Evidence map›Paper›PMID 38360038›Full record

ArticleRMD open2024

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

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 and 10 more

Open access · goldAbstract read
In one paragraph

Article in RMD open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 1 country.

Jasmin B Kuemmerle-DeschnerDivision of Paediatric Rheumatology and autoinflammation reference centre Tübingen, Department of Paediatrics, University Hospital Tübingen, Tübingen, Germany Jasmin.Kuemmerle-Deschner@med.uni-tuebingen.de.ORCID 0000-0002-6365-6598
Tilmann KallinichDepartment of Paediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité Universitätsmedizin and Deutsches Rheuma-Forschungszentrum (DRFZ), an Institute of the Leibniz Association, Berlin, Germany.ORCID 0000-0003-2404-9397
Joerg HenesCenter of Interdisciplinary Rheumatology, Immunology and autoimmune diseases (INDIRA), University Hospital Tübingen, Tübingen, Germany.ORCID 0000-0002-8385-6861
Birgit Kortus-GötzeDepartment of Internal Medicine, Division of Nephrology, University Hospital of Giessen and Marburg, Marburg, Germany.
Prasad T OommenDepartment of Paediatric Oncology, Haematology and Clinical Immunology, Division of Paediatric Rheumatology, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Juergen RechDepartment of Internal Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander University (FAU) Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
Tobias KrickauDZI (Deutsches Zentrum für Immuntherapie), Erlangen, Germany.
Frank Weller-HeinemannDivision of Paediatric Rheumatology, Prof. Hess Children's Hospital, Bremen, Germany.
Gerd HorneffDepartment of Paediatrics, Asklepios Kinderklinik Sankt Augustin, Sankt Augustin, Germany.
Aleš JandaDepartment of Paediatrics and Adolescent Medicine, University Medical Centre Ulm, Ulm, Germany.
Ivan FoeldvariHamburg Centre for Paediatric and Adolescence Rheumatology, Hamburg, Germany.
Catharina SchuetzDepartment of Paediatrics, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Frank DresslerDepartment of Paediatric Pneumonology, Allergology and Neonatology, Hannover Medical School, Hannover, Germany.
Michael BorteHospital for Children & Adolescents, St. Georg Hospital, Leipzig, Germany.
Markus HufnagelDivision of Paediatric Infectious Diseases and Rheumatology, Department of Paediatrics and Adolescent Medicine, University Medical Centre, Medical Faculty, University of Freiburg, Freiburg, Germany.
Florian MeierDepartment of Medicine II, Rheumatology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
Michael FieneRheumazentrum Greifswald, Greifswald, Germany.
Ioana AndreicaRheumazentrum Ruhrgebiet Herne, Ruhr-Universität Bochum, Bochum, Germany.ORCID 0000-0002-8007-9905
Julia Weber-ArdenNovartis Pharma GmbH, Nürnberg, Germany.
Norbert BlankDivision of Rheumatology, Department of Internal Medicine, University Hospital Heidelberg, Heidelberg, Germany.
Universitätsklinikum Erlangen · DEAsklepios Klinik Sankt Augustin · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGoethe University Frankfurt · DEHeidelberg University · DEHeinrich Heine University Düsseldorf · DEKlinikum St. Georg · DELeibniz Association · DEMedizinische Hochschule Hannover · DENovartis (Germany) · DEProf. Hess Kinderklinik · DERheumazentrum Ruhrgebiet · DEUniversitätsklinikum Gießen und Marburg · DEUniversity Hospital Carl Gustav Carus · DEUniversity Hospital Ulm · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInterim 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).

methodsFrom 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.

resultsAt 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.

conclusionData from this analysis confirm the long-term safety and effectiveness of canakinumab for the treatment of CAPS, FMF, TRAPS and MKD/HIDS.

Indexed as

Antibodies, Monoclonal, HumanizedCryopyrin-Associated Periodic SyndromesFamilial Mediterranean FeverMevalonate Kinase DeficiencyAdolescentAdultChildFemaleHumansMaleProspective StudiesQuality of LifeRegistriesAntibodies, Monoclonal, HumanizedcanakinumabCryopyrin-Associated Periodic SyndromesFamilial Mediterranean FeverInflammation

Identifiers

PMID38360038
PMCPMC10875478
OpenAlexW4391850734

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.