Disease status, reasons for discontinuation and adverse events in 1038 Italian children with juvenile idiopathic arthritis treated with etanercept
| Autor: | Marta Torcoletti, Achille Marino, Francesco La Torre, Giovanni Conti, Patrizia Barone, Donato Rigante, Francesco Zulian, Francesca Rovelli, Angelo Ravelli, Fabrizio De Benedetti, Gianfranco D'Angelo, Adele Civino, Alessandro De Fanti, Rebecca Nicolai, Valeria Gerloni, Irene Pontikaki, Silvia Magni-Manzoni, Francesca Bovis, Maria Cristina Maggio, Nicolino Ruperto, Serena Pastore, C Fede, Denise Pires Marafon, Alberto Martini, Chiara Sandrin, Fabrizia Corona, Romina Gallizzi, Sergio Davì, MG Alpigiani, Rita Consolini, Sara Verazza, Alessandro Consolaro, Giorgia Martini, Antonella Insalaco, Mauro Jorini, Alma Nunzia Olivieri, Rolando Cimaz, Rosanna Podda, Valentina Muratore, Luciana Breda, Marco Cattalini, Elisabetta Cortis |
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| Přispěvatelé: | Verazza, Sara, Davì, Sergio, Consolaro, Alessandro, Bovis, Francesca, Insalaco, Antonella, Magni Manzoni, Silvia, Nicolai, Rebecca, Marafon, Denise Pire, De Benedetti, Fabrizio, Gerloni, Valeria, Pontikaki, Irene, Rovelli, Francesca, Cimaz, Rolando, Marino, Achille, Zulian, Francesco, Martini, Giorgia, Pastore, Serena, Sandrin, Chiara, Corona, Fabrizia, Torcoletti, Marta, Conti, Giovanni, Fede, Claudia, Barone, Patrizia, Cattalini, Marco, Cortis, Elisabetta, Breda, Luciana, Olivieri, Alma Nunzia, Civino, Adele, Podda, Rosanna, Rigante, Donato, La Torre, Francesco, D'Angelo, Gianfranco, Jorini, Mauro, Gallizzi, Romina, Maggio, Maria Cristina, Consolini, Rita, De Fanti, Alessandro, Muratore, Valentina, Alpigiani, Maria Giannina, Ruperto, Nicolino, Martini, Alberto, Ravelli, Angelo, Verazza, S., Davì, S., Consolaro, A., Bovis, F., Insalaco, A., Magni-Manzoni, S., Nicolai, R., Marafon, D., De Benedetti, F., Gerloni, V., Pontikaki, I., Rovelli, F., Cimaz, R., Marino, A., Zulian, F., Martini, G., Pastore, S., Sandrin, C., Corona, F., Torcoletti, M., Conti, G., Fede, C., Barone, P., Cattalini, M., Cortis, E., Breda, L., Olivieri, A., Civino, A., Podda, R., Rigante, D., La Torre, F., D'Angelo, G., Jorini, M., Gallizzi, R., Maggio, M., Consolini, R., De Fanti, A., Muratore, V., Alpigiani, M., Ruperto, N., Martini, A., Ravelli, A. |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Biologic therapie Biologic therapies Etanercept Juvenile idiopathic arthritis Pediatric rheumatology TNF inhibitors Adolescent Antirheumatic Agents Arthritis Juvenile Child Child Preschool Cross-Sectional Studies Drug Substitution Female Humans Methotrexate Patient Outcome Assessment Retrospective Studies Treatment Outcome Pediatrics Perinatology and Child Health Rheumatology Immunology and Allergy Arthritis Juvenile Pediatrics Inflammatory bowel disease Settore MED/38 - Pediatria Generale E Specialistica 0302 clinical medicine Quality of life Retrospective Studie 030212 general & internal medicine Antirheumatic Agent Perinatology and Child Health 3. Good health Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA Research Article Human medicine.drug medicine.medical_specialty 03 medical and health sciences Juvenile idiopathic arthriti Internal medicine medicine Pediatrics Perinatology and Child Health Adverse effect Preschool Cross-Sectional Studie 030203 arthritis & rheumatology business.industry Retrospective cohort study medicine.disease Discontinuation Physical therapy business TNF inhibitor |
| Zdroj: | Pediatric Rheumatology Online Journal |
| Popis: | Background: Data from routine clinical practice are needed to further define the efficacy and safety of biologic medications in children with juvenile idiopathic arthritis (JIA). The aim of this analysis was to investigate the disease status, reasons for discontinuation and adverse events in Italian JIA patients treated with etanercept (ETN). Methods: In 2013, all centers of the Italian Pediatric Rheumatology Study Group were asked to make a census of patients given ETN after January 2000. Patients were classified in three groups: group 1 = patients still taking ETN; group 2 = patients discontinued from ETN for any reasons; group 3 = patients lost to follow-up while receiving ETN. All three groups received a retrospective assessment; patients in group 1 also underwent a cross-sectional assessment. Results: 1038 patients were enrolled by 23 centers: 422 (40.7%) were in group 1, 462 (44.5%) in group 2, and 154 (14.8%) in group 3. Median duration of ETN therapy was 2.5 years. At cross-sectional assessment, 41.8% to 48.6% of patients in group 1 met formal criteria for inactive disease, whereas 52.4% of patients in group 2 and 55.8% of patients in group 3 were judged in clinical remission by their caring physician at last visit. A relatively greater proportion of patients with systemic arthritis were discontinued or lost to follow-up. Parent evaluations at cross-sectional visit in group 1 showed that 52.4% of patients had normal physical function, very few had impairment in quality of life, 51.2% had no pain, 76% had no morning stiffness, and 82.7% of parents were satisfied with their child's illness outcome. Clinically significant adverse events were reported for 27.8% of patients and ETN was discontinued for side effects in 9.5%. The most common adverse events were new onset or recurrent uveitis (10.2%), infections (6.6%), injection site reactions (4.4%), and neuropsychiatric (3.1%), gastrointestinal (2.4%), and hematological disorders (2.1%). Ten patients developed an inflammatory bowel disease and 2 had a malignancy. One patient died of a fulminant streptococcal sepsis. Conclusions: Around half of the patients achieved complete disease quiescence under treatment with ETN. The medication was overall well tolerated, as only one quarter of patients experienced clinically significant adverse events and less than 10% had treatment discontinued for toxicity. |
| Databáze: | OpenAIRE |
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