Background/Purpose:
To evaluate short and long-term response to biological therapy in uveitis associated to Behçet´s syndrome refractory to standard systemic treatment.
Methods:
Multicenter study of 124 patients followed in uveitis units from 38 hospitals. All of them presented inadequate response to conventional therapy with corticosteroids and at least 1 systemic immunosuppressive drug.
The degree of ocular inflammation was evaluated according to “The Standardization of Uveitis Nomenclature (SUN)” (Am J Ophthalmol 2005; 140: 509-516) and macular thickness by optical coherence tomography (OCT). Comparisons were made between baseline and 1st week, 1st month, 6th month, 1st year, 2nd year, 3rd year and 4thyear. Statistical analysis was performed using the software STATISTICA (StatSoft Inc. Tulsa, Oklahoma, USA). Results were expressed as mean±SD for variables with a normal distribution, or as median [25th-75th interquartile range (IQR)] when they were not normally distributed. The comparison of continuous variables was performed using the Wilcoxon test.
Results:
We studied 124 patients/221 affected eyes (68 men/56 women) with a mean age of 38.6±10.4 years (range 10-67). HLA-B51 was positive in 66.1%. Besides oral steroids and before biologic therapy onset patients had received methylprednisolone i.v. boluses (34 patients), cyclosporine A (CyA) (102), methotrexate (MTX) (62) or azathioprine (AZA) (66). Anti-TNF drugs were the first choice biological agents; Infliximab (IFX) in 77 cases (62%) and adalimumab (ADA) in the remaining 47 cases (38%). They were used in 25 cases as monotherapy or in combination with: CyA (52 cases), MTX (27), AZA (17), mycophenolate (1), tacrolimus (1) or cyclophosphamide (1). The IFX regimen more frequently used were 5 mg/kg /i.v./every 4-8 weeks and ADA 40 mg/sc/EOW. In cases of refractory uveitis or intolerance to a 1stbiologic other agents were used; namely: Golimumab (4 cases), Tocilizumab (1 case), rituximab (1 case) and etanercept (1 case). The mean follow-up of anti-TNF therapy was 35.9±20.3 months. Visual acuity (VA), Tyndall, vitritis and OCT showed a rapid and statistically significant improvement at the 1ª week. From biological onset to 2 years mean improvement was observed in VA from 0.5±0.3 to 0.7±0.3 (p<0.01); tyndall from a median [IQR] of 1 [0-2] to 0 [0-0] (p<0.01) and vitritis, from a median [IQR] of 1 [0-2] to 0 [0-0] (p<0.01). At baseline, 50 patients, (80 eyes) had macular thickening (OCT>250μ) and 35 patients (49 eyes) had cystoid macular edema (CME) (OCT>300μ). The CME improved from 420±119.5 microns to 282.5±55 microns at 2 years (p<0.01).
The more severe side-effects observed were milliary tuberculosis and fatal lymphoma (in one case each).
Conclusion:
Biological therapy, especially IFX and ADA, yields short and long-term efficacy and has a relatively safety profile in uveitis refractory to standard systemic treatment of Behcet’s syndrome.
|
Basal
active patients,N /active eyes (%) |
1 week
active eyes (%)
|
1 month
active eyes (%)
|
6 months
active eyes (%)
|
1 year
active eyes (%)
|
2 years
active eyes (%)
|
3 years
active eyes (%)
|
4 years
active eyes (%)
|
Anterior inflammation (Tyndall)
|
80 / 57%
|
51%
|
32.3%
|
19.3%
|
9.2%
|
11.7%
|
5.7%
|
6.1%
|
Vitritis
|
96 / 64.4%
|
58.4%
|
42.8%
|
24.6%
|
16.9%
|
13.9%
|
9.4%
|
5.8%
|
Choroiditis
|
28 / 17.6%
|
15.1%
|
12.1%
|
4.1%
|
2.5%
|
1.7%
|
0%
|
0%
|
Retinitis
|
45 / 30.7%
|
24.5%
|
14.3%
|
2.8%
|
0.5%
|
0.6%
|
1.1%
|
0%
|
Retinal vasculitis
|
89 / 61.1%
|
56.5%
|
34.8%
|
15.7%
|
7.1%
|
9.7%
|
8.2%
|
2.3%
|
Macular thickness ≥ 250 microns
|
55 / 61.4%
|
62.2%
|
56.5%
|
48.3%
|
43.5%
|
50%
|
27.3%
|
37.5%
|
Disclosure:
F. Ortiz-Sanjuan,
None;
V. Calvo-Río,
None;
R. Blanco,
None;
E. Beltrán,
None;
J. Sánchez-Bursón,
None;
M. Mesquida,
None;
A. M. Adan,
None;
M. Hernandez Grafella,
None;
E. Valls Pascual,
None;
L. Martínez-Costa,
None;
A. Sellas-Fernàndez,
None;
M. Cordero-Coma,
None;
M. Diaz-llopis,
None;
D. Salom,
None;
J. García Serrano,
None;
N. Ortego,
None;
J. Herreras,
None;
A. Fonollosa,
None;
A. Aparicio,
None;
O. Maíz,
None;
A. Blanco,
None;
I. Torre,
None;
C. Fernández-Espartero,
None;
V. Jovani,
None;
D. Peitado-Lopez,
None;
E. Pato,
None;
J. Cruz,
None;
J. C. Fernandez-Cid,
None;
E. Aurrecoechea,
None;
M. García,
None;
M. Caracuel,
None;
C. Montilla,
None;
A. Atanes,
None;
F. Francisco,
None;
S. Insua,
None;
S. González-Suárez,
None;
A. Sánchez-Andrade,
None;
F. Gamero,
None;
L. Linares,
None;
F. Romero-Bueno,
None;
A. García González,
None;
R. Almodovar,
None;
E. Minguez,
None;
C. Carrasco Cubero,
None;
A. Olive Marques,
None;
J. Vázquez,
None;
O. Ruiz Moreno,
None;
F. Jimenez-Zorzo,
None;
J. Manero,
None;
J. Loricera,
None;
M. A. González-Gay,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/short-and-long-term-biological-therapy-in-refractory-uveitis-of-behcets-syndrome-multicenter-study-of-124-patients/