroso, Soraya, Pileggi, Gecilmara, Romanelli, Paulo Roberto S., Saad-Magalhaes, Claudia, Sakamoto, Ana, Santos, Maria Carolina, Silva, Marco Felipe, Spelling, Paulo, Sztajnbok, Slavio, Terreri, Maria, Cabral, David, Chédeville, Gaëlle, Ellsworth, Janet, Huber, Adam, Tucker, Lori, Houghton, Kristin, Borzutzky, Arturo, Ladino, Mabel, Norambuena, Ximena, Eraso, Ruth, Mosquera, Angela, Velasquez, Monica, Harjacek, Miroslav, Jelusic, Marija, Coto Hermosilla, Cecilia, Dolezalova, Pavla, Nielsen, Susan, Tineo, Carmen, Alegria, Mauricio, Dressler, Frank, Foell, Dirk, Ganser, Gerd, Hinze, Claa, Hufnagel, Marku, Lutz, Thoma, Trauzeddel, Ralf, Boiu, Sorina, Trachana, Maria, Tsitsami, Elena, Cifuentes, Mayra, Orbán, Ilonka, Aggarwal, Amita, Sawhney, Sujata, Butbul Aviel, Yonatan, Cimaz, Rolando, Maggio, Maria Cristina, Rumba-Rozenfelde, Ingrid, Hashad, Soad, Lim, Sern Chin, Abud, Carlo, Burgos-Vargas, Ruben, Carreño-Manjarrez, Roberto, Enciso Pelaez, Sandra, Hernandez-Huirache, Hayde, Maldonado Velázquez, Rocio, Orozco, Javier, Rodriguez-Lozano, Ana Luisa, Rojas Pacheco, Omar Ernesto, Suárez Larios, Luz Maria, Vega, Gabriel, Ramírez Miramontes, Julia Verónica, Ruíz Lopez, Ivon Karina, Kamphuis, Sylvia, Schonenberg-Meinema, Dieneke, Concannon, Anthony, Yan, Jaqueline, Jarquin Jaime, Martha, Al Abrawi, Safiya, Vega, Cynthia, Lopez-Benitez, Jorge, Ibáñez Estrella, Amparo, Miraval, Tatiana, Dans, Leonia, Kimseng, Karen Joy, Opoka-Winiarska, Violetta, Rutkowska-Sak, Lidia, Smolewska, Elzbieta, Conde, Marta, Guedes, Margarida, del Valle, Enid, Quintero-Del Rio, Ana, Ailioaie, Constantin, Sparchez, Mihaela, Alekseeva, Ekaterina, Keltsev, Vladimir, Al-Mayouf, Sulaiman, Asiri, Abdurhman, Suwairi, Wafaa, Susic, Gordana, Vijatov-Djuric, Gordana, Ang, Elizabeth, Arkachaisri, Thaschawee, Boteanu, Alina-Lucica, Lopez-Robledillo, Juan Carlo, Medrano San Ildefonso, Marta, Modesto, Consuelo, Calvo, Inmaculada, Sotoca-Fernandez, Jorge, Bolt, Isabel, Vilaiyuk, Soamarat, Al-Abadi, Eslam, Baildam, Eileen, Fotis, Lampro, Pain, Clare, Pilkington, Clarissa, Abulaban, Khalid, Barbar-Smiley, Fatima, Binstadt, Bryce, Bohnsack, John, Boneparth, Alexi, Brown, Diane, Chira, Peter, Cron, Randy, Dedeoglu, Fatma, Eberhard, Anne, Gedalia, Abraham, Grom, Alexei, Henrickson, Michael, Hom, Christine, Huggins, Jennifer, Jerath, Rita, Jones, Jordan, Jung, Lawrence, Kingsbury, Daniel, Lai, Jamie, Lovell, Daniel, Nanda, Kabita, Nocton, Jame, Olson, Judyann, O’Neil, Kathleen, Onel, Karen, Punaro, Lynn, Reiff, Andrea, Rouster-Stevens, Kelly, Ruth, Natasha, Schikler, Ken, Murphy Schmidt, Kara, Schulert, Grant, Shaham, Bracha, Singer, Nora, Smith, Judith, Sundel, Robert, Syverson, Grant, Vega-Fernandez, Patricia, Vehe, Richard, Wagner-Weiner, Linda, Cameto, Juan, Jurado, Rosario, Maldonado, Irama, and Pediatrics

Subjects
medicine.medical_specialty, Outcome Assessment, Health Care/methods, Adolescent, Delphi Technique, Antirheumatic Agents/therapeutic use, Severity of Illness Index, Child health, Article, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Internal medicine, Severity of illness, Outcome Assessment, Health Care, medicine, Pediatric nephrology, Humans, Lupus Erythematosus, Systemic, skin and connective tissue diseases, Child, 030203 arthritis & rheumatology, Systemic lupus erythematosus, Lupus erythematosus, Lupus Erythematosus, Receiver operating characteristic, business.industry, Consensus conference, childhood-onset systemic lupus erythematosus, Outcome Assessment, Health Care/methods, medicine.disease, Rheumatology,Systemic lupus erythematosus,autoimmune inflammatory disease, Antirheumatic Agents, Lupus Erythematosus, Systemic/drug therapy, Systemic/drug therapy, business, Algorithms
Abstract

OBJECTIVE: To develop a Childhood Lupus Improvement Index (CHILI) as a tool to measure response to therapy in childhood-onset systemic lupus erythematosus (cSLE), with a focus on clinically relevant improvement (CRIc SLE ). METHODS: Pediatric nephrology and rheumatology subspecialists (n = 213) experienced in cSLE management were invited to define CRIc SLE and rate a total of 433 unique patient profiles for the presence/absence of CRIc SLE . Patient profiles included the following cSLE core response variables (CRVs): global assessment of patient well-being (patient-global), physician assessment of cSLE activity (MD-global), disease activity index score (here, we used the Systemic Lupus Erythematosus Disease Activity Index), urine protein-to-creatinine ratio, and Child Health Questionnaire physical summary score. Percentage and absolute changes in these cSLE- CRVs (baseline versus follow-up) were considered in order to develop candidate algorithms and validate their performance (sensitivity, specificity, area under the receiver operating characteristic curve [AUC] ; range 0-1). RESULTS: During an international consensus conference, unanimous agreement on a definition of CRIc SLE was achieved ; cSLE experts (n = 13) concurred (100%) that the preferred CHILI algorithm considers absolute changes in the cSLE- CRVs. After transformation to a range of 0-100, a CHILI score of ≥54 had outstanding accuracy for identifying CRIc SLE (AUC 0.93, sensitivity 81.1%, and specificity 84.2%). CHILI scores also reflect minor, moderate, and major improvement for values exceeding 15, 68, and 92, respectively (all AUC ≥0.92, sensitivity ≥93.1%, and specificity ≥73.4%). CONCLUSION: The CHILI is a new, seemingly highly accurate index for measuring CRI in cSLE over time. This index is useful to categorize the degree of response to therapy in children and adolescents with cSLE.

Published
2019

82. OA37 Secukinumab treatment in children and adolescents with enthesitis-related arthritis and juvenile psoriatic arthritis: efficacy and safety results from a Phase 3 study

Author

Ramanan, Athimalaipet V, primary, Brunner, Hermine I, additional, Foeldvari, Ivan, additional, Alexeeva, Ekaterina, additional, Ayaz, Nuray A, additional, Calvo, Inmaculada, additional, Kasapcopur, Ozgur, additional, Chasnyk, Vyacheslav G, additional, Hufnagel, Markus, additional, Zuber, Zbigniew, additional, Schulert, Grant, additional, Ozen, Seza, additional, Popov, Artem, additional, Scott, Christiaan, additional, Sözeri, Betul, additional, Zholobova, Elena, additional, Zhu, Xuan, additional, Whelan, Sarah, additional, Pricop, Luminita, additional, Ravelli, Angelo, additional, Martini, Alberto, additional, Lovell, Daniel J, additional, and Ruperto, Nicolino, additional

Published
2022
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83. The Geospatial Distribution of Myositis and Its Phenotypes in the United States and Associations With Roadways: Findings From a National Myositis Patient Registry

Author

Hossain, Md M., primary, Wilkerson, Jesse, additional, McGrath, John A., additional, Farhadi, Payam N., additional, Brokamp, Cole, additional, Khan, Md T. F., additional, Goldberg, Bob, additional, Brunner, Hermine I., additional, Macaluso, Maurizio, additional, Miller, Frederick W., additional, and Rider, Lisa G., additional

Published
2022
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84. Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis: results from the PREVENT-JIA trial

Author

Gerss, Joachim, primary, Tedy, Monika, additional, Klein, Ariane, additional, Horneff, Gerd, additional, Miranda-Garcia, Maria, additional, Kessel, Christoph, additional, Holzinger, Dirk, additional, Stanevica, Valda, additional, Swart, Joost F, additional, Cabral, David A, additional, Brunner, Hermine I, additional, and Foell, Dirk, additional

Published
2022
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86. Contributors

Author

Akikusa, Jonathan, primary, Albani, Salvatore, additional, Allen, Roger, additional, Alsaeid, Khaled, additional, Avčin, Tadej, additional, Babyn, Paul S., additional, Bagga, Arvind, additional, Barron, Karyl S., additional, Becker, Mara L., additional, Benseler, Susanne M., additional, Beukelman, Timothy, additional, Brogan, Paul, additional, Brunner, Hermine I., additional, Burgos-Vargas, Rubèn, additional, Buyon, Jill, additional, Cabral, David A., additional, Choo, Sharon, additional, Cimaz, Rolando, additional, Colbert, Robert Allen, additional, Cole, William G., additional, Davidson, Iris, additional, Benedetti, Fabrizio De, additional, Doria, Andrea S., additional, Dressler, Frank, additional, Duffy, Ciarán M., additional, Eleftheriou, Despina, additional, Feldman, Brian M., additional, Ferguson, Polly J., additional, Fuhlbrigge, Robert, additional, Gattorno, Marco, additional, Grom, Alexei A., additional, Hashkes, Philip J., additional, Houghton, Kristin, additional, Huppertz, Hans-Iko, additional, Ilowite, Norman T., additional, Jaeggi, Edgar, additional, Kastner, Daniel L., additional, Kirton, Adam, additional, Klein-Gitelman, Marisa, additional, Kuchta, Gay, additional, Lane, Jerome Charles, additional, Laxer, Ronald M., additional, LeBlanc, Claire, additional, Leeder, Steven J., additional, Legger, G. Elizabeth, additional, Li, Suzanne C., additional, Lindsley, Carol B., additional, Lovell, Dan, additional, Makitie, Outi, additional, Martini, Alberto, additional, Miller, Frederick W., additional, Morishita, Kimberly, additional, Nigrovic, Peter A., additional, Oen, Kiem G., additional, O'Neil, Kathleen M., additional, Ozen, Seza, additional, Pepmueller, Peri H., additional, Petty, Ross E., additional, Pope, Elena, additional, Prahalad, Sampath, additional, Prakken, Berent, additional, Rapoff, Michael, additional, Rider, Lisa G., additional, Rosé, Carlos Daniel, additional, Rosenbaum, James T., additional, Rosenberg, Alan M., additional, Roth, Johannes, additional, Guillermo, Ricardo Alberto, additional, Schneider, Rayfel, additional, Scott, Christiaan, additional, Sherry, David D., additional, Silverman, Earl, additional, Son, Mary Beth, additional, Sundel, Robert P., additional, Thompson, Susan D., additional, Tiedemann, Karin, additional, Tse, Shirley M.L., additional, Tucker, Lori, additional, Uziel, Yosef, additional, van Montfrans, Joris, additional, Vazques-Mellado, Janitzia, additional, Ward, Leanne, additional, Wedderburn, Lucy R., additional, Wouters, Carine, additional, Wright, James, additional, Wulffraat, Nico M., additional, Zemel, Lawrence, additional, and Zulian, Francesco, additional

Published
2016
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89. Hydroxychloroquine blood levels predicts flare in childhood-onset lupus nephritis

Author

Andrade Balbi, Verena, primary, Artur Silva, Clovis, additional, Nascimento Pedrosa, Tatiana, additional, Maria Rodrigues Pereira, Rosa, additional, Maria de Arruda Campos, Lucia, additional, Pires Leon, Elaine, additional, Duarte, Nilo, additional, Melechco Carvalho, Valdemir, additional, Gofinet Pasoto, Sandra, additional, Cordeiro do Rosário, Debora, additional, Kolachinski Brandao, Leticia, additional, I Brunner, Hermine, additional, Bonfá, Eloisa, additional, and Emi Aikawa, Nadia, additional

Published
2021
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90. 503 Developing a standardized steroid dosing regimen in pediatric proliferative lupus nephritis

Author

Brunner, Hermine I, primary, Rouster-Stevens, K, additional, Klein-Gitelman, Marisa S, additional, Onel, Karen, additional, Goilav, Beatrice, additional, Ruth, Natasha, additional, Qiu, Tingting, additional, Aljaberi, Najla, additional, Deng, Jianghong, additional, Laskin, Benjamin L, additional, Sagcal-Gironella, Anna Carmela P, additional, Ardoin, Stacy P, additional, Levy, Deborah M, additional, Wenderfer, Scott E, additional, and Huang, Bin, additional

Published
2021
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91. Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial

Author

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

Published
2021
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92. 2021 DORIS definition of remission in SLE: final recommendations from an international task force

Author

van Vollenhoven, Ronald F, primary, Bertsias, George, additional, Doria, Andrea, additional, Isenberg, David, additional, Morand, Eric, additional, Petri, Michelle A, additional, Pons-Estel, Bernardo A, additional, Rahman, Anisur, additional, Ugarte-Gil, Manuel Francisco, additional, Voskuyl, Alexandre, additional, Arnaud, Laurent, additional, Bruce, Ian N, additional, Cervera, Ricard, additional, Costedoat-Chalumeau, Nathalie, additional, Gordon, Caroline, additional, Houssiau, Frédéric A, additional, Mosca, Marta, additional, Schneider, Matthias, additional, Ward, Michael M, additional, Alarcon, Graciela, additional, Aringer, Martin, additional, Askanase, Anca D, additional, Bae, Sang-Cheol, additional, Bootsma, Hendrika, additional, Boumpas, Dimitrios T, additional, Brunner, Hermine, additional, Clarke, Ann Elaine, additional, Coney, Cindy, additional, Czirják, László, additional, Dörner, Thomas, additional, Faria, Raquel, additional, Fischer, Rebecca, additional, Fritsch-Stork, Ruth, additional, Inanc, Murat, additional, Jacobsen, Søren, additional, Jayne, David, additional, Kuhn, Annegret, additional, van Leeuw, Bernadette, additional, Limper, Maarten, additional, Mariette, Xavier, additional, Navarra, Sandra, additional, Nikpour, Mandana, additional, Olesinska, Marzena Helena, additional, Pons-Estel, Guillermo, additional, Romero-Diaz, Juanita, additional, Rubio, Blanca, additional, Schoenfeld, Yehuda, additional, Bonfá, Eloisa, additional, Smolen, Josef, additional, Teng, Y K Onno, additional, Tincani, Angela, additional, Tsang-A-Sjoe, Michel, additional, Vasconcelos, Carlos, additional, Voss, Anne, additional, Werth, Victoria P, additional, Zakharhova, Elena, additional, and Aranow, Cynthia, additional

Published
2021
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93. 2016 Classification Criteria for Macrophage Activation Syndrome Complicating Systemic Juvenile Idiopathic Arthritis: A European League Against Rheumatism/American College of Rheumatology/Paediatric Rheumatology International Trials Organisation Collaborative Initiative

Author

Ravelli, Angelo, Minoia, Francesca, Davì, Sergio, Horne, AnnaCarin, Bovis, Francesca, Pistorio, Angela, Aricò, Maurizio, Avcin, Tadej, Behrens, Edward M, De Benedetti, Fabrizio, Filipovic, Lisa, Grom, Alexei A, Henter, Jan-Inge, Ilowite, Norman T, Jordan, Michael B, Khubchandani, Raju, Kitoh, Toshiyuki, Lehmberg, Kai, Lovell, Daniel J, Miettunen, Paivi, Nichols, Kim E, Ozen, Seza, Pachlopnik Schmid, Jana, Ramanan, Athimalaipet V, Russo, Ricardo, Schneider, Rayfel, Sterba, Gary, Uziel, Yosef, Wallace, Carol, Wouters, Carine, Wulffraat, Nico, Demirkaya, Erkan, Brunner, Hermine I, Martini, Alberto, Ruperto, Nicolino, and Cron, Randy Q

Published
2016
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94. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab

Author

Grom, Alexei A., Ilowite, Norman T., Pascual, Virginia, Brunner, Hermine I., Martini, Alberto, Lovell, Daniel, Ruperto, Nicolino, Leon, Karolynn, Lheritier, Karine, Abrams, Ken, Cuttica, Ruben, Emminger, Wolfgang, Goffin, Laurence, Joos, Rik, Lauwerys, Bernard, Wouters, Carine, Hilário, Maria Odete Esteves, de Oliveira, Sheila Knupp Feitosa, Len, Claudio, Radominski, Sebastiao, Sztajnbok, Flavio Roberto, Haddad, Elie, Hofer, Michael, Houghton, Kristin, Huber, Adam, Saurenmann, Traudel, Schneider, Rayfel, Tucker, Lori, Bader-Meunier, Brigitte, Desjonqueres, Marine, Fischbach, Michel, Kone-Paut, Isabelle, Marie, Isabelle, Mogenet, Agnes, Mouy, Richard, Quartier, Pierre, Berner, Reinhard, Foeldvari, Ivan, Foell, Dirk, Frosch, Michael, Haas, Johannes-Peter, Horneff, Gerd, Hufnagel, Markus, Kallinich, Tilmann, Kuemmerle-Deschner, Jasmin, Lehmann, Hartwig, Lutz, Thomas, Thon, Angelika, Trauzeddel, Ralf, Tzaribachev, Nikolay, Weibarth-Riedel, Elisabeth, Chrousos, Georgios, Trachana, Maria, Vougiouka, Olga, Constantin, Tamas, Barash, Judith, Berkun, Yackov, Brik, Riva, Harel, Liora, Nahum, Amit, Pade, Shay, Uziel, Yosef, Alessio, Maria, Cimaz, Rolando, Corona, Fabrizia, Gerloni, Valeria, Wulffraat, N. M., Ferrandiz, Manuel, Rutkowska-Sak, Lidia, Alekseeva, Ekaterina, Chasnyk, Vyacheslav, Nasonov, Evgeny, Stanislav, Marina, Anton, Jordi, Calvo, Inmaculada, Gamir, Mari Luz, Robledillos, Juan Carlos, Magnusson, Bo, Erguven, Muferet, Kasapcopur, Ozgur, Ozdogan, Huri, Ozen, Seza, Unsal, Erbil, Chieng, Alice, Foster, Helen, McCann, Liza, Ramanan, Athimalaip, Southwood, Taunton, Wilkinson, Nicholas, Woo, Patricia, Higgins, Gloria Christine, Kingsbury, Daniel, Lopez-Benitez, Jorge, Marzan, Katherine, Morris, Paula, Natter, Marc, and Schikler, Kenneth Noel

Published
2016
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95. Proceedings from the 4th NextGen Therapies for SJIA and MAS virtual symposium held February 13–14, 2022.

Author

Sinha, Rashmi, De Benedetti, Fabrizio, Grom, Alexei A., on behalf of the participants listed below, Abu-Arja, Rolla F., Behrens, Edward, Brunner, Hermine, Canna, Scott W., Cannizzaro, Elvira, Chandrakasan, Shanmuganathan, Cron, Randy, Driest, Kyla, Kimura, Yukiko, Leptak, Christopher, Lovell, Daniel J., Marsh, Rebecca, Neven, Bénédicte, Nigrovic, Peter A., Nikolov, Nikolay, and Onel, Karen

Subjects
MACROPHAGE activation syndrome, PULMONARY alveolar proteinosis, JUVENILE idiopathic arthritis, DISEASE risk factors, JUVENILE diseases
Abstract

The article discusses the proceedings of the 4th NextGen Therapies for SJIA and MAS virtual symposium, which aimed to identify barriers to clinical research and develop new strategies for refractory Systemic Juvenile Idiopathic Arthritis (SJIA) and Macrophage Activation Syndrome (MAS). SJIA is a severe subtype of chronic childhood arthropathy characterized by systemic immune activation, while MAS is a potentially fatal episode of systemic hyperinflammation. The symposium focused on the development of new therapies for SJIA-associated lung disease (SJIA-LD) and MAS, as well as alternative designs for clinical trials and the use of biomarkers for treatment response. The article also highlights the need for improved outcome measures that capture the systemic component of SJIA, particularly the lung disease. [Extracted from the article]

Published
2023
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96. Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial.

Author

Brunner, Hermine I., Foeldvari, Ivan, Alexeeva, Ekaterina, Ayaz, Nuray Aktay, Penades, Inmaculada Calvo, Kasapcopur, Ozgur, Chasnyk, Vyacheslav G., Hufnagel, Markus, Żuber, Zbigniew, Schulert, Grant, Ozen, Seza, Rakhimyanova, Adelina, Ramanan, Athimalaipet, Scott, Christiaan, Sozeri, Betul, Zholobova, Elena, Martin, Ruvie, Xuan Zhu, Whelan, Sarah, and Pricop, Luminita

Published
2023
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98. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison

Author

Brunner, Hermine I, primary, Abud-Mendoza, Carlos, additional, Mori, Masaaki, additional, Pilkington, Clarissa A, additional, Syed, Reema, additional, Takei, Syuji, additional, Viola, Diego O, additional, Furie, Richard A, additional, Navarra, Sandra, additional, Zhang, Fengchun, additional, Bass, Damon L, additional, Eriksson, Gina, additional, Hammer, Anne E, additional, Ji, Beulah N, additional, Okily, Mohamed, additional, Roth, David A, additional, Quasny, Holly, additional, and Ruperto, Nicolino, additional

Published
2021
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99. Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial

Author

Brunner, Hermine I, Ruperto, Nicolino, Zuber, Zbigniew, Keane, Caroline, Harari, Olivier, Kenwright, Andrew, Lu, Peng, Cuttica, Ruben, Keltsev, Vladimir, Xavier, Ricardo M, Calvo, Inmaculada, Nikishina, Irina, Rubio-Pérez, Nadina, Alexeeva, Ekaterina, Chasnyk, Vyacheslav, Horneff, Gerd, Opoka-Winiarska, Violetta, Quartier, Pierre, Silva, Clovis A, Silverman, Earl, Spindler, Alberto, Baildam, Eileen, Gámir, M Luz, Martin, Alan, Rietschel, Christoph, Siri, Daniel, Smolewska, Elzbieta, Lovell, Daniel, Martini, Alberto, De Benedetti, Fabrizio, Espada, Graciela, Allen, Roger, Chaitow, Jeffrey, Joos, Rik, Wouters, Carine, Knupp, Sheila, Sztajnbok, Flavio, Cabral, David, Houghton, Kristin, Roth, Johannes, Schmeling, Heinrike, Job-Deslandre, Chantal, Jorgensen, Christian, Paut, Isabelle Kone, Minden, Kirsten, Weller-Heinemann, Frank, Gerloni, Valeria, Zulian, Francesco, Burgos-Vargas, Ruben, Salazar, Carolina Duarte, Solis-Vallejo, Eunice, Calvo, Armando, Chavez, José, Zavaler, Manuel Ferrandiz, Gruenpeter, Anna, Kobusinska, Katarzyna, Sarychev, Alexey, Zholobova, Elena, Ramanan, Athimalaipet, Woo, Patricia, Goodman, Steven, Gedalia, Abraham, Kimura, Yukiko, Onel, Karen, and Schikler, Kenneth

Published
2015
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