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Multicenter Study
. 2015 Aug:62:67-74.
doi: 10.1016/j.jaut.2015.06.005. Epub 2015 Jul 8.

Efficacy of anti-TNF alpha in severe and/or refractory Behçet's disease: Multicenter study of 124 patients

H Vallet  1 , S Riviere  2 , A Sanna  3 , A Deroux  4 , G Moulis  5 , O Addimanda  6 , C Salvarani  6 , M Lambert  7 , P Bielefeld  8 , P Seve  9 , J Sibilia  10 , Jl Pasquali  11 , Jb Fraison  12 , I Marie  13 , L Perard  14 , L Bouillet  4 , F Cohen  15 , D Sene  16 , Y Schoindre  17 , O Lidove  18 , P Le Hoang  19 , E Hachulla  7 , O Fain  20 , X Mariette  21 , T Papo  22 , B Wechsler  1 , B Bodaghi  19 , M Resche Rigon  3 , P Cacoub  1 , D Saadoun  23 ; French Behçet Network
Affiliations
Multicenter Study

Efficacy of anti-TNF alpha in severe and/or refractory Behçet's disease: Multicenter study of 124 patients

H Vallet et al. J Autoimmun. 2015 Aug.

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).

Keywords: Anti-TNF; Behçet's disease; Efficacy; Safety; Vasculitis.

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