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351. 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

354. 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

355. Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials

Author

Ruperto, Nicolino, Brunner, Hermine I., Quartier, Pierre, Constantin, Tamas, Wulffraat, Nico M., Horneff, Gerd, Kasapcopur, Ozgur, Schneider, Rayfel, Anton, Jordi, Barash, Judith, Berner, Reinhard, Corona, Fabrizia, Cuttica, Ruben, Fouillet-desjonqueres, Marine, Fischbach, Michel, Foster, Helen E., Foell, Dirk, Radominski, Sebastiao C., Ramanan, Athimalaipet V., Trauzeddel, Ralf, Unsal, Erbil, Levy, Jeremy, Vritzali, Eleni, Martini, Alberto, Lovell, Daniel J., Ruperto, Nicolino, Brunner, Hermine I., Quartier, Pierre, Constantin, Tamas, Wulffraat, Nico M., Horneff, Gerd, Kasapcopur, Ozgur, Schneider, Rayfel, Anton, Jordi, Barash, Judith, Berner, Reinhard, Corona, Fabrizia, Cuttica, Ruben, Fouillet-desjonqueres, Marine, Fischbach, Michel, Foster, Helen E., Foell, Dirk, Radominski, Sebastiao C., Ramanan, Athimalaipet V., Trauzeddel, Ralf, Unsal, Erbil, Levy, Jeremy, Vritzali, Eleni, Martini, Alberto, and Lovell, Daniel J.

Abstract

Objectives To evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA). Methods Patients (2-19 years) entered two phase III studies and continued in the long-term extension (LTE) study. Efficacy assessments were performed every 3 months, including adapted JIA American College of Rheumatology (aJIA-ACR) criteria, Juvenile Arthritis Disease Activity Score (JADAS) and ACR clinical remission on medication criteria (CRACR). Efficacy analyses are reported as per the intent-to-treat population. Results 144 of the 177 patients (81%) enrolled in the core study entered the LTE. Overall, 75 patients (42%) completed and 102 (58%) discontinued mainly for inefficacy (63/102, 62%), with higher discontinuation rates noted in the late responders group (n=25/31, 81%) versus early responders (n=11/38, 29%). At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively. CRACR was achieved by 20% of patients at month 6; 32% at 2 years. A JADAS low disease activity score was achieved by 49% of patients at 2 years. Efficacy results were maintained up to 5 years. Of the 128/177 (72.3%) patients on glucocorticoids, 20 (15.6%) discontinued and 28 (22%) tapered to 0.150 mg/kg/ day. Seven patients discontinued canakinumab due to CR. There were 13 macrophage activation syndrome (three previously reported) and no additional deaths (three previously reported). No new safety findings were observed. Conclusion Response to canakinumab treatment was sustained and associated with substantial glucocorticoid dose reduction or discontinuation and a relatively low retention-on-treatment rate. No new safety findings were observed on long-term use of canakinumab.

Published
2018

356. Vitamin D deficiency is associated with higher disease activity and the risk for uveitis in juvenile idiopathic arthritis - data from a German inception cohort

Author

Sengler, Claudia, Zink, Julian, Klotsche, Jens, Niewerth, Martina, Liedmann, Ina, Horneff, Gerd, Kessel, Christoph, Ganser, Gerd, Thon, Angelika, Haas, Johannes-Peter, Hospach, Anton, Weller-Heinemann, Frank, Heiligenhaus, Arnd, Foell, Dirk, Zink, Angela, Minden, Kirsten, Sengler, Claudia, Zink, Julian, Klotsche, Jens, Niewerth, Martina, Liedmann, Ina, Horneff, Gerd, Kessel, Christoph, Ganser, Gerd, Thon, Angelika, Haas, Johannes-Peter, Hospach, Anton, Weller-Heinemann, Frank, Heiligenhaus, Arnd, Foell, Dirk, Zink, Angela, and Minden, Kirsten

Abstract

ObjectiveThe objective was to evaluate the 25(OH) vitamin D (25(OH)D) status of patients with juvenile idiopathic arthritis (JIA) and determine whether the 25(OH)D level is associated with disease activity and the course of JIA.MethodsPatients 16years of age with recently diagnosed JIA (<12months) were enrolled in the inception cohort of patients with newly diagnosed JIA (ICON), an ongoing prospective observational, controlled multicenter study started in 2010. Clinical and laboratory parameters were ascertained quarterly during the first year and half-yearly thereafter.Of the 954 enrolled patients, 360 patients with two blood samples taken during the first 2years after inclusion and with follow up of 3years were selected. The serum 25(OH)D levels were determined and compared with those of subjects from the general population after matching for age, sex, migration status and the month of blood-drawing.ResultsNearly half of the patients had a deficient 25(OH)D level (<20ng/ml) in the first serum sample and a quarter had a deficient level in both samples. Disease activity and the risk of developing JIA-associated uveitis were inversely correlated with the 25(OH)D level (=-0.20, 95% CI -0.37; 0.03, hazard ratio 0.95, 95% CI 0.91; 0.99, respectively).ConclusionIn this study, 25(OH)D deficiency was common and associated with higher disease activity and risk of developing JIA-associated uveitis. Further studies are needed to substantiate these results and determine whether correcting 25(OH)D deficiency is beneficial in JIA.

Published
2018

357. Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries

Author

Swart, Joost, Giancane, Gabriella, Horneff, Gerd, Magnusson, Bo, Hofer, Michael, Alexeeva, Ekaterina, Panaviene, Violeta, Bader-Meunier, Brigitte, Anton, Jordi, Nielsen, Susan, De Benedetti, Fabrizio, Kamphuis, Sylvia, Stanevica, Valda, Tracahana, Maria, Ailioaie, Laura Marinela, Tsitsami, Elena, Klein, Ariane, Minden, Kirsten, Foeldvari, Ivan, Haas, Johannes Peter, Klotsche, Jens, Horne, Anna Carin, Consolaro, Alessandro, Bovis, Francesca, Bagnasco, Francesca, Pistorio, Angela, Martini, Alberto, Wulffraat, Nico, Ruperto, Nicolino, Swart, Joost, Giancane, Gabriella, Horneff, Gerd, Magnusson, Bo, Hofer, Michael, Alexeeva, Ekaterina, Panaviene, Violeta, Bader-Meunier, Brigitte, Anton, Jordi, Nielsen, Susan, De Benedetti, Fabrizio, Kamphuis, Sylvia, Stanevica, Valda, Tracahana, Maria, Ailioaie, Laura Marinela, Tsitsami, Elena, Klein, Ariane, Minden, Kirsten, Foeldvari, Ivan, Haas, Johannes Peter, Klotsche, Jens, Horne, Anna Carin, Consolaro, Alessandro, Bovis, Francesca, Bagnasco, Francesca, Pistorio, Angela, Martini, Alberto, Wulffraat, Nico, and Ruperto, Nicolino

Abstract

BackgroundThe availability of methotrexate and the introduction of multiple biological agents have revolutionized the treatment of juvenile idiopathic arthritis (JIA). Several international and national drug registries have been implemented to accurately monitor the long-term safety/efficacy of these agents. This report aims to present the combined data coming from Pharmachild/PRINTO registry and the national registries from Germany (BiKeR) and Sweden.MethodsDescriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESIs). For the Swedish register, AE data were not available.ResultsData from a total of 15,284 patients were reported: 8274 (54%) from the Pharmachild registry and 3990 (26%) and 3020 (20%) from the German and the Swedish registries, respectively. Pharmachild children showed a younger age (median of 5.4versus 7.6 years) at JIA onset and shorter disease duration at last available visit (5.3 versus 6.1-6.8) when compared with the other registries. The most frequent JIA category was the rheumatoid factor-negative polyarthritis (range of 24.6-29.9%). Methotrexate (61-84%) and etanercept (24%-61.8%) were the most frequently used synthetic and biologic disease-modifying anti-rheumatic drugs (DMARDs), respectively. There was a wide variability in glucocorticoid use (16.7-42.1%). Serious AEs were present in 572 (6.9%) patients in Pharmachild versus 297 (7.4%) in BiKeR. Infection and infestations were the most frequent AEs (29.4-30.1%) followed by gastrointestinal disorders (11.5-19.6%). The most frequent ESIs were infections (75.3-89%).ConclusionsThis article is the first attempt to present a very large sample of data on JIA patients from different national and international registries and represents the first proposal for data merging as the most powerful tool for future analysis of safety and effectiveness of immunosuppressive therapies in JIA.Registry registrationThe Pharmachild registry

Published
2018

358. Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: Combined data of more than 15,000 patients from Pharmachild and national registries

Author

Immuno/reuma patientenzorg, Child Health, Immunologie/Reumatologie, Cluster B, Immuno/reuma onderzoek 1 (Vastert), Onderzoek, Regenerative Medicine and Stem Cells, Infection & Immunity, Swart, Joost, Giancane, Gabriella, Horneff, Gerd, Magnusson, Bo, Hofer, Michael, Alexeeva, Ekaterina, Panaviene, Violeta, Bader-Meunier, Brigitte, Anton, Jordi, Nielsen, Susan, De Benedetti, Fabrizio, Kamphuis, Sylvia, Staņěviča, Valda, Tracahana, Maria, Ailioaie, Laura Marinela, Tsitsami, Elena, Klein, Ariane, Minden, Kirsten, Foeldvari, Ivan, Haas, Johannes Peter, Klotsche, Jens, Horne, Anna Carin, Consolaro, Alessandro, Bovis, Francesca, Bagnasco, Francesca, Pistorio, Angela, Martini, Alberto, Wulffraat, Nico, Ruperto, Nicolino, Immuno/reuma patientenzorg, Child Health, Immunologie/Reumatologie, Cluster B, Immuno/reuma onderzoek 1 (Vastert), Onderzoek, Regenerative Medicine and Stem Cells, Infection & Immunity, Swart, Joost, Giancane, Gabriella, Horneff, Gerd, Magnusson, Bo, Hofer, Michael, Alexeeva, Ekaterina, Panaviene, Violeta, Bader-Meunier, Brigitte, Anton, Jordi, Nielsen, Susan, De Benedetti, Fabrizio, Kamphuis, Sylvia, Staņěviča, Valda, Tracahana, Maria, Ailioaie, Laura Marinela, Tsitsami, Elena, Klein, Ariane, Minden, Kirsten, Foeldvari, Ivan, Haas, Johannes Peter, Klotsche, Jens, Horne, Anna Carin, Consolaro, Alessandro, Bovis, Francesca, Bagnasco, Francesca, Pistorio, Angela, Martini, Alberto, Wulffraat, Nico, and Ruperto, Nicolino

Published
2018

359. Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

Author

Cluster B, Onderzoek, Child Health, Regenerative Medicine and Stem Cells, Infection & Immunity, BOO, Divisieleiding O&O, Immuno/reuma onderzoek 1 (Vastert), Infectiezieken, Reumatologie, Reumatologie onderzoek 2, Immuno/reuma onderzoek 5 (Vastert2), Reumatologie patientenzorg, Immuno/reuma patientenzorg, Circulatory Health, Kuemmerle-Deschner, Jasmin B., Hansmann, Sandra, Wulffraat, Nico M., Vastert, Sebastiaan J., Hens, Kristien, Anton, Jordi, Avcin, Tadej, Martini, Alberto, Koné-Paut, Isabelle, Uziel, Yosef, Ravelli, Angelo, Wouters, Carine, Shaw, David, Özen, Seza, Eikelberg, Andreas, Prakken, Berent J., Ruperto, Nicolino, Horneff, Gerd, Constantin, Tamas, Beresford, Michael W., Sikken, Marijn, Foster, Helen E., Haug, Iris, Schuller, Sabrina, Jägle, Christine, Benseler, Susanne M., Cluster B, Onderzoek, Child Health, Regenerative Medicine and Stem Cells, Infection & Immunity, BOO, Divisieleiding O&O, Immuno/reuma onderzoek 1 (Vastert), Infectiezieken, Reumatologie, Reumatologie onderzoek 2, Immuno/reuma onderzoek 5 (Vastert2), Reumatologie patientenzorg, Immuno/reuma patientenzorg, Circulatory Health, Kuemmerle-Deschner, Jasmin B., Hansmann, Sandra, Wulffraat, Nico M., Vastert, Sebastiaan J., Hens, Kristien, Anton, Jordi, Avcin, Tadej, Martini, Alberto, Koné-Paut, Isabelle, Uziel, Yosef, Ravelli, Angelo, Wouters, Carine, Shaw, David, Özen, Seza, Eikelberg, Andreas, Prakken, Berent J., Ruperto, Nicolino, Horneff, Gerd, Constantin, Tamas, Beresford, Michael W., Sikken, Marijn, Foster, Helen E., Haug, Iris, Schuller, Sabrina, Jägle, Christine, and Benseler, Susanne M.

Published
2018

360. Treating juvenile idiopathic arthritis to target: Recommendations of an international task force

Author

Cluster B, Divisieleiding O&O, Immuno/reuma onderzoek 1 (Vastert), Child Health, Regenerative Medicine and Stem Cells, Infection & Immunity, BOO, Infectiezieken, Onderzoek, Reumatologie, Immuno/reuma patientenzorg, Reumatologie patientenzorg, Immuno/reuma onderzoek 5 (Vastert2), Ravelli, Angelo, Consolaro, Alessandro, Horneff, Gerd, Laxer, Ronald M., Lovell, Daniel J., Wulffraat, Nico M., Akikusa, Jonathan D., Al-Mayouf, Sulaiman M., Antón, Jordi, Avcin, Tadej, Berard, Roberta A., Beresford, Michael W., Burgos-Vargas, Ruben, Cimaz, Rolando, De Benedetti, Fabrizio, Demirkaya, Erkan, Foell, Dirk, Itoh, Yasuhiko, Lahdenne, Pekka, Morgan, Esi M., Quartier, Pierre, Ruperto, Nicolino, Russo, Ricardo, Saad-Magalhães, Claudia, Sawhney, Sujata, Scott, Christiaan, Shenoi, Susan, Swart, Joost F., Uziel, Yosef, Vastert, Sebastiaan J., Smolen, Josef S., Cluster B, Divisieleiding O&O, Immuno/reuma onderzoek 1 (Vastert), Child Health, Regenerative Medicine and Stem Cells, Infection & Immunity, BOO, Infectiezieken, Onderzoek, Reumatologie, Immuno/reuma patientenzorg, Reumatologie patientenzorg, Immuno/reuma onderzoek 5 (Vastert2), Ravelli, Angelo, Consolaro, Alessandro, Horneff, Gerd, Laxer, Ronald M., Lovell, Daniel J., Wulffraat, Nico M., Akikusa, Jonathan D., Al-Mayouf, Sulaiman M., Antón, Jordi, Avcin, Tadej, Berard, Roberta A., Beresford, Michael W., Burgos-Vargas, Ruben, Cimaz, Rolando, De Benedetti, Fabrizio, Demirkaya, Erkan, Foell, Dirk, Itoh, Yasuhiko, Lahdenne, Pekka, Morgan, Esi M., Quartier, Pierre, Ruperto, Nicolino, Russo, Ricardo, Saad-Magalhães, Claudia, Sawhney, Sujata, Scott, Christiaan, Shenoi, Susan, Swart, Joost F., Uziel, Yosef, Vastert, Sebastiaan J., and Smolen, Josef S.

Published
2018

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

Author

Immuno/reuma patientenzorg, Infection & Immunity, Child Health, Reumatologie patientenzorg, UMC Utrecht, Brunner, Hermine I, Ruperto, Nicolino, Tzaribachev, Nikolay, Horneff, Gerd, Chasnyk, Vyacheslav G., Panaviene, Violeta Vladislava, 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., Martini, Alberto, Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG), Immuno/reuma patientenzorg, Infection & Immunity, Child Health, Reumatologie patientenzorg, UMC Utrecht, Brunner, Hermine I, Ruperto, Nicolino, Tzaribachev, Nikolay, Horneff, Gerd, Chasnyk, Vyacheslav G., Panaviene, Violeta Vladislava, 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., Martini, Alberto, and Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG)

Published
2018

362. The burden of systemic juvenile idiopathic arthritis for patients and caregivers: An international survey and retrospective chart review

Author

Cluster B, Immuno/reuma onderzoek 1 (Vastert), Onderzoek, Child Health, Regenerative Medicine and Stem Cells, Infection & Immunity, Immunologie/Reumatologie, Shenoi, Susan, Horneff, Gerd, Cidon, Michal, Ramanan, Athimalaipet V., Kimura, Yukiko, Quartier, Pierre, Foeldvari, Ivan, Zeft, Andrew, Lomax, Kathleen G., Gregson, Jill, Abma, Tineke, Campbell-Hill, Sarah, Weiss, Jeffrey, Patel, Dony, Marinsek, Nina, Wulffraat, Nico, Cluster B, Immuno/reuma onderzoek 1 (Vastert), Onderzoek, Child Health, Regenerative Medicine and Stem Cells, Infection & Immunity, Immunologie/Reumatologie, Shenoi, Susan, Horneff, Gerd, Cidon, Michal, Ramanan, Athimalaipet V., Kimura, Yukiko, Quartier, Pierre, Foeldvari, Ivan, Zeft, Andrew, Lomax, Kathleen G., Gregson, Jill, Abma, Tineke, Campbell-Hill, Sarah, Weiss, Jeffrey, Patel, Dony, Marinsek, Nina, and Wulffraat, Nico

Published
2018

363. Additional file 1: of Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study

Author

Ruperto, Nicolino, Brunner, Hermine, Zuber, Zbigniew, Tzaribachev, Nikolay, Kingsbury, Daniel, Foeldvari, Ivan, Horneff, Gerd, Elzbieta Smolewska, Vehe, Richard, Anasuya Hazra, Wang, Rong, Mebus, Charles, Alvey, Christine, Lamba, Manisha, Sriram Krishnaswami, Stock, Thomas, Wang, Min, Suehiro, Ricardo, Martini, Alberto, and Lovell, Daniel

Abstract

Inclusion criteria for the long-term extension study, dosing scheme, and descriptive summary of plasma tofacitinib pharmacokinetic parameter values by gender. (PDF 39Â kb)

Published
2017
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364. Additional file 1: Figure S1. of Experience with etanercept, tocilizumab and interleukin-1 inhibitors in systemic onset juvenile idiopathic arthritis patients from the BIKER registry

Author

Horneff, Gerd, Schulz, Anna, Klotsche, Jens, Hospach, Anton, Minden, Kirsten, Foeldvari, Ivan, Trauzeddel, Ralf, Ganser, Gerd, Weller-Heinemann, Frank, and Haas, Johannes

Subjects
musculoskeletal diseases, immune system diseases, skin and connective tissue diseases
Abstract

Proportions of patients with a JIA-ACR 30/50/70/90 response from month 3 until month 24 as compared to baseline (week 0). The number of patient scontributing to the calculation is given below the figure. (PPT 1206 kb)

Published
2017
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365. Additional file 1: Table S1. of Protocols on classification, monitoring and therapy in children’s rheumatology (PRO-KIND): results of the working group Polyarticular juvenile idiopathic arthritis

Author

Horneff, Gerd, Klein, Ariane, Ganser, Gerd, Sailer-Höck, Michaela, Günther, Annette, Foeldvari, Ivan, and Weller-Heinemann, Frank

Abstract

17 Statements that were approved by the web-based survey with >80% approval. Table S2. Agreement of 68 participants of the web survey. The first two possible answers were formulated in such a way that consent was given without a condition. (DOCX 17 kb)

Published
2017
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366. Predictors of Clinical Remission With Etanercept in Paediatric Patients With Extended Oligoarticular, Enthesitis-Related Arthritis and Psoriatic Arthritis : Findings From the CLIPPER Study

Author

Consolaro, Alessandro, Horneff, Gerd, Burgos-Vargas, Ruben, Foeldvari, Ivan, Vojinovic, J., Dehoorne, Joke, Panaviene, Violeta Vladislava, Susic, Gordana, Stanevica, V., Kobusinska, K., Zuber, Z., Mouy, R., Rumba-Rozenfelde, I., Dolezalova, Pavla, Job-Deslandre, Chantal, Wulffraat, NM, Pederson, R., Bukowski, J., Hinnershitz, T., Vlahos, B., Martini, A., and Ruperto, Nicolino

Published
2016

367. Multizentrische, doppelblinde, randomisierte Studie von Golimumab bei pädiatrischen Patienten mit aktiver pJIA trotz Methotrexat: Ergebnisse nach 48 Wochen

Author

Brunner, Hermine, Horneff, Gerd, Ruperto, Nicola, Tzaribachev, Nikolay, Wouters, Carine, Chasnyk, Vyacheslav, Cuttica, Ruben, Keltsev, V., Nasonov, Evgeny, Kingsbury, D., Weller-Heinemann, Frank, Lovell, Daniel J., Martini, Alberto, Panaviene, Violeta Vladislava, Abud Mendoza, Carlos, Reiff, Andreas, Alexeeva, Ekaterina, Joos, Rik, Bandeira, Márcia, Silverman, Earl, Van Royen-Kerkhof, Annet, Kim, Lilianne, and Rubio-Perez, Nadina

Subjects
ddc: 610, randomisiert, doppelblind, 610 Medical sciences, Medicine, klinische Remission, ACR30-Ansprechen, Golimumab, juvenile idiopathische Arthritis
Abstract

Einleitung: Beurteilung der Wirksamkeit und Sicherheit von Golimumab (GLM) bei pädiatrischen Patienten (2-17 Jahre) mit aktiver polyartikulärer juveniler idiopathischer Arthritis (pJIA) trotz mindestens 3-monatiger MTX-Therapie. Methoden: GO-KIDS war eine 3-phasige (P1: Wo0-16, P2: Wo16-48,[zum vollständigen Text gelangen Sie über die oben angegebene URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2016

368. Fieber, Myositis, Dermatose und Lipodystrophie im jungen Erwachsenenalter

Author

Schalm, Susanne and Horneff, Gerd

Subjects
junges Erwachsenenalter, Baricitinib, ddc: 610, Candle Syndrom, Autoinflammation, 610 Medical sciences, Medicine
Abstract

Einleitung: 2012 stellte sich der 1994 geborene Patient in der Erwachsenenrheumatologie vor. Vorgeschichte: Der heute 22-jährige Patient M. erkrankte bereits im ersten Lebensjahr an rez. Fieberepisoden, von unterschiedlicher Dauer, begleitet von Abgeschlagenheit, Müdigkeit, Arthritiden[zum vollständigen Text gelangen Sie über die oben angegebene URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2016

369. Spontane Regression einer EBV-assoziierten diffus großzelligen B-Zell-Lymphoms nach Absetzen von Methotrexat und Etanercept bei einer Patientin mit juveniler idiopathischer Arthritis (JIA)

Author

Klein, Ariane, Reinhard, Harald, Müller, Annette, and Horneff, Gerd

Subjects
JIA Malignome Methotrexat, ddc: 610, 610 Medical sciences, Medicine, Etanercept
Abstract

Einleitung: Patienten mit JIA haben möglicherweise ein erhöhtes Tumor- und Lymphomrisiko. Bisher gibt es keine ausreichenden Hinweise, dass eine Behandlung mit Etanercept dieses Risiko weiter verstärkt. EBV-assoziierte Lymphoproliferationen und Lymphome wurden bei erwachsenen Patienten[zum vollständigen Text gelangen Sie über die oben angegebene URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2016
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370. Protokolle zur Klassifikation, Überwachung und Therapie der polyartikulären Verlaufsform der JIA in der Kinderrheumatologie (PRO-KIND)

Author

Weller-Heinemann, Frank, Günther, Annette, Sailer-Höck, Michaela, Ganser, Gerd, Foeldvari, Ivan, and Horneff, Gerd

Subjects
ddc: 610, Konsensustherapieprotokolle, 610 Medical sciences, Medicine, Therapie, JIA
Abstract

Einleitung: Die klinische Versorgung von Patienten mit rheumatischen Erkrankungen in Deutschland ist heterogen. Dies bezieht sich auf Diagnostik, Therapie und Überwachung/Überprüfung der Behandlung. Validierte und international gebräuchliche Definitionen und Standards, Leitlinien[zum vollständigen Text gelangen Sie über die oben angegebene URL], 44. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 30. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 26. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2016

375. S100A12 Is Associated with Response to Therapy in Juvenile Idiopathic Arthritis

Author

Gohar, Faekah, primary, Anink, Janneke, additional, Moncrieffe, Halima, additional, Van Suijlekom-Smit, Lisette W.A., additional, Prince, Femke H.M., additional, van Rossum, Marion A.J., additional, Dolman, Koert M., additional, Hoppenreijs, Esther P.A.H., additional, ten Cate, Rebecca, additional, Ursu, Simona, additional, Wedderburn, Lucy R., additional, Horneff, Gerd, additional, Frosch, Michael, additional, Foell, Dirk, additional, and Holzinger, Dirk, additional

Published
2018
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377. Additional file 1: Table S1. of Comparison of treatment response, remission rate and drug adherence in polyarticular juvenile idiopathic arthritis patients treated with etanercept, adalimumab or tocilizumab

Author

Horneff, Gerd, Klein, Ariane, Klotsche, Jens, Minden, Kirsten, Hans-Iko Huppertz, Weller-Heinemann, Frank, Kuemmerle-Deschner, Jasmin, Johannes-Peter Haas, and Hospach, Anton

Abstract

Patient characteristics (unweighted as reported in BIKER). (DOCX 17 kb)

Published
2016
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378. Additional file 3: Figure S2. of Comparison of treatment response, remission rate and drug adherence in polyarticular juvenile idiopathic arthritis patients treated with etanercept, adalimumab or tocilizumab

Author

Horneff, Gerd, Klein, Ariane, Klotsche, Jens, Minden, Kirsten, Hans-Iko Huppertz, Weller-Heinemann, Frank, Kuemmerle-Deschner, Jasmin, Johannes-Peter Haas, and Hospach, Anton

Subjects
musculoskeletal diseases, skin and connective tissue diseases
Abstract

Drug survival during treatment with etanercept, adalimumab or tocilizumab (combined cohorts) depending on the concomitant use of methotrexate, weighted Kaplan-Meier analyses weighted by an inverse probability of treatment estimated by a generalized propensity score. No significant differences were found between the two groups. (PPT 74 kb)

Published
2016
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379. Additional file 2: Figure S1. of Comparison of treatment response, remission rate and drug adherence in polyarticular juvenile idiopathic arthritis patients treated with etanercept, adalimumab or tocilizumab

Author

Horneff, Gerd, Klein, Ariane, Klotsche, Jens, Minden, Kirsten, Hans-Iko Huppertz, Weller-Heinemann, Frank, Kuemmerle-Deschner, Jasmin, Johannes-Peter Haas, and Hospach, Anton

Abstract

Pediatric ACR30/50/70/90 improvement in patients receiving etanercept, adalimumab or tocilizumab as a first-line or second-line biologic agent. (PPT 172 kb)

Published
2016
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380. Experience with etanercept, tocilizumab and interleukin-1 inhibitors in systemic onset juvenile idiopathic arthritis patients from the BIKER registry

Author

Horneff, Gerd, primary, Schulz, Anna Carina, additional, Klotsche, Jens, additional, Hospach, Anton, additional, Minden, Kirsten, additional, Foeldvari, Ivan, additional, Trauzeddel, Ralf, additional, Ganser, Gerd, additional, Weller-Heinemann, Frank, additional, and Haas, Johannes Perter, additional

Published
2017
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382. Fluorescence optical imaging in pediatric patients with inflammatory and non-inflammatory joint diseases: a comparative study with ultrasonography

Author

Beck, Marisa Christin, primary, Glimm, Anne-Marie, additional, Ohrndorf, Sarah, additional, Minden, Kirsten, additional, Trauzeddel, Ralf, additional, Werner, Stephanie Gabriele, additional, Horneff, Gerd, additional, Backhaus, Marina, additional, Burmester, Gerd Rüdiger, additional, Kallinich, Tilmann, additional, Girschick, Hermann, additional, and Klotsche, Jens, additional

Published
2017
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383. Recommendations for collaborative paediatric research including biobanking in Europe: a Single Hub and Access point for paediatric Rheumatology in Europe (SHARE) initiative

Author

Kuemmerle-Deschner, Jasmin B, primary, Hansmann, Sandra, additional, Wulffraat, Nico M, additional, Vastert, Sebastiaan J, additional, Hens, Kristien, additional, Anton, Jordi, additional, Avcin, Tadej, additional, Martini, Alberto, additional, Koné-Paut, Isabelle, additional, Uziel, Yosef, additional, Ravelli, Angelo, additional, Wouters, Carine, additional, Shaw, David, additional, Özen, Seza, additional, Eikelberg, Andreas, additional, Prakken, Berent J, additional, Ruperto, Nicolino, additional, Horneff, Gerd, additional, Constantin, Tamas, additional, Beresford, Michael W, additional, Sikken, Marijn, additional, Foster, Helen E, additional, Haug, Iris, additional, Schuller, Sabrina, additional, Jägle, Christine, additional, and Benseler, Susanne M, additional

Published
2017
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384. Fluorescence optical imaging and musculoskeletal ultrasonography in juvenile idiopathic polyarticular disease before and during antirheumatic treatment - a multicenter non-interventional diagnostic evaluation

Author

Klein, Ariane, primary, Just, Georg Werner, additional, Werner, Stephanie Gabriele, additional, Oommen, Prasad T., additional, Minden, Kirsten, additional, Becker, Ingrid, additional, Langer, Hans-Eckhard, additional, Klee, Dirk, additional, and Horneff, Gerd, additional

Published
2017
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386. Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial

Author

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

Published
2017
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387. A survey of national and multi-national registries and cohort studies in juvenile idiopathic arthritis: challenges and opportunities

Author

Beukelman, Timothy, primary, Anink, Janneke, additional, Berntson, Lillemor, additional, Duffy, Ciaran, additional, Ellis, Justine A., additional, Glerup, Mia, additional, Guzman, Jaime, additional, Horneff, Gerd, additional, Kearsley-Fleet, Lianne, additional, Klein, Ariane, additional, Klotsche, Jens, additional, Magnusson, Bo, additional, Minden, Kirsten, additional, Munro, Jane E., additional, Niewerth, Martina, additional, Nordal, Ellen, additional, Ruperto, Nicolino, additional, Santos, Maria Jose, additional, Schanberg, Laura E., additional, Thomson, Wendy, additional, van Suijlekom-Smit, Lisette, additional, Wulffraat, Nico, additional, and Hyrich, Kimme, additional

Published
2017
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388. In Children With Systemic Juvenile Idiopathic Arthritis With And Without Fever Canakinumab is Long Term Safe and Efficacious

Author

Horneff, Gerd, Ruperto, Nicola, Brunner, Hermine, Quartier, Pierre, Constantin, Tamas, Alexeeva, Ekaterina, Kone-Paut, Isabelle, Marzan, Katherine, Wulffraat, Nico, Schneider, Rayfel, Padeh, Shai, Chasnyk, Vyacheslav, Wouters, Carine, Kümmerle-Deschner, Jasmin, Kallinich, Tilmann, Lauwerys, Bernard. R., Haddad, Elie, Nasonov, Evgeny, Trachana, Maria, Vougiouka, Olga, Abrams, Ken, Leon, Karolynn, Lheritier, Karine, Martini, Alberto, and Lovell, Daniel J.

Subjects
ddc: 610, fungi, food and beverages, 610 Medical sciences, Medicine
Abstract

Introduction: Rapid and sustained efficacy of canakinumab (CAN) were previously demonstrated in patients with systemic juvenile idiopathic arthritis (SJIA)1. However, little is known about potential differences in response to CAN treatment between pts with vs. without SJIA associated fever. The objective[for full text, please go to the a.m. URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

389. Verträglichkeit von Tocilizumab bei jungen Erwachsenen mit einer juvenilen idiopathischen Arthritis (JIA)

Author

Klotsche, Jens, Niewerth, Martina, Haas, Johannes Peter, Aries, Peer, Ochs, Wolfgang, Zink, Angela, Horneff, Gerd, and Minden, Kirsten

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Tocilizumab ist für die Behandlung der systemischen (sJIA) und polyartikulären JIA (pJIA) zugelassen. Das Ziel der Untersuchung ist eine erste Beurteilung der Verträglichkeit von Tocilizumab unter Alltagsbedingungen bei JIA Patienten im jungen Erwachsenenalter. Methoden:[zum vollständigen Text gelangen Sie über die oben angegebene URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015
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390. STING-associated vasculopathy with onset in infancy (SAVI): Severe autoinflammatory disease with mutilating necrotizing dermatitis and relapsing pneumonias

Author

Siepermann, Kathrin Julia, Dückers, Gregor, Brauer, Nina, Perez-Becker, Ruy, Sinha, Kumar, Wirth, Stefan, Lehmann, Percy, Horneff, Gerd, and Niehues, Tim

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Results: Our patient, second male of nonconsanguineous Italian parents, presented with failure to thrive due to a severe idiopathic, systemic inflammation with onset in the first weeks of life, continuous fever (39-40°C), recurrent ulcerative, erythematous pyoderma, ulcerative mucositis, mutilating[for full text, please go to the a.m. URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

391. Krankheitskosten der juvenilen idiopathischen Arthritis (JIA) in den ersten Erkrankungsjahren

Author

Kurt, Pascale, Klotsche, Jens, Niewerth, Martina, Liedmann, Ina, Foeldvari, Ivan, Ganser, Gerd, Horneff, Gerd, Mönkemöller, Kirsten, and Minden, Kirsten

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Die JIA stellt mit über 1.000 Neuerkrankungen pro Jahr in Deutschland die häufigste chronisch entzündlich-rheumatische Erkrankung im Kindes- und Jugendalter dar. Sie ist mit einer enormen finanziellen gesamtgesellschaftlichen Belastung verbunden. Wie sich der Ressourcenverbrauch[zum vollständigen Text gelangen Sie über die oben angegebene URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

392. Verträglichkeit und Wirksamkeit von Etanercept bei Kindern mit juveniler idiopathischer Arthritis

Author

Horneff, Gerd, Haas, Johannes Peter, Ganser, Gerd, Foeldvari, Ivan, Hospach, Anton, Minden, Kirsten, Huppertz, Hans-Iko, Böschow, Gundula, Küster, Rolf-Michael, Trauzeddel, Ralf, and Thon, Angelika

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Seit der Zulassung (2000) für die polyartikuläre JIA werden Etanerceptbehandlungen prospektiv im JIA Biologika Register (BiKeR) dokumentiert. Ziel dieser Zwischenanalyse ist die Beurteilung von Wirksamkeit und Verträglichkeit unter Praxisbedingungen. Methoden: Demographische[zum vollständigen Text gelangen Sie über die oben angegebene URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

393. 8-jähriger Junge mit Chronisch-Rekurrierender-Multifokaler Osteomyelitis (CRMO/NBO) und hereditärer sensorischer Neuropathie Typ II (HSAN II)

Author

Geikowski, Tilman and Horneff, Gerd

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Kasuistik: 8-jähriger Patient mit auswertig diagnostizierter und bioptisch gesicherter CRMO/NBO bei seit drei Jahren bestehenden Schmerzen in beiden Füßen mit Schwellung, Rötung und Überwärmung. Zudem bestehen massive fixierte Knick-Senk-Füße und persistierende[zum vollständigen Text gelangen Sie über die oben angegebene URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

394. Verträglichkeit und Wirksamkeit von Tocilizumab in Kindern mit systemischer juveniler idiopathischer Arthritis (JIA)

Author

Horneff, Gerd, Huppertz, Hans-Iko, Haas, Johannes Peter, Minden, Kirsten, Ganser, Gerd, Hospach, Anton, and Trauzeddel, Ralf

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Seit der Zulassung (2011) für die systemische JIA werden Tocilizumabbehandlungen im deutschen JIA Biologika Register (BiKeR) dokumentiert. Ziel dieser Zwischenanalyse ist die Beurteilung der Wirksamkeit und Verträglichkeit von Tocilizumab unter Praxisbedingungen. Methoden: Demographische[zum vollständigen Text gelangen Sie über die oben angegebene URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015

395. Geschlechtsspezifische Komorbiditäten bei der juvenilen idiopathischen Arthritis

Author

Horneff, Gerd, Minden, Kirsten, Huppertz, Hans-Iko, Tenbrock, Klaus, and Haas, Johannes Peter

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Das Ziel dieser Studie ist es, das Auftreten von Begleiterkrankungen in einer großen Kohorte JIA analysieren. Methoden: Seit 2001 wurden JIA Patienten zu Beginn der Behandlung mit Biologika oder Methotrexat im Biologika in der Kinderrheumatologie (BIKER) Register aufgenommen. Die[zum vollständigen Text gelangen Sie über die oben angegebene URL], 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2015
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396. Nebulised ALX-0171 for respiratory syncytial virus lower respiratory tract infection in hospitalised children: a double-blind, randomised, placebo-controlled, phase 2b trial

Author

Cunningham, Steve, Piedra, Pedro A, Martinon-Torres, Federico, Szymanski, Henryk, Brackeva, Benedicte, Dombrecht, Evelyne, Detalle, Laurent, Fleurinck, Carmen, Cunningham, Steve, Piedra, Pedra A, Verhulst, Stijn, Matthijs, Inge, Proesmans, Marijke, Goetghebuer, Tessa, Bosheva, Miroslava, Dosev, Svilen, Nikolova, Olga, Chakarova, Petranka, Wu Hupat, Elba, Mesa Monsalve, Juan, Turkalj, Mirjana, Mesaric Antoncic, Natasa, Tesovic, Goran, SIPL, Mirna, Kljaic Bukvic, Blazenka, Ivkovic-Jurekovic, Irena, Cicak, Biserka, Skalova, Sylva, Horneff, Gerd, Vogelberg, Christian, Gacs, Éva, Kalocsai, Krisztina, Madarasi, Anna, Kovacs, Lajos, Novak, Zoltan, Bene, Zsolt, Ashkenazi, Shai, Goldbart, Aviv, Bentur, Lea, Kolosa, Nadezda, Gardovska, Dace, Khaw, Poh Guan, Toh, Teck Hock, De Bruyne, Jessie Anne, Tan, Kah Kee, Alberto, Edison, Benjamin, Sablan, Junior, de Leon, Anjanette, Szymanski, Henryk, Repko, Miroslav, Kralinsky, Karol, Salamanca de la Cueva, Ignacio, Rodrigo Gonzalo de Liria, Carlos, Martinón-Torres, Federico, Cedena Romero, María Pilar, Monteagudo Montesinos, Emilio, Teeratakulpisarn, Jamaree, Puthanakit, Thanyawee, Oberdorfer, Peninnah, Warachit, Boonyarat, Brackeva, Benedicte, Dombrecht, Evelyne, Detalle, Laurent, and Fleurinck, Carmen

Abstract

Respiratory syncytial virus (RSV) is the most common cause of severe lower respiratory tract infection, with a high global health burden. There are no effective treatments available. ALX-0171 is a novel trivalent Nanobody with antiviral properties against RSV. We aimed to assess the safety and antiviral activity of nebulised ALX-0171 in children admitted to hospital with RSV lower respiratory tract infection.

Published
2021
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397. Biologic Therapies in Polyarticular Juvenile Idiopathic Arthritis. Comparison of Long‐Term Safety Data from the German BIKER Registry.

Author

Klein, Ariane, Becker, Ingrid, Minden, Kirsten, Hospach, Anton, Schwarz, Tobias, Foeldvari, Ivan, Huegle, Boris, Borte, Michael, Weller‐Heinemann, Frank, Dressler, Frank, Kuemmerle‐Deschner, Jasmin, Oommen, Prasad Thomas, Foell, Dirk, Trauzeddel, Ralf, Rietschel, Christoph, and Horneff, Gerd

Abstract

Objective: Biologics have an important role in the treatment of juvenile idiopathic arthritis (JIA). Long‐term safety data are limited. Direct comparison of different agents regarding occurrence of adverse events (AEs), especially of rare events, requires large quantities of patient years. In this analysis, long‐term safety with regard to AE of special interest (AESI) was compared between different biologics. Methods: Patients with nonsystemic JIA were selected from the German BIKER registry. Safety assessments were based on AE reports. Number of AEs, serious AEs, and 25 predefined AESIs, including medically important infection, uveitis, inflammatory bowel disease, cytopenia, hepatic events, anaphylaxis, depression, pregnancy, malignancy, and death, were analyzed. Event rates and relative risks were calculated using AEs reported after first dose through 70 days after last dose. Results: A total of 3873 patients entered the analysis with 7467 years of exposure to biologics. The most common AESIs were uveitis (n = 231) and medically important infections (n = 101). Cytopenia and elevation of transaminases were more frequent with tocilizumab (risk ratio [RR] 8.0, 95% confidence interval [CI] 4.2‐15, and RR 4.7, 95% CI 1.8‐12.2, respectively). Anaphylactic events were associated with intravenous route of administration. In patients ever exposed to biologics, eight malignancies were reported. Six pregnancies have been documented in patients with tumor necrosis factor inhibitors. No death occurred in this patient cohort during observation. Conclusion: Surveillance of pharmacotherapy as provided by the BIKER registry is an import approach, especially for long‐term treatment of children. Overall, tolerance was acceptable. Differences between biologics were noted and should be considered in daily patient care. [ABSTRACT FROM AUTHOR]

Published
2020
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399. A survey of national and multi-national registries and cohort studies in juvenile idiopathic arthritis : challenges and opportunities

Author

Beukelman, Timothy, Anink, Janneke, Berntson, Lillemor, Duffy, Ciaran, Ellis, Justine A., Glerup, Mia, Guzman, Jaime, Horneff, Gerd, Kearsley-Fleet, Lianne, Klein, Ariane, Klotsche, Jens, Magnusson, Bo, Minden, Kirsten, Munro, Jane E., Niewerth, Martina, Nordal, Ellen, Ruperto, Nicolino, Santos, Maria Jose, Schanberg, Laura E., Thomson, Wendy, van Suijlekom-Smit, Lisette, Wulffraat, Nico, Hyrich, Kimme, Beukelman, Timothy, Anink, Janneke, Berntson, Lillemor, Duffy, Ciaran, Ellis, Justine A., Glerup, Mia, Guzman, Jaime, Horneff, Gerd, Kearsley-Fleet, Lianne, Klein, Ariane, Klotsche, Jens, Magnusson, Bo, Minden, Kirsten, Munro, Jane E., Niewerth, Martina, Nordal, Ellen, Ruperto, Nicolino, Santos, Maria Jose, Schanberg, Laura E., Thomson, Wendy, van Suijlekom-Smit, Lisette, Wulffraat, Nico, and Hyrich, Kimme

Abstract

Background: To characterize the existing national and multi-national registries and cohort studies in juvenile idiopathic arthritis (JIA) and identify differences as well as areas of potential future collaboration. Methods: We surveyed investigators from North America, Europe, and Australia about existing JIA cohort studies and registries. We excluded cross-sectional studies. We captured information about study design, duration, location, inclusion criteria, data elements and collection methods. Results: We received survey results from 18 studies, including 11 national and 7 multi-national studies representing 37 countries in total. Study designs included inception cohorts, prevalent disease cohorts, and new treatment cohorts (several of which contribute to pharmacosurveillance activities). Despite numerous differences, the data elements collected across the studies was quite similar, with most studies collecting at least 5 of the 6 American College of Rheumatology core set variables and the data needed to calculate the 3-variable clinical juvenile disease activity score. Most studies were collecting medication initiation and discontinuation dates and were attempting to capture serious adverse events. Conclusion: There is a wide-range of large, ongoing JIA registries and cohort studies around the world. Our survey results indicate significant potential for future collaborative work using data from different studies and both combined and comparative analyses.

Published
2017
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400. Risk of Serious Infection in Juvenile Idiopathic Arthritis Patients Associated With Tumor Necrosis Factor Inhibitors and Disease Activity in the German Biologics in Pediatric Rheumatology Registry

Author

Becker, Ingrid, Horneff, Gerd, Becker, Ingrid, and Horneff, Gerd

Abstract

Objective. To examine the effects of tumor necrosis factor inhibitors on the risk for serious infections and other influencing factors in a registry. Methods. Patients exposed for the first time to etanercept, adalimumab, or methotrexate and serious infections were identified in theGerman BiologicRegistry for Pediatric Rheumatology (BIKER) registry. Serious infection rates per 1,000 observation-years and relative riskswere calculated. Cox regressionidentifiedrisk factorsandprovidedhazard ratios (HRs) for occurrence of infections. Results. A total of 3,350 patients with 5,919 observation-years fulfilled the inclusion criteria for the study. The first biologic agents were etanercept (1,720 cases) and adalimumab (177 cases). A total of 1,453 patients were treated with methotrexate and no biologic agent. In total, 28 serious infections were reported in 26 patients (4.7 per 1,000 patient-years), 5 with methotrexate (1.6 per 1,000 patient-years), 21 with etanercept (8.1 per 1,000 patient-years), and 2 with adalimumab (9.7 per 1,000 patientyears). Significant univariate risk factors for infection were therapy with biologic agents, disease duration before therapy start, corticosteroid medication, nonbiologic premedications, higher clinical Juvenile Arthritis Disease Activity Score including maximal 10 joints (cJADAS10) at therapy start, and highermean cJADAS10 during therapy. In multivariate Cox regression, only biologic therapy and cJADAS10 at therapy start remained significant. Risk for infection was increased by etanercept (univariate HR 6.0 [95% confidence interval (95% CI) 2.0-17.5]) or adalimumab (HR 7.3 [95% CI 1.3-40.0]) compared to methotrexate as well as by an elevated cJADAS10 at therapy start (HR 1.1 [95% CI 1.0-1.2] per unit increase). Conclusion. The total rate of serious infections reported in the BIKER registry seems low. Treatment with etanercept or adalimumab increases the risk for serious infection slightly, compared to methotrexate. Disease activity expr

Published
2017

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