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Abstract Number: 1250

Golimumab As an Alternative Therapy in Patients with Uveitis Refractory to Other Anti-TNFα Drugs. Multicenter Study of 29 Cases

Montserrat Santos-Gómez1, Francisco Ortiz-Sanjuán1, Ricardo Blanco1, Joaquín Cañal Villanueva2, Alfredo Adan3, Marina Mesquida3, M. Victoria Hernández4, Esteban Rubio Romero5, Angel M. Garcia-Aparicio6, Antonio Atanes7, Ignacio Torre Salaberri8, Félix Francisco9, Cruz Fernández- Espartero10, Natalia Palmou11, Vanesa Calvo-Río1, Javier Loricera1, Juan Ventosa12, Trinitario Pina Murcia13, Leyre Riancho-Zarrabeitia1 and Miguel A. González-Gay1, 1Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Spain, Santander, Spain, 2Ophthalmology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Spain, Santander, Spain, 3Ophthalmology, Hospital Clinic. Barcelona. Spain, Barcelona, Spain, 4Arthritis Unit, Department of Rheumatology, Hospital Clinic, Barcelona, Barcelona, Spain, 5Rheumatology, Hospital Universitario Virgen del Rocío. Sevilla. Spain, Sevilla, Spain, 6Rheumatology, Virgen de la Salud Hospital, Toledo, Spain, 7HUCA. La coruña. Spain, La Coruña, Spain, 8Rheumatology, Hospital Universitario de Basurto. Bilbao. Spain, Bilbao, Spain, 9Rheumatology, Hospital Doctor Negrín. Las Palmas de Gran Canaria. Spain, Las Palmas de Gran Canaria, Spain, 10Rheumatology, Hospital Universitario de Móstoles. Madrid. Spain, Madrid, Spain, 11Complejo Hospitalario Universitario de Albacete. Spain, Albacete, Spain, 12Ophtalmology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Spain, Santander, Spain, 13Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, IDIVAL, Santander, Spain

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Biologic agents and uveitis

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Session Information

Session Title: Miscellaneous Rheumatic and Inflammatory Diseases

Session Type: Abstract Submissions (ACR)

Background/Purpose

To evaluate the clinical response and safety of golimumab (GLM) in a series of patients with non-infectious uveitis refractory to other anti-TNFα drugs.

Methods

Multicenter study of 29 patients with uveitis that was refractory to previous standard synthetic immunosuppressive drugs and at least 1 anti-TNFα drug. GLM was given at the standard dose of 50 mg/sc/month. The main outcome measures were degree of anterior and posterior chamber inflammation, visual acuity, and macular thickness.

Results

A total of 29 patients (44 affected eyes) (21 men/8 women) with a mean age of 34.6±9.5 years (range 11-48) were studied. Uveitis was bilateral (n=15 cases) or unilateral (n=14). The pattern of ocular involvement was anterior uveitis (n=19), panuveitis (n=6) and intermediate, anterior+intermediate, anterior+posterior and intermediate+posterior (one case each). Uveitis was acute (n=1), chronic (n=16) or recurrent (n=12).The underlying diseases were spondyloarthritis (n=9), psoriatic arthritis (n=5), juvenile idiopathic arthritis (n=4), Behçet disease (n=4), sarcoidosis (n=3), uveitis associated with HLA-B27 and ulcerative colitis (n=1), undifferentiated arthritis (n=1), pars planitis (n=1) and Vogt-Koyanagi-Harada (n=1).

Besides oral steroids and before GLM onset they had received: intraocular corticosteroids (n=11), intravenous pulses of methylprednisolone (n=6), methotrexate (n=23), cyclosporine A (n=6), azathioprine (n=7), adalimumab (n=17), infliximab (n=15), abatacept (n=2) and certolizumab (n=1). GLM was started because inefficacy (n=27) and/or toxicity (n=2) to other biologics. GLM was used as monotherapy (n=11) or in combination with methotrexate (n=10), azathioprine (n=4), leflunomide (n=2), and mycophenolate (n=2).

After one year of GLM therapy all the following variables improved significantly (p<0.05)(TABLE): a) The mean best corrected visual acuity (from 0.68±0.3 at baseline to 0.75±0.3); b) anterior chamber and vitreous inflammation (from 62.7% and 40.4% of eyes, to 12.5% and 0% respectively); c) Cystoid Macular Edema (OCT>300 μm), (from 50% to 0%), d) the mean OCT (from 318.9±76 to 244.2±43.2 μm); and d) the mean dose of prednisone (from 24±20.1 to 7.7±7.6 mg/day). After a mean follow-up of 13.1±8.5 (range 2-30) months the most important side-effects observed were Injection site erythema (n=3) and herpes zoster (n=1).

Conclusion

Our results suggest that GLM may be an effective and safe treatment for patients with uveitis refractory to other anti-TNFα drugs.


TABLE

Basal

active patients, N

active eyes (%)

1 week

active eyes (%)

1 month

active eyes (%)

3 months

active eyes (%)

6 months

active eyes (%)

1 year

active eyes (%)

Anterior chamber cells

22

62.7%

55.5% *

30.6% *

23.25% *

7.3% *

9.7% *

Vitritis

12

40.4%

29.7% *

21.9% *

10.5% *

2.7% *

0% *

Choroiditis

2

2.12%

2.12%

0%

0%

0%

0%

Retinitis

1

1.96%

1.96% *

0% *

0% *

0% *

0% *

Retinal vasculitis

3

5.88%

5.88% *

4.1% *

0% *

0% *

0% *

Macular thickness ≥ 300 microns

8

50%

45.4% *

22.7% *

25% *

20% *

0% *

*p<0.05 compare with baseline


Disclosure:

M. Santos-Gómez,
None;

F. Ortiz-Sanjuán,
None;

R. Blanco,
None;

J. Cañal Villanueva,
None;

A. Adan,
None;

M. Mesquida,
None;

M. V. Hernández,
None;

E. Rubio Romero,
None;

A. M. Garcia-Aparicio,
None;

A. Atanes,
None;

I. Torre Salaberri,
None;

F. Francisco,
None;

C. Fernández- Espartero,
None;

N. Palmou,
None;

V. Calvo-Río,
None;

J. Loricera,
None;

J. Ventosa,
None;

T. Pina Murcia,
None;

L. Riancho-Zarrabeitia,
None;

M. A. González-Gay,
None.

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