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The safety of canakinumab in systemic juvenile idiopathic arthritis and autoinflammatory diseases in pediatric patients: a multicenter study.
Coskuner, Taner; Çaglayan, Sengül; Akgün, Özlem; Torun, Rüya; Yayla, Emine Nur Sunar; Bagrul, I Lknur; Kilbas, Gülsah; Yener, Gülçin Otar; Köse, Hülya; Öztürk, Kübra; Baba, Özge; Çakan, Mustafa; Demir, Ferhat; Sönmez, Hafize Emine; Kalyoncu, Mukaddes; Kiliç, Sara Sebnem; Yüksel, Selçuk; Baglan, Esra; Bakkaloglu, Sevcan A; Ünsal, Erbil; Aktay Ayaz, Nuray; Sözeri, Betül.
Afiliación
  • Çaglayan S; Department of Pediatric Rheumatology, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
  • Akgün Ö; Department of Pediatric Rheumatology, Faculty of Medicine, Istanbul University, Istanbul, Turkey.
  • Torun R; Department of Pediatric Rheumatology, Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey.
  • Yayla ENS; Department of Pediatric Rheumatology, Gazi University Faculty of Medicine, Ankara, Turkey.
  • Bagrul IL; Department of Pediatric Rheumatology, University of Health Sciences Turkey, Ankara, Turkey.
  • Kilbas G; Department of Pediatric Rheumatology, School of Medicine, Pamukkale University, Denizli, Turkey.
  • Yener GO; Department of Pediatric Rheumatology, Sanliurfa Research and Training Hospital, Sanliurfa, Turkey.
  • Köse H; Department of Pediatrics, Division of Immunology and Rheumatology, Uludag University Faculty of Medicine, Bursa, Turkey.
  • Öztürk K; Department of Pediatric Rheumatology, Göztepe Research and Training Hospital, Istanbul Medeniyet University, Istanbul, Turkey.
  • Baba Ö; Department of Pediatric Rheumatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey.
  • Çakan M; Department of Pediatric Rheumatology, Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey.
  • Demir F; Department of Pediatric Rheumatology, Acibadem University Faculty of Medicine, Istanbul, Turkey.
  • Sönmez HE; Department of Pediatric Rheumatology, Kocaeli University Faculty of Medicine, Kocaeli, Turkey.
  • Kalyoncu M; Department of Pediatric Rheumatology, Karadeniz Technical University Faculty of Medicine, Trabzon, Turkey.
  • Kiliç SS; Department of Pediatrics, Division of Immunology and Rheumatology, Uludag University Faculty of Medicine, Bursa, Turkey.
  • Yüksel S; Department of Pediatric Rheumatology, School of Medicine, Pamukkale University, Denizli, Turkey.
  • Baglan E; Department of Pediatric Rheumatology, University of Health Sciences Turkey, Ankara, Turkey.
  • Bakkaloglu SA; Department of Pediatric Rheumatology, Gazi University Faculty of Medicine, Ankara, Turkey.
  • Ünsal E; Department of Pediatric Rheumatology, Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey.
  • Aktay Ayaz N; Department of Pediatric Rheumatology, Faculty of Medicine, Istanbul University, Istanbul, Turkey.
  • Sözeri B; Department of Pediatric Rheumatology, Umraniye Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
Expert Opin Biol Ther ; 23(12): 1299-1306, 2023.
Article en En | MEDLINE | ID: mdl-37970654
OBJECTIVE: To evaluate the safety of canakinumab using real-world data in patients with systemic juvenile idiopathic arthritis (sJIA) and autoinflammatory diseases (AID). RESEARCH DESIGN AND METHODS: This was a cross-sectional observational, multicenter study. Patients diagnosed with AID and sJIA treated with canakinumab were included in the study. The participating 13 centers retrospectively collected their patients' data. RESULTS: A total of 335 patients were involved in the study. Among these patients, 280 were in the AID group and 55 were in the sJIA group. Canakinumab was administered at a median dose of 3 (2.5-4) mg/kg. The median total exposure time to canakinumab was 1.9 (0.8-3.2) years, corresponding to 759.5 patient-years. Seven hundred and seventy-nine total adverse events (AE) were identified. The total incidence of AE, and serious adverse events (SAE) throughout the study period was 1.02 per patient-years. The upper respiratory tract infection rate was 0.7 per patient-years, while the other infection rate was 0.13 per patient-years. While no death was observed in any patient, SAE were observed in 8 patients. Interstitial lung disease, anaphylaxis, or anaphylactoid reactions were not observed in any patient. CONCLUSIONS: Real-life data from a large cohort of patients suggests that canakinumab is as safe as claimed in clinical trials.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Artritis Juvenil / Enfermedades Autoinflamatorias Hereditarias Límite: Child / Humans Idioma: En Revista: Expert Opin Biol Ther Asunto de la revista: BIOLOGIA / TERAPEUTICA Año: 2023 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Artritis Juvenil / Enfermedades Autoinflamatorias Hereditarias Límite: Child / Humans Idioma: En Revista: Expert Opin Biol Ther Asunto de la revista: BIOLOGIA / TERAPEUTICA Año: 2023 Tipo del documento: Article