title: Efficacy of abatacept in systemic lupus erythematosus: a retrospective analysis of 11 patients with refractory disease.
abstract: Objective The objective of this study was to assess the safety and efficacy of abatacept in patients with SLE refractory to conventional treatment in routine clinical practice. Methods This retrospective study included 11 SLE patients treated with abatacept for an active and refractory disease. The primary endpoint was the change in SLE Disease Activity Index (SLEDAI) score at six months. Response was defined as a decrease of SLEDAI ≥4 in a patient continuing abatacept. Results Indications of abatacept treatment were articular ( n=8), renal ( n=1) and cutaneous ( n=1) involvement and autoimmune thrombocytopenia ( n=1). Abatacept was discontinued before six months in two patients, because of adverse event ( n=1) and/or lupus flare ( n=2). The median SLEDAI decreased from 6 (2-20) to 4 (0-20) ( p=0.031). Decrease of SLEDAI ≥4 was observed in 6/11 patients (55%) and response to treatment according to the physician's judgement in 8/11 (73%) patients. Improvement of articular involvement was observed in 7/8 (87.5%) patients. Four adverse events were observed in three patients, but no severe infection occurred. Conclusion This study suggests some efficacy of abatacept in patients with refractory disease in routine clinical practice, particularly in the case of articular manifestations, with an acceptable safety profile. These data support conducting new controlled trials of abatacept in SLE patients.
authors.affiliation: 1 Hôpitaux Universitaires de Strasbourg, CHU Hautepierre, Service de Rhumatologie, Centre de Rèfèrence des Maladies Auto-Immunes Systèmiques Rares; Universitè de Strasbourg; Fèdèration de Mèdecine Translationnelle de Strasbourg; INSERM UMR 1109, Strasbourg, France.
authors.forename: F
authors.initials: F
authors.lastname: Danion
authors.affiliation: 2 Assistance Publique-Hopitaux de Paris, Hôpitaux Universitaires Paris-Sud, Rheumatology, Le Kremlin Bicêtre, France; Université Paris-Sud; INSERM UMR-S 1184, Centre de Recherches IMVA, France.
authors.forename: N
authors.initials: N
authors.lastname: Rosine
authors.affiliation: 2 Assistance Publique-Hopitaux de Paris, Hôpitaux Universitaires Paris-Sud, Rheumatology, Le Kremlin Bicêtre, France; Université Paris-Sud; INSERM UMR-S 1184, Centre de Recherches IMVA, France.
authors.forename: R
authors.initials: R
authors.lastname: Belkhir
authors.affiliation: 1 Hôpitaux Universitaires de Strasbourg, CHU Hautepierre, Service de Rhumatologie, Centre de Rèfèrence des Maladies Auto-Immunes Systèmiques Rares; Universitè de Strasbourg; Fèdèration de Mèdecine Translationnelle de Strasbourg; INSERM UMR 1109, Strasbourg, France.
authors.forename: J E
authors.initials: JE
authors.lastname: Gottenberg
authors.affiliation: 3 Service de Mèdecine Interne, Hopital Claude Huriez, Universitè Nord de France, Lille, France.
authors.forename: E
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: 1 Hôpitaux Universitaires de Strasbourg, CHU Hautepierre, Service de Rhumatologie, Centre de Rèfèrence des Maladies Auto-Immunes Systèmiques Rares; Universitè de Strasbourg; Fèdèration de Mèdecine Translationnelle de Strasbourg; INSERM UMR 1109, Strasbourg, France.
authors.forename: E
authors.initials: E
authors.lastname: Chatelus
authors.affiliation: 4 Service de Mèdecine Interne, CHU Purpan, Toulouse, France.
authors.forename: G
authors.initials: G
authors.lastname: Pugnet
authors.affiliation: 5 Service de Rhumatologie, CHU Lapeyronie Montpellier, France.
authors.forename: Y M
authors.initials: YM
authors.lastname: Pers
authors.affiliation: 2 Assistance Publique-Hopitaux de Paris, Hôpitaux Universitaires Paris-Sud, Rheumatology, Le Kremlin Bicêtre, France; Université Paris-Sud; INSERM UMR-S 1184, Centre de Recherches IMVA, France.
authors.forename: X
authors.initials: X
authors.lastname: Mariette
authors.affiliation: 1 Hôpitaux Universitaires de Strasbourg, CHU Hautepierre, Service de Rhumatologie, Centre de Rèfèrence des Maladies Auto-Immunes Systèmiques Rares; Universitè de Strasbourg; Fèdèration de Mèdecine Translationnelle de Strasbourg; INSERM UMR 1109, Strasbourg, France.
authors.forename: J
authors.initials: J
authors.lastname: Sibilia
authors.affiliation: 2 Assistance Publique-Hopitaux de Paris, Hôpitaux Universitaires Paris-Sud, Rheumatology, Le Kremlin Bicêtre, France; Université Paris-Sud; INSERM UMR-S 1184, Centre de Recherches IMVA, France.
authors.forename: R
authors.initials: R
authors.lastname: Seror
mesh_terms: D000069594:Abatacept / Q000008:administration & dosage* / Q000627:therapeutic use; D000328:Adult; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000069594:Abatacept
keywords: SLE; Systemic lupus erythematosus; abatacept; articular manifestations; efficacy; safety