Intravitreal Aflibercept Treatment Strategies in Routine Clinical Practice of Neovascular Age-Related Macular Degeneration in Belgium: A Retrospective Observational Study
Tóm tắt
STELLAR was a Belgian, multicentre, retrospective, observational chart review that described the utilization (number of injections and treatment regimen) and effectiveness of intravitreal aflibercept (IVT-AFL) in patients with anti-vascular endothelial growth factor (VEGF) treatment-naïve neovascular age-related macular degeneration (nAMD) during the first 12 months of IVT-AFL treatment. Patients initiating IVT-AFL between July 2013 and July 2017 were included in STELLAR. Primary endpoints were number of visits and IVT-AFL injections, and number of patients who received ≥ 7 versus < 7 IVT-AFL injections during the first 12 months of treatment. A total of 337 patients completed ≥ 12 months of IVT-AFL treatment. The mean number of visits and mean number of injections during the first 12 months was 9.8 and 7.1 injections, respectively (64% received ≥ 7 injections). Overall, 96% of patients received ≥ 3 initial monthly injections. Of the 337 patients, 180 received VT-AFL as needed (pro re nata), 141 received it as treat-and-extend dosing and 16 received it as fixed dosing. The proportion of patients who received treat-and-extend dosing increased year-on-year. Mean best-corrected visual acuity (BCVA) (± standard deviation) was 61.6 (± 14.9) Early Treatment Diabetic Retinopathy Study (ETDRS) letters at baseline and improved by + 3.9 and + 5.7 ETDRS letters at 3 and 12 months, respectively. Mean BCVA improvement was numerically greater in patients who received ≥ 7 versus < 7 injections during the first 12 months 7 (+ 6.5 vs. + 4.4 ETDRS letters) and in patients who received ≥ 3 versus < 3 initial monthly injections (+ 5.2 vs. − 0.25 ETDRS letters [3 at months]; + 5.9 vs + 1.2 ETDRS letters [at 12 months]). No specific adverse events were reported. Most patients in this Belgian study received ≥ 7 IVT-AFL injections during a mean of 9.8 visits over the 12 months assessed. IVT-AFL was an effective treatment for nAMD in clinical practice, with numerically higher BCVA gains in patients receiving ≥ 7 versus < 7 injections over the first 12 months and ≥ 3 versus < 3 injections in the first 3 months.
Tài liệu tham khảo
McCannel CA (ed). 2019–2020 Basic and clinical science course. San Francisco: American Academy Of Ophthalmology; 2019.
Chen Y, Bedell M, Zhang K. Age-related macular degeneration: genetic and environmental factors of disease. Mol Interv. 2010;10(5):271–81.
Schmidt-Erfurth U, Chong V, Loewenstein A, et al. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014;98(9):1144–67.
American Academy of Ophthalmology. Preferred practice. Pattern® Guidelines age-related macular degeneration. San Francisco: American Academy of Ophthalmology; 2015.
Bakri SJ, Thorne JE, Ho AC, et al. Safety and efficacy of anti-vascular endothelial growth factor therapies for neovascular age-related macular degeneration: a report by the American Academy of Ophthalmology. Ophthalmology. 2019;126(1):55–63.
Busbee BG, Ho AC, Brown DM, et al. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013;120(5):1046–56.
Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: 2-year results. Ophthalmology. 2012;119(7):1388–98.
Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537–48.
Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, et al. Intravitreal aflibercept injection for neovascular age-related macular degeneration: 96-week results of the VIEW studies. Ophthalmology. 2014;121(1):193–201.
Bayer Pharma AG. Eylea® (aflibercept solution for injection) summary of product characteristics. Leverkusen: Bayer Pharma AG; 2020.
Ohji M, Takahashi K, Okada AA, et al. Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR. Adv Ther. 2020;37(3):1173–87.
Almuhtaseb H, Johnston RL, Talks JS, Lotery AJ. Second-year visual acuity outcomes of nAMD patients treated with aflibercept: data analysis from the UK Aflibercept Users Group. Eye (Lond). 2017;31(11):1582–8.
Almuhtaseb H, Kanavati S, Rufai SR, Lotery AJ. One-year real-world outcomes in patients receiving fixed-dosing aflibercept for neovascular age-related macular degeneration. Eye (Lond). 2017;31(6):878–83.
Framme C, Eter N, Hamacher T, et al. Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany: 12 month outcomes of PERSEUS. Ophthalmol Retina. 2018;2(6):539–49.
Ozturk M, Harris ML, Nguyen V, Barthelmes D, Gillies MC, Mehta H. Real-world visual outcomes in patients with neovascular age-related macular degeneration receiving aflibercept at fixed intervals as per UK licence. Clin Exp Ophthalmol. 2018;46(4):407–11.
Weber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmol. 2019;4(1):e000109.
European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Amsterdam: European Medicines Agency; 2017.
Ross AH, Downey L, Devonport H, et al. Recommendations by a UK expert panel on an aflibercept treat-and-extend pathway for the treatment of neovascular age-related macular degeneration. Eye. 2020:1–10. https://doi.org/10.1038/s41433-019-0747-x.
Traine PG, Pfister IB, Zandi S, Spindler J, Garweg JG. Long-term outcome of intravitreal aflibercept treatment for neovascular age-related macular degeneration using a "treat-and-extend" regimen. Ophthalmol Retina. 2019;3(5):393–9.
Lanzetta P, Cruess AF, Cohen SY, et al. Predictors of visual outcomes in patients with neovascular age-related macular degeneration treated with anti-vascular endothelial growth factor therapy: post hoc analysis of the VIEW studies. Acta Ophthalmol. 2018;96(8):e911–e918918.
Ho AC, Saroj N, Baker K, et al. Impact of baseline characteristics on treatment response to intravitreal aflibercept injection for wet age-related macular degeneration. Ophthalmol Retina. 2018;2(7):676–83.