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Long-term safety and effectiveness of canakinumab in patients with monogenic autoinflammatory diseases: results from the interim analysis of the RELIANCE registry

Objective Interim analysis of the RELIANCE registry, an on-going, non-interventional, open-label, multicentre, prospective study evaluating the long-term safety, dosing regimens and effectiveness of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS), familial Mediterranean f...

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Main Authors: Kümmerle-Deschner, Jasmin (Author) , Kallinich, Tilmann (Author) , Henes, Joerg (Author) , Kortus-Götze, Birgit (Author) , Oommen, Prasad (Author) , Rech, Jürgen (Author) , Krickau, Tobias (Author) , Weller-Heinemann, Frank (Author) , Horneff, Gerd (Author) , Janda, Ales̆ (Author) , Foeldvari, Ivan (Author) , Schuetz, Catharina (Author) , Dressler, Frank (Author) , Borte, Michael (Author) , Hufnagel, Markus (Author) , Meier, Florian (Author) , Fiene, Michael (Author) , Andreica, Ioana (Author) , Weber-Arden, Julia (Author) , Blank, Norbert (Author)
Format: Article (Journal)
Language:English
Published: February 15, 2024
In: RMD Open
Year: 2024, Volume: 10, Issue: 1, Pages: 1-15
ISSN:2056-5933
DOI:10.1136/rmdopen-2023-003890
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1136/rmdopen-2023-003890
Verlag, lizenzpflichtig, Volltext: https://rmdopen.bmj.com/content/10/1/e003890
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Author Notes:Jasmin B. Kuemmerle-Deschner, Tilmann Kallinich, Joerg Henes, Birgit Kortus-Götze, Prasad T. Oommen, Juergen Rech, Tobias Krickau, Frank Weller-Heinemann, Gerd Horneff, Aleš Janda, Ivan Foeldvari, Catharina Schuetz, Frank Dressler, Michael Borte, Markus Hufnagel, Florian Meier, Michael Fiene, Ioana Andreica, Julia Weber-Arden, Norbert Blank
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Summary:Objective Interim analysis of the RELIANCE registry, an on-going, non-interventional, open-label, multicentre, prospective study evaluating the long-term safety, dosing regimens and effectiveness of canakinumab in patients with cryopyrin-associated periodic syndromes (CAPS), familial Mediterranean fever (FMF), tumour-necrosis factor receptor-associated periodic syndrome (TRAPS) or mevalonate-kinase deficiency (MKD)/hyperimmunoglobulin-D syndrome (HIDS). - Methods From September 2017 for patients with CAPS, and June 2018 for patients with FMF, TRAPS or MKD/HIDS, the registry enrolled paediatric (aged ≥2 years) and adult patients (aged ≥18 years) receiving canakinumab as part of their routine medical care. Safety, canakinumab dose, disease activity and quality of life outcome measures were evaluated at baseline and every 6 months until end of study visit. - Results At the analysis cut-off date (December 2020), 168 patients (91 CAPS, 54 FMF, 16 TRAPS and 7 MKD/HIDS) were enrolled. 85 (50.9%) patients were female and 72 (43.1%) were children (<18 years). The median patient age was 20.0 years (range 2.0-79.0 years). In the CAPS cohort, serious infections and serious adverse drug-reactions were more common in patients receiving higher than the recommended starting dose (SD) of canakinumab. A trend to receive >SD of canakinumab was observed in the pooled population. The majority of patients were reported as having either absent or mild/moderate disease activity (physician’s global assessment) from baseline to Month 30, with a stable proportion of patients (~70%) in remission under canakinumab treatment. Patient-reported disease activity (Visual Analogue Scale (VAS), Autoinflammatory Disease Activity Index), fatigue (VAS); markers of inflammation (C-reactive protein, serum amyloid A and erythrocyte sedimentation rate) remained well-controlled throughout. - Conclusion Data from this analysis confirm the long-term safety and effectiveness of canakinumab for the treatment of CAPS, FMF, TRAPS and MKD/HIDS.
Item Description:Gesehen am 10.09.2024
Physical Description:Online Resource
ISSN:2056-5933
DOI:10.1136/rmdopen-2023-003890

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