title: Efficacy of anti-TNF alpha in severe and/or refractory Behçet's disease: Multicenter study of 124 patients.
abstract: OBJECTIVE
  To report the efficacy and safety of anti-TNF agents in patients with severe and/or refractory manifestations of Behçet's disease (BD).
  
  
  METHODS
  We performed a multicenter study of main characteristics and outcomes of anti-TNF alpha treatments [mainly infliximab (62%), and adalimumab (30%)] in 124 BD patients [48% of men; median age of 33.5 (28-40) years].
  
  
  RESULTS
  Overall response (i.e. complete and partial) rate was 90.4%. Clinical responses were observed in 96.3%, 88%, 70%, 77.8%, 92.3% and 66.7% of patients with severe and/or refractory ocular, mucocutaneous, joint, gastro-intestinal manifestations, central nervous system manifestations and cardiovascular manifestations, respectively. No significant difference was found with respect to the efficacy of anti-TNF used as monotherapy or in association with an immunosuppressive agent. The incidence of BD flares/patient/year was significantly lower during anti-TNF treatment (0.2 ± 0.5 vs 1.7 ± 2.4 before the use of anti-TNF, p < 0.0001). The prednisone dose was significantly reduced at 6 and 12 months (p < 0.0001). In multivariate analysis, retinal vasculitis was negatively associated with complete response to anti-TNF (OR = 0.33 [0.12-0.89]; p = 0.03). The efficacy and relapse free survival were similar regardless of the type of anti-TNF agent used. After a median follow-up of 21 [7-36] months, side effects were reported in 28% of patients, including infections (16.3%) and hypersensitivity reactions (4.1%). Serious adverse events were reported in 13% of cases.
  
  
  CONCLUSIONS
  Anti-TNF alpha therapy is efficient in all severe and refractory BD manifestations. Efficacy appears to be similar regardless of the anti-TNF agent used (infliximab or adalimumab).
authors.affiliation: Department of Internal Medicine and Clinical Immunology, Pitié-Salpêtrière hospital, 83, boulevard de l'Hôpital, Paris 75013, France; Centre national de référence maladies systémiques et autoimmunes rares, DHU Inflammation, Immunopathologie, Biothérapie, Université Paris VI-Pierre et Marie Curie, Paris, France.
authors.forename: H
authors.initials: H
authors.lastname: Vallet
authors.affiliation: Department of Internal Medicine, Saint Eloi Hospital, Montpellier, France.
authors.forename: S
authors.initials: S
authors.lastname: Riviere
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, Saint Louis Hospital, France.
authors.forename: A
authors.initials: A
authors.lastname: Sanna
authors.affiliation: Department of Internal Medicine, University Hospital, Grenoble, France.
authors.forename: A
authors.initials: A
authors.lastname: Deroux
authors.affiliation: Department of Internal Medicine, University Hospital, Toulouse, France.
authors.forename: G
authors.initials: G
authors.lastname: Moulis
authors.affiliation: Department of Rheumatology, Santa Maria Nuova Hospital, Reggio Emilia, Italy.
authors.forename: O
authors.initials: O
authors.lastname: Addimanda
authors.affiliation: Department of Rheumatology, Santa Maria Nuova Hospital, Reggio Emilia, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Salvarani
authors.affiliation: Department of Internal Medicine, University Hospital, Lille, France.
authors.forename: M
authors.initials: M
authors.lastname: Lambert
authors.affiliation: Department of Internal Medicine, University Hospital, Dijon, France.
authors.forename: P
authors.initials: P
authors.lastname: Bielefeld
authors.affiliation: Department of Internal Medicine, Croix Rousse Hospital, Lyon, France.
authors.forename: P
authors.initials: P
authors.lastname: Seve
authors.affiliation: Department of Rheumatology, University Hospital, Strasbourg, France.
authors.forename: J
authors.initials: J
authors.lastname: Sibilia
authors.affiliation: Department of Internal Medicine, University Hospital, Strasbourg, France.
authors.forename: Jl
authors.initials: J
authors.lastname: Pasquali
authors.affiliation: Department of Internal Medicine, Jean Verdier Hospital, Bondy, France.
authors.forename: Jb
authors.initials: J
authors.lastname: Fraison
authors.affiliation: Department of Internal Medicine, University Hospital, Rouen, France.
authors.forename: I
authors.initials: I
authors.lastname: Marie
authors.affiliation: Department of Internal Medicine, Edouard Herriot Hospital, Lyon, France.
authors.forename: L
authors.initials: L
authors.lastname: Perard
authors.affiliation: Department of Internal Medicine, University Hospital, Grenoble, France.
authors.forename: L
authors.initials: L
authors.lastname: Bouillet
authors.affiliation: Department of Internal Medicine, E3M Institut, Pitié Salpêtrière Hospital, Paris, France.
authors.forename: F
authors.initials: F
authors.lastname: Cohen
authors.affiliation: Department of Internal Medicine, Lariboisière Hospital, Paris, France.
authors.forename: D
authors.initials: D
authors.lastname: Sene
authors.affiliation: Department of Internal Medicine, Pitié Salpêtrière Hospital, Paris, France.
authors.forename: Y
authors.initials: Y
authors.lastname: Schoindre
authors.affiliation: Department of Internal Medicine, Croix Saint Simon Hospital, Paris, France.
authors.forename: O
authors.initials: O
authors.lastname: Lidove
authors.affiliation: Department of Ophtalmology, Pitié Salpêtrière Hospital, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Le Hoang
authors.affiliation: Department of Internal Medicine, University Hospital, Lille, France.
authors.forename: E
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: Department of Internal Medicine, Saint Antoine Hospital, Paris, France.
authors.forename: O
authors.initials: O
authors.lastname: Fain
authors.affiliation: Department of Rheumatology, Kremlin Bicetre University Hospital, Kremlin Bicetre, France.
authors.forename: X
authors.initials: X
authors.lastname: Mariette
authors.affiliation: Department of Internal Medicine, Bichat Hospital, Paris, France.
authors.forename: T
authors.initials: T
authors.lastname: Papo
authors.affiliation: Department of Internal Medicine and Clinical Immunology, Pitié-Salpêtrière hospital, 83, boulevard de l'Hôpital, Paris 75013, France; Centre national de référence maladies systémiques et autoimmunes rares, DHU Inflammation, Immunopathologie, Biothérapie, Université Paris VI-Pierre et Marie Curie, Paris, France.
authors.forename: B
authors.initials: B
authors.lastname: Wechsler
authors.affiliation: Department of Ophtalmology, Pitié Salpêtrière Hospital, Paris, France.
authors.forename: B
authors.initials: B
authors.lastname: Bodaghi
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, Saint Louis Hospital, France.
authors.forename: M Resche
authors.initials: MR
authors.lastname: Rigon
authors.affiliation: Department of Internal Medicine and Clinical Immunology, Pitié-Salpêtrière hospital, 83, boulevard de l'Hôpital, Paris 75013, France; Centre national de référence maladies systémiques et autoimmunes rares, DHU Inflammation, Immunopathologie, Biothérapie, Université Paris VI-Pierre et Marie Curie, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Cacoub
authors.affiliation: Department of Internal Medicine and Clinical Immunology, Pitié-Salpêtrière hospital, 83, boulevard de l'Hôpital, Paris 75013, France; Centre national de référence maladies systémiques et autoimmunes rares, DHU Inflammation, Immunopathologie, Biothérapie, Université Paris VI-Pierre et Marie Curie, Paris, France. Electronic address: david.saadoun@psl.aphp.fr.
authors.forename: D
authors.initials: D
authors.lastname: Saadoun
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001528:Behcet Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D012008:Recurrence; D019233:Retreatment; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors; D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha
keywords: Anti-TNF; Behçet's disease; Efficacy; Safety; Vasculitis