Open-label, multicentre, dose-escalating ...
Type de document :
Article dans une revue scientifique
PMID :
URL permanente :
Titre :
Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still's disease.
Auteur(s) :
Gabay, Cem [Auteur]
Fautrel, Bruno [Auteur]
Université Pierre et Marie Curie - Paris 6 [UPMC]
Rech, Jurgen [Auteur]
Spertini, Francois [Auteur]
Feist, Eugen [Auteur]
Kotter, Ina [Auteur]
Hachulla, Eric [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Morel, Jacques [Auteur]
Schaeverbeke, Thierry [Auteur]
Hamidou, Mohamed [Auteur]
Université de Nantes [UN]
Martin, Thierry [Auteur]
Laboratoire de Génie des Procédés et Matériaux - EA 4038 [LGPM]
Hellmich, Bernhard [Auteur]
Lamprecht, Peter [Auteur]
Schulze-Koops, Hendrik [Auteur]
Courvoisier Delphine, Sophie [Auteur]
Sleight, Andrew [Auteur]
Schiffrin Eduardo, Jorge [Auteur]
Fautrel, Bruno [Auteur]
Université Pierre et Marie Curie - Paris 6 [UPMC]
Rech, Jurgen [Auteur]
Spertini, Francois [Auteur]
Feist, Eugen [Auteur]
Kotter, Ina [Auteur]
Hachulla, Eric [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Morel, Jacques [Auteur]
Schaeverbeke, Thierry [Auteur]
Hamidou, Mohamed [Auteur]
Université de Nantes [UN]
Martin, Thierry [Auteur]
Laboratoire de Génie des Procédés et Matériaux - EA 4038 [LGPM]
Hellmich, Bernhard [Auteur]
Lamprecht, Peter [Auteur]
Schulze-Koops, Hendrik [Auteur]
Courvoisier Delphine, Sophie [Auteur]
Sleight, Andrew [Auteur]
Schiffrin Eduardo, Jorge [Auteur]
Titre de la revue :
Annals of the Rheumatic Diseases
Nom court de la revue :
Ann. Rheum. Dis.
Numéro :
77
Pagination :
840-847
Date de publication :
2018-05-10
ISSN :
1468-2060
Mot(s)-clé(s) :
adult onset still''s disease
inflammation
juvenile idiopathic arthritis
inflammation
juvenile idiopathic arthritis
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Objectives : Adult-onset Still’s disease (AOSD) is a rare systemic autoinflammatory disease; its management is largely empirical. This is the first clinical study to determine if interleukin (IL)-18 inhibition, using the ...
Lire la suite >Objectives : Adult-onset Still’s disease (AOSD) is a rare systemic autoinflammatory disease; its management is largely empirical. This is the first clinical study to determine if interleukin (IL)-18 inhibition, using the recombinant human IL-18 binding protein, tadekinig alfa, is a therapeutic option in AOSD. Methods : In this phase II, open-label study, patients were ≥18 years with active AOSD plus fever or C reactive protein (CRP) levels ≥10 mg/L despite treatment with prednisone and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Previous biological DMARD treatment was permitted. Patients received tadekinig alfa 80 mg or 160 mg subcutaneously three times per week for 12 weeks; those receiving 80 mg not achieving early predicted response criteria (reduction of ≥50% CRP values from baseline and fever resolution) were up-titrated to 160 mg for a further 12 weeks. The primary endpoint was the occurrence of adverse events (AEs) throughout the study. Results : Ten patients were assigned to receive 80 mg tadekinig alfa and 13 patients to the 160 mg dose. One hundred and fifty-five treatment-emerging AEs were recorded, and 47 were considered related to the study drug. Most AEs were mild and resolved after drug discontinuation. Three serious AEs occurred, one possibly related to treatment (toxic optic neuropathy). At week 3, 5 of 10 patients receiving 80 mg and 6 of 12 patients receiving 160 mg achieved the predefined response criteria. Conclusions : Our results indicate that tadekinig alfa appears to have a favourable safety profile and is associated with early signs of efficacy in patients with AOSD.Lire moins >
Lire la suite >Objectives : Adult-onset Still’s disease (AOSD) is a rare systemic autoinflammatory disease; its management is largely empirical. This is the first clinical study to determine if interleukin (IL)-18 inhibition, using the recombinant human IL-18 binding protein, tadekinig alfa, is a therapeutic option in AOSD. Methods : In this phase II, open-label study, patients were ≥18 years with active AOSD plus fever or C reactive protein (CRP) levels ≥10 mg/L despite treatment with prednisone and/or conventional synthetic disease-modifying antirheumatic drugs (DMARDs). Previous biological DMARD treatment was permitted. Patients received tadekinig alfa 80 mg or 160 mg subcutaneously three times per week for 12 weeks; those receiving 80 mg not achieving early predicted response criteria (reduction of ≥50% CRP values from baseline and fever resolution) were up-titrated to 160 mg for a further 12 weeks. The primary endpoint was the occurrence of adverse events (AEs) throughout the study. Results : Ten patients were assigned to receive 80 mg tadekinig alfa and 13 patients to the 160 mg dose. One hundred and fifty-five treatment-emerging AEs were recorded, and 47 were considered related to the study drug. Most AEs were mild and resolved after drug discontinuation. Three serious AEs occurred, one possibly related to treatment (toxic optic neuropathy). At week 3, 5 of 10 patients receiving 80 mg and 6 of 12 patients receiving 160 mg achieved the predefined response criteria. Conclusions : Our results indicate that tadekinig alfa appears to have a favourable safety profile and is associated with early signs of efficacy in patients with AOSD.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Inserm
Université de Lille
CHU Lille
Université de Lille
CHU Lille
Équipe(s) de recherche :
Immunity, inflammation and fibrsis in auto and allo-reactivity
Date de dépôt :
2019-03-01T14:46:26Z
2024-01-25T09:39:26Z
2024-01-25T09:39:26Z
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