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Long-term Effectiveness and Safety of Canakinumab in Patients with TRAPS: Analysis of the RELIANCE Non-Interventional
Norbert Blank1, Catharina Schuetz2, Markus Hufnagel3
1Division of Rheumatology, Department of Internal Medicine, Heidelberg University Hospital, Heidelberg, Germany. norbert.blank@med.uni-heidelberg.de.
Insights
This study shows canakinumab is effective and safe for treating tumor necrosis factor receptor-associated periodic syndrome (TRAPS). Long-term data indicate good disease control and minimal adverse events in TRAPS patients.
Area of Science:
- Immunology
- Rheumatology
- Pharmacology
Background:
- Tumor necrosis factor receptor-associated periodic syndrome (TRAPS) is a rare autoinflammatory disorder.
- Canakinumab is an interleukin-1β inhibitor used for autoinflammatory conditions.
Purpose of the Study:
- To evaluate the long-term effectiveness and safety of canakinumab in patients with TRAPS.
- To analyze disease activity, dosing patterns, and adverse events in the TRAPS cohort of the RELIANCE study.
Main Methods:
- Interim analysis of the RELIANCE non-interventional study.
- Inclusion of pediatric and adult TRAPS patients receiving canakinumab.
- Evaluation of physician- and patient-reported outcomes every six months.
Main Results:
- 21 TRAPS patients enrolled; 61.9% were pediatric.
- Disease activity was generally well-controlled based on multiple physician- and patient-reported measures.
- No serious adverse drug reactions were reported during long-term canakinumab treatment.
Conclusions:
- Canakinumab demonstrates long-term effectiveness in managing TRAPS.
- The safety profile of canakinumab is favorable for long-term use in TRAPS patients.
- This interim analysis supports canakinumab as a viable treatment option for TRAPS.
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.
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