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

Author

Ruperto, Nicolino, Brunner, Hermine I, Ramanan, Athimalaipet V, Horneff, Gerd, Cuttica, Rubén, Henrickson, Michael, Anton, Jordi, Boteanu, Alina Lucica, Penades, Inmaculada Calvo, Minden, Kirsten, Schmeling, Heinrike, Hufnagel, Markus, Weiss, Jennifer E, Pardeo, Manuela, Nanda, Kabita, Roth, Johannes, Rubio-Pérez, Nadina, Hsu, Joy C, Wimalasundera, Sunethra, and Wells, Chris

Subjects
DRUG efficacy, TOCILIZUMAB, JUVENILE idiopathic arthritis, RANDOMIZED controlled trials, DESCRIPTIVE statistics, STATISTICAL sampling, SUBCUTANEOUS injections, PATIENT safety, PHARMACODYNAMICS, CHILDREN
Abstract

Objectives To determine s.c. tocilizumab (s.c.-TCZ) dosing regimens for systemic JIA (sJIA) and polyarticular JIA (pJIA). Methods In two 52-week phase 1 b trials, s.c.-TCZ (162 mg/dose) was administered to sJIA patients every week or every 2 weeks (every 10 days before interim analysis) and to pJIA patients every 2 weeks or every 3 weeks with body weight ≥30 kg or <30 kg, respectively. Primary end points were pharmacokinetics, pharmacodynamics and safety; efficacy was exploratory. Comparisons were made to data from phase 3 trials with i.v. tocilizumab (i.v.-TCZ) in sJIA and pJIA. Results Study participants were 51 sJIA patients and 52 pJIA patients aged 1–17 years who received s.c.-TCZ. Steady-state minimum TCZ concentration (Ctrough) >5th percentile of that achieved with i.v.-TCZ was achieved by 49 (96%) sJIA and 52 (100%) pJIA patients. In both populations, pharmacodynamic markers of disease were similar between body weight groups. Improvements in Juvenile Arthritis DAS-71 were comparable between s.c.-TCZ and i.v.-TCZ. By week 52, 53% of sJIA patients and 31% of pJIA patients achieved clinical remission on treatment. Safety was consistent with that of i.v.-TCZ except for injection site reactions, reported by 41.2% and 28.8% of sJIA and pJIA patients, respectively. Infections were reported in 78.4% and 69.2% of patients, respectively. Two sJIA patients died; both deaths were considered to be related to TCZ. Conclusion s.c.-TCZ provides exposure and risk/benefit profiles similar to those of i.v.-TCZ. S.c. administration provides an alternative administration route that is more convenient for patients and caregivers and that has potential for in-home use. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov , NCT01904292 and NCT01904279 [ABSTRACT FROM AUTHOR]

Published
2021
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3. Phenotypic variability and disparities in treatment and outcomes of childhood arthritis throughout the world: an observational cohort study

Author

Adriana Apostol, Matilda Laday, Michael Hofer, Amita Aggarwal, Pierre Quartier, Dirk Foell, Raju Khubchandani, Nikolay Tzaribachev, Patrizia Barone, Angela Pistorio, Ivan Foeldvari, Angela Miniaci, Pamela Weiss, Nicolino Ruperto, Violeta Panaviene, Claudia Saad Magalhães, Betül Sözeri, Gordana Vijatov-Djuric, Erkan Demirkaya, Carine Wouters, Calin Lazar, Rubén Burgos-Vargas, Tamás Constantin, Zoilo Morel Ayala, Carmen De Cunto, Elena Tsitsami, Marta Torcoletti, B Varbanova, Angelo Ravelli, Nahid Shafaie, Soad Hashad, Maria Greca Magnolia, José Melo-Gomes, Kirsten Minden, Ilonka Orbán, Flavio Sztajnbok, Maka Ioseliani, Ingrida Rumba-Rozenfelde, Silvia Magni Manzoni, Francesca Bovis, Berit Flatø, Stella Garay, Olga Arguedas, Maria Cristina Maggio, Yahya Aghighi, Sujata Sawhney, Francesco La Torre, Ruben Cuttica, Jaime de Inocencio, Clara Malagon, Alina Boteanu, Gerd Horneff, Silvana Martino, Sulaiman M. Al-Mayouf, Alberto Martini, Maria Trachana, Christiaan Scott, Rolando Cimaz, Nuray Aktay Ayaz, Maya-Feriel Aiche, Irina Nikishina, Valeria Gerloni, Sylvia Kamphuis, Olga Vougiouka, Dirk Holzinger, Reza Shiari, Sara Pieropan, Nico M Wulffraat, Inmaculada Calvo Penades, MM Katsicas, Pablo Mesa-del-Castillo, Lidia Rutkowska-Sak, Cristina Herrera, Jelena Vojinovic, Daniel J. Lovell, Erbil Unsal, Miroslav Harjacek, Yosef Uziel, Dimitrina Mihaylova, Gordana Susic, Susan Nielsen, Pekka Lahdenne, Soamarat Vilaiyuk, Rita Consolini, Ekaterina Alexeeva, Chris Pruunsild, Gaëlle Chédeville, Nicolae Iagaru, Ozgur Kasapcopur, Troels Herlin, Anne Estmann Christensen, Yaryna Boyko, Carolina Montobbio, Sarah Ringold, Johannes-Peter Haas, Gerd Ganser, Jordi Anton, Marite Rygg, Liisa Kröger, Reem Abdwani, Pavla Dolezalova, Paivi Miettunen, Rosa Anna Podda, Sheila Knupp Feitosa de Oliveira, Graciela Espada, Richard Vesely, Merja Malin, Liora Harel, Veronika Vargova, Mohammad Hasan Moradinejad, Neil A. Martin, Adele Civino, Tadej Avcin, Hans-Iko Huppertz, Ellen Nordal, Ximena Norambuena, Alessandra Alongi, Serena Pastore, Karaman Pagava, Maria Ekelund, Donato Rigante, Rotraud K. Saurenmann, Lillemor Berntson, Tomáš Dallos, Elżbieta Smolewska, Rik Joos, Andrea Militaru, Alessandro Consolaro, C. Ailioaie, Romina Gallizzi, Gabriella Giancane, Agustin Remesal, Anuela Kondi, Safiya Al-Abrawi, Anne Putto-Laurila, Joost F Swart, Paula Vähäsalo, Evert Hendrik Pieter van Dijkhuizen, Amparo Ibanez Estrella, Yasser El Miedany, Consolaro, Alessandro, Giancane, Gabriella, Alongi, Alessandra, van Dijkhuizen, Evert Hendrik Pieter, Aggarwal, Amita, Al-Mayouf, Sulaiman M, Bovis, Francesca, De Inocencio, Jaime, Demirkaya, Erkan, Flato, Berit, Foell, Dirk, Garay, Stella Mari, Lazăr, Călin, Lovell, Daniel J, Montobbio, Carolina, Miettunen, Paivi, Mihaylova, Dimitrina, Nielsen, Susan, Orban, Ilonka, Rumba-Rozenfelde, Ingrida, Magalhães, Claudia Saad, Shafaie, Nahid, Susic, Gordana, Trachana, Maria, Wulffraat, Nico, Pistorio, Angela, Martini, Alberto, Ruperto, Nicolino, Ravelli, Angelo, Abdwani, Reem, Aghighi, Yahya, Aiche, Maya-Feriel, Ailioaie, Constantin, Aktay Ayaz, Nuray, Al-Abrawi, Safiya, Alexeeva, Ekaterina, Anton, Jordi, Apostol, Adriana, Arguedas, Olga, Avcin, Tadej, Barone, Patrizia, Berntson, Lillemor, Boteanu, Alina Lucica, Boyko, Yaryna, Burgos-Vargas, Ruben, Calvo Penades, Inmaculada, Chédeville, Gaëlle, Cimaz, Rolando, Civino, Adele, Consolini, Rita, Constantin, Tama, Cuttica, Ruben, Dallos, Toma, Martin, Neil, Magni Manzoni, Silvia, De Cunto, Carmen, Dolezalova, Pavla, Ekelund, Maria, El Miedany, Yasser, Espada, Graciela, Estmann Christensen, Anne, Foeldvari, Ivan, Gallizzi, Romina, Ganser, Gerd, Gerloni, Valeria, Haas, Johannes-Peter, Harel, Liora, Harjacek, Miroslav, Hashad, Soad, Herlin, Troel, Herrera, Cristina, Hofer, Michael, Holzinger, Dirk, Horneff, Gerd, Huppertz, Hans-Iko, Iagăru, Nicolae, Ibanez Estrella, Amparo, Ioseliani, Maka, Joos, Rik, Knupp Oliveira, Sheila, Kamphuis, Sylvia, Kasapcopur, Ozgur, Katsicas, Maria Martha, Khubchandani, Raju, Kondi, Anuela, Kröger, Liisa, La Torre, Francesco, Laday, Matilda, Lahdenne, Pekka, Maggio, Maria Cristina, Magnolia, Maria Greca, Malagon, Clara, Malin, Merja, Martino, Silvana, Melo-Gomes, Jose Antonio, Mesa-del-Castillo, Pablo, Militaru, Andrea, Minden, Kirsten, Miniaci, Angela, Moradinejad, Mohammad Hasan, Morel Ayala, Zoilo, Nikishina, Irina, Norambuena, Ximena, Nordal, Ellen Berit, Pagava, Karaman, Panaviene, Violeta, Pastore, Serena, Pieropan, Sara, Podda, Rosa Anna, Pruunsild, Chri, Putto-Laurila, Anne, Quartier, Pierre, Remesal, Agustin, Rigante, Donato, Ringold, Sarah, Rutkowska-Sak, Lidia, Rygg, Marite, Saurenmann, Rotraud Katharina, Sawhney, Sujata, Scott, Christiaan, Shiari, Reza, Smolewska, Elzbieta, Sozeri, Betul, Swart, Joost Fran, Sztajnbok, Flavio, Torcoletti, Marta, Tsitsami, Elena, Tzaribachev, Nikolay, Unsal, Erbil, Uziel, Yosef, Vähäsalo, Paula, Varbanova, Boriana, Vargova, Veronika, Vesely, Richard, Vijatov-Djuric, Gordana, Vilaiyuk, Soamarat, Vojinovic, Jelena, Vougiouka, Olga, Weiss, Pamela, Wouters, Carine, Pediatrics, Univ Genoa, Wilhelmina Childrens Hosp, Sanjay Gandhi Postgrad Inst Med Sci, Univ Hosp 12 Octubre, Alfaisal Univ, Western Univ Childrens Hosp, Oslo Univ Hosp, Univ Oslo, Univ Hosp Munster, Hosp Sor Maria Ludovica, Bucharest Emergency Hosp, Childrens Emergency Hosp, Cincinnati Childrens Hosp Med Ctr, Alberta Childrens Prov Gen Hosp, Sofiamed, Rigshosp, Natl Inst Rheumatism & Physiotherapy, Univ Latvia, Universidade Estadual Paulista (Unesp), Shariati Hosp, Inst Rheumatol Belgrade, and Thessaloniki Univ

Subjects
Male, medicine.medical_specialty, Childhood arthritis, Cross-sectional study, Population, Global Health, Pediatrics, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, Epidemiology, medicine, Developmental and Educational Psychology, Journal Article, Humans, Pediatrics, Perinatology and Child Health, 030212 general & internal medicine, Healthcare Disparities, Child, education, Disease burden, Pain Measurement, Retrospective Studies, education.field_of_study, Oligoarthritis, business.industry, Perinatology and Child Health, Juvenile idiopathic arthritis, medicine.disease, JUVENILE IDIOPATHIC ARTHRITIS, OF-RHEUMATOLOGY RECOMMENDATIONS, DISEASE-ACTIVITY SCORE, DEFINING CRITERIA, CLASSIFICATION, CHILDREN, EPIDEMIOLOGY, VALIDATION, COUNTRIES, VALIDITY, Arthritis, Juvenile, childhood arthritis,phenotypic variability,observational cohort study, Cross-Sectional Studies, Biological Variation, Population, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Antirheumatic Agents, Child, Preschool, Quality of Life, Female, Polyarthritis, Juvenile idiopatic arthritis, of-rheumatology recommentadions, disease-activity score, defining criteria, classification, children, epidemiology, validation, countries, validity, business, Demography, Cohort study
Abstract

Made available in DSpace on 2019-10-05T16:54:20Z (GMT). No. of bitstreams: 0 Previous issue date: 2019-04-01 IRCCS Istituto Giannina Gaslini Background To our knowledge, the characteristics and burden of childhood arthritis have never been studied on a worldwide basis. We aimed to investigate, with a cross-sectional study, the prevalence of disease categories, treatment methods, and disease status in patients from across different geographical areas and from countries with diverse wealth status. Methods In this multinational, cross-sectional, observational cohort study, we asked international paediatric rheumatologists from specialised centres to enrol children with a diagnosis of juvenile idiopathic arthritis, according to International League of Associations for Rheumatology criteria, who were seen consecutively for a period of 6 months. Each patient underwent retrospective and cross-sectional assessments, including measures of disease activity and damage and questionnaires on the wellbeing and quality of life of the children. We qualitatively compared the collected data across eight geographical areas, and we explored an association between disease activity and damage and a country's gross domestic product (GDP) with a multiple logistic regression analysis. Findings Between April 4, 2011, and Nov 21, 2016, 9081 patients were enrolled at 130 centres in 49 countries, grouped into eight geographical areas. Systemic arthritis (125 [33.0%] of 379 patients) and enthesitis-related arthritis (113 [29.8%] of 379) were more common in southeast Asia, whereas oligoarthritis was more prevalent in southern Europe (1360 [56.7%] of 2400) and rheumatoid factor-negative polyarthritis was more frequent in North America (165 [31.5%] of 523) than in the other areas. Prevalence of uveitis was highest in northern Europe (161 [19.1%] of 845 patients) and southern Europe (450 [18.8%] of 2400) and lowest in Latin America (54 [6.4%] of 849), Africa and Middle East (71 [5.9%] of 1209), and southeast Asia (19 [5.0%] of 379). Median age at disease onset was lower in southern Europe (3.5 years, IQR 1.9-7.3) than in other regions. Biological, disease-modifying antirheumatic drugs were prescribed more frequently in northern Europe and North America than in other geographical settings. Patients living in countries with lower GDP had greater disease activity and damage than those living in wealthier countries. Damage was associated with referral delay. Interpretation Our study documents a variability in prevalence of disease phenotypes and disparities in therapeutic choices and outcomes across geographical areas and wealth status of countries. The greater disease burden in lowerresource settings highlights the need for public health efforts aimed at improving equity in access to effective treatments and care for juvenile idiopathic arthritis. Copyright (C) 2019 Elsevier Ltd. All rights reserved. Univ Genoa, Ist Giannina Gaslini, IRCCS, Clin Paediat & Rheumatol, Genoa, Italy Univ Genoa, Ist Giannina Gaslini, IRCCS, Epidemiol & Biostat Serv, Genoa, Italy Univ Genoa, Ist Giannina Gaslini, IRCCS, Sci Directory, Genoa, Italy Univ Genoa, PRINTO, IRCCS, Ist Giannina Gaslini, Genoa, Italy Univ Genoa, Dept Neurosci Rehabil Ophthalmol Genet & Maternal, Genoa, Italy Wilhelmina Childrens Hosp, Dept Pediat Immunol & Rheumatol, Utrecht, Netherlands Sanjay Gandhi Postgrad Inst Med Sci, Lucknow, Uttar Pradesh, India Univ Hosp 12 Octubre, Dept Pediat Rheumatol, Madrid, Spain Alfaisal Univ, Dept Pediat Rheumatol, King Faisal Specialist Hosp, Riyadh, Saudi Arabia Alfaisal Univ, Res Ctr, Riyadh, Saudi Arabia Western Univ Childrens Hosp, Hlth Sci Ctr, London, ON, Canada Oslo Univ Hosp, Dept Rheumatol, Oslo, Norway Oslo Univ Hosp, Med Fac, Oslo, Norway Univ Oslo, Oslo, Norway Oslo Univ Hosp, Norwegian Natl Advisory Unit Rheumat Dis Children, Oslo, Norway Univ Hosp Munster, Dept Pediat Rheumatol & Immunol, Munster, Germany Hosp Sor Maria Ludovica, Rheumatol Serv, La Plata, Buenos Aires, Argentina Bucharest Emergency Hosp, Cluj Napoca, Romania Childrens Emergency Hosp, Cluj Napoca, Romania Cincinnati Childrens Hosp Med Ctr, Div Rheumatol, Cincinnati, OH 45229 USA Alberta Childrens Prov Gen Hosp, Div Pediat Rheumatol, Dept Pediat, Calgary, AB, Canada Sofiamed, Pediat Dept, Sofia, Bulgaria Rigshosp, Juliane Marie Ctr, Paediat Rheumatol Unit, Copenhagen, Denmark Natl Inst Rheumatism & Physiotherapy, Clin Immunol Adult & Paediat Rheumatol Dept, Budapest, Hungary Univ Latvia, Pediat Dept, Riga, Latvia Univ Latvia, Univ Childrens Hosp, Riga, Latvia Univ Estadual Paulista, Botucatu Fac Med, Botucatu, SP, Brazil Shariati Hosp, Rheumatol Res Ctr, Dept Pediat & Rheumatol, Tehran, Iran Inst Rheumatol Belgrade, Div Pediat Rheumatol, Belgrade, Serbia Thessaloniki Univ, Dept Pediat 1, Hippokrat Gen Hosp, Sch Med, Thessaloniki, Greece Univ Estadual Paulista, Botucatu Fac Med, Botucatu, SP, Brazil

Published
2019
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