Studies show efficacy of aflibercept with treat-and-extend dosing regimens
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Comparison of treat-and-extend dosing regimens and visual outcomes showed that intravitreal aflibercept was effective over 2 years, with more than half of patients achieving a last treatment interval of 12 weeks or longer.
“Proactive T&E regimens can help identify patents who require frequent treatments vs. those who can be extended. In addition, they offer potential advantages such as reduced treatment burden, fewer visits and can be applied in real-world clinical practice,” Paul Mitchell, MD, said in a poster presented at the virtual Association for Research in Vision and Ophthalmology meeting.
ARIES and ALTAIR were two open-label, active-controlled studies, the first conducted in eight countries and the second in Japan. The two cohorts included 210 patients and 246 patients, respectively, with neovascular age-related macular degeneration. In both studies, patients received a loading dose of three monthly injections followed by a treat-and-extend regimen. In the poster, Mitchell and co-authors highlighted the differences and similarities in the design of the two studies and noted that the results “complemented each other.”
“The ARIES included a fixed-dosing arm in the first year, which is in line with the indications at the time of the study design. ALTAIR explored injection interval adjustments of 2 or 4 weeks and included a high proportion of men and patients with [polypoidal choroidal vasculopathy]. Each study had different prespecified T&E treatment criteria,” he said.
In both studies, most patients gained more than five letters from baseline. In ARIES, best corrected visual acuity improved from 60.8 letters at baseline to 66.9 letters at week 104. In ALTAIR, BCVA improved from 55 letters to 61.9 letters at week 96. ARIES patients received a mean of 7.5 injections in the first year and 12.5 over the 104 weeks of the study. In ALTAIR, patients received an average of seven injections in the first year and 10.4 injections over the 96 weeks of the study.
“A last injection interval of 12 or more weeks was achieved in 49.5% of patients in ARIES and 58.5% of patients in ALTAIR. Overall, 28.6% of patients in ARIES and 43.9% in ALTAIR achieved a last injection interval of 16 weeks,” Mitchell said.
“The goal of proactive, flexible T&E strategies is to reduce the treatment burden associated with anti-VEGF therapy while maintaining VA gains,” he said.
ARIES and ALTAIR demonstrated that treatment intervals of 12 weeks or more and good improvement of visual outcomes, with a five-letter gain or more, can be achieved with aflibercept administered by a treat-and-extend regimen in neovascular AMD.
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Mitchell P, et al. Comparison of treat-and-extend (T&E) dosing regimens and visual outcomes in the ARIES and ALTAIR studies of intravitreal aflibercept (IVT-AFL) in neovascular age-related macular degeneration (nAMD). Presented at: Association for Research in Vision and Ophthalmology annual meeting; June 12, 2020 (virtual meeting).
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