| アブストラクト | TNFalpha inhibitors, including adalimumab, are widely used in inflammatory rheumatologic and bowel diseases. Well-known adverse effects include: opportunistic infections, immunogenicity and new inflammatory manifestations. Myositis is an inflammatory disease, which manifests with muscle symptoms and can be life-threatening. Little is known about drug-induced myositis. We aimed to describe a case of myositis induced by adalimumab and reviewed national and international pharmacovigilance databases for other cases until 01/02/2019. This was a 63 years old woman with Crohn's disease, who developed muscle weakness, and rhabdomyolysis 3 months after starting adalimumab. Diagnosis of myositis was suspected and confirmed with electromyography and muscle biopsy. Improvement in muscle symptoms was observed after stopping adalimumab and starting corticosteroids. Muscular adverse effects are well-known and usually benign with adalimumab. However, five cases of myositis during treatment with adalimumab were registered in French PharmacoVigilance Database (FPVD) with muscle symptoms observed 3 months to 7 years after starting adalimumab. In VigiBase(), 90 cases of myositis associated with adalimumab with some similar characteristics were registered. When a patient treated with adalimumab complains of muscular symptoms, inflammatory myopathies should be considered. This adverse effect should be mentioned in a 'Summary of Product Characteristics' to alert healthcare professionals. |
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| 投稿者 | Gaboriau, Louise; Davion, Jean-Baptiste; Combret, Sandrine; Lebrun-Vignes, Benedicte; Rocher, Fanny; Rouby, Franck; Renaud, Florence; Morell-Dubois, Sandrine; Gautier, Sophie |
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| 組織名 | Centre regional de PharmacoVigilance, service de pharmacologie medicale, CHU;Lille, 1, place de Verdun, F-59000 Lille, France. Electronic address:;louise.gaboriau@chru-lille.fr.;Centre de reference des Maladies Neuromusculaires, CHU Lille, F-59000 Lille,;France.;Centre regional de pharmacovigilance, Vigilances - qualite - risques, CHU Dijon;Bourgogne, F-21000 Dijon, France.;Centre regional de pharmacovigilance, Pharmacologie, Groupe Hospitalier;Pitie-Salpetriere, APHP, F-75000 Paris, France; EA 7379 EpidermE, Universite;Paris-Est Creteil, UPEC, F-94010 Creteil, France.;Centre regional de pharmacovigilance, CHU Nice, F-06000 Nice, France.;Centre regional de pharmacovigilance de Marseille Provence Corse, Assistance;Publique, Hopitaux de Marseille, F-13000 Marseille, France.;Centre de biologie pathologie, CHU Lille, F-59000 Lille, France.;Service de Medecine interne, CHU Lille, F-59000 Lille, France.;Lille, 1, place de Verdun, F-59000 Lille, France. |
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