Author: lihteh Wu (Costa Rica)
Co-authors: Arnaldo F. Bordon, Martin Charles, Francisco J. Rodriguez, JinKyung Lee, Tobias Machewitz, Margarete Mueller
Purpose
The purpose of AQUILA was to evaluate the clinical effectiveness (functional and anatomic outcomes) and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular age related degeneration (nAMD) and with diabetic macular edema (DME) in routine clinical practice in Latin America. The study was also designed to understand how patients with nAMD and DME are treated with IVT-AFL in Latin America, including treatment regimens utilized and the reasons for changes in treatment regimens or treatment discontinuation. The results for the patients with nAMD are presented here.
Setting/Venue
AQUILA (NCT03470103) was a prospective, multicenter, observational, 12-month study evaluating the effectiveness of IVT-AFL in patients with nAMD or DME. The data below summarize the outcomes for the patients with nAMD.
Methods
Treatment-naïve and pre-treated patients with nAMD (aged ≥55 years) were enrolled from April 2018 to September 2019. Patients became eligible for the study once the decision was made to treat with IVT-AFL according to routine clinical practice and local prescribing information. Decisions regarding IVT-AFL treatment were made at the discretion of the prescribing physician, according to their medical practice. The primary efficacy endpoint was change in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to Month [M] 12 in treatment-naïve and pre-treated patients. Secondary endpoints included the change in central retinal thickness (CRT) from baseline, number of visits and IVT-AFL injections, mean duration of treatment intervals, and the proportions of patients with no fluid on optical coherence tomography, a Snellen equivalent of 20/40 or better (~70 ETDRS letters), and ≥15 ETDRS letter gain. Patients who received at least one IVT-AFL injection and had a BCVA assessment in the study eye at both baseline and at least one follow-up visit were included in the full analysis set (FAS: Argentina, n=196; Mexico, n=41; Colombia, n=19; Costa Rica, n=18).
Results
Of 324 patients with nAMD, 274 (201 treatment-naïve; 73 pre-treated) were included in the FAS (mean age: 77 years; male: 35%) and 215/324 patients (66%) completed 12 months’ follow-up. Median duration from diagnosis to IVT-AFL treatment was 1.2 months (treatment-naïve) and 19.5 months (pre-treated) and the mean±SD number of IVT AFL injections by M12 was 4.2±1.9 (treatment-naïve) and 5.2±2.7 (pre-treated). Overall, 170/274 patients (62%) received ≥3 initial monthly IVT-AFL injections (127/201 treatment-naïve; 43/73 pre-treated) and 47/274 patients (17%) received ≥7 injections by M12 (24/201 treatment-naïve; 23/73 pre-treated). Mean BCVA improved from baseline to M12 by +5.2±18.3 (treatment-naïve; baseline: 48.2±23.5) and +3.1±15.3 letters (pre-treated; baseline: 47.7±21.4). BCVA change from baseline to M12 was +5.5±19.5 (treatment-naïve) and +7.0±15.1 (pre-treated) in patients who received ≥3 initial monthly doses and +4.6±16.2 (treatment-naïve) and –2.5±14.1 (pre-treated) in patients who received <3 initial monthly injections. By M12, 25% of patients (both groups) had BCVA improvements of ≥15 letters and 36% of patients had a BCVA ≥70 letters (treatment-naïve: 37% [from 21% at baseline]; pre-treated: 32% [from 19% at baseline]). By M12, mean CRT decreased by ‒106.7±143.0 μm (treatment-naïve; baseline: 377.9±136.6) and ‒80.9±154.8 μm (pre treated; baseline: 400.2±136.8). No new safety signals were observed.
Conlusions
AQUILA is the first study to assess the use of IVT-AFL in routine clinical practice in Latin America. In AQUILA, >60% of patients with nAMD received ≥3 initial monthly doses of IVT-AFL, but <20% received ≥7 injections in the first year of treatment. Functional and anatomic outcomes improved during 12 months’ treatment with IVT-AFL. Improvements in BCVA were numerically greater in treatment-naïve patients than pre-treated patients and in patients who received ≥3 initial monthly injections than those who did not. Thus, in real-world studies, patients treated regularly and proactively with IVT-AFL have the potential to achieve outcomes consistent with those observed in interventional studies. The safety profile of IVT-AFL was consistent with previous studies.
Financial Disclosure
Lihteh Wu: Speaker: Bayer and Quantel Medical Arnaldo F. Bordon: Speaker: Bayer, Allergan, and Novartis Martin Charles: Consultant: Alcon; Speaker: Alcon, Bayer, and Novartis; Research funds: Alcon Francisco J. Rodriguez: Consultant: Bayer, Novartis, and Roche; Speaker: Bayer, Novartis, and Roche; Research funds: Novartis JinKyung Lee: Employee of Bayer AG, Berlin, Germany Tobias Machewitz: Employee of Bayer AG, Berlin, Germany Margarete Mueller: Employee of Bayer AG, Berlin, Germany Gabriela del Carmen Gay: Employee of Bayer SA, Munro, Argentina Jans Fromow-Guerra: Consultant: Bayer and Novartis; Speaker: Bayer, DORC, IOSA, and Novartis Funding: The AQUILA study was funded by Bayer AG, Germany. Medical writing support was provided by ApotheCom, and funded by Bayer Consumer Care AG, Pharmaceuticals, Switzerland.
Comments
Important add below co-authors: 7. Gabriela del Carmen Gay: Bayer S.A., Munro, Argentina 8. Jans Fromow-Guerra: Macula Retina Consultores, Mexico City, Mexico
