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

Author

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

Published
2023
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3. 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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6. Association of Ultraviolet Radiation Exposure With Dermatomyositis in a National Myositis Patient Registry

Author

Parks, Christine G., primary, Wilkerson, Jesse, additional, Rose, Kathryn M., additional, Faiq, Abdullah, additional, Noroozi Farhadi, Payam, additional, Long, Craig S., additional, Bayat, Nastaran, additional, Brunner, Hermine I., additional, Goldberg, Bob, additional, McGrath, John A., additional, Miller, Frederick W., additional, and Rider, Lisa G., additional

Published
2020
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7. A 4‐Year‐Old Child with Digital Clubbing

Author

Schultz, Katherine, primary, Divanovic, Allison, additional, Towe, Christopher, additional, Miethke, Alexander, additional, Wusik, Katie, additional, Hammill, Adrienne, additional, and Brunner, Hermine, additional

Published
2020
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8. Safety and Effectiveness of Adalimumab in Patients With Polyarticular Course of Juvenile Idiopathic Arthritis: STRIVE Registry Seven-Year Interim Results

Author

Brunner, Hermine I., Nanda, Kabita, Toth, Mary, Foeldvari, Ivan, Bohnsack, John, Milojevic, Diana, Rabinovich, C. Egla, Kingsbury, Daniel J., Marzan, Katherine, Chalom, Elizabeth, Horneff, Gerd, Kuester, Rolf-Michael, Dare, Jason A., Trachana, Maria, Jung, Lawrence K., Olson, Judyann, Minden, Kirsten, Quartier, Pierre, Bereswill, Mareike, Kalabic, Jasmina, Kupper, Hartmut, Lovell, Daniel J., Martini, Alberto, Ruperto, Nicolino, Brunner, Hermine I., Nanda, Kabita, Toth, Mary, Foeldvari, Ivan, Bohnsack, John, Milojevic, Diana, Rabinovich, C. Egla, Kingsbury, Daniel J., Marzan, Katherine, Chalom, Elizabeth, Horneff, Gerd, Kuester, Rolf-Michael, Dare, Jason A., Trachana, Maria, Jung, Lawrence K., Olson, Judyann, Minden, Kirsten, Quartier, Pierre, Bereswill, Mareike, Kalabic, Jasmina, Kupper, Hartmut, Lovell, Daniel J., Martini, Alberto, and Ruperto, Nicolino

Abstract

Objective To evaluate safety and effectiveness of adalimumab (ADA) in polyarticular-course juvenile idiopathic arthritis (JIA) in the STRIVE registry. Methods STRIVE enrolled patients with polyarticular-course JIA into 2 arms based on treatment with methotrexate (MTX) alone or ADA with/without MTX (ADA +/- MTX). Adverse events (AEs) per 100 patient-years of observation time were analyzed by registry arm. Patients who entered the registry within 4 weeks of starting MTX or ADA +/- MTX, defined as new users, were evaluated for change in disease activity assessed by the 27-joint Juvenile Arthritis Disease Activity Score with the C-reactive protein level (JADAS-27(CRP)). Results At the 7-year cutoff date (June 1, 2016), data from 838 patients were available (MTX arm n = 301, ADA +/- MTX arm n = 537). The most common AEs were nausea (10.3%), sinusitis (4.7%), and vomiting (4.3%) in the MTX arm and arthritis (3.9%), upper respiratory tract infection (3.5%), sinusitis, tonsillitis, and injection site pain (3.0% each) in the ADA +/- MTX arm. Rates of serious infection were 1.5 events/100 patient-years in the MTX arm and 2.0 events/100 patient-years in the ADA +/- MTX arm. AE and serious AE rates were similar in patients receiving ADA with versus without MTX. No deaths or malignancies were reported. New users in the ADA +/- MTX arm showed a trend toward lower mean JADAS-27(CRP)compared with new users in the MTX arm in the first year of STRIVE. Conclusion The STRIVE registry 7-year interim results support the idea that ADA +/- MTX is well tolerated by most children. Registry median ADA exposure was 2.47 (interquartile range 1.0-3.6) years, with 42% of patients continuing ADA at the 7-year cutoff date.

Published
2020

9. Efficacy and Safety of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis With and Without Fever at Baseline: Results From an Open-Label, Active-Treatment Extension Study.

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Brunner, Hermine I, Quartier, Pierre, Alexeeva, Ekaterina, Constantin, Tamàs, Koné-Paut, Isabelle, Marzan, Katherine, Schneider, Rayfel, Wulffraat, Nico M, Chasnyk, Vyacheslav, Tirosh, Irit, Kallinich, Tilmann, Kuemmerle-Deschner, Jasmin, Wouters, Carine, Lauwerys, Bernard, Nikishina, Irina, Trachana, Maria, Vougiouka, Olga, Martini, Alberto, Lovell, Daniel J, Levy, Jeremy, Vritzali, Eleni, Ruperto, Nicolino, Paediatric Rheumatology International Trials Organisation, the Pediatric Rheumatology Collaborative Study Group, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, UCL - (SLuc) Service de rhumatologie, Brunner, Hermine I, Quartier, Pierre, Alexeeva, Ekaterina, Constantin, Tamàs, Koné-Paut, Isabelle, Marzan, Katherine, Schneider, Rayfel, Wulffraat, Nico M, Chasnyk, Vyacheslav, Tirosh, Irit, Kallinich, Tilmann, Kuemmerle-Deschner, Jasmin, Wouters, Carine, Lauwerys, Bernard, Nikishina, Irina, Trachana, Maria, Vougiouka, Olga, Martini, Alberto, Lovell, Daniel J, Levy, Jeremy, Vritzali, Eleni, Ruperto, Nicolino, and Paediatric Rheumatology International Trials Organisation, the Pediatric Rheumatology Collaborative Study Group

Abstract

OBJECTIVE: To evaluate the long-term efficacy and safety of canakinumab and explore prediction of response in patients with systemic juvenile idiopathic arthritis (JIA) with or without fever at treatment initiation. METHODS: At enrollment, patients with active systemic JIA (ages 2 to <20 years) started open-label canakinumab (4 mg/kg every 4 weeks subcutaneously). Efficacy measures included the adapted American College of Rheumatology (ACR) Pediatric 50/70/90 criteria, the Juvenile Arthritis Disease Activity Score (JADAS), and clinically inactive disease and clinical remission on medication, evaluated by either the JADAS or ACR criteria. RESULTS: Of the 123 patients (70 with fever and 52 without fever [fever status was not reported for 1 patient]), 84 (68.3%) completed the study (median duration 1.8 years). Comparable efficacy (adapted ACR Pediatric 50/70/90/100) was observed by day 15 in both subgroups (60.0%/48.6%/37.1%/24.3% in those with fever and 67.3%/48.1%/34.6%/19.2% in those without fever), and further increased thereafter. By month 6, clinical remission according to the JADAS or the ACR criteria was achieved in 17 (24.3%) and 26 (37.1%), respectively, of patients with fever and 9 (17.3%) and 12 (23.1%), respectively, of patients without fever. Median time to onset of clinical remission according to the JADAS or ACR criteria was 57 and 30 days, respectively, in those with fever, and 58 and 142 days, respectively, in those without fever. An adapted ACR Pediatric 50 response by day 15 was the strongest predictor of achieving clinical remission according to the JADAS (odds ratio [OR] 13 [95% confidence interval (95% CI) 4, 42]; P < 0.0001) or glucocorticoid discontinuation (OR 19 [95% CI 3, 114]; P = 0.002). Of the 71 of 123 patients (57.7%) who received glucocorticoids at study entry, 27 (38.0%) discontinued glucocorticoids and 21 (29.6%) reached a dose of <0.2 mg/kg/day, with no difference between those with and those without fever; 13 patients (10.6%) toler

Published
2020

10. Systemic Juvenile Idiopathic Arthritis–Associated Lung Disease: Characterization and Risk Factors

Author

Schulert, Grant S., primary, Yasin, Shima, additional, Carey, Brenna, additional, Chalk, Claudia, additional, Do, Thuy, additional, Schapiro, Andrew H., additional, Husami, Ammar, additional, Watts, Allen, additional, Brunner, Hermine I., additional, Huggins, Jennifer, additional, Mellins, Elizabeth D., additional, Morgan, Esi M., additional, Ting, Tracy, additional, Trapnell, Bruce C., additional, Wikenheiser‐Brokamp, Kathryn A., additional, Towe, Christopher, additional, and Grom, Alexei A., additional

Published
2019
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11. Serum S100A8/A9 and S100A12 Levels in Children With Polyarticular Forms of Juvenile Idiopathic Arthritis: Relationship to Maintenance of Clinically Inactive Disease During Anti–Tumor Necrosis Factor Therapy and Occurrence of Disease Flare After Discontinuation of Therapy

Author

Hinze, Claas H., primary, Foell, Dirk, additional, Johnson, Anne L., additional, Spalding, Steven J., additional, Gottlieb, Beth S., additional, Morris, Paula W., additional, Kimura, Yukiko, additional, Onel, Karen, additional, Li, Suzanne C., additional, Grom, Alexei A., additional, Taylor, Janalee, additional, Brunner, Hermine I., additional, Huggins, Jennifer L., additional, Nocton, James J., additional, Haines, Kathleen A., additional, Edelheit, Barbara S., additional, Shishov, Michael, additional, Jung, Lawrence K., additional, Williams, Calvin B., additional, Tesher, Melissa S., additional, Costanzo, Denise M., additional, Zemel, Lawrence S., additional, Dare, Jason A., additional, Passo, Murray H., additional, Ede, Kaleo C., additional, Olson, Judyann C., additional, Cassidy, Elaine A., additional, Griffin, Thomas A., additional, Wagner‐Weiner, Linda, additional, Weiss, Jennifer E., additional, Vogler, Larry B., additional, Rouster‐Stevens, Kelly A., additional, Beukelman, Timothy, additional, Cron, Randy Q., additional, Kietz, Daniel, additional, Schikler, Kenneth, additional, Mehta, Jay, additional, Ting, Tracy V., additional, Verbsky, James W., additional, Eberhard, Anne B., additional, Huang, Bin, additional, Giannini, Edward H., additional, and Lovell, Daniel J., additional

Published
2019
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12. Risk, Timing, and Predictors of Disease Flare After Discontinuation of Anti-Tumor Necrosis Factor Therapy in Children With Polyarticular Forms of Juvenile Idiopathic Arthritis With Clinically Inactive Disease

Author

Lovell, Daniel J., primary, Johnson, Anne L., additional, Huang, Bin, additional, Gottlieb, Beth S., additional, Morris, Paula W., additional, Kimura, Yukiko, additional, Onel, Karen, additional, Li, Suzanne C., additional, Grom, Alexei A., additional, Taylor, Janalee, additional, Brunner, Hermine I., additional, Huggins, Jennifer L., additional, Nocton, James J., additional, Haines, Kathleen A., additional, Edelheit, Barbara S., additional, Shishov, Michael, additional, Jung, Lawrence K., additional, Williams, Calvin B., additional, Tesher, Melissa S., additional, Costanzo, Denise M., additional, Zemel, Lawrence S., additional, Dare, Jason A., additional, Passo, Murray H., additional, Ede, Kaleo C., additional, Olson, Judyann C., additional, Cassidy, Elaine A., additional, Griffin, Thomas A., additional, Wagner-Weiner, Linda, additional, Weiss, Jennifer E., additional, Vogler, Larry B., additional, Rouster-Stevens, Kelly A., additional, Beukelman, Timothy, additional, Cron, Randy Q., additional, Kietz, Daniel, additional, Schikler, Kenneth, additional, Schmidt, Kara M., additional, Mehta, Jay, additional, Wahezi, Dawn M., additional, Ting, Tracy V., additional, Verbsky, James W., additional, Eberhard, B. Anne, additional, Spalding, Steven, additional, Chen, Chen, additional, and Giannini, Edward H., additional

Published
2018
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15. Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis : Results From a Phase III Open-Label Study

Author

UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, Brunner, Hermine I., Tzaribachev, Nikolay, Vega-Cornejo, Gabriel, Louw, Ingrid, Berman, Alberto, Calvo Penadés, Inmaculada, Antón, Jordi, Ávila-Zapata, Francisco, Cuttica, Rubén, Horneff, Gerd, Foeldvari, Ivan, Keltsev, Vladimir, Kingsbury, Daniel J., Viola, Diego Oscar, Joos, Rik, Lauwerys, Bernard, Paz Gastañaga, Maria Eliana, Rama, Maria Elena, Wouters, Carine, Bohnsack, John, Breedt, Johannes, Fischbach, Michel, Lutz, Thomas, Minden, Kirsten, Miraval, Tatiana, Ally, Mahmood M. T. M., Rubio-Pérez, Nadina, Solau Gervais, Elisabeth, van Zyl, Riana, Li, Xiaohui, Nys, Marleen, Wong, Robert, Banerjee, Subhashis, Lovell, Daniel J., Martini, Alberto, Ruperto, Nicolino, UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales, Brunner, Hermine I., Tzaribachev, Nikolay, Vega-Cornejo, Gabriel, Louw, Ingrid, Berman, Alberto, Calvo Penadés, Inmaculada, Antón, Jordi, Ávila-Zapata, Francisco, Cuttica, Rubén, Horneff, Gerd, Foeldvari, Ivan, Keltsev, Vladimir, Kingsbury, Daniel J., Viola, Diego Oscar, Joos, Rik, Lauwerys, Bernard, Paz Gastañaga, Maria Eliana, Rama, Maria Elena, Wouters, Carine, Bohnsack, John, Breedt, Johannes, Fischbach, Michel, Lutz, Thomas, Minden, Kirsten, Miraval, Tatiana, Ally, Mahmood M. T. M., Rubio-Pérez, Nadina, Solau Gervais, Elisabeth, van Zyl, Riana, Li, Xiaohui, Nys, Marleen, Wong, Robert, Banerjee, Subhashis, Lovell, Daniel J., Martini, Alberto, and Ruperto, Nicolino

Published
2018

16. Identification of Optimal Subcutaneous Doses of Tocilizumab in Children with Systemic Juvenile Idiopathic Arthritis

Author

Brunner, Hermine I., Ruperto, Nicola, Lovell, Daniel J., Horneff, Gerd, Gamir-Gamir, Maria Luz, Hufnagel, Markus, Hsu, Joy, Bao, Min, Douglass, Wendy, Mallalieu, Navita L., Wells, Chris, Mala, Christopher M., De Benedetti, Fabrizio, Brunner, Hermine I., Ruperto, Nicola, Lovell, Daniel J., Horneff, Gerd, Gamir-Gamir, Maria Luz, Hufnagel, Markus, Hsu, Joy, Bao, Min, Douglass, Wendy, Mallalieu, Navita L., Wells, Chris, Mala, Christopher M., and De Benedetti, Fabrizio

Published
2018

17. Long-Term Safety of Subcutaneous Tocilizumab Administration in Systemic and Polyarticular Juvenile Idiopathic Arthritis

Author

Brunner, Hermine I., Ruperto, Nicola, Martini, Alberto, Ramanan, Athimalaipet V., Cuttica, Ruben J., Weiss, Jennifer E., Henrickson, Michael, Schmeling, Heinrike, Anton, Jordi, Minden, Kirsten, Horneff, Gerd, Luz Gamir-Gamir, Maria, Hufnagel, Markus, Douglass, Wendy, Wells, Chris, Wimalasundera, Sunethra, Mallalieu, Navita L., Lovell, Daniel J., De Benedetti, Fabrizio, Brunner, Hermine I., Ruperto, Nicola, Martini, Alberto, Ramanan, Athimalaipet V., Cuttica, Ruben J., Weiss, Jennifer E., Henrickson, Michael, Schmeling, Heinrike, Anton, Jordi, Minden, Kirsten, Horneff, Gerd, Luz Gamir-Gamir, Maria, Hufnagel, Markus, Douglass, Wendy, Wells, Chris, Wimalasundera, Sunethra, Mallalieu, Navita L., Lovell, Daniel J., and De Benedetti, Fabrizio

Published
2018

18. Predictors of Reduced Health‐Related Quality of Life in Adult Patients With Idiopathic Inflammatory Myopathies

Author

Feldon, Michal, primary, Farhadi, Payam Noroozi, additional, Brunner, Hermine I., additional, Itert, Lukasz, additional, Goldberg, Bob, additional, Faiq, Abdullah, additional, Wilkerson, Jesse, additional, Rose, Kathryn M., additional, Rider, Lisa G., additional, Miller, Frederick W., additional, and Giannini, Edward H., additional

Published
2017
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21. Development of a Novel Renal Activity Index of Lupus Nephritis in Children and Young Adults

Author

Brunner, Hermine I., primary, Bennett, Michael R., additional, Abulaban, Khalid, additional, Klein‐Gitelman, Marisa S., additional, O'Neil, Kathleen M., additional, Tucker, Lori, additional, Ardoin, Stacy P., additional, Rouster‐Stevens, Kelly A., additional, Onel, Karen B., additional, Singer, Nora G., additional, Anne Eberhard, B., additional, Jung, Lawrence K., additional, Imundo, Lisa, additional, Wright, Tracey B., additional, Witte, David, additional, Rovin, Brad H., additional, Ying, Jun, additional, and Devarajan, Prasad, additional

Published
2016
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23. Validation of the Lupus Nephritis Clinical Indices in Childhood-Onset Systemic Lupus Erythematosus

Author

Mina, Rina, primary, Abulaban, Khalid, additional, Klein-Gitelman, Marisa S., additional, Eberhard, Barbara A., additional, Ardoin, Stacy P., additional, Singer, Nora, additional, Onel, Karen, additional, Tucker, Lori, additional, O'neil, Kathleen, additional, Wright, Tracey, additional, Brooks, Elizabeth, additional, Rouster-Stevens, Kelly, additional, Jung, Lawrence, additional, Imundo, Lisa, additional, Rovin, Brad, additional, Witte, David, additional, Ying, Jun, additional, and Brunner, Hermine I., additional

Published
2016
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24. Initial Benchmarking of the Quality of Medical Care in Childhood-Onset Systemic Lupus Erythematosus

Author

Mina, Rina, primary, Harris, Julia G., additional, Klein-Gitelman, Marisa S., additional, Appenzeller, Simone, additional, Centeville, Maraisa, additional, Eskra, Diane, additional, Huggins, Jennifer L., additional, Johnson, Anne L., additional, Khubchandani, Raju, additional, Khandekar, Prachi, additional, Lee, Jiha, additional, Liu, Hai Mei, additional, Pendl, Joshua D., additional, Silva, Clovis A., additional, Silva, Marco F., additional, Zaal, Ahmad I., additional, DeWitt, Esi Morgan, additional, Ardoin, Stacy P., additional, and Brunner, Hermine I., additional

Published
2016
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25. A134: Validation of Patient Reported Outomes Measurement Information System Modules for use in Childhood-;onset Lupus

Author

Alexandria J. Greenler, Jennifer Huggins, Kasha Wiley, Laura E. Schanberg, Shannen L. Nelson, Brunner Hermine, Jun Ying, Jordan T. Jones, Jiha Lee, Brianna Liberio, and Janet Wootton

Subjects
Patient-Reported Outcomes Measurement Information System, medicine.medical_specialty, education.field_of_study, business.industry, Immunology, Concurrent validity, Population, Discriminant validity, Construct validity, Standard score, Rheumatology, Quality of life, Physical therapy, Immunology and Allergy, Medicine, Electronic data, business, education
Abstract

Background/Purpose: Childhood-onset lupus (cSLE) is a chronic autoimmune disease and its effect on health-related quality of life (HRQoL) has not been systematically established. The Patient Reported Outcomes Measurement Information System (PROMIS™, http://nihpromis.org) is a publicly available system to measure patient reported outcomes that features electronic data collection. Although several validated legacy QoL measures exist for cSLE, each is longer than the PROMIS™ Pediatric Short Forms (Short Forms). The objective of this study was to investigate the feasibility, construct and discriminant validity of the Short Forms in cSLE in a clinical setting. Methods: In this ongoing study at two sites, 98 of 100 projected patients completed the Pediatric PROMIS™ Short Forms (Anger, Anxiety, Depressive, Fatigue, Mobility, Upper Extremity, Pain Interference, Peer Relations) and legacy QoL measures (Pediatric Quality of Life Inventory™ Generic Core [GC] & Rheumatology Modules [RM], Simple Measure Of Impact Of Lupus Erythematosus In Youngsters [SMILEY], Childhood Health Assessment Questionnaire [CHAQ], Child Health Questionnaire [CHQ], pain and well-being visual analog scales [VAS]). Questionnaire scores were compared and Spearman correlation analysis was performed in support of the construct validity of the Short Forms when used in cSLE. The discriminant validity was supported by analysis of PROMIS™ and legacy QoL score change at sequential visits and relationship of change was made with Spearman correlation analysis (to be shown). Results: Participants (78% female; 41% White, 44% Black, 6% Asian) had a mean age of 16 yrs (SD 3) and mean SLEDAI score of 6.07 (SD 5.99). There were no problems with completion of any of the PROMIS™ Short Forms (mean score = 50, clinically relevant difference = 10) which required 5–10 minutes in total (legacy QoL tools >15 min. each). On average, cSLE patients scored importantly worse in the Short Form assessing upper extremity function and mobility than the healthy children, while the other QoL domains were less affected (Table 1). This is also supported by the scores of the CHQ–PHS. Concurrent validity of the Short Forms is supported by moderate correlations with the scores of various legacy measures (to be shown). Table 1. Comparative scores for HRQoL in cSLE* PROMIS Short formsa CHAQ PedsQL-GC PedsQL-RM SMILEY CHQ-P50 Values are means (standard deviations). a The PROMIS™ short forms use T score distributions (50 represents the average for the US general population, with a standard deviation of 10. High scores represent more of the concept being measured (for negatively-worded concepts like pain, fatigue, and anxiety, a 60 is one standard deviation worse than average; for positively-worded concepts like physical or peer relationships, a 60 is one standard deviation better than average). Anger 52.0 (4.3) Emotional 74.1 (21.1) Worry 70.0 (27.6) Effect 63.3 (19.9) Behavior (BE) 83.4 (15.9) Anxiety 49.6 (3.8) Treatment 80.8 (15.0) Burden 60.1 (17.4) Mental Health (MH) 77.5 (15.9) Depression 51.9 (3.2) Self-esteem (SE) 81.8 (15.5) Fatigue 53.5 (3.4) Role/Social Limits-Physical (RP) 87.5 (25.8) Mobility 42.8 (3.5) Walk 0.3 (0.6) Physical 74.0 (20.3) Activity 87.0 (17.7) Limitation 68.2 (17.0) Physical Function (PF) 78.2 (30.5) Arise 0.4 (0.6) Hygiene 0.3 (0.7) Play 0.7 (0.9) Upper Extremity Function 46.1 (3.9) Dress & Groom 0.3 (0.7) Physical Summary (PHS) 43.0 (13.2) Eat 0.3 (0.7) Reach 0.5 (0.8) Grip 0.4 (0.7) Pain 52.7 (3.1) Pain 66.1 (28.2) Bodily Pain/Discomfort (BP) 65.7 (29.7) Peer Relations 46.7 (3.5) Social 82.4 (20.0) Social 72.8 (18.6) Social & Emotional Limits (REB) 86.0 (29.3) General Health Perception (GH) 56.6 (14.9) School 66.0 (20.3) Communicate 71.6 (27.6) Psychosocial Summary (PSS) 52.8 (7.9) Completed by Child Completed by Parent Conclusion: This pilot study supports QoL measurement using the PROMIS™ Short Forms as feasible and concurrently valid. PROMIS™ measures can now be utilized by clinicians treating cSLE for a more efficient patient reported health outcomes measure, taking advantage of their easy interpretation of scores and changes in scores, thereby, reducing respondent burden and making QoL assessment feasible in both research and clinical care settings.

Published
2014
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26. A133: Initial Benchmarking of the Quality of Medical Care of Children and Adolescents with Lupus

Author

Jiha Lee, Marco F. Silva, Ahmad I. Zaal, Jennifer Huggins, Anne Johnson, Simone Appenzeller, Julia G. Harris, HaiMei Liu, Clovis A. Silva, Maraisa Centeville, Brunner Hermine, and Joshua Pendl

Subjects
Nephrology, medicine.medical_specialty, Pediatrics, Proteinuria, Systemic lupus erythematosus, business.industry, Medical record, medicine.medical_treatment, Immunology, Lupus nephritis, medicine.disease, visual_art.visual_artist, Rheumatology, Sunbathing, Internal medicine, visual_art, medicine, Physical therapy, Immunology and Allergy, Smoking cessation, medicine.symptom, business, Patient education
Abstract

Background/Purpose: Recently, 26 quality indicators (QI) categorized into 9 domains for childhood-onset systemic lupus erythematous (cSLE) have been developed based on international consensus and scientific evidence. QI are defined as minimum standards of medical care in support of optimal disease outcomes. The current level at which these QI are followed has not been well documented. Hence, the objective of this study is to assess the current quality of medical care received by patients with cSLE at tertiary pediatric rheumatology centers. Methods: Cross-sectional data pertaining to the QI were acquired via chart review and analyzed collectively in 290 cSLE patients followed at four tertiary pediatric rheumatology centers—two in the United States and two in Brazil. Results: Adherence to the QI differed by QI domain, ranging from 41 to 100%. The QI domain with the highest adherence 100% was Laboratory Testing at the time of diagnosis, and the lowest domain 41% was Medication Management. The recommended kidney biopsies for newly diagnosed lupus nephritis were done in only 67% of the patients and 85% of the patients received at least one of the recommended vaccinations (Table 1). Cardiovascular risks factors were discussed in 86% of cases when patient was 13 years or older. Adherence to the QI differences between countries and insurance status will be presented, supporting that the set of current QI are suitable for international use. Table 1. Adherence to QI by Domain Quality Indicators by Domain Results Lab testing at diagnosis & screening Obtained diagnostic/confirmatory labs within first two visits 100% Obtained lab surveillance of CBC, renal, LFT every 12 months 85% General prevention Prescribed influenza and/or encapsulated organisms vaccination, unless contraindicated 85% Discussed and documented education on sun avoidance at least once in the medical record (e.g., wearing protective clothing, applying sunscreens whenever outdoors, and avoiding sunbathing) 89% Discussed transition plan to appropriate adult healthcare providers with patient age ≥14 years. 78% Lupus nephritis (LN) and hypertension management Kidney biopsy discussed/ordered/performed if developed proteinuria >500 mg/day, or worsening GFR, or urinary sediment 60% Evaluated by a nephrologist in the last year of care for lupus nephritis (LN) and of hypertension 65% Evaluated by rheumatologist every 3 months in last year if a patient has known LN regardless of disease activity. 96% Received kidney biopsy when diagnosed with LN 67% Class III/IV, treated with immunosuppressive + glucocorticoids within 1 month 92% Angiotensin receptor blocker (ARB) or, Angiotensin–converting enzyme (ACE) inhibitor were prescribed if ongoing proteinuria >500 mg/day or worsening GFR in last year of care. 96% Check assessments (Kidney function, urine sediment, and proteinuria) every three months. 99% Medication Management If started new meds, discussed risk vs. benefit of therapy 97% Currently prescribed any antimalarial therapy 92% Attempted to taper a dose of steroids not acceptable for chronic use. 89% Attempted to taper and unable to decrease steroid; added/increased steroid sparing agent. 41% Surveillance for medication safety done at regular intervals. 99% Bone Health Received at least one bone mineral density testing DEXA scan 72% Repeat bone mineral density testing if baseline testing outside normal limits (Z score ≤2) 62% Prescribed calcium/vitamin D if a patient is on any steroid therapy. 78% Ophthalmological surveillance Receives eye exams annually while on anti-malarial therapy 82% Receives eye exams annually while on glucocorticoids 85% Education on cardiovascular risk factors Education on cardiovascular risk factors (smoking, hypertension, high BMI) every 1 year with patient and parent if patient is 13 years or older. 86% Discussed lifestyle modifications (smoking cessation, weight control, exercise) every 2 years with parent and patient 13 years or older. 87% Pregnancy Anti-SSA, anti-SB and anti-phospholipid antibodies have been assessed during pregnancy 100% CNS health Prescribed Immunosuppressive therapy if patient has major neuropsychiatric manifestations in last year of care (Optic neuritis, coma, psychosis … etc.) 94% Conclusion: Based on this initial benchmarking effort, the medical care of patients with cSLE at tertiary pediatric rheumatology centers is very good. Systematic planning and documentation of patient education on lifestyle modifications seems warranted and is expected to improve the self-management skills of cSLE patients. Furthermore, increased focus on bone health, eye exams annually, and adequate vaccination of cSLE patients are areas to continue to monitor.

Published
2014
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28. Cognitive Performance Scores for the Pediatric Automated Neuropsychological Assessment Metrics in Childhood-Onset Systemic Lupus Erythematosus

Author

Vega-Fernandez, Patricia, primary, Vanderburgh White, Shana, additional, Zelko, Frank, additional, Ruth, Natasha M., additional, Levy, Deborah M., additional, Muscal, Eyal, additional, Klein-Gitelman, Marisa S., additional, Huber, Adam M., additional, Tucker, Lori B., additional, Roebuck-Spencer, Tresa, additional, Ying, Jun, additional, and Brunner, Hermine I., additional

Published
2015
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29. Distinctions Between Diagnostic and Classification Criteria?

Author

Aggarwal, Rohit, primary, Ringold, Sarah, additional, Khanna, Dinesh, additional, Neogi, Tuhina, additional, Johnson, Sindhu R., additional, Miller, Amy, additional, Brunner, Hermine I., additional, Ogawa, Rikke, additional, Felson, David, additional, Ogdie, Alexis, additional, Aletaha, Daniel, additional, and Feldman, Brian M., additional

Published
2015
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30. Randomized, Double-Blind, Dose-Escalation Trial of Triptorelin for Ovary Protection in Childhood-Onset Systemic Lupus Erythematosus

Author

Brunner, Hermine I., primary, Silva, Clovis A., additional, Reiff, Andreas, additional, Higgins, Gloria C., additional, Imundo, Lisa, additional, Williams, Calvin B., additional, Wallace, Carol A., additional, Aikawa, Nadia E., additional, Nelson, Shannen, additional, Klein-Gitelman, Marisa S., additional, and Rose, Susan R., additional

Published
2015
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33. A4: Efficacy and Safety of Tocilizumab in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: 2-Year Data From CHERISH

Author

Brunner, Hermine, primary, Ruperto, Nicolino, additional, Zuber, Zbigniew, additional, Cuttica, Rubén J., additional, Xavier, Ricardo, additional, Calvo, Inmaculada, additional, Rubio, Nadina, additional, Alekseeva, Ekaterina, additional, Chasnyk, Vyacheslav, additional, Chavez, Jose, additional, Horneff, Gerd, additional, Opoka-Winiarska, Violetta, additional, Quartier, Pierre, additional, Spindler, Alberto, additional, Keane, Caroline, additional, Bharucha, Kamal N., additional, Wang, Jianmei, additional, Lovell, Daniel J., additional, Martini, Alberto, additional, and De Benedetti, Fabrizio, additional

Published
2014
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34. A148: A Multi-Center, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab in Pediatric Patients With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy: Week 48 Results

Author

Brunner, Hermine, primary, Ruperto, N., additional, Tzaribachev, N., additional, Horneff, G., additional, Wouters, C., additional, Panaviene, V., additional, Chasnyk, V., additional, Abud-Mendoza, C., additional, Cuttica, R., additional, Reiff, A., additional, Maldonado-Velázquez, M., additional, Rubio-Perez, N., additional, Alexeeva, Ekaterina, additional, Joos, R., additional, Keltsev, V., additional, Nasonov, E., additional, Kingsbury, D., additional, Bandeira, M., additional, Silverman, E., additional, Weller-Heinemann, F., additional, van Royen-Kerkhof, A., additional, Mendelsohn, Alan, additional, Kim, Lilianne, additional, Lovell, D., additional, and Martini, A., additional

Published
2014
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36. A78: Urine Biomarkers Role in Predicting the Future Development of Renal Functional Loss With Lupus Nephritis in Children and Adults

Author

Abulaban, Khalid, primary, Brunner, Hermine, additional, Nelson, Shannen L., additional, Bennett, Michael, additional, Ying, Jun, additional, Song, Huijuan, additional, Kimmel, Paul, additional, Kusek, John, additional, Feldman, Harold, additional, Ramachandran, Vasan, additional, and Rovin, Brad H., additional

Published
2014
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37. A6: Tapering and Withdrawal of Tocilizumab in Patients With Systemic Juvenile Idiopathic Arthritis in Inactive Disease: Results From an Alternative Dosing Regimen in the TENDER Study

Author

De Benedetti, Fabrizio, primary, Ruperto, Nicolino, additional, Brunner, Hermine, additional, Grom, Alexei A., additional, Wulffraat, Nico, additional, Henrickson, Michael, additional, Jerath, Rita, additional, Kimura, Yuki, additional, Kadva, Alysha K., additional, Wang, Jianmei, additional, Martini, Alberto, additional, and Lovell, Daniel J., additional

Published
2014
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38. A52: The Impact of Adalimumab on Growth in Patients With Juvenile Idiopathic Arthritis

Author

Lovell, Daniel J., primary, Ruperto, Nicola, additional, Jarosova, Katerina, additional, Nemcova, Dana, additional, Vargova, Veronika, additional, Michels, Hartmut, additional, Chalom, Elizabeth, additional, Ilowite, Norman, additional, Wouters, Carine, additional, Brunner, Hermine, additional, Kupper, Hartmut, additional, Giannini, Edward, additional, and Martini, Alberto, additional

Published
2014
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39. A14: Neutropenia With Tocilizumab Treatment Is Not Associated With Increased Infection Risk in Patients With Systemic Juvenile Idiopathic Arthritis

Author

De Benedetti, Fabrizio, primary, Ruperto, Nicolino, additional, Baildam, Eileen, additional, Burgos-Vargas, Ruben, additional, Horneff, Gerd, additional, Huppertz, Hans Iko, additional, Minden, Kirsten, additional, Myones, Barry L., additional, Onel, Karen, additional, Wang, Jianmei, additional, Bharucha, Kamal N., additional, Lovell, Daniel J., additional, Martini, Alberto, additional, and Brunner, Hermine, additional

Published
2014
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41. A45: Neutropenia With Tocilizumab Treatment Is Not Associated With Increased Infection Risk in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Author

Benedetti, Fabrizio De, primary, Rubio-Pérez, Nadina, additional, Salazar, Carolina Duarte, additional, Goodman, Steven, additional, Job-Deslandre, Chantal, additional, Joos, Rik, additional, Kone-Paut, Isabelle, additional, Minden, Kirsten, additional, Onel, Karen, additional, Porter-Brown, Benjamin, additional, Bharucha, Kamal, additional, Wang, Jianmei, additional, Martini, Alberto, additional, Lovell, Daniel J., additional, and Brunner, Hermine I., additional

Published
2014
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42. A22: Consensus Treatment Plans for Induction Therapy in Childhood Proliferative Lupus Nephritis-Status of Use in Daily Clinical Care

Author

von Scheven, Emily, primary, Punaro, Marilynn, additional, Ardoin, Stacy P., additional, Brunner, Hermine, additional, Hsu, Joyce J., additional, Mehta, Jay, additional, Wagner-Weiner, Linda, additional, Klein-Gitelman, Marisa, additional, Rouster Stevens, Kelly, additional, Haines, Kathleen A., additional, Schanberg, Laura, additional, and Eberhard, B. Anne, additional

Published
2014
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43. A33: Cognitive Performance Scores for the Pediatric Automated Neuropsychological Assessment Metrics in Childhood-Onset Systemic Lupus Erythematosus

Author

Vega-Fernandez, Patricia, primary, Vanderburgh, Shana, additional, Ruth, Natasha M., additional, Levy, Deborah M., additional, Zelko, Frank A., additional, Muscal, Eyal, additional, Klein-Gitelman, Marisa S., additional, Huber, Adam, additional, Wiley, Kasha, additional, Thomas, Erin C., additional, Tucker, Lori B., additional, Roebuck-Spencer, Tresa, additional, Ying, Jun, additional, and Brunner, Hermine, additional

Published
2014
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44. A66: Assessment of Radiographic Progression in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Tocilizumab: 2-Year Results From the TENDER Trial

Author

Malattia, Clara, primary, Ruperto, Nicolino, additional, Palmisani, Elena, additional, Pederzoli, Silvia, additional, Pistorio, Angela, additional, Brunner, Hermine, additional, Cuttica, Rubén J., additional, Calvo, Inmaculada, additional, Garay, Stella Maris, additional, Eleftheriou, Despina, additional, Wouters, Carine, additional, Wang, Jianmei, additional, Devlin, Clare, additional, Lovell, Daniel J., additional, Martini, Alberto, additional, De Benedetti, Fabrizio, additional, and Ravelli, Angelo, additional

Published
2014
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45. A58: Demographics, Clinical Features and Therapies of Patients with Juvenile Dermatomyositis Participating in a National Myositis Patient Registry

Author

Rider, Lisa G, primary, Faiq, Abdullah, additional, Farhadi, Payam Noroozi, additional, Bayat, Nastaran, additional, Itert, Lukasz, additional, Chase, Mikaela, additional, Ulrey, Robert, additional, Malley, Karen, additional, Wilkerson, Jesse, additional, Johnson, Anne, additional, Rose, Kathryn, additional, Morris, Richard, additional, Parks, Christine, additional, Giannini, Edward H., additional, Brunner, Hermine, additional, Goldberg, Bob, additional, and Miller, Frederick W, additional

Published
2014
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46. A54: Insulin Sensitivity Is Improved in sJIA Children With Insulin Resistance After Tocilizumab Treatment: Results From the TENDER Study

Author

Mirjafari, Hoda, primary, Ruperto, Nicolino, additional, Brunner, Hermine I., additional, Zuber, Zbigniew, additional, Zulian, Francesco, additional, Maldonado-Velázquez, Maria del Rocio, additional, Mantzourani, Evangelia, additional, Murray, Kevin, additional, Roth, Johannes, additional, Rovensky, Jozef, additional, Vougiouka, Olga, additional, Wang, Jianmei, additional, Harari, Olivier, additional, Lovell, Daniel J., additional, Martini, Alberto, additional, and De Benedetti, Fabrizio, additional

Published
2014
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48. International Consensus for Provisions of Quality‐Driven Care in Childhood‐Onset Systemic Lupus Erythematosus

Author

Hollander, Matthew C., primary, Sage, Jessica M., additional, Greenler, Alexandria J., additional, Pendl, Joshua, additional, Avcin, Tadej, additional, Espada, Graciela, additional, Beresford, Michael W., additional, Henrickson, Michael, additional, Lee, Tsz‐Leung, additional, Punaro, Marilynn, additional, Huggins, Jennifer, additional, Stevens, Anne M., additional, Klein‐Gitelman, Marisa S., additional, and Brunner, Hermine I., additional

Published
2013
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49. Brain Morphometric Changes Associated With Childhood‐Onset Systemic Lupus Erythematosus and Neurocognitive Deficit

Author

Gitelman, Darren R., primary, Klein‐Gitelman, Marisa S., additional, Ying, Jun, additional, Sagcal‐Gironella, Anna Carmela P., additional, Zelko, Frank, additional, Beebe, Dean W., additional, DiFrancesco, Mark, additional, Parrish, Todd, additional, Hummel, Jessica, additional, Beckwith, Travis, additional, and Brunner, Hermine I., additional

Published
2013
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50. Validation of the Pediatric Automated Neuropsychological Assessment Metrics in childhood-onset systemic lupus erythematosus

Author

Brunner, Hermine I., primary, Klein-Gitelman, Marisa S., additional, Zelko, Frank, additional, Thomas, Erin C., additional, Hummel, Jessica, additional, Nelson, Shannen M., additional, Huggins, Jennifer, additional, Curran, Megan L., additional, Roebuck-Spencer, Tresa, additional, Beebe, Dean W., additional, and Ying, Jun, additional

Published
2013
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