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