Long-term Effectiveness and Safety of Canakinumab in Patients with TRAPS: Analysis of the RELIANCE Non-Interventional Study
Year: 2025
Type: article
Study design: Observational Study
Abstract: INTRODUCTION: This is an interim analysis of the long-term effectiveness and safety of canakinumab in the tumor necrosis factor receptor-associated periodic syndrome (TRAPS) cohort of the RELIANCE non-interventional study. METHODS: From June 2018, the RELIANCE non-interventional study enrolled paediatric (aged ≥ 2 - < 18 years) and adult patients (aged ≥ 18 years) with TRAPS who were receiving canakinumab as part of their routine medical care. Physician- and patient-reported measures of disease activity, dosing patterns and safety were evaluated at baseline and every 6 months until the end-of-study visit. RESULTS: A total of 21 patients with TRAPS were enrolled by the analysis cut-off date of December 2022, of which 61.9% (13/21) were paediatric patients (< 18 years) and 66.7% (14/21) were female. All patients were pre-treated with canakinumab prior to enrolment (median duration of canakinumab treatment prior to study inclusion: 1.2 years). Disease activity, evaluated by physician-reported (physician's global assessment, disease remission, C-reactive protein, serum amyloid A) and patient-reported (disease activity, fatigue, impact on social life, autoinflammatory disease activity index diary) measures, was generally well controlled throughout the study. At baseline, the majority of patients (71.4%) were receiving the recommended starting dose (SD) of canakinumab, with a more even distribution between the < SD, SD, and > SD dosing schedules observed from month 6. No serious adverse drug reactions were reported. Patients continued to receive vaccinations during long-term treatment with canakinumab. In total, 85.7% (18/21) of patients met the Eurofever/PRINTO classification criteria for TRAPS, 42.9% (9/21) with the presence of a confirmative TNFRSF1A genotype and 42.9% (9/21) without. In total, 14.3% (3/21) of patients did not meet the classification criteria. CONCLUSIONS: Data from this interim analysis support the long-term effectiveness and safety of canakinumab for the treatment of TRAPS.
Source: Rheumatology and Therapy
Institutions: Heidelberg University, University Hospital Heidelberg, Technische Universität Dresden, University of Freiburg, University Medical Center Freiburg, University of Cologne, Asklepios Klinik Sankt Augustin, University Hospital Cologne, Klinikum St. Georg, Leipzig University, Leibniz Association, German Rheumatism Research Centre, Charité - Universitätsmedizin Berlin, Heinrich Heine University Düsseldorf, Universität Ulm, University Hospital Ulm, Universitätsklinikum Tübingen, University of Tübingen, Novartis (Germany), University Children's Hospital Tübingen
Language: English
Subfield: Molecular Biology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $7,400
Funder: Novartis
OpenAlex ID: W4416718519