H Vallet1, S Riviere2, A Sanna3, A Deroux4, G Moulis5, O Addimanda6, C Salvarani6, M Lambert7, P Bielefeld8, P Seve9, J Sibilia10, Jl Pasquali11, Jb Fraison12, I Marie13, L Perard14, L Bouillet4, F Cohen15, D Sene16, Y Schoindre17, O Lidove18, P Le Hoang19, E Hachulla7, O Fain20, X Mariette21, T Papo22, B Wechsler1, B Bodaghi19, M Resche Rigon3, P Cacoub1, D Saadoun23. 1. 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. 2. Department of Internal Medicine, Saint Eloi Hospital, Montpellier, France. 3. Department of Clinical Epidemiology and Biostatistics, Saint Louis Hospital, France. 4. Department of Internal Medicine, University Hospital, Grenoble, France. 5. Department of Internal Medicine, University Hospital, Toulouse, France. 6. Department of Rheumatology, Santa Maria Nuova Hospital, Reggio Emilia, Italy. 7. Department of Internal Medicine, University Hospital, Lille, France. 8. Department of Internal Medicine, University Hospital, Dijon, France. 9. Department of Internal Medicine, Croix Rousse Hospital, Lyon, France. 10. Department of Rheumatology, University Hospital, Strasbourg, France. 11. Department of Internal Medicine, University Hospital, Strasbourg, France. 12. Department of Internal Medicine, Jean Verdier Hospital, Bondy, France. 13. Department of Internal Medicine, University Hospital, Rouen, France. 14. Department of Internal Medicine, Edouard Herriot Hospital, Lyon, France. 15. Department of Internal Medicine, E3M Institut, Pitié Salpêtrière Hospital, Paris, France. 16. Department of Internal Medicine, Lariboisière Hospital, Paris, France. 17. Department of Internal Medicine, Pitié Salpêtrière Hospital, Paris, France. 18. Department of Internal Medicine, Croix Saint Simon Hospital, Paris, France. 19. Department of Ophtalmology, Pitié Salpêtrière Hospital, Paris, France. 20. Department of Internal Medicine, Saint Antoine Hospital, Paris, France. 21. Department of Rheumatology, Kremlin Bicetre University Hospital, Kremlin Bicetre, France. 22. Department of Internal Medicine, Bichat Hospital, Paris, France. 23. 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.
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. CONCLUSION: 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).
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. CONCLUSION: 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: Angela Ceribelli; Maria De Santis; Natasa Isailovic; M Eric Gershwin; Carlo Selmi Journal: Clin Rev Allergy Immunol Date: 2017-02 Impact factor: 8.667