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

Kuemmerle-Deschner JB, Kallinich T, Henes J, Kortus-Götze B, Oommen PT, Rech J, Krickau T, Weller-Heinemann F, Horneff G, Janda A, Foeldvari I, Schuetz C, Dressler F, Borte M, Hufnagel M, Meier F, Fiene M, Andreica I, Weber-Arden J, Blank N (2024)

Publication Language: English

Publication Type: Journal article, Original article

Publication year: 2024

Journal

Book Volume: 10

Article Number: e003890

Journal Issue: 1

DOI: 10.1136/rmdopen-2023-003890

Abstract

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.

Authors with CRIS profile

Involved external institutions

Universitätsklinikum Freiburg Germany (DE) Universitätsklinikum Heidelberg Germany (DE) Universitätsklinikum Tübingen Germany (DE) Klinikverbund Bremen (Gesundheit Nord) Germany (DE) Novartis AG Switzerland (CH) Asklepios Kliniken Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) Germany (DE) Rheumazentrum Ruhrgebiet Germany (DE) Medizinische Hochschule Hannover (MHH) / Hannover Medical School Germany (DE) Universitätsklinikum Ulm Germany (DE) Deutsches Rheuma-Forschungszentrum (DRFZ) Germany (DE) Universitätsklinikum Gießen und Marburg (UKGM) Germany (DE) Klinikum St. Georg Germany (DE) Technische Universität Dresden Germany (DE) Heinrich-Heine-Universität Düsseldorf Germany (DE) Hamburger Zentrum für Kinder- und Jugendrheumatologie / Hamburg Centre for Pediatric and Adolescent Rheumatology Germany (DE)

How to cite

APA:

Kuemmerle-Deschner, J.B., Kallinich, T., Henes, J., Kortus-Götze, B., Oommen, P.T., Rech, J.,... Blank, N. (2024). Long-term safety and effectiveness of canakinumab in patients with monogenic autoinflammatory diseases: results from the interim analysis of the RELIANCE registry. RMD Open, 10(1). https://doi.org/10.1136/rmdopen-2023-003890

MLA:

Kuemmerle-Deschner, Jasmin B., et al. "Long-term safety and effectiveness of canakinumab in patients with monogenic autoinflammatory diseases: results from the interim analysis of the RELIANCE registry." RMD Open 10.1 (2024).

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