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1. Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Author

Brunner H. I., Tzaribachev N., Vega-Cornejo G., Louw I., Berman A., Calvo Penades I., Anton J., Avila-Zapata F., Cuttica R., Horneff G., Foeldvari I., Keltsev V., Kingsbury D. J., Viola D. O., Joos R., Lauwerys B., Paz Gastanaga M. E., Rama M. E., Wouters C., Bohnsack J., Breedt J., Fischbach M., Lutz T., Minden K., Miraval T., Ally M. M. T. M., Rubio-Perez N., Solau Gervais E., van Zyl R., Li X., Nys M., Wong R., Banerjee S., Lovell D. J., Martini A., Ruperto N., Becker M. L., Ilowite N. T., Dare J. A., Morris P. K., Beukelman T. G., Wagner-Weiner L., Zemel L., Quartier P., Kone-Paut I., Belot A., Gerloni V., Ferrandiz M., Van Rensburg D. J., Scheibel I. M., Goldstein-Schainberg C., Silva C., Terreri M. T. S. E. L. A., Gamir M., Burgos Vargas R., Faugier Fuentes E., Cimaz R., Alessio M., Espada G., Brunner, H. I., Tzaribachev, N., Vega-Cornejo, G., Louw, I., Berman, A., Calvo Penades, I., Anton, J., Avila-Zapata, F., Cuttica, R., Horneff, G., Foeldvari, I., Keltsev, V., Kingsbury, D. J., Viola, D. O., Joos, R., Lauwerys, B., Paz Gastanaga, M. E., Rama, M. E., Wouters, C., Bohnsack, J., Breedt, J., Fischbach, M., Lutz, T., Minden, K., Miraval, T., Ally, M. M. T. M., Rubio-Perez, N., Solau Gervais, E., van Zyl, R., Li, X., Nys, M., Wong, R., Banerjee, S., Lovell, D. J., Martini, A., Ruperto, N., Becker, M. L., Ilowite, N. T., Dare, J. A., Morris, P. K., Beukelman, T. G., Wagner-Weiner, L., Zemel, L., Quartier, P., Kone-Paut, I., Belot, A., Gerloni, V., Ferrandiz, M., Van Rensburg, D. J., Scheibel, I. M., Goldstein-Schainberg, C., Silva, C., Terreri, M. T. S. E. L. A., Gamir, M., Burgos Vargas, R., Faugier Fuentes, E., Cimaz, R., Alessio, M., and Espada, G.

Subjects
Male, musculoskeletal diseases, 0301 basic medicine, medicine.medical_specialty, Adolescent, genetic structures, Immunology, Juvenile, Arthritis, Injections, Subcutaneou, Abatacept, Arthritis, Juvenile, Child, Child, Preschool, Cohort Studies, Female, Humans, Immunosuppressive Agents, Injections, Subcutaneous, Treatment Outcome, Injections, Immunosuppressive Agent, 03 medical and health sciences, 0302 clinical medicine, Rheumatology, Pharmacokinetics, Open label study, medicine, Immunology and Allergy, In patient, Preschool, skin and connective tissue diseases, 030203 arthritis & rheumatology, business.industry, Subcutaneous, medicine.disease, Dermatology, Clinical trial, 030104 developmental biology, Methotrexate, Cohort Studie, business, Human, medicine.drug
Abstract

Objective: To investigate the pharmacokinetics, effectiveness, and safety of subcutaneous (SC) abatacept treatment over 24 months in patients with polyarticular-course juvenile idiopathic arthritis (JIA). Methods: In this phase III, open-label, international, multicenter, single-arm study, patients with polyarticular JIA (cohort 1, ages 6–17 years and cohort 2, ages 2–5 years) in whom treatment with ≥1 disease-modifying antirheumatic drug was unsuccessful received weight-tiered SC abatacept weekly: 10 to

Published
2018
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2. Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

Author

Giancane G1, Swart JF2, Castagnola E3, Groll AH4, Horneff G5, 6, Huppertz HI7, Lovell DJ8, Wolfs T2, Herlin T9, Dolezalova P10, Sanner H11, Susic G13, Sztajnbok F14, Maritsi D15, Constantin T16, Vargova V17, Sawhney S18, Rygg M19, K Oliveira S21, Cattalini M22, Bovis F1, Bagnasco F1, Pistorio A23, Martini A24, Wulffraat N2, Ruperto N25, Paediatric Rheumatology International Trials Organisation (PRINTO). Cuttica R, Garay SM, Brunner J, Emminger W, Appenzeller S, Len C, Saad Magalhaes C, Telcharova-Mihaylovska A, Harjacek M, Jelusic M, Estmann A, Nielsen S, Herrera Mora C, Gervais E, Koné-Paut I, Quartier P, Foeldvari I, Horneff G, Lutz T, Minden K, Tzaribachev N, Trachana M, Tsitsami E, Vougiouka O, Orban I, Harel L, Hashkes P, Uziel Y, Cimaz R, Civino A, Consolini R, D'Angelo G, De Benedetti F, Filocamo G, Fueri E, Gallizzi R, Maggio MC, Magnolia MG, Miniaci A, Montin D, Olivieri A. N., Pastore S, Rigante D, Zulian F, Rumba-Rozenfelde I, Stanevicha V, Panaviene V, Rodriguez Lozano AL, Rubio-Perez N, Vega Cornejo G, Hoppenreijs E, Kamphuis S, Flato B, Nordal EB, Abdwani R, Miraval T, Paz Gastanaga ME, Smolewska E, Ailioaie C, Cochino AV, Laday M, Lazar C, Alexeeva E, Chasnyk V, Keltsev V, Suwairi WMS, Vijatov-Djuric G, Vojinovic J, Arkachaisri T, Koskova E, Avcin T, Ally M, Van Rensburg CJ, Louw I, Lopez JA, Boteanu AL, Calvo Penades I, De Inocencio J, Mesa-Del-Castillo P, Moreno E, Remesal A, Hofer M, Gok F, Ozen S, Ramanan A, Pallotti C, Villa L., Giancane, G1, Swart, Jf2, Castagnola, E3, Groll, Ah4, Horneff, G5, Huppertz, Hi7, Lovell, Dj8, Wolfs, T2, Herlin, T9, Dolezalova, P10, Sanner, H11, Susic, G13, Sztajnbok, F14, Maritsi, D15, Constantin, T16, Vargova, V17, Sawhney, S18, Rygg, M19, K Oliveira, S21, Cattalini, M22, Bovis, F1, Bagnasco, F1, Pistorio, A23, Martini, A24, Wulffraat, N2, Ruperto, N25, Paediatric Rheumatology International Trials Organisation (PRINTO)., Cuttica R, Garay, Sm, Brunner, J, Emminger, W, Appenzeller, S, Len, C, Saad Magalhaes, C, Telcharova-Mihaylovska, A, Harjacek, M, Jelusic, M, Estmann, A, Nielsen, S, Herrera Mora, C, Gervais, E, Koné-Paut, I, Quartier, P, Foeldvari, I, Horneff, G, Lutz, T, Minden, K, Tzaribachev, N, Trachana, M, Tsitsami, E, Vougiouka, O, Orban, I, Harel, L, Hashkes, P, Uziel, Y, Cimaz, R, Civino, A, Consolini, R, D'Angelo, G, De Benedetti, F, Filocamo, G, Fueri, E, Gallizzi, R, Maggio, Mc, Magnolia, Mg, Miniaci, A, Montin, D, Olivieri, A. N., Pastore, S, Rigante, D, Zulian, F, Rumba-Rozenfelde, I, Stanevicha, V, Panaviene, V, Rodriguez Lozano, Al, Rubio-Perez, N, Vega Cornejo, G, Hoppenreijs, E, Kamphuis, S, Flato, B, Nordal, Eb, Abdwani, R, Miraval, T, Paz Gastanaga, Me, Smolewska, E, Ailioaie, C, Cochino, Av, Laday, M, Lazar, C, Alexeeva, E, Chasnyk, V, Keltsev, V, Suwairi, Wm, Vijatov-Djuric, G, Vojinovic, J, Arkachaisri, T, Koskova, E, Avcin, T, Ally, M, Van Rensburg, Cj, Louw, I, Lopez, Ja, Boteanu, Al, Calvo Penades, I, De Inocencio, J, Mesa-Del-Castillo, P, Moreno, E, Remesal, A, Hofer, M, Gok, F, Ozen, S, Ramanan, A, Pallotti, C, Villa, L., Giancane, Gabriella, Swart, Joost F, Castagnola, Elio, Groll, Andreas H, Horneff, Gerd, Huppertz, Hans-Iko, Lovell, Daniel J, Wolfs, Tom, Herlin, Troel, Dolezalova, Pavla, Sanner, Helga, Susic, Gordana, Sztajnbok, Flavio, Maritsi, Despoina, Constantin, Tama, Vargova, Veronika, Sawhney, Sujata, Rygg, Marite, K Oliveira, Sheila, Cattalini, Marco, Bovis, Francesca, Bagnasco, Francesca, Pistorio, Angela, Martini, Alberto, Wulffraat, Nico, Ruperto, Nicolino, Cuttica, Ruben, Garay, Stella Mari, Brunner, Jurgen, Emminger, Wolfgang, Appenzeller, Simone, Len, Claudio, Saad Magalhaes, Claudia, Telcharova-Mihaylovska, Albena, Harjacek, Miroslav, Jelusic, Marija, Estmann, Anne, Nielsen, Susan, Herrera Mora, Cristina, Gervais, Elisabeth, Koné-Paut, Isabelle, Quartier, Pierre, Foeldvari, Ivan, Lutz, Thoma, Minden, Kirsten, Tzaribachev, Nikolay, Trachana, Maria, Tsitsami, Elena, Vougiouka, Olga, Orban, Ilonka, Harel, Liora, Hashkes, Philip, Uziel, Yosef, Cimaz, Rolando, Civino, Adele, Consolini, Rita, D'Angelo, Gianfranco, De Benedetti, Fabrizio, Filocamo, Giovanni, Fueri, Elena, Gallizzi, Romina, Maggio, Maria Cristina, Magnolia, Maria Greca, Miniaci, Angela, Montin, Davide, Olivieri, Alma Nunzia, Pastore, Serena, Rigante, Donato, Zulian, Francesco, Rumba-Rozenfelde, Ingrida, Stanevicha, Valda, Panaviene, Violeta, Rodriguez Lozano, Ana Luisa, Rubio-Perez, Nadina, Vega Cornejo, Gabriel, Hoppenreijs, Esther, Kamphuis, Sylvia, Flato, Berit, Nordal, Ellen Berit, Abdwani, Reem, Miraval, Tatiana, Paz Gastanaga, Maria Eliana, Smolewska, Elzbieta, Ailioaie, Constantin, Cochino, Alexis-Virgil, Laday, Matilda, Lazar, Calin, Alexeeva, Ekaterina, Chasnyk, Vyacheslav, Keltsev, Vladimir, Suwairi, Wafaa Mohammed Saad, Vijatov-Djuric, Gordana, Vojinovic, Jelena, Arkachaisri, Thaschawee, Koskova, Elena, Avcin, Tadej, Ally, Mahmood, Van Rensburg, Christa Janse, Louw, Ingrid, Lopez, Jordi Anton, Boteanu, Alina Lucica, Calvo Penades, Inmaculada, De Inocencio, Jaime, Mesa-Del-Castillo, Pablo, Moreno, Estefania, Remesal, Agustin, Hofer, Michael, Gok, Faysal, Ozen, Seza, Ramanan, Athimalaipet, Pallotti, Chiara, Villa, Luca, and Pediatrics

Subjects
Male, lcsh:Diseases of the musculoskeletal system, Biologic, Paediatrics: 760 [VDP], Artritis infecciosa, MedDRA, Infants malalts, Arthritis, Severity of Illness Index, Hospital patients, Cohort Studies, Pharmacovigilance, 0302 clinical medicine, 030212 general & internal medicine, Registries, Child, Biologics, Immunosuppressive therapy, Infections, Juvenile idiopathic arthritis, Opportunistic, biologics, immunosuppressive therapy, infections, juvenile idiopathic arthritis, opportunistic, Barneleddgikt, 3. Good health, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Antirheumatic Agents, Child, Preschool, Cohort, Pediatric Infectious Disease, Female, Infection, Research Article, medicine.medical_specialty, Tuberculosis, juvenil idiopathic arthritis, Opportunistic Infections, Herpes Zoster, 03 medical and health sciences, Immunocompromised Host, Juvenile idiopathic arthriti, Internal medicine, medicine, Humans, book, 030203 arthritis & rheumatology, Malalts hospitalitzats, Immunosupressió, business.industry, Sick children, medicine.disease, Rheumatology, Arthritis, Juvenile, Infectious arthritis, Pediatri: 760 [VDP], Orthopedic surgery, Opportunistiske infeksjoner, book.journal, lcsh:RC925-935, business, Infeccions oportunistes, Immunosuppression
Abstract

Background: To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods: The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. Results: A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. Conclusions: We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies. © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Published
2020
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3. 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, Ruperto, N., Tzaribachev, N., Horneff, G., Wouters, C., Panaviene, V., Chasnyk, V., Abud-Mendoza, C., Cuttica, R., Reiff, A., Maldonado-Velázquez, M., Rubio-Perez, N., Alexeeva, Ekaterina, Joos, R., Keltsev, V., Nasonov, E., Kingsbury, D., Bandeira, M., Silverman, E., Weller-Heinemann, F., van Royen-Kerkhof, A., Mendelsohn, Alan, Kim, Lilianne, Lovell, D., and Martini, A.

Published
2014
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4. Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

Author

Giancane, G, Swart, Jf, Castagnola, E, Groll, Ah, Horneff, G, Huppertz, Hi, Lovell, Dj, Wolfs, T, Herlin, T, Dolezalova, P, Sanner, H, Susic, G, Sztajnbok, F, Maritsi, D, Constantin, T, Vargova, V, Sawhney, S, Rygg, M, K Oliveira, S, Cattalini, M, Bovis, F, Bagnasco, F, Pistorio, A, Martini, A, Wulffraat, N, Ruperto, N, Cuttica, R, Garay, Sm, Brunner, J, Emminger, W, Appenzeller, S, Len, C, Saad Magalhaes, C, Telcharova-Mihaylovska, A, Harjacek, M, Jelusic, M, Estmann, A, Nielsen, S, Herrera Mora, C, Gervais, E, Koné-Paut, I, Quartier, P, Foeldvari, I, Lutz, T, Minden, K, Tzaribachev, N, Trachana, M, Tsitsami, E, Vougiouka, O, Orban, I, Harel, L, Hashkes, P, Uziel, Y, Cimaz, R, Civino, A, Consolini, R, D'Angelo, G, De Benedetti, F, Filocamo, G, Fueri, E, Gallizzi, R, Maggio, Mc, Magnolia, Mg, Miniaci, A, Montin, D, Olivieri, An, Pastore, S, Rigante, Donato, Zulian, F, Rumba-Rozenfelde, I, Stanevicha, V, Panaviene, V, Rodriguez Lozano, Al, Rubio-Perez, N, Vega Cornejo, G, Hoppenreijs, E, Kamphuis, S, Flato, B, Nordal, Eb, Abdwani, R, Miraval, T, Paz Gastanaga, Me, Smolewska, E, Ailioaie, C, Cochino, Av, Laday, M, Lazar, C, Alexeeva, E, Chasnyk, V, Keltsev, V, Suwairi, Wm, Vijatov-Djuric, G, Vojinovic, J, Arkachaisri, T, Koskova, E, Avcin, T, Ally, M, Van Rensburg, Cj, Louw, I, Lopez, Ja, Boteanu, Al, Calvo Penades, I, De Inocencio, J, Mesa-Del-Castillo, P, Moreno, E, Remesal, A, Hofer, M, Gok, F, Ozen, S, Ramanan, A, Pallotti, C, Villa, L &amp, Paediatric Rheumatology International Trials Organisation, (PRINTO), Rigante D (ORCID:0000-0001-7032-7779), Giancane, G, Swart, Jf, Castagnola, E, Groll, Ah, Horneff, G, Huppertz, Hi, Lovell, Dj, Wolfs, T, Herlin, T, Dolezalova, P, Sanner, H, Susic, G, Sztajnbok, F, Maritsi, D, Constantin, T, Vargova, V, Sawhney, S, Rygg, M, K Oliveira, S, Cattalini, M, Bovis, F, Bagnasco, F, Pistorio, A, Martini, A, Wulffraat, N, Ruperto, N, Cuttica, R, Garay, Sm, Brunner, J, Emminger, W, Appenzeller, S, Len, C, Saad Magalhaes, C, Telcharova-Mihaylovska, A, Harjacek, M, Jelusic, M, Estmann, A, Nielsen, S, Herrera Mora, C, Gervais, E, Koné-Paut, I, Quartier, P, Foeldvari, I, Lutz, T, Minden, K, Tzaribachev, N, Trachana, M, Tsitsami, E, Vougiouka, O, Orban, I, Harel, L, Hashkes, P, Uziel, Y, Cimaz, R, Civino, A, Consolini, R, D'Angelo, G, De Benedetti, F, Filocamo, G, Fueri, E, Gallizzi, R, Maggio, Mc, Magnolia, Mg, Miniaci, A, Montin, D, Olivieri, An, Pastore, S, Rigante, Donato, Zulian, F, Rumba-Rozenfelde, I, Stanevicha, V, Panaviene, V, Rodriguez Lozano, Al, Rubio-Perez, N, Vega Cornejo, G, Hoppenreijs, E, Kamphuis, S, Flato, B, Nordal, Eb, Abdwani, R, Miraval, T, Paz Gastanaga, Me, Smolewska, E, Ailioaie, C, Cochino, Av, Laday, M, Lazar, C, Alexeeva, E, Chasnyk, V, Keltsev, V, Suwairi, Wm, Vijatov-Djuric, G, Vojinovic, J, Arkachaisri, T, Koskova, E, Avcin, T, Ally, M, Van Rensburg, Cj, Louw, I, Lopez, Ja, Boteanu, Al, Calvo Penades, I, De Inocencio, J, Mesa-Del-Castillo, P, Moreno, E, Remesal, A, Hofer, M, Gok, F, Ozen, S, Ramanan, A, Pallotti, C, Villa, L &amp, Paediatric Rheumatology International Trials Organisation, (PRINTO), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

BACKGROUND: To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). METHODS: The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching the adjudicated infections with the provisional list of OI. RESULTS: A total of 772 infectious events in 572 eligible patients, of which 335 serious/severe/very severe non-OI and 437 OI (any intensity/severity), according to the provisional list, were retrieved. Six hundred eighty-two of 772 (88.3%) were adjudicated as infections, of them 603/682 (88.4%) as common and 119/682 (17.4%) as OI by the SAC. Matching these 119 opportunistic events with the provisional list, 106 were confirmed by the SAC as OI, and among them infections by herpes viruses were the most frequent (68%), followed by tuberculosis (27.4%). The remaining events were divided in the groups of non-OI and possible/patient and/or pathogen-related OI. CONCLUSIONS: We found a significant number of OI in JIA patients on immunosuppressive therapy. The proposed list of OI, created by consensus and validated in the Pharmachild cohort, could facilitate comparison among future pharmacovigilance studies.

Published
2020

5. Growth During Tocilizumab Therapy for Polyarticular-course Juvenile Idiopathic Arthritis: 2-year Data from a Phase III Clinical Trial

Author

Bharucha, KN, Brunner, HI, Penades, IC, Nikishina, I, Rubio-Perez, N, Oliveira, S, Kobusinska, K, Schmeling, H, Sztajnbok, F, Weller-Heinemann, F, Zholobova, E, Zulian, F, Allen, R, Chaitow, J, Frane, J, Wells, C, Ruperto, N, De Benedetti, F, Paediat Rheumatol Int Trials Org, and Pediat Rheumatology Collaborative

Subjects
INTERLEUKINS, BIOLOGICAL THERAPY, GROWTH, JUVENILE IDIOPATHIC ARTHRITIS
Abstract

Objective. Evaluate growth in patients with polyarticular-course juvenile idiopathic arthritis (pcJIA) treated with tocilizumab (TCZ) for up to 2 years in a phase III trial. Methods. Patients with pcJIA lasting at least 6 months and inadequate response to methotrexate received open-label TCZ intravenously every 4 weeks (randomly assigned to 8 or 10 mg/kg if they weighed = 30 kg) for 16 weeks. Patients with JIA American College of Rheumatology 30 response at Week 16 were randomly assigned to TCZ or placebo for 24 weeks, with an open-label extension through Week 104. Mean +/- SD height velocity (cm/yr) and World Health Organization (WHO) height SD score (SDS) were measured in patients receiving >= 1 dose of TCZ who did not receive growth hormone and in patients whose baseline Tanner stage was

Published
2018

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

Author

Brunner, H, Horneff, G, Ruperto, N, Tzaribachev, N, Wouters, C, Chasnyk, V, Cuttica, R, Keltsev, V, Nasonov, E, Kingsbury, D, Weller-Heinemann, F, Lovell, DJ, Martini, A, Panaviene, VV, Abud Mendoza, C, Reiff, A, Alexeeva, E, Joos, R, Bandeira, M, Silverman, E, van Royen-Kerkhof, A, Kim, L, Rubio-Perez, N, Brunner, H, Horneff, G, Ruperto, N, Tzaribachev, N, Wouters, C, Chasnyk, V, Cuttica, R, Keltsev, V, Nasonov, E, Kingsbury, D, Weller-Heinemann, F, Lovell, DJ, Martini, A, Panaviene, VV, Abud Mendoza, C, Reiff, A, Alexeeva, E, Joos, R, Bandeira, M, Silverman, E, van Royen-Kerkhof, A, Kim, L, and Rubio-Perez, N

Published
2016

7. Oral Abstracts 3: Adolescent and Young Adult * O13. Hypermobility is a Risk Factor for Musculoskeletal Pain in Adolescence: Findings From a Prospective Cohort Study

Author

Tobias, J., primary, Deere, K., additional, Palmer, S., additional, Clark, E., additional, Clinch, J., additional, Fikree, A., additional, Aktar, R., additional, Wellstead, G., additional, Knowles, C., additional, Grahame, R., additional, Aziz, Q., additional, Amaral, B., additional, Murphy, G., additional, Ioannou, Y., additional, Isenberg, D. A., additional, Tansley, S. L., additional, Betteridge, Z. E., additional, Gunawardena, H., additional, Shaddick, G., additional, Varsani, H., additional, Wedderburn, L., additional, McHugh, N., additional, De Benedetti, F., additional, Ruperto, N., additional, Espada, G., additional, Gerloni, V., additional, Flato, B., additional, Horneff, G., additional, Myones, B. L., additional, Onel, K., additional, Frane, J., additional, Kenwright, A., additional, Lipman, T. H., additional, Bharucha, K. N., additional, Martini, A., additional, Lovell, D. J., additional, Baildam, E., additional, Brunner, H., additional, Zuber, Z., additional, Keane, C., additional, Harari, O., additional, Cuttica, R. J., additional, Keltsev, V., additional, Xavier, R., additional, Penades, I. C., additional, Nikishina, I., additional, Rubio-Perez, N., additional, Alekseeva, E., additional, Chasnyk, V., additional, Chavez, J., additional, Opoka-Winiarska, V., additional, Quartier, P., additional, Silva, C. A., additional, Silverman, E. D., additional, Spindler, A., additional, Hendry, G. J., additional, Watt, G. F., additional, Brandon, M., additional, Friel, L., additional, Turner, D., additional, Lorgelly, P. K., additional, Gardner-Medwin, J., additional, Sturrock, R. D., additional, Woodburn, J., additional, Firth, J., additional, Waxman, R., additional, Law, G., additional, Siddle, H., additional, Nelson, A. E., additional, Helliwell, P., additional, Otter, S., additional, Butters, V., additional, Loughrey, L., additional, Alcacer-Pitarch, B., additional, Tranter, J., additional, Davies, S., additional, Hryniw, R., additional, Lewis, S., additional, Baker, L., additional, Dures, E., additional, Hewlett, S., additional, Ambler, N., additional, Clarke, J., additional, Gooberman-Hill, R., additional, Jenkins, R., additional, Wilkie, R., additional, Bucknall, M., additional, Jordan, K., additional, McBeth, J., additional, Norton, S., additional, Walsh, D., additional, Kiely, P., additional, Williams, R., additional, Young, A., additional, Harkess, J. E., additional, McAlarey, K., additional, Chesterton, L., additional, van der Windt, D. A., additional, Sim, J., additional, Lewis, M., additional, Mallen, C. D., additional, Mason, E., additional, Hay, E., additional, Clarson, L. E., additional, Hider, S. L., additional, Belcher, J., additional, Heneghan, C., additional, Roddy, E., additional, Gibson, J., additional, Whiteford, S., additional, Williamson, E., additional, Beatty, S., additional, Hamilton-Dyer, N., additional, Healey, E. L., additional, Ryan, S., additional, McHugh, G. A., additional, Main, C. J., additional, Porcheret, M., additional, Nio Ong, B., additional, Pushpa-Rajah, A., additional, Dziedzic, K. S., additional, MacRae, C. S., additional, Shortland, A., additional, Lewis, J., additional, Morrissey, M., additional, Critchley, D., additional, Muller, S., additional, Helliwell, T., additional, Cole, Z., additional, Parsons, C., additional, Crozier, S., additional, Robinson, S., additional, Taylor, P., additional, Inskip, H., additional, Godfrey, K., additional, Dennison, E., additional, Harvey, N. C., additional, Cooper, C., additional, Prieto Alhambra, D., additional, Lalmohamed, A., additional, Abrahamsen, B., additional, Arden, N., additional, de Boer, A., additional, Vestergaard, P., additional, de Vries, F., additional, Kendal, A., additional, Carr, A., additional, Prieto-Alhambra, D., additional, Judge, A., additional, Chapurlat, R., additional, Bellamy, N., additional, Czerwinski, E., additional, Pierre Devogelaer, J., additional, March, L., additional, Pavelka, K., additional, Reginster, J.-Y., additional, Kiran, A., additional, Javaid, M. K., additional, Sundy, J. S., additional, Baraf, H. S., additional, Becker, M., additional, Treadwell, E. L., additional, Yood, R., additional, and Ottery, F. D., additional

Published
2013
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9. The HyperPed-COVID international registry: Impact of age of onset, disease presentation and geographical distribution on the final outcome of MIS-C.

Author

Caorsi R, Consolaro A, Speziani C, Sozeri B, Ulu K, Faugier-Fuentes E, Menchaca-Aguayo H, Ozen S, Sener S, Akhter Rahman S, Imnul Islam M, Haerynck F, Simonini G, Mastri MV, Avcin T, Sršen S, de Albuquerque Pedrosa Fernandes T, Stanevicha V, Vojinovic J, Sobh A, Fingerhutova S, Minxova L, Gagro A, Rodrigues Fonseca A, Pandya D, Varbanova B, Sánchez-Manubens J, Ganeva M, Montin D, Boyarchuk O, Minghini A, Bracaglia C, Brogan P, Candotti F, Cattalini M, Meyts I, Minoia F, Taddio A, Wouters C, De Benedetti F, Bovis F, Ravelli A, Ruperto N, Gattorno M, Bilginer Y, Laila K, Islam MM, Meertens B, Hoste L, Dehoorne J, Schelstraete P, Vandekerckhove K, Willems J, Matthijs I, Filocamo E Gisella Beatrice Beretta G, Magalhaes CS, Chubata O, Ricci F, Vukovic A, Temelkova K, Avramovic MZ, Emersic N, Bizjak M, Vesel T, Rodrigues MF, Gasparello de Almeida R, Lukjanovica K, Elnagdy MH, Soliman A, Terifajova E, Brejchova I, Magner M, Myrup C, Vougiouka O, Jelusic M, La Torre F, Rigante D, Maggio MC, Verdoni L, Rubio-Perez N, Cornejo GV, Villarreal Trevino AV, Brito I, Oliveira-Ramos F, Alexeeva E, Chasnyk V, Arkachaisri T, Boyko Y, Vyzhga Y, and Samsonenko S

Subjects
Humans, Child, Child, Preschool, Female, Male, Infant, Adolescent, Retrospective Studies, Europe epidemiology, Infant, Newborn, Registries, COVID-19 epidemiology, COVID-19 mortality, COVID-19 complications, Age of Onset, Systemic Inflammatory Response Syndrome epidemiology, Systemic Inflammatory Response Syndrome diagnosis, Systemic Inflammatory Response Syndrome therapy, SARS-CoV-2
Abstract

Objectives: The aim of the study was to establish an international multicenter registry to collect data on patients with Multisystem Inflammatory Syndrome in Children (MIS-C), in order to highlight a relationship between clinical presentation, age of onset and geographical distribution on the clinical outcome., Study Design: Multicenter retrospective study involving different international societies for rare immunological disorders.1009 patients diagnosed with MIS-C between March and September 2022, from 48 centers and 22 countries were collected. Five age groups (<1, 1-4, 5-11, 12-16, >16 years) and four geographic macro-areas, Western Europe, Central-Eastern Europe, Latin America, Asian-African resource-limited countries (LRC), were identified., Results: Time to referral was significantly higher in LRC. Intensive anti-inflammatory treatment, including biologics, respiratory support and mechanic ventilation were more frequently used in older children and in European countries. The mortality rate was higher in very young children (<1 year), in older patients (>16 years of age) and in LRC. Multivariate analysis identified the residence in LRC, presence of severe cardiac involvement, renal hypertension, lymphopenia and non-use of heparin prophylaxis, as the factors most strongly associated with unfavorable outcomes., Conclusions: The stratification of patients by age and geographic macro-area provided insights into the clinical presentation, treatment and outcome of MIS-C. The mortality and sequelae rates exhibited a correlation with the age and geographical areas. Patients admitted and treated in LRC displayed more severe outcomes, possibly due to delays in hospital admission and limited access to biologic drugs and to intensive care facilities., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Published
2024
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10. Increased incidence of inflammatory bowel disease on etanercept in juvenile idiopathic arthritis regardless of concomitant methotrexate use.

Author

van Straalen JW, Krol RM, Giancane G, Panaviene V, Ailioaie LM, Doležalová P, Cattalini M, Susic G, Sztajnbok FR, Maritsi D, Constantin T, Sawhney S, Rygg M, Oliveira SK, Nordal EB, Saad-Magalhães C, Rubio-Perez N, Jelusic M, de Roock S, Wulffraat NM, Ruperto N, and Swart JF

Subjects
Child, Etanercept adverse effects, Humans, Incidence, Male, Methotrexate therapeutic use, Registries, Antirheumatic Agents adverse effects, Arthritis, Juvenile drug therapy, Arthritis, Juvenile epidemiology, Inflammatory Bowel Diseases drug therapy, Inflammatory Bowel Diseases epidemiology
Abstract

Objective: To describe risk factors for IBD development in a cohort of children with JIA., Methods: JIA patients who developed IBD were identified from the international Pharmachild register. Characteristics were compared between IBD and non-IBD patients and predictors of IBD were determined using multivariable logistic regression analysis. Incidence rates of IBD events on different DMARDs were calculated, and differences between therapies were expressed as relative risks (RR)., Results: Out of 8942 patients, 48 (0.54% ) developed IBD. These were more often male (47.9% vs 32.0%) and HLA-B27 positive (38.2% vs 21.0%) and older at JIA onset (median 8.94 vs 5.33 years) than patients without IBD development. They also had more often a family history of autoimmune disease (42.6% vs 24.4%) and enthesitis-related arthritis (39.6% vs 10.8%). The strongest predictors of IBD on multivariable analysis were enthesitis-related arthritis [odds ratio (OR): 3.68, 95% CI: 1.41, 9.40] and a family history of autoimmune disease (OR: 2.27, 95% CI: 1.12, 4.54). Compared with methotrexate monotherapy, the incidence of IBD on etanercept monotherapy (RR: 7.69, 95% CI: 1.99, 29.74), etanercept with methotrexate (RR: 5.70, 95% CI: 1.42, 22.77) and infliximab (RR: 7.61, 95% CI: 1.27, 45.57) therapy was significantly higher. Incidence on adalimumab was not significantly different (RR: 1.45, 95% CI: 0.15, 13.89)., Conclusion: IBD in JIA was associated with enthesitis-related arthritis and a family history of autoimmune disease. An increased IBD incidence was observed for etanercept therapy regardless of concomitant methotrexate use., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Published
2022
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11. Cross-cultural validation of the paediatric Gait, Arms, Legs, Spine (pGALS) tool for the screening of musculoskeletal disorders in Mexican children.

Author

Moreno-Torres LA, Hernández-Garduño AG, Arellano-Valdés CA, Salinas-Rodríguez A, Rubio-Perez N, and Peláez-Ballestas I

Subjects
Adolescent, Age Factors, Area Under Curve, Case-Control Studies, Child, Cross-Sectional Studies, Female, Humans, Male, Mexico epidemiology, Musculoskeletal Diseases ethnology, Musculoskeletal Diseases physiopathology, Predictive Value of Tests, ROC Curve, Reproducibility of Results, Translating, Cultural Characteristics, Gait, Lower Extremity physiopathology, Musculoskeletal Diseases diagnosis, Spine physiopathology, Surveys and Questionnaires, Upper Extremity physiopathology
Abstract

The aim of this study was to validate the paediatric Gait, Arms, Legs, Spine (pGALS) tool for Mexican Spanish to screen Mexican paediatric population for musculoskeletal (MSK) disorders. A cross-sectional study was performed in the Paediatric Hospital of the Mexican Social Security Institute in Guadalajara, Jalisco. The validation included children and adolescents aged 6-16 years, 87 patients with musculoskeletal disorders and 88 controls without musculoskeletal disorders. The cross-cultural validation followed the current published guidelines. The average pGALS administration time was 2.9 min (SD 0.54). The internal consistency score (Cronbach's α) was 0.90 (0.89 for inflammatory and 0.77 for non-inflammatory disorders) for MSK disorders, with a sensitivity of 97 % (95 % CI 92-99 %), a specificity of 93 % (95 % CI 86-97 %), a LR+ of 14.3, and a ROC curve of 0.95 (95 % CI 0.92-0.98 %). The inflammatory disorders group had a sensitivity of 97 % (95 % CI 86-99 %), a specificity of 93 % (95 % CI 86-97 %), a LR+ of 14.2, and a ROC curve of 0.95 % (95 % CI 0.91-0.99 %). The non-inflammatory disorders group had a sensitivity of 98 % (95 % CI 89-99 %), a specificity of 93 % (95 % CI 86-97 %), and a LR+ of 14.37, with a ROC curve of 0.95 % (95 % CI 0.92-0.98 %). pGALS is a valid screening tool, fast, easy to administer, and useful for detecting musculoskeletal disorders in Mexican children and adolescents.

Published
2016
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