Adalimumab Versus Infliximab in Cystoid Macular Edema of Uveitis Associated to BehçEt Disease. Multicenter Study of 34 Patients

Lucia Cristina Domínguez-Casas¹, Vanesa Calvo-Río¹, Ricardo Blanco², Carlos Fernández-Díaz¹, Paz Rodríguez-Cundín³, Emma Beltran⁴, Marisa Hernández-Garfella⁵, Jose M Herreras⁶, Miguel Cordero-Coma⁷, Marina Mesquida⁸, Alfredo Adan⁹, M. Victoria Hernández¹⁰, David Diaz-Valle¹¹, Ignacio Torre-Salaberri¹², Manuel Díaz-Llopis¹³, Roberto Gallego¹⁴, Olga Maiz-Alonso¹⁵, Santos Insua¹⁶, Félix Francisco¹⁷, Raquel Almodóvar González¹⁸, Oscar Ruiz Moreno¹⁹, Fernando Jiménez-Zorzo²⁰, Javier Manero²¹, Myriam Gandía²², Joan Miquel Nolla²³, Nuria Vegas-Revenga²⁴, Natalia Palmou-Fontana¹ and Miguel Angel Gonzalez-Gay¹, ¹Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Santander, Spain, ²Rheumatology Department. Hospital Universitario Marqués de Valdecilla, Santander, Spain, ³Preventive Medicine, Hospital Universitario Marqués de Valdecilla. IDIVAL, Santander, Spain, ⁴Rheumatology, Hospital General Universitario de Valencia, Valencia, Spain, ⁵Ophtamology, Hospital General Universitario de Valencia, Valencia, Spain, ⁶Ophthalmology, Hospital Universitario, IOBA, Valladolid, Spain, ⁷Ophthalmology, Hospital de León, León, Spain, ⁸Ophthalmology, Hospital Clinic. Barcelona. Spain, Barcelona, Spain, ⁹Ophthalmology, Hospital Clinic de Barcelona,, Barcelona, Spain, ¹⁰Rheumatology, Hospital Clinic. Barcelona. Spain, Barcelona, Spain, ¹¹Ophthalmology Department, Hospital Clínico San Carlos, Madrid, Spain, ¹²Rheumatology, Hospital de Basurto, Bilbao, Spain, ¹³Hospital Universitario La Fe, Valencia, Spain, ¹⁴Ophtalmology, Hospital Universitario La Fe, Valencia, Spain, ¹⁵Hospital Universitario Donostia, Donostia, Spain, ¹⁶Rheumatology, Hospital Universitario Santiago de Compostela, La Coruña, Spain, ¹⁷Rheumatology, Hospital Doctor Negrín, Las Palmas de Gran Canaria, Spain, ¹⁸Rheumatology Unit, Hospital Universitario Fundación Alcorcón, Madrid, Spain, ¹⁹Ophthalmology and Rheumatology., Hospital Miguel Servet, Zaragoza, Spain, ²⁰Hospital Miguel Servet, Zaragoza, Spain, ²¹Rheumatology, Hospital Miguel Servet, Zaragoza, Spain, ²²Rheumatology, Hospital Puerta del Mar, Cadiz, Spain, ²³Rheumatology, Department of Rheumatology, Hospital Universitario de Bellvitge, Barcelona, Spain, ²⁴Hospital Universitario Marqués de Valdecilla. IDIVAL, Santander, Spain

Meeting: ACR/ARHP Annual Meeting 2016

Date of first publication: September 28, 2016

Keywords: Adalimumab, Behcet's syndrome, infliximab and uveitis

Session Information

Date: Tuesday, November 15, 2016

Title: Vasculitis - Poster III: Rarer Vasculitides

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Cystoid macular edema (CME) is the most serious complication of uveitis and the most common cause of blindness in uveitis. Our aim was to compare the efficacy and safety of adalimumab (ADA) vs infliximab (IFX) as the first biologic therapy in refractory CME of uveitis associated to Behçet Disease during one year period.

Methods: Multicenter study that included 175 patients with uveitis associated to Behçet Disease refractory to high dose of corticosteroids and at least one conventional systemic immunosuppressive drug. CME (OCT >300 μm) was present at baseline In 34 of these 175 patients, and it was the main reason for anti-TNFα therapy use. Infliximab (3-5 mg/kg/iv at 0, 2 and 6 weeks and after every 4-8 weeks) was used in 12 cases and ADA (40 mg/sc/2 weeks) in 22 cases. Our main objective was the complete resolution of CME. Secondary objectives were the improvement in visual acuity (VA) (VA improvement of at least 20% in one of the eyes), the complete absence of inflammation in the anterior chamber and resolution of vitritis, retinal vasculitis and retinitis. A bivariate analysis was performed to compare the response of the two types of biologic agents (ADA and IFX). A logistic regression model was performed to evaluate the effect of the biologic therapy on outcome. The analysis was performed using the SPSS version 20.0.

Results: We studied 34 patients (63 affected eyes). There were no significant differences between groups at baseline (IFX vs ADA) in sex (♂/♀; 4/6 vs 11/11; p =0.35), mean age (37.3±10.1 vs 41.5±8.3; p=0.2), positive HLA-B51 (70% vs 80.9%; p =0.5), uveitis duration before anti TNFα onset (median [IQR]; 36 [10-82] vs 33 months [15.5 to 83]; p =0.8), VA (0.4±0.33 vs 0.46±0.29; p =0.44), retinal vasculitis (75% vs 77%; p =0.87), retinitis (46% vs 30%; p =0.2), macular thickening (410.13±140.9 vs 409.46±138.55; p =0.98) and combined immunosuppressive therapy (58.33% vs 59.1 %; p =0.96). However, there were differences in the presence of cells in the anterior chamber (median [IQR] 1 [0-1.2] vs 1 [0-3]; p =0.02) and vitritis (median [IQR], 1 [0-2] vs 3 [0.5-3]; p =0.002). Although CME resolution (main objective) was more commonly found with ADA, no significant differences were found. No significant differences were found between ADA and IFX when the secondary objectives were assessed, even after the adjustment for duration of illness, age and sex (TABLE)

Conclusion: Both ADA and IFX are effective in CME associated to Behçet Disease refractory to conventional immunosuppressive therapy. These two anti-TNFα agents show equivalent efficacy. TABLE

	ADA/IFX (%)	crude OR	CI 95%	p	adjusted OR**	CI 95%	p
After one month
– Absence of CME (OCT <300)	38.9%/18.2%	2.86	0.473-17.35	0.252	3.88	0.384-39.25	0.25
– VA improvement*	80.0%/72.7%	1.5	0.268-8.383	0.644	3.003	0.342-26.401	0.321
– Absence of cells in Anterior Chamber	56.2%/71.4%	0.514	0.076-3.488	0.496	0.174	0.00-1.98	0.199
– Inactive vitritis	23.5%/50.0%	0.308	0.052-1.829	0.151	0.385	0.053-2.807	0.346
– Inactive retinitis	57.1%/71.4%	0.533	0.058-4.912	0.579	–	–	–
– Inactive vasculitis	50.0%/63.6%	0.571	0.123-2.658	0.476	1.056	0.177-6.321	0.952
After one year
– Absence of CME (OCT <300)	88.9%/66.7%	4	0.53-30.16	0.179	7.03	0.511-96.91	0.145
– VA improvement	68.2%/66.7%	1.071	0.239-4.794	0.928	1.1	0.171-7.086	0.92
– Absence of cells in Anterior Chamber	93.8%/100%	1.467	1.102-1.951	0.99	–	–	–
– Inactive vitritis	87.5%/100%	1.5	1.109-2.03	0.99
– Inactive retinitis	–	–	–	–	–	–	–
– Inactive vasculitis	–	–	–	–	–	–	–

* improvement at least of 20% in VA **after adjusting for duration of illness, age and sex

Disclosure: L. C. Domínguez-Casas, None; V. Calvo-Río, None; R. Blanco, None; C. Fernández-Díaz, None; P. Rodríguez-Cundín, None; E. Beltran, None; M. Hernández-Garfella, None; J. M. Herreras, None; M. Cordero-Coma, None; M. Mesquida, None; A. Adan, AbbVie, Santen and Allergan, 9; M. V. Hernández, None; D. Diaz-Valle, None; I. Torre-Salaberri, None; M. Díaz-Llopis, None; R. Gallego, None; O. Maiz-Alonso, None; S. Insua, None; F. Francisco, None; R. Almodóvar González, None; O. Ruiz Moreno, None; F. Jiménez-Zorzo, None; J. Manero, None; M. Gandía, None; J. M. Nolla, None; N. Vegas-Revenga, None; N. Palmou-Fontana, None; M. A. Gonzalez-Gay, None.

To cite this abstract in AMA style:

Domínguez-Casas LC, Calvo-Río V, Blanco R, Fernández-Díaz C, Rodríguez-Cundín P, Beltran E, Hernández-Garfella M, Herreras JM, Cordero-Coma M, Mesquida M, Adan A, Hernández MV, Diaz-Valle D, Torre-Salaberri I, Díaz-Llopis M, Gallego R, Maiz-Alonso O, Insua S, Francisco F, Almodóvar González R, Ruiz Moreno O, Jiménez-Zorzo F, Manero J, Gandía M, Nolla JM, Vegas-Revenga N, Palmou-Fontana N, Gonzalez-Gay MA. Adalimumab Versus Infliximab in Cystoid Macular Edema of Uveitis Associated to BehçEt Disease. Multicenter Study of 34 Patients [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/adalimumab-versus-infliximab-in-cystoid-macular-edema-of-uveitis-associated-to-behcet-disease-multicenter-study-of-34-patients/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/adalimumab-versus-infliximab-in-cystoid-macular-edema-of-uveitis-associated-to-behcet-disease-multicenter-study-of-34-patients/