The safety of canakinumab in systemic juvenile idiopathic arthritis and autoinflammatory diseases in pediatric patients: a multicenter study.

Autor:	Coşkuner T, Çağlayan Ş; 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., Kılbaş G; Department of Pediatric Rheumatology, School of Medicine, Pamukkale University, Denizli, Turkey., Yener GO; Department of Pediatric Rheumatology, Şanlıurfa Research and Training Hospital, Şanlıurfa, Turkey., Köse H; Department of Pediatrics, Division of Immunology and Rheumatology, Uludağ 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, Acıbadem 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., Kılıç SS; Department of Pediatrics, Division of Immunology and Rheumatology, Uludağ University Faculty of Medicine, Bursa, Turkey., Yüksel S; Department of Pediatric Rheumatology, School of Medicine, Pamukkale University, Denizli, Turkey., Bağlan E; Department of Pediatric Rheumatology, University of Health Sciences Turkey, Ankara, Turkey., Bakkaloğlu 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.
Jazyk:	angličtina
Zdroj:	Expert opinion on biological therapy [Expert Opin Biol Ther] 2023 Jul-Dec; Vol. 23 (12), pp. 1299-1306. Date of Electronic Publication: 2023 Dec 28.
DOI:	10.1080/14712598.2023.2282133
Abstrakt:	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.
Databáze:	MEDLINE
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