July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Drug Retention Rate of Adalimumab in Uveitis. Real-World Data from the Spanish Biotherapies in Uveitis (BioÚvea) Study Group.
Author Affiliations & Notes
  • Victor Llorens
    Clínic Institute of Ophthalmology (ICOF), Clínic Hospital of Barcelona, Barcelona, Spain
  • Miguel Cordero-Coma
    Ophthalmology, Hospital de León, León, Spain
  • Ana Blanco-Esteban
    Ophthalmology, Hospital Universitario de Donostia, San Sebastián, Spain
  • Henar Heras-Mulero
    Ophtalmology/Rheumatology, Complejo Hospitalario de Navarra, Pamplona, Spain
  • María-José Losada-Castillo
    Ophtalmology/Rheumatology, Hospital Universitario de Tenerife, Tenerife, Spain
  • Vega Jovani-Casano
    Ophtalmology/Rheumatology, Hospital General Universitario de Alicante, Alicante, Spain
  • Lucía Martínez-Costa
    Ophthalmology, Hospital Universitari Dr. Peset, Valencia, Spain
  • Margarita Jodar-Marquez
    Ophtalmology/Rheumatology, Hospital Regional de Málaga, Málaga, Spain
  • Ángel-María Garcia-Aparicio
    Rheumatology, Hospital Virgen de la Salud, Toledo, Spain
  • Alejandro Fonollosa-Calduch
    Ophthalmology, Hospital de Cruces, Bilbao, Spain
  • Cristina Hernando-Hernandez
    Ophtalmology/Rheumatology, Hospital Universitario La Princesa, Madrid, Spain
  • Luís Rodriguez-Melian
    Ophtalmology/Rheumatology, Hospital Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain
  • Manuel Fernandez-Prada
    Rheumatology, Hospital de Guadalajara, Guadalajara, Spain
  • María Jerez-Fidalgo
    Ophtalmology/Rheumatology, Hospital Perpetuo Socorro, Badajoz, Spain
  • Marisa Hernandez-Garfella
    Ophthalmology, Hospital General de Valencia, Valencia, Spain
  • Alfredo Adan
    Clínic Institute of Ophthalmology (ICOF), Clínic Hospital of Barcelona, Barcelona, Spain
  • Footnotes
    Commercial Relationships   Victor Llorens, Abbvie (F), Allergan (R), UCB (R); Miguel Cordero-Coma, Abbvie (F); Ana Blanco-Esteban, None; Henar Heras-Mulero, None; María-José Losada-Castillo, None; Vega Jovani-Casano, None; Lucía Martínez-Costa, None; Margarita Jodar-Marquez, None; Ángel-María Garcia-Aparicio, None; Alejandro Fonollosa-Calduch, Abbvie (F); Cristina Hernando-Hernandez, None; Luís Rodriguez-Melian, None; Manuel Fernandez-Prada, None; María Jerez-Fidalgo, None; Marisa Hernandez-Garfella, None; Alfredo Adan, Abbvie (C), Allergan (C), Roche (F), Topcon (R), UCB (F)
  • Footnotes
    Support  Sociedad Española de Inflamación Ocular (SEIOC). BioÚvea project.
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 3855. doi:https://doi.org/
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      Victor Llorens, Miguel Cordero-Coma, Ana Blanco-Esteban, Henar Heras-Mulero, María-José Losada-Castillo, Vega Jovani-Casano, Lucía Martínez-Costa, Margarita Jodar-Marquez, Ángel-María Garcia-Aparicio, Alejandro Fonollosa-Calduch, Cristina Hernando-Hernandez, Luís Rodriguez-Melian, Manuel Fernandez-Prada, María Jerez-Fidalgo, Marisa Hernandez-Garfella, Alfredo Adan; Drug Retention Rate of Adalimumab in Uveitis. Real-World Data from the Spanish Biotherapies in Uveitis (BioÚvea) Study Group.. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3855. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To study drug retention rate (DRR) of adalimumab (ADA) in real-world uveitis practice.

Methods : Multicentric, ambispective, observational study of ADA for uveitis. From Nov 2016 to Nov 2017. Demographics, clinical data, timing and reasons for discontinuation, if occurred, were recorded in an electronic encrypted standardized database. Two multivariate Cox proportional random models were done to identify predictors for discontinuation and inefficacy. DRR was included as time-dependent variable. The estimate of censored data was performed using the Kaplan-Meier method. Hazard ratio (HR) and 95%CI are shown.

Results : 392 patients were analyzed, 55.6% females. Median age, 39 (IQR 25) years. Posterior and panuveitis accounted for 48.9%. DRR at 12, 24 and 60 months was 90%, 80.3% and 54.5%, respectively. Median retention time was 2.3 (IQR 3.5) years. ADA was discontinued in 39.5% patients. Discontinuation was due to sustained quiescence in 11.2%, lack of efficacy in 19% and to an adverse event in 7.1%. Recorded adverse events included: Infections in 1.2% and neoplasms (benign or malignant) in 0.7%. Concurrent DMARDs were given to 64.5% patients. Anterior uveitis showed longer DRR (p=0.002), whereas those that received ocular/periocular corticosteroid injection/s showed shorter DRR (p=0.002). We did not find DRR differences depending on the use of concurrent DMARDs. Regarding dosage optimization, ADA treatment was intensified in 5.73% patients and DRR was significantly shorter when intensified (p<0.001) whereas it was spared in 20.67%, without DRR differences between spared and standard posology. Predictors discontinuation were necessity of ocular/periocular corticosteroids (HR 1.52, 95%CI 1.09-2.11, p=0.013) and patients not naïve for biotherapies (HR 1.48, 95%CI 1.03-2.13, p=0.033). The only predictor of inefficacy was the necessity of ocular/periocular injection/s of corticosteroids before ADA (HR 1.61, 95%CI 1.01-2.57, p=0.047).

Conclusions : DRR of ADA in uveitis at 24 months was 80.3%, with a good safety profile. Concurrent DMARDs do not extend the period of treatment or determine efficacy or withdrawal of adalimumab in uveitis. However, the use of ADA in refractory patients to other biotherapies and a previous necessity of ocular/periocular injections of corticosteroids are predictive for discontinuation.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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