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Abstract Number: 1773

Comparative Study of Infliximab Versus Adalimumab in Refractory Uveitis Due to Behçet’s Disease. National Multicenter Study of 177 Cases

Belén Atienza-Mateo1, José Luis Martín-Varillas1, Vanesa Calvo-Río2, Rosalía Demetrio-Pablo3, Emma Beltrán4, Marina Mesquida5, Alfredo Adan5, Juan Sánchez Bursón Sr.6, M. Victoria Hernández7, Marisa Hernández8, Elia Valls-Pascual9, L. Martinez-Costa9, Agusti Sellas-Fernandez10, Miguel Cordero-Coma11, Manuel Díaz-Llopis12, Roberto Gallego12, Jose L. García Serrano13, Norberto Ortego Centeno14, Angel Garcia-Aparicio15, Olga Maiz-Alonso16, Ana Blanco17, Cruz Fernandez-Espartero18, Vega Jovaní19, Diana Peiteado20, Elena Aurrecoechea21, Amalia Sanchez-Andrade22, Enrique Minguez23, Carmen Carrasco-Cubero24, Alejandro Olivé-Marqués25, Esteban Rubio-Romero26, Francisco J. Toyos Sáenz de Miera27, David Diaz-Valle28, Joan Miquel Nolla29, Marcelino Revenga Martínez30, Santos Castañeda31, Jose M Herreras32, Alejandro Fonollosa33, Ignacio Torre-Salaberri34, Esperanza Pato Cour35, Juan Cruz36, Carlos Férnandez Cid37, Miriam García-Arias38, Miguel Angel Caracuel-Ruiz39, Carlos Alberto Montilla-Morales40, Antonio Atanes41, Félix Francisco42, Santos Insua43, Senen González-Suárez44, Fernando Gamero45, Luis Francisco Linares46, Fredeswinda I. Romero-Bueno47, Raquel Almodóvar González48, Julio Vázquez49, A. Javier García-González50, Oscar Ruiz Moreno51, Fernando Jiménez-Zorzo51, Javier Manero51, Santiago Muñoz Fernandez52, Fred Antón Pages53, Myriam Gandía54, Francisco Javier López Longo55, Enrique Raya Álvarez56, Paz Rodríguez-Cundín57, Diana Prieto Peña2, Monica Calderón Goercke2, Enar Pons1, José Luis Hernández3, Miguel Angel González-Gay1 and Ricardo Blanco1, 1Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, 2Rheumatology, Rheumatology. Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, 3Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain, Santander, Spain, 4Rheumatology, Hospital del Mar. Barcelona. Spain, Barcelona, Spain, 5Hospital Clinic. Barcelona. Spain, Barcelona, Spain, 6Rheumatology, Hospital de Valme. Sevilla. Spain, Sevilla, Spain, 7Rheumatology, Hospital Clinic. Barcelona. Spain, Barcelona, Spain, 8Ophthalmology, Hospital General Universitario de Valencia. Spain, Valencia, Spain, 9Hospital Universitario Doctor Peset. Valencia. Spain, Valencia, Spain, 10Vall d'Hebron Hospital Research Institute, Barcelona, Spain, 11Ophthalmology, Hospital de León. Spain, León, Spain, 12Hospital Universitario La Fe. Valencia. Spain, Valencia, Spain, 13Ophthalmology, Hospital Universitario San Cecilio. Granada. Spain, Granada, Spain, 14Medicine Department, Hospital Universitario San Cecilio. Granada. Spain, Granada, Spain, 15Rheumatology, Hospital de Toledo. Toledo. Spain, Toledo, Spain, 16Hospital Universitario Donostia. San Sebastian. Spain, Donostia, Spain, 17Ophtamology, Hospital Universitario Donostia. San Sebastian. Spain, San Sebastian, Spain, 18Rheumatology, Hospital de Móstoles. Madrid. Spain, Madrid, Spain, 19Rheumatology, Hospital General Universitario de Alicante. Spain, Alicante, Spain, 20Rheumatology, Rheumatology, La Paz University Hospital, Madrid, Spain, 21Rheumatology, Hospital de Sierrallana, Torrelavega. Cantabria. Spain, Torrelavega, Spain, 22Rheumatology, Hospital Lucus Augusti. Lugo. Spain, Lugo, Spain, 23Ophthalmology, Hospital Clínico de Zaragoza. Spain, Zaragoza, Spain, 24Hospital de Mérida. Spain, Mérida, Spain, 25Rheumatology, Hospital Universitari Germans Trias i Pujol, Badalona, Spain, 26Hospital Universitario Virgen del Rocío. Sevilla. Spain, Sevilla, Spain, 27Hospital Virgen de La Macarena. Sevilla. Spain, Sevilla, Spain, 28Hospital Clínico San Carlos. Madrid. Spain, Madrid, Spain, 29Rheumatology, Hospital Universitario de Bellvitge, Barcelona, Spain, 30Hospital Universitario Ramón y Cajal. Madrid. Spain, Madrid, Spain, 31Rheumatology, Rheumatology Department, Hospital Universitario la Princesa, IIS-Princesa, Madrid, Spain, 32Ophthalmology, Hospital Universitario, IOBA. Valladolid. Spain, Valladolid, Spain, 33Ophthalmology, Hospital de Cruces. Bilbao. Spain, Bilbao, Spain, 34Rheumatology, Hospital Universitario de Basurto. Bilbao. Spain, Bilbao, Spain, 35Rheumatology, Hospital Clínico San Carlos, Madrid, Spain, 36Rheumatology, Hospital de Pontevedra. Pontevedra. Spain, Pontevedra, Spain, 37Ophthalmology, Hospital de Pontevedra. Pontevedra. Spain, Pontevedra, Spain, 38Hospital Universitario de la Princesa. Madrid. Spain, Madrid, Spain, 39Rheumatology service, Hospital Universitario Reina Sofía. Córdoba. Spain, Córdoba, Spain, 40Hospital Clínico Universitario de Salamanca. Spain, Salamanca, Spain, 41Complejo Hospitalario Universitario A Coruña. Spain, A Coruna, Spain, 42Rheumatology, Hospital Doctor Negrín. Las Palmas de Gran Canaria. Spain, Las Palmas de Gran Canaria, Spain, 43Rheumatology, Hospital Universitario Santiago de Compostela. La Coruña. Spain, La Coruña, Spain, 44Rheumatology, Hospital de Cabueñes. Gijón. Spain, Gijón, Spain, 45Rheumatology, Hospital San Pedro Alcántara. Cáceres. Spain, Cáceres, Spain, 46Rheumatology, Hospital Virgen de la Arrixaca. Murcia. Spain, Murcia, Spain, 47Section for Autoimmune Diseases, Rheumatology, Fundación Jiménez Díaz University Hospital & Health Research Institute, Madrid, Spain, 48Rheumatology, Hospital Universitario Fundación Alcorcón. Madrid. Spain, Madrid, Spain, 49Rheumatology, Hospital de Ferrol. La Coruña. Spain, La Coruña, Spain, 50Rheumatology, Instituto de Investigación Hospital 12 de octubre. Madrid. Spain, Madrid, Spain, 51Ophthalmology and Rheumatology, Hospital Miguel Servet. Zaragoza. Spain, Zaragoza, Spain, 52Hospital Universitario Infanta Sofía. Madrid. Spain, San Sebastián de los Reyes (Madrid), Spain, 53Rheumatology, Hospital Universitario Virgen del Rocío. Sevilla. Spain, Sevilla, Spain, 54Rheumatology, Hospital Puerta del Mar. Cádiz. Spain, Cádiz, Spain, 55Rheumatology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain, 56Rheumatology, Hospital Universitario San Cecilio. Granada. Spain, Granada, Spain, 57Preventive Medicine, Preventive Medicine. Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Universidad de Cantabria. Spain., Santander, Spain

Meeting: 2018 ACR/ARHP Annual Meeting

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

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Session Information

Date: Monday, October 22, 2018

Title: Vasculitis Poster II: Behҫet’s Disease and IgG4-Related Disease

Session Type: ACR Poster Session B

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

Background/Purpose: Uveitis is one of the major causes of disability of Behçet’s disease (BD). According to the “Expert panel recommendations” (Ophthalmology. 2014; 121:785-96), anti-TNF therapy with infliximab (IFX) or adalimumab (ADA) may be considered as first- or second-line therapy for patients with ophthalmic manifestations of BD. Our aim was to compare IFX versus ADA as first biologic drug in refractory uveitis due to BD for 1-year period.

Methods: Multicenter study of BD-associated uveitis refractory to conventional non-biologic treatment. Dosing schedule was: IFX: 3-5 mg/kg iv at 0, 2 and 6 weeks and then every 4-8 week, and ADA: 40 mg/sc/every other week without loading dose. The main comparative outcome measures were safety and efficacy, assessing the intraocular inflammation, macular thickness, visual acuity, degree of immunosuppression load, drug retention, and glucocorticoid-sparing effect.

Results: 177 patients (316 affected eyes) were included. IFX was used in 103 cases and ADA in 74. No significant differences at baseline were observed between IFX vs ADA groups regarding main demographic features, previous therapy and ocular severity. After one year of therapy, we observed an improvement in all ocular parameters in both groups; IFX vs ADA groups: AC inflammation (78.18% vs 92.31%; p=0.06), vitritis (78.95% vs 93.33%; p=0.04), retinal vasculitis (97% vs 95%; p=0.28), macular thickness (264.89±59.74 vs 250.62±36.85; p=0.15), and BCVA (0.67±0.34 vs 0.81±0.26; p=0.001). Drug withdrawal was observed in 57 (55.33%) of IFX group and in 21 (28.37%) of ADA group; p<0.01. TABLE 1 shows main baseline features and follow-up of both groups.

Conclusion: After one year of therapy in refractory BD-associated uveitis, ADA showed a statistically better outcome than IFX in improvement of BCVA, vitritis and drug retention.

TABLE 1. Main baseline features and follow-up of a series of 177 patients with refractory uveitis due to Behçet’s disease undergoing infliximab (IFX) or adalimumab (ADA) therapy.

IFX group

(N=103)

ADA group

(N=74)

p

Number of patients/affected eyes, (n/n)

103/185

74/131

Age, mean (SD) years

40.4 (10.1)

38.7 (11.3)

0.29

Sex, men/women, n/n

55/48

39/35

0.92

HLA-B51 positive, (%)

69.4

68.9

0.74

Duration of uveitis before anti-TNFα, median [IQR] months

36 [12-72]

24 [12-60]

0.69

Ocular features at the time of anti TNF-α onset

AC cells, median [IQR]

Vitritis, median [IQR]

BCVA, mean (SD)

Macular thickness, mean (SD)

Presence of retinal vasculitis, n (%)

Presence of choroiditis, n (%)

1 [0-2]

1 [0-2]

0.50 (0.35)

331.11 (131.97)

114 (58)

41 (21)

1 [0-2]

1 [0-2]

0.56 (0.34)

346.37 (136.14)

78 (55)

10 (7)

0.25

0.12

0.08

0.49

0.51

<0.01

Pattern of uveitis, n (%)

Bilateral

Unilateral

Anterior

Posterior

Panuveitis

Intermediate

82 (79.61)

21 (20.39)

11 (10.68)

28 (27.18)

64 (62.14)

0 (0)

57 (77.03)

17 (22.97)

14 (18.92)

14 (18.92)

45 (60.81)

1 (1.35)

0.68

0.68

0.19

0.19

0.19

0.19

Treatment before anti TNF-α onset, %

Oral corticosteroids

Intravenous pulses of MP

CsA

AZA

MTX

Other treatments

95

31

75

57

44

3.84

88

31

78

42

42

1.92

0.08

0.98

0.65

0.049

0.77

0.41

Prednisone dose at anti TNF-α onset, mean (SD), mg/d

54.35 (15.84)

53.37 (17.52)

0.37

Combined treatment, %

AZA

CsA

MTX

CFM

MMF

FK-506

76.5

21.8

41.1

33.3

1.3

1.3

1.3

70.3

19.2

55.7

21.1

0.0

3.8

0.0

0.35

Follow-up on anti TNFα therapy, mean (SD), months

Remission, n (%)

Relapses, mean (SD)

Drug withdrawal, n (%)

…………….remission, n (%)

…………….inefficacy, n (%)

…………….severe side-effects/toxicity, n (%)

…………….others, n (%)

Serious side-effects, n (per 100 patients/year)

31.52 (23.51)

78 (76.47)

1.13 (2.62)

57 (55.33)

20 (19.41)

18 (17.47)

8 (7.76)

11 (10.68)

4 (1.48)

26.48 (18.57)

61 (82.43)

1.66 (8.62)

21 (28.37)

6 (8.45)

11 (14.86)

4 (3.88)

0 (0)

4 (2.46)

0.13

0.34

0.61

<0.01

0.58

0.09

0.58

0.03

0.40

Abbreviations: ADA, adalimumab; AZA, azathioprine; CFM, cyclophosphamide; CsA, cyclosporine A; FK-506, tacrolimus; IFX, infliximab; IQR: interquartile range; MMF, mycophenolate mofetil; MTX, methotrexate; MP, methylprednisolone; SD: standard deviation; TNF-α: tumor necrosis factor alpha.


Disclosure: B. Atienza-Mateo, None; J. L. Martín-Varillas, None; V. Calvo-Río, None; R. Demetrio-Pablo, None; E. Beltrán, None; M. Mesquida, None; A. Adan, None; J. Sánchez Bursón Sr., None; M. V. Hernández, None; M. Hernández, None; E. Valls-Pascual, None; L. Martinez-Costa, None; A. Sellas-Fernandez, None; M. Cordero-Coma, None; M. Díaz-Llopis, None; R. Gallego, None; J. L. García Serrano, None; N. Ortego Centeno, None; A. Garcia-Aparicio, None; O. Maiz-Alonso, None; A. Blanco, None; C. Fernandez-Espartero, None; V. Jovaní, None; D. Peiteado, None; E. Aurrecoechea, None; A. Sanchez-Andrade, None; E. Minguez, None; C. Carrasco-Cubero, None; A. Olivé-Marqués, None; E. Rubio-Romero, None; F. J. Toyos Sáenz de Miera, None; D. Diaz-Valle, None; J. M. Nolla, None; M. Revenga Martínez, None; S. Castañeda, None; J. M. Herreras, None; A. Fonollosa, None; I. Torre-Salaberri, None; E. Pato Cour, None; J. Cruz, None; C. Férnandez Cid, None; M. García-Arias, None; M. A. Caracuel-Ruiz, None; C. A. Montilla-Morales, None; A. Atanes, None; F. Francisco, None; S. Insua, None; S. González-Suárez, None; F. Gamero, None; L. F. Linares, None; F. I. Romero-Bueno, None; R. Almodóvar González, None; J. Vázquez, None; A. J. García-González, None; O. Ruiz Moreno, None; F. Jiménez-Zorzo, None; J. Manero, None; S. Muñoz Fernandez, None; F. A. Pages, None; M. Gandía, None; F. J. López Longo, None; E. Raya Álvarez, None; P. Rodríguez-Cundín, None; D. Prieto Peña, None; M. Calderón Goercke, None; E. Pons, None; J. L. Hernández, None; M. A. González-Gay, None; R. Blanco, None.

To cite this abstract in AMA style:

Atienza-Mateo B, Martín-Varillas JL, Calvo-Río V, Demetrio-Pablo R, Beltrán E, Mesquida M, Adan A, Sánchez Bursón J Sr., Hernández MV, Hernández M, Valls-Pascual E, Martinez-Costa L, Sellas-Fernandez A, Cordero-Coma M, Díaz-Llopis M, Gallego R, García Serrano JL, Ortego Centeno N, Garcia-Aparicio A, Maiz-Alonso O, Blanco A, Fernandez-Espartero C, Jovaní V, Peiteado D, Aurrecoechea E, Sanchez-Andrade A, Minguez E, Carrasco-Cubero C, Olivé-Marqués A, Rubio-Romero E, Toyos Sáenz de Miera FJ, Diaz-Valle D, Nolla JM, Revenga Martínez M, Castañeda S, Herreras JM, Fonollosa A, Torre-Salaberri I, Pato Cour E, Cruz J, Férnandez Cid C, García-Arias M, Caracuel-Ruiz MA, Montilla-Morales CA, Atanes A, Francisco F, Insua S, González-Suárez S, Gamero F, Linares LF, Romero-Bueno FI, Almodóvar González R, Vázquez J, García-González AJ, Ruiz Moreno O, Jiménez-Zorzo F, Manero J, Muñoz Fernandez S, Pages FA, Gandía M, López Longo FJ, Raya Álvarez E, Rodríguez-Cundín P, Prieto Peña D, Calderón Goercke M, Pons E, Hernández JL, González-Gay MA, Blanco R. Comparative Study of Infliximab Versus Adalimumab in Refractory Uveitis Due to Behçet’s Disease. National Multicenter Study of 177 Cases [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/comparative-study-of-infliximab-versus-adalimumab-in-refractory-uveitis-due-to-behcets-disease-national-multicenter-study-of-177-cases/. Accessed .
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