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eu/docs/en_gb/document_library/epar_-_product_information/human/000363/wc500042310 eu/docs/en_gb/document_library/epar_-_product_information/human/001109/wc500031680 université lille nord-de-france kuemmerle-deschner jb retrospective cross-sectional design article download pdf real-life clinical practice multi-factorial autoinflammatory diseases auto-immune diseases treated il-1-mediated autoinflammatory diseases autoinflammatory muckle-wells syndrome article rossi-semerano il-1r inhibitor anakinra interleukin-1-receptor antagonist anakinra maladies auto-inflammatoires sequential placebo-controlled studies minor injection-site reactions national reference centre mild injection-site reaction mild injection-site reactions anti–il-1 treatments anakinra label anti-interleukin-1 treatments nlrp12-asociated periodic syndrome anti–il-1 treatment included label anti–il-1 agent anti–il-1 treatment duration linda rossi-semerano 3-year open-label follow long-term anakinra treatment il-36 receptor antagonist anti–il-1 treatment anakinra generalized pustular psoriasis interleukin-1-receptor antagonist interleukin-1 receptor antagonist privacy choices/manage cookies anti–il-1 treatment efficacy auto-inflammatory diseases isabelle koné-paut behrens em open access license made substantial contributions inflammatory biological markers anti–il-1 treatments full access european medicines agency label search search familial mediterranean fever anti–il-1 drugs mas successfully treated interleukin-1 mediated diseases

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         headline:Tolerance and efficacy of off-label anti-interleukin-1 treatments in France: a nationwide survey
         description:Despite their limited licensed indications, anti–interleukin-1 (anti–IL-1) agents are often used in clinical practice for an increasing number of auto-inflammatory diseases. We conducted a national cross-sectional observational study from January 2011 to January 2013 to record the off-label use of such agents in France. We aimed to estimate the off-label use of anti–IL-1 treatments in France, assess their efficacy in rare diseases, and increase the reporting of their possible side effects. Physicians answered a questionnaire that covered patient and disease data, anti–IL-1 agent use, efficacy and adverse events. The study involved adult or paediatric patient who had received an anti–IL-1 agent after January 2005 in France. In total, 189 patients from 38 centres were included. The main diseases were adult-onset Still’s disease (AOSD) (35), gout (28), systemic juvenile idiopathic arthritis (27), cryopyrin-associated periodic syndrome (CAPS) (21), familial Mediterranean fever (14) and mevalonate kinase deficiency (12). The main off-label used agent was anakinra, used at least once for 185 patients, with canakinumab used for 25. Anakinra was effective in most patients (90%), with higher complete clinical response rates for Schnitzler’s syndrome, gout, CAPS and AOSD. Overall, 58% of patients showed at least one adverse event, mainly minor injection-site reactions. The main reported serious adverse event was severe infection. Injection-site reactions and liver toxicity were significantly more frequent in children than adults. The main non-cutaneous adverse event was liver toxicity, significantly associated with treatment duration. Weight gain was reported in about 10% of patients and was associated with treatment duration and CAPS. Canakinumab was rarely used and showed better cutaneous tolerance than anakinra but similar rates of non-cutaneous and severe adverse events. Anakinra was well tolerated and effective in most patients with various inflammatory diseases. The main adverse events were mild injection-site reactions, especially in children. The survey allowed for collecting limited information on the off-label use of canakinumab.
         datePublished:2015-02-15T00:00:00Z
         dateModified:2015-02-15T00:00:00Z
         pageStart:1
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         license:http://creativecommons.org/publicdomain/zero/1.0/
         sameAs:https://doi.org/10.1186/s13023-015-0228-7
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            Auto-inflammatory diseases
            IL-1
            Anakinra
            Canakinumab
            Tolerance
            Off-label
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            Human Genetics
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                     address:
                        name:Department of Rheumatology, Hôpital La Pitié Salpêtrière, APHP; UPMC, GRC 08, Institut Pierre Louis d’Epidémiologie et Santé Publique, Paris, France
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                        name:Department of Rheumatology, University Teaching Hospital, CHRU Besançon, and University of Franche-Comté, Besançon, France
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                     address:
                        name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
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               name:Isabelle Touitou
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                        name:Maladies Auto-inflammatoires, Laboratoire de Génétique, Hôpital A de Villeneuve, CHRU Montpellier, Montpellier, France
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                     address:
                        name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
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      headline:Tolerance and efficacy of off-label anti-interleukin-1 treatments in France: a nationwide survey
      description:Despite their limited licensed indications, anti–interleukin-1 (anti–IL-1) agents are often used in clinical practice for an increasing number of auto-inflammatory diseases. We conducted a national cross-sectional observational study from January 2011 to January 2013 to record the off-label use of such agents in France. We aimed to estimate the off-label use of anti–IL-1 treatments in France, assess their efficacy in rare diseases, and increase the reporting of their possible side effects. Physicians answered a questionnaire that covered patient and disease data, anti–IL-1 agent use, efficacy and adverse events. The study involved adult or paediatric patient who had received an anti–IL-1 agent after January 2005 in France. In total, 189 patients from 38 centres were included. The main diseases were adult-onset Still’s disease (AOSD) (35), gout (28), systemic juvenile idiopathic arthritis (27), cryopyrin-associated periodic syndrome (CAPS) (21), familial Mediterranean fever (14) and mevalonate kinase deficiency (12). The main off-label used agent was anakinra, used at least once for 185 patients, with canakinumab used for 25. Anakinra was effective in most patients (90%), with higher complete clinical response rates for Schnitzler’s syndrome, gout, CAPS and AOSD. Overall, 58% of patients showed at least one adverse event, mainly minor injection-site reactions. The main reported serious adverse event was severe infection. Injection-site reactions and liver toxicity were significantly more frequent in children than adults. The main non-cutaneous adverse event was liver toxicity, significantly associated with treatment duration. Weight gain was reported in about 10% of patients and was associated with treatment duration and CAPS. Canakinumab was rarely used and showed better cutaneous tolerance than anakinra but similar rates of non-cutaneous and severe adverse events. Anakinra was well tolerated and effective in most patients with various inflammatory diseases. The main adverse events were mild injection-site reactions, especially in children. The survey allowed for collecting limited information on the off-label use of canakinumab.
      datePublished:2015-02-15T00:00:00Z
      dateModified:2015-02-15T00:00:00Z
      pageStart:1
      pageEnd:11
      license:http://creativecommons.org/publicdomain/zero/1.0/
      sameAs:https://doi.org/10.1186/s13023-015-0228-7
      keywords:
         Auto-inflammatory diseases
         IL-1
         Anakinra
         Canakinumab
         Tolerance
         Off-label
         Medicine/Public Health
         general
         Pharmacology/Toxicology
         Human Genetics
      image:
      isPartOf:
         name:Orphanet Journal of Rare Diseases
         issn:
            1750-1172
         volumeNumber:10
         type:
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            PublicationVolume
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         name:BioMed Central
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            url:https://www.springernature.com/app-sn/public/images/logo-springernature.png
            type:ImageObject
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      author:
            name:Linda Rossi-Semerano
            affiliation:
                  name:Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud
                  address:
                     name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
                     type:PostalAddress
                  type:Organization
            email:[email protected]
            type:Person
            name:Bruno Fautrel
            affiliation:
                  name:Hôpital La Pitié Salpêtrière, APHP; UPMC, GRC 08, Institut Pierre Louis d’Epidémiologie et Santé Publique
                  address:
                     name:Department of Rheumatology, Hôpital La Pitié Salpêtrière, APHP; UPMC, GRC 08, Institut Pierre Louis d’Epidémiologie et Santé Publique, Paris, France
                     type:PostalAddress
                  type:Organization
            type:Person
            name:Daniel Wendling
            affiliation:
                  name:University Teaching Hospital, CHRU Besançon, and University of Franche-Comté
                  address:
                     name:Department of Rheumatology, University Teaching Hospital, CHRU Besançon, and University of Franche-Comté, Besançon, France
                     type:PostalAddress
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            type:Person
            name:Eric Hachulla
            affiliation:
                  name:Hôpital Claude Huriez, Université Lille Nord-de-France
                  address:
                     name:Centre de Référence des Maladies Autoimmunes et systémiques Rares, Service de Médecine Interne, Hôpital Claude Huriez, Université Lille Nord-de-France, Lille Cedex, France
                     type:PostalAddress
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            name:Caroline Galeotti
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                  name:Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud
                  address:
                     name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
                     type:PostalAddress
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                  name:INSERM UMR 1125, Paris 13 University
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                     name:Department of Rheumatology, Hôpital Avicenne, APHP, INSERM UMR 1125, Paris 13 University, Bobigny, France
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                  address:
                     name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
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               type:PostalAddress
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      email:[email protected]
      name:Bruno Fautrel
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            name:Hôpital La Pitié Salpêtrière, APHP; UPMC, GRC 08, Institut Pierre Louis d’Epidémiologie et Santé Publique
            address:
               name:Department of Rheumatology, Hôpital La Pitié Salpêtrière, APHP; UPMC, GRC 08, Institut Pierre Louis d’Epidémiologie et Santé Publique, Paris, France
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      name:Eric Hachulla
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            name:Hôpital Claude Huriez, Université Lille Nord-de-France
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               type:PostalAddress
            type:Organization
      name:Caroline Galeotti
      affiliation:
            name:Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud
            address:
               name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
               type:PostalAddress
            type:Organization
      name:Luca Semerano
      affiliation:
            name:INSERM UMR 1125, Paris 13 University
            address:
               name:Department of Rheumatology, Hôpital Avicenne, APHP, INSERM UMR 1125, Paris 13 University, Bobigny, France
               type:PostalAddress
            type:Organization
      name:Isabelle Touitou
      affiliation:
            name:Hôpital A de Villeneuve, CHRU Montpellier
            address:
               name:Maladies Auto-inflammatoires, Laboratoire de Génétique, Hôpital A de Villeneuve, CHRU Montpellier, Montpellier, France
               type:PostalAddress
            type:Organization
      name:Isabelle Koné-Paut
      affiliation:
            name:Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud
            address:
               name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
               type:PostalAddress
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      name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
      name:Department of Rheumatology, Hôpital La Pitié Salpêtrière, APHP; UPMC, GRC 08, Institut Pierre Louis d’Epidémiologie et Santé Publique, Paris, France
      name:Department of Rheumatology, University Teaching Hospital, CHRU Besançon, and University of Franche-Comté, Besançon, France
      name:Centre de Référence des Maladies Autoimmunes et systémiques Rares, Service de Médecine Interne, Hôpital Claude Huriez, Université Lille Nord-de-France, Lille Cedex, France
      name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France
      name:Department of Rheumatology, Hôpital Avicenne, APHP, INSERM UMR 1125, Paris 13 University, Bobigny, France
      name:Maladies Auto-inflammatoires, Laboratoire de Génétique, Hôpital A de Villeneuve, CHRU Montpellier, Montpellier, France
      name:Department of Paediatric Rheumatology, Hôpital de Bicêtre, APHP, National Reference Centre for Auto-inflammatory Diseases, Le Kremlin-Bicêtre, University of Paris Sud, Le Kremlin, France

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