Drug Retention Rate and Causes of Discontinuation of Adalimumab in Uveitis Real-World Data from the Biotherapies in Uveitis (BioUvea) Study Group
Por:
Llorenç V, Cordero-Coma M, Blanco-Esteban A, Heras-Mulero H, Losada-Castillo MJ, Jovani M, Valls-Pascual E, Jodar-Marquez M, García-Aparicio Á, Fonollosa A, González-Guijarro JJ, Rodriguez-Melian L, Fernández-Prada M, Jerez-Fidalgo M, Hernandez-Garfella M, Esquinas C, Sainz-de-la-Maza M and Adán A
Publicada:
1 jun 2020
Ahead of Print:
2 dic 2019
Categoría:
Ophthalmology
Resumen:
Purpose: To study the drug retention rate (DRR), causes, and predictors of discontinuation of adalimumab (ADA) in a real-world uveitis setting.
Design: Multicentric, nationwide, registry-based, ambispective, observational study.
Participants: Patients treated with ADA for noninfectious uveitis (NIU) in the Biotherapies for Uveitis (BioUvea) Spanish registry from November 2016 to November 2017.
Methods: Demographics, clinical data, timing, and reasons for discontinuation, if occurred, were recorded. The DRRand drug retention time (DRT) were estimated using the Kaplan-Meier method. Median follow-up was analyzed by reverse Kaplan-Meier. Log-rank test was used for comparisons. Cox proportional-hazards model (PHM) and propensity score matching were used to identify predictors for discontinuation due to inefficacy and adverse events.
Main Outcome Measures: Drug retention rate and DRT.
Results: A total of 392 patients were analyzed, including 218 women. Median age was 39 (interquartile range, 25) years. Nonanterior uveitis was recorded in 242 patients. Median follow-up was 49.07 (0.97-131.67) months, median DRT (survival) was 69.3 months, and 14 patients were lost to follow-up. The DRR at 6, 12, 24, and 60 months was 92.97%, 87.68%, 76.31%, and 54.28%, respectively. Adalimumab was discontinued in 151 patients. Discontinuation was due to lack or loss of efficacy in 74 patients, adverse event in 34 patients, and sustained quiescence in 25 patients. Recorded adverse events included infections in 10 patients and malignant neoplasms in 3 patients. Concurrent classic immunomodulatory therapy (IMT) was given to 251 patients. We did not find DRT differences regarding the use of concurrent IMT. Adalimumab was prescribed as a second or greater biotherapy line in 76 patients who showed shorter DRT (P = 0.038). Starting ADA in nonbiotherapy-naive patients was a predictor for "discontinuation due to inefficacy," whereas undifferentiated uveitis was a predictor for "discontinuation due to adverse event." Drug retention time was significantly shorter when spared or intensified, mainly due to discontinuation after sustained quiescence.
Conclusions: Drug retention rate of ADA in uveitis at 60 months was 54.28%, with a good safety profile. The use of concurrent IMT did not show a significant influence on DRT. The use of ADA as a second or further biotherapy could be predictive for discontinuation due to inefficacy. Undifferentiated uveitis may be prone to premature discontinuation of ADA due to adverse events. (C) 2019 by the American Academy of Ophthalmology
Filiaciones:
Llorenç V:
Clínic Institute of Ophthalmology (ICOF), Clínic Hospital of Barcelona, Barcelona, Spain
Cordero-Coma M:
Ophthalmology Department, Hospital de León, León, Spain
Blanco-Esteban A:
Ophthalmology Department, Hospital Universitario de Donostia, San Sebastián, Spain
Heras-Mulero H:
Ophthalmology Department, Complejo Hospitalario de Navarra, Pamplona, Spain
Losada-Castillo MJ:
Ophthalmology Department, Hospital Universitario de Canarias, Tenerife, Spain
Jovani M:
Rheumatology Department, Hospital General Universitario de Alicante, Alicante, Spain
:
Rheumatology Department, Hospital Dr. Peset, Valencia, Spain
Jodar-Marquez M:
Ophthalmology Department, Hospital Regional de Málaga, Málaga, Spain
García-Aparicio Á:
Rheumatology Department, Hospital Virgen de la Salud, Toledo, Spain
Fonollosa A:
Ophthalmology Department, Hospital de Cruces, Bilbao, Spain
González-Guijarro JJ:
Ophthalmology Department, Hospital Universitario de la Princesa, Madrid, Spain
Rodriguez-Melian L:
Ophthalmology Department, Hospital Insular de Gran Canaria, Las Palmas, Spain
Fernández-Prada M:
Rheumatology Department, Hospital Universitario de Guadalajara, Guadalajara, Spain
Jerez-Fidalgo M:
Ophthalmology Department, Hospital Perpetuo Socorro, Badajoz, Spain
Hernandez-Garfella M:
Ophthalmology Department, Hospital General de Valencia, Valencia, Spain
Esquinas C:
Vall d'Hebron Research Institute, Autonomous University of Barcelona, Barcelona, Spain
Sainz-de-la-Maza M:
Clínic Institute of Ophthalmology (ICOF), Clínic Hospital of Barcelona, Barcelona, Spain
Adán A:
Clínic Institute of Ophthalmology (ICOF), Clínic Hospital of Barcelona, Barcelona, Spain
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