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52. 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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53. 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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54. 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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55. 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. 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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58. 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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61. 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

62. 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

63. 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

66. 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

68. 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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69. 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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70. 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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72. 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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74. 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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77. 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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78. 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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79. 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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80. 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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81. 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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83. 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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84. 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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87. International Consensus for the Dosing of Corticosteroids in Childhood-Onset Systemic Lupus Erythematosus With Proliferative Lupus Nephritis

Author

Chalhoub, Nathalie E., Wenderfer, Scott E., Levy, Deborah M., Rouster-Stevens, Kelly, Aggarwal, Amita, Savani, Sonia I., Ruth, Natasha M., Arkachaisri, Thaschawee, Qiu, Tingting, Merritt, Angela, Onel, Karen, Goilav, Beatrice, Khubchandani, Raju P., Deng, Jianghong, Fonseca, Adriana R., Ardoin, Stacy P., Ciurtin, Coziana, Kasapcopur, Ozgur, Jelusic, Marija, Huber, Adam M., Ozen, Seza, Klein-Gitelman, Marisa S., Appenzeller, Simone, Cavalcanti, André, Fotis, Lampros, Lim, Sern Chin, Silva, Rodrigo M., Miramontes, Julia Ramírez, Rosenwasser, Natalie L., Saad-Magalhaes, Claudia [UNESP], Schonenberg-Meinema, Dieneke, Scott, Christiaan, Silva, Clovis A., Enciso, Sandra, Terreri, Maria T., Torres-Jimenez, Alfonso-Ragnar, Trachana, Maria, Al-Mayouf, Sulaiman M., Devarajan, Prasad, Huang, Bin, Brunner, Hermine I., Abulaban, Khalid, Aguiar, Cassyanne, Ahn, Sun-Young, Akoghlanian, Shoghik, Al-Abrawi, Safiya, Aljaberi, Najla, Alperin, Risa, Angeles-Han, Sheila, Ardalan, Kaveh, Bader-Meunier, Brigitte, Balboni, Imelda, Barbar-Smiley, Fatima, Baxter, Sarah, Beary, John, Boneparth, Alexis, Brakeman, Paul, Bridges, John, Burgos-Vargas, Ruben, Cabral, David A., Cameto, Juan, Carter, Caitlin, Chang, Joyce, Chédeville, Gaëlle, Chhakchhuak, Christine, Chiraseveenuprapund, Peter, Cifuentes Alvarado, Mayra, Concannon, Anthony, Cooper, Jennifer, Cron, Randy, De Carvalho, Luciana Martins, De Quattro, Kimberly, De Ranieri, Deirdre, Dizon, Brian, Donnelly Wrigley, Catherine, Duong, Minh Dien, Eberhard, Anne, Ede, Kaleo, Edelheit, Barbara, Edens, Cuoghi, Espada, Graciela, Farhey, Yolanda, Flores, Francisco, Fritz, Deborah, Ganguli, Suhas, Gilbert, Mileka, Gittar, Patsy, Greenbaum, Larry, Grom, Alexei, Gulati, Gaurav, Harry, Onengiya, Hayward, Kristen, Henrickson, Michael, Hersh, Aimee, Hiraki, Linda, Hiskey, Megan, Hoffmann, Sarah, Hollander, Matthew, Hom, Christine, Houk, Lawrence, Houk, J. Brian, Hsieh, Elena W.Y., Hsu, Joyce, Jensen, Paul, Joos, Rik, Jurado, Rosario, Jusan Fiorot, Fernanda, Kallash, Mahmoud, Kamphuis, Sylvia, Keltsev, Vladimir, Khanna, Surabhi, Kim, Susan, Kimseng, Karen Joy, Knight, Andrea, Kunder, Rebecca, Lai, Jamie, Laskin, Benjamin, Lewandowski, Laura, Lim, Lily, Linda, Wagner-Weiner, Lo, Mindy, Lovell, Daniel, Luggen, Michael, Madison, Jacqueline, Mansuri, Asif, Martin, Lorena, Mason, Sherene, Miller, Michael, Mina, Rina, Mohammed, Abdul, Moncrieffe, Halima, Moorthy, Lakshmi, Morgan, Esi, Mosquera, Angela, Muntel, Emily, Muscal, Eyal, Myones, Barry, Nocton, James, Ogbu, Ekemini, Okamura, Daryl, Olson, Judyann, Orrock, Janet, Paim-Marques, Luciana, Pain, Clare, Park, Catherine, Patel, Pooja, Pereira, Maria, Prado, Rogerio do, Radhakrishna, Suhas, Rheault, Michelle, Ridgway, William, Riskalla, Mona, Ronis, Tova, Sadun, Rebecca, Sagcal-Gironella, Anna Carmela, Santos, Maria carolina, Schikler, Kenneth, AL Suwairi, Wafaa, Siddiqi, Nabeela, Silva, Marco Felipe, Singh-Grewal, Davinder, Smitherman, Emily, Smolewska, Elzbieta, Son, Mary Beth, Srinivasalu, Hemalatha, Sule, Sangeeta, Susic, Gordana, Syed, Reema, Thatayatikom, Akaluck, Ting, Tracy, Toth, Mary, Turnier, Jessica, Vashisht, Priyanka, Vega Fernandez, Patricia, Velasquez, Monica, von Scheven, Emily, Wahezi, Dawn, Ware, Avis, Wu, Eveline, Yan, Jacqueline, Yildirim-Toruner, Cagri, Zamparo, Celso, Zhang, Yujuan, Lawson, Erica, Graduate School, Paediatric Infectious Diseases / Rheumatology / Immunology, AII - Inflammatory diseases, University of Cincinnati College of Medicine, Baylor College of Medicine, The Hospital for Sick Children and The University of Toronto, Emory University and Children's Healthcare of Atlanta, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Medical University of South Carolina, KK Women's and Children's Hospital, Cincinnati Children's Hospital Medical Center, Hospital for Special Surgery, Albert Einstein College of Medicine, SRCC Children's Hospital, Capital Medical University and National Center for Children's Health, Universidade Federal do Rio de Janeiro (UFRJ), Nationwide Children's Hospital, University College London, Istanbul University-Cerrahpasa, University of Zagreb School of Medicine, IWK Health Centre and Dalhousie University, Hacettepe University, Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago, Universidade Estadual de Campinas (UNICAMP), Universidade Federal de Pernambuco (UFPE), National and Kapodistian University of Athens, University Teknologi MARA, Instituto Mexicano del Seguro Social, University of Washington and Seattle Children's Hospital, Universidade Estadual Paulista (UNESP), Amsterdam University Medical Center, Red Cross War Memorial Children's Hospital and University of Cape Town, Universidade de São Paulo (USP), Hospital de la Beneficencia Española, Universidade Federal de São Paulo (UNIFESP), National Medical Center La Raza, Aristotle University of Thessaloniki, King Faisal Specialist Hospital and Research Center and Alfaisal University, and University of Cincinnati College of Medicine and Cincinnati Children's Hospital Medical Center

Subjects
Male, medicine.medical_specialty, Adolescent, medicine.drug_class, Immunology, Lupus nephritis, Renal function, Article, Rheumatology, childhood-onset systemic lupus erythematosus, corticosteroids, lupus nephritis, treatment, Internal medicine, Biopsy, Immunology and Allergy, Medicine, Humans, Lupus Erythematosus, Systemic, Dosing, Age of Onset, Child, Glucocorticoids, Retrospective Studies, Kidney, Proteinuria, medicine.diagnostic_test, business.industry, food and beverages, medicine.disease, Lupus Nephritis, Clinical trial, medicine.anatomical_structure, Corticosteroid, Female, medicine.symptom, business
Abstract

Made available in DSpace on 2022-04-28T19:49:00Z (GMT). No. of bitstreams: 0 Previous issue date: 2022-02-01 Arthritis Foundation Institute of Clinical and Translational Sciences Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Center for Advancing Translational Sciences Objective: To develop a standardized steroid dosing regimen (SSR) for physicians treating childhood-onset systemic lupus erythematosus (SLE) complicated by lupus nephritis (LN), using consensus formation methodology. Methods: Parameters influencing corticosteroid (CS) dosing were identified (step 1). Data from children with proliferative LN were used to generate patient profiles (step 2). Physicians rated changes in renal and extrarenal childhood-onset SLE activity between 2 consecutive visits and proposed CS dosing (step 3). The SSR was developed using patient profile ratings (step 4), with refinements achieved in a physician focus group (step 5). A second type of patient profile describing the course of childhood-onset SLE for ≥4 months since kidney biopsy was rated to validate the SSR-recommended oral and intravenous (IV) CS dosages (step 6). Patient profile adjudication was based on majority ratings for both renal and extrarenal disease courses, and consensus level was set at 80%. Results: Degree of proteinuria, estimated glomerular filtration rate, changes in renal and extrarenal disease activity, and time since kidney biopsy influenced CS dosing (steps 1 and 2). Considering these parameters in 5,056 patient profile ratings from 103 raters, and renal and extrarenal course definitions, CS dosing rules of the SSR were developed (steps 3–5). Validation of the SSR for up to 6 months post–kidney biopsy was achieved with 1,838 patient profile ratings from 60 raters who achieved consensus for oral and IV CS dosage in accordance with the SSR (step 6). Conclusion: The SSR represents an international consensus on CS dosing for use in patients with childhood-onset SLE and proliferative LN. The SSR is anticipated to be used for clinical care and to standardize CS dosage during clinical trials. University of Cincinnati College of Medicine Baylor College of Medicine The Hospital for Sick Children and The University of Toronto Emory University and Children's Healthcare of Atlanta Sanjay Gandhi Postgraduate Institute of Medical Sciences Medical University of South Carolina KK Women's and Children's Hospital Cincinnati Children's Hospital Medical Center Hospital for Special Surgery Albert Einstein College of Medicine SRCC Children's Hospital Capital Medical University and National Center for Children's Health Universidade Federal do Rio de Janeiro Nationwide Children's Hospital University College London Cerrahpasa Medical School Istanbul University-Cerrahpasa University of Zagreb School of Medicine IWK Health Centre and Dalhousie University Hacettepe University Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago University of Campinas Hospital das Clínicas da Universidade Federal de Pernambuco National and Kapodistian University of Athens University Teknologi MARA Instituto Mexicano del Seguro Social University of Washington and Seattle Children's Hospital São Paulo State University Amsterdam University Medical Center Red Cross War Memorial Children's Hospital and University of Cape Town Universidade de São Paulo Hospital de la Beneficencia Española Universidade Federal de São Paulo National Medical Center La Raza Aristotle University of Thessaloniki King Faisal Specialist Hospital and Research Center and Alfaisal University University of Cincinnati College of Medicine and Cincinnati Children's Hospital Medical Center São Paulo State University CNPq: 303422/2015-7 FAPESP: FAPESP 2015/03756-4 National Institute of Arthritis and Musculoskeletal and Skin Diseases: P30-AR-076316 National Institute of Diabetes and Digestive and Kidney Diseases: P50-DK-096418 National Institute of Arthritis and Musculoskeletal and Skin Diseases: R34-AR-071651 National Center for Advancing Translational Sciences: T32-AR-050958

Published
2021

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

Author

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

Subjects
NEUROPSYCHOLOGICAL tests, WECHSLER Adult Intelligence Scale, PSYCHOMETRICS, CRONBACH'S alpha, STATISTICAL reliability
Abstract

Automated neuropsychiatric batteries have been used in research and clinical practice, including for chronic diseases, such as Systemic Lupus Erythematosus. The Pediatric Automated Neuropsychological Assessment Metrics battery (Ped-ANAM), originally developed for use in American-English speaking individuals, allows tracking of cognitive functions. It can be applied to people over 9 years old. The aim of this study was to translate and present initial validation data from the Ped-ANAM into Brazilian-Portuguese. We translated the battery according to Beaton's guidelines. Psychometric properties were tested, internal consistency was analyzed by Cronbach's alpha coefficient, test-retest reliability by the intraclass correlation coefficient (ICC). Further, we measured the test execution speed at both times as a temporal stability. Principal component analysis (PCA) was used for structural validity. Evidence of construct validity was assessed through assessment of the relationships with the Wechsler Intelligence Scales. All participants prior to the start of study related activities signed an informed consent form approved by the local ethics committee. A sample of 230 individuals [mean (range) of age: 23 (9 to 60) years; 65% females] was included; a subset of 51 individuals [mean (range) of age: 18 (9 to 57) years, 59% female] completed the Ped-ANAM twice to assess test-retest reliability, and another subset of 54 individuals [mean (range) of age: 20.4 (7 to 62) years; 67% female] completed the Wechsler Intelligence Scales for Children and Adult for assessment of the Ped-ANAM's construct validity. Our results suggest that the internal consistency of the Ped-ANAM (Cronbach's a = 0.890) and its subtest test-retest reliability were excellent (ICC: 0.59 to 0.94). There was no clustering in the Principal Components Analysis, suggestive of non-grouping of the evaluated variables. Construct validity assessment to theWechsler Scales showed expected ranges of low to strong correlations (Spearman correlations: ρ = 0.40 to ρ = 0.69). We concluded that, based on the results of this study, a cross-culturally validated Brazilian-Portuguese version of the Ped-ANAM has been developed and it is a reliable tool for the screening cognitive function. [ABSTRACT FROM AUTHOR]

Published
2022
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89. Efficacy and safety of tocilizumab for polyarticular-course juvenile idiopathic arthritis in the open-label two-year extension of a phase III trial

Author

Brunner, Hermine I., Xavier, Ricardo Machado, and Benedetti, Fabrizio de

Subjects
Estudo clínico, Artrite, Eficácia, Adolescente
Abstract

Objective. To report the 2-year efficacy and safety of tocilizumab (TCZ) in patients with polyarticular-course juvenile idiopathic arthritis (JIA). Methods. Patients ages 2–17 years with active polyarticular-course JIA, in whom treatment with methotrexate was unsuccessful, received 16 weeks of open-label intravenous TCZ in part 1 (once every 4 weeks: 8 mg/kg or 10 mg/kg for body weight [BW] 1 of the remaining JIA CRVs by >30%) at week 16 were randomly assigned (1:1) to receive TCZ or placebo in part 2. Patients remained in part 2 until either week 40 or the occurrence of JIA flare. Upon starting part 3, all patients received open-label TCZ. At week 104 of the study, efficacy was assessed using JIA-ACR50/70/90 response rates (defined as 50%, 70%, or 90% improvement, respectively), achievement of inactive disease, and the Juvenile Arthritis Disease Activity Score in 71 joints (JADAS-71). Safety was assessed in the all-exposure population per 100 patient-years of exposure. Results. Overall, 188 patients entered part 1, 166 patients entered part 2, and 160 patients entered part 3. By week 104, among the 188 patients in the modified intent-to-treat group who received TCZ, JIA-ACR50/70/90 response rates were 80.3%/77.1%/59.6%, respectively, the median JADAS-71 score decreased from 3.6 at week 40 to 0.7 at week 104, 51.1% of patients had achieved inactive disease, and 31 of 66 patients who had been receiving glucocorticoids discontinued them. Adverse event (AE) and serious AE rates were 406.5 per 100 patient-years and 11.1 per 100 patient-years, respectively. The infection rate was 151.4 per 100 patient-years, and the serious infection rate was 5.2 per 100 patient-years. Conclusion. Patients treated with TCZ for polyarticular-course JIA showed high-level disease control for up to 2 years. The TCZ safety profile was consistent with that previously reported.

Published
2021

90. Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis

Author

Ruperto, Nicolino, Brunner, Hermine, I, Ramanan, Athimalaipet, V, Horneff, Gerd, Cuttica, Ruben, Henrickson, Michael, Anton, Jordi, Lucica Boteanu, Alina, Calvo Penades, Inmaculada, Minden, Kirsten, Schmeling, Heinrike, Hufnagel, Markus, Weiss, Jennifer E., Pardeo, Manuela, Nanda, Kabita, Roth, Johannes, Rubio-Perez, Nadina, Hsu, Joy C., Wimalasundera, Sunethra, Wells, Chris, Bharucha, Kamal, Douglass, Wendy, Bao, Min, Mallalieu, Navita L., Martini, Alberto, Lovell, Daniel, De Benedetti, Fabrizio, Ruperto, Nicolino, Brunner, Hermine, I, Ramanan, Athimalaipet, V, Horneff, Gerd, Cuttica, Ruben, Henrickson, Michael, Anton, Jordi, Lucica Boteanu, Alina, Calvo Penades, Inmaculada, Minden, Kirsten, Schmeling, Heinrike, Hufnagel, Markus, Weiss, Jennifer E., Pardeo, Manuela, Nanda, Kabita, Roth, Johannes, Rubio-Perez, Nadina, Hsu, Joy C., Wimalasundera, Sunethra, Wells, Chris, Bharucha, Kamal, Douglass, Wendy, Bao, Min, Mallalieu, Navita L., Martini, Alberto, Lovell, Daniel, and De Benedetti, Fabrizio

Abstract

Objectives. To determine s.c. tocilizumab (s.c.-TCZ) dosing regimens for systemic JIA (sJIA) and polyarticular JIA (pJIA). Methods. In two 52-week phase 1 b trials, s.c.-TCZ (162 mg/dose) was administered to sJIA patients every week or every 2 weeks (every 10 days before interim analysis) and to pJIA patients every 2 weeks or every 3 weeks with body weight >= 30 kg or <30 kg, respectively. Primary end points were pharmacokinetics, pharmacodynamics and safety; efficacy was exploratory. Comparisons were made to data from phase 3 trials with i.v. tocilizumab (i.v.-TCZ) in sJIA and pJIA. Results. Study participants were 51 sJIA patients and 52 pJIA patients aged 1-17 years who received s.c.-TCZ. Steady-state minimum TCZ concentration (C-trough) >5th percentile of that achieved with i.v.-TCZ was achieved by 49 (96%) sJIA and 52 (100%) pJIA patients. In both populations, pharmacodynamic markers of disease were similar between body weight groups. Improvements in Juvenile Arthritis DAS-71 were comparable between s.c.-TCZ and i.v.-TCZ. By week 52, 53% of sJIA patients and 31% of pJIA patients achieved clinical remission on treatment. Safety was consistent with that of i.v.-TCZ except for injection site reactions, reported by 41.2% and 28.8% of sJIA and pJIA patients, respectively. Infections were reported in 78.4% and 69.2% of patients, respectively. Two sJIA patients died; both deaths were considered to be related to TCZ. Conclusion. s.c.-TCZ provides exposure and risk/benefit profiles similar to those of i.v.-TCZ. S.c. administration provides an alternative administration route that is more convenient for patients and caregivers and that has potential for in-home use.

Published
2021

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