Background/Purpose
Behçet’s disease (BD) is a systemic large vessel vasculitis with recurrent genital and oral ulceration, uveitis, cardiovascular, joints, neurological or gut symptoms. Treatment of BD is dependent of the nature and the severity of clinical manifestations. Increased levels of TNF alpha and soluble TNF receptors have been found in the serum, plasma and in the aqueous humor of patients with BD. Although, anti-TNF alpha have proved effective in refractory uveitis, few data are available relative to its efficacy in extraocular manifestations of BD. The aim of this study is to report on the efficacy and the safety of anti-TNF alpha in BD.
Methods
We performed a retrospective multicenter study of main characteristics and outcomes of 122 patients with BD treated with anti-TNF alpha.
Results
One hundred twenty two observations were collected in 21 centers. Mean ± SD age at the anti-TNF alpha introduction was 35 ±12 years with 47% of men. Ninety one (75%) patients received at less one immunosuppressive therapy before the use of anti-TNF alpha.
The main indications of anti-TNF alpha were uveitis (n=80, 66%), mucocutaneous manifestations (n=26, 21%) [oral (n=21) and genital ulcerations (n=13)], articular (n=29, 24%), neurologic (n=12, 10%), cardio-vascular (n=5, 4%) and digestive manifestations (n=9, 7%). Infliximab was frequently used (61%), followed by adalimumab (30%), etanercept (8%) and golimumab (1%). Associated therapy included prednisolone (84%), azathioprine (28%), mycophenolate mofetil (6%), and methotrexate (10%). Median duration of follow up was 31 months [11-55]. 96% and 81% of BD patients achieved a complete or partial response of uveitis and extraocular manifestations, respectively. Relapse free survival was similar regardless of anti-TNF alpha used. Anti-TNF alpha had a significant corticosteroid sparing effect (daily prednisolone dose of 40mg at time of introduction of anti-TNF alpha vs 10mg and 5mg at 6 and 12 months, respectively; p<0,0001). The median time for clinical improvement was 62 days [31-92]. Adverse events were reported in 28% of patients, mainly with infliximab (infliximab 61%, adalimumab 32%; p=0.02). They mainly included infections (52%) and hypersensitivity reactions (16%). Serious adverse events were reported in 13% of patients and required treatment interruption in all cases.
Conclusion
These results show that TNF alpha inhibitors are highly and rapidly efficient in all BD manifestations. Although tolerance seems satisfactory, infliximab is associated with more frequent and more serious side effects.
Disclosure:
H. Vallet,
None;
S. Rivière,
None;
A. Deroux,
None;
G. Moulis,
None;
O. Addimanda,
None;
C. Salvarani,
Novartis Pharma AG,
2;
M. Lambert,
None;
P. Bielfeld,
None;
P. Sève,
None;
J. Sibilia,
None;
J. B. Fraison,
None;
Y. Schoindre,
None;
I. Marie,
None;
L. Perard,
None;
T. Papo,
None;
D. Sène,
None;
G. Leroux,
None;
V. Royant,
None;
A. Perlat,
None;
X. Mariette,
None;
O. Lidove,
None;
O. Fain,
None;
C. De Moreuil,
None;
G. Blaison,
None;
P. LE Hoang,
None;
E. Hachulla,
None;
B. Wechsler,
None;
B. Bodaghi,
None;
P. Cacoub,
None;
D. Saadoun,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-anti-tnf-alpha-in-behcet-disease-a-international-multicenter-registry-of-122-patients/