Ophthalmology. Retina · 2025
Adherence to Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: 24-Month Results from the ANDROMEDA Study.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Holz Frank G, Ziemssen Focke, Bauer-Steinhusen Ulrike, Wachtlin Joachim, Schürks Markus, Lorenz Katrin, Scholz Paula, Machewitz Tobias, Rech Christine, Lanzl Ines, Lommatzsch Albrecht, Finger Robert P, ANDROMEDA Study Group
Аннотация
PURPOSE: The ANDROMEDA (intravitreal Aflibercept in Neovascular amD: an obseRvational study assessing patient relevant OutcoMes, rEal-worlD treatment pattern And effectiveness) study was planned to assess adherence to intravitreal aflibercept (IVT-AFL) 2 mg treatment over 24 months for neovascular age-related macular degeneration (nAMD) and to identify patient- and physician-related factors for nonadherence (NA) in clinical settings.
DESIGN: Prospective, observational, noncontrolled, multicenter cohort study.
SUBJECTS: Treatment-naïve and previously treated adult patients with nAMD under IVT-AFL treatment from 41 centers in Germany.
METHODS: Time to first occurrence of NA was analyzed descriptively using Kaplan-Meier methods followed by a Cox model to explore the potential impact of patient- and physician-related factors on NA. Participants reported reasons for NA in standardized telephone interviews.
MAIN OUTCOME MEASURES: Primary endpoints were time to first occurrence of and reasons for NA. Secondary endpoints included change in best-corrected visual acuity and central retinal thickness from baseline to months 4, 12, and 24.
RESULTS: The median time to first NA was 180 days in the 509 study participants (mean age: 77.2 years; 57.2% female). Among them, 44.0% were treatment-naïve, 22.6% were previously treated with IVT-AFL, and 33.4% were previously treated with other anti-VEGF agents (VEGF). Adherence rates, particularly among treatment-naïve participants, fell early and markedly: 69.6% at 4 months (95% confidence interval [CI]: 62.9%-75.3%), 53.0% at 12 months (95% CI: 46.0%-59.5%), and 40.1% at 24 months (95% CI: 33.3%-46.9%). Key risk factors for NA (hazard ratio [HR] <1 indicating a higher risk of NA for the mentioned factor, HR > 1 indicating a lower risk for the mentioned factor) included presence of any "other diseases" in the treatment-naïve cohort at baseline (HR: 0.57; 95% CI: 0.37-0.88), and patient-reported "lack of information for accompanying persons" (HR: 1.36; 95% CI: 1.03-1.79), involvement of referrals and multiple providers (HR: 0.76; 95% CI: 0.60-0.97), and "bilateral AMD" (HR: 0.73; 95% CI: 0.57-0.93) in the total cohort.
CONCLUSIONS: In the ANDROMEDA study, key determinants of NA were comorbidities, bilateral disease, treatment by multiple providers, and a lack of patient caregiver education. Thus, better adherence may be achieved through holistic patient management, considering additional disease parameters, single-center treatment, and improved (caregiver) education.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
DESIGN: Prospective, observational, noncontrolled, multicenter cohort study.
SUBJECTS: Treatment-naïve and previously treated adult patients with nAMD under IVT-AFL treatment from 41 centers in Germany.
METHODS: Time to first occurrence of NA was analyzed descriptively using Kaplan-Meier methods followed by a Cox model to explore the potential impact of patient- and physician-related factors on NA. Participants reported reasons for NA in standardized telephone interviews.
MAIN OUTCOME MEASURES: Primary endpoints were time to first occurrence of and reasons for NA. Secondary endpoints included change in best-corrected visual acuity and central retinal thickness from baseline to months 4, 12, and 24.
RESULTS: The median time to first NA was 180 days in the 509 study participants (mean age: 77.2 years; 57.2% female). Among them, 44.0% were treatment-naïve, 22.6% were previously treated with IVT-AFL, and 33.4% were previously treated with other anti-VEGF agents (VEGF). Adherence rates, particularly among treatment-naïve participants, fell early and markedly: 69.6% at 4 months (95% confidence interval [CI]: 62.9%-75.3%), 53.0% at 12 months (95% CI: 46.0%-59.5%), and 40.1% at 24 months (95% CI: 33.3%-46.9%). Key risk factors for NA (hazard ratio [HR] <1 indicating a higher risk of NA for the mentioned factor, HR > 1 indicating a lower risk for the mentioned factor) included presence of any "other diseases" in the treatment-naïve cohort at baseline (HR: 0.57; 95% CI: 0.37-0.88), and patient-reported "lack of information for accompanying persons" (HR: 1.36; 95% CI: 1.03-1.79), involvement of referrals and multiple providers (HR: 0.76; 95% CI: 0.60-0.97), and "bilateral AMD" (HR: 0.73; 95% CI: 0.57-0.93) in the total cohort.
CONCLUSIONS: In the ANDROMEDA study, key determinants of NA were comorbidities, bilateral disease, treatment by multiple providers, and a lack of patient caregiver education. Thus, better adherence may be achieved through holistic patient management, considering additional disease parameters, single-center treatment, and improved (caregiver) education.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Предметные рубрики MeSH
HumansReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsFemaleIntravitreal InjectionsAgedMaleProspective StudiesVisual AcuityWet Macular DegenerationFollow-Up StudiesAngiogenesis InhibitorsAged, 80 and overTomography, Optical CoherenceTreatment OutcomeTime FactorsVascular Endothelial Growth Factor AMiddle AgedDose-Response Relationship, Drug