Those who were switched to aflibercept improved 9 letters of VA, and 110 µm in CST from months 6 to 12.
Michael S. Ip, MD
Those with a poor response to treatment with bevacizumab 1.25 mg (Avastin, Genentech), while uncommon, were revealed to have improvements in both visual acuity (VA) letter score and central subfield thickness (CST) when their treatment was switched.
According to the results of the phase 2 SCORE2 trial, patients who switched to aflibercept 2.0 mg (Eylea, Regeneron) after poor response at 6 months experienced a 9.0 letter gain (P <.01) for the following 6 months, as well as a 110 µm decrease in CST (P <.01). The data were presented at the American Society of Retina Specialists (ASRS) 36th Annual Meeting in Vancouver, British Columbia.
Conducted by Michael S. Ip, MD, a professor of ophthalmology at the UCLA David Geffen School of Medicine, and colleagues, the examination was the second analysis to the baseline to 6 months data originally collected in 2017, which included 362 patients with macular edema due to either central or hemispheric retinal vein occlusion, randomized to either bevacizumab (n = 182) or aflibercept (n = 180). Patients were stratified by a protocol-defined response of good, moderate, or poor.
Ip and colleagues noted that while “few eyes in either the aflibercept or bevacizumab groups met the protocol-defined criteria for a poor response at month 6,” those who did display a protocol-defined poor response VA letter score (48 to 19 [approximate Snellen VA 20/125 to 20/400]), were switched from bevacizumab to aflibercept (n = 68), or aflibercept to an intravitreal dexamethasone implant (n = 70).
The bevacizumab-to-aflibercept group received a mean of 5.0 injections between months 6 and 11. The aflibercept-to-dexamethasone implant group received a mean of 1.8 implants in the same time period. The average change from month 6 to month 12 in VA letter score for patients who switched from aflibercept to receive the dexamethasone implant was 2.5 letters (P = .36), and the change in CST was 39 µm (P = .49).
In the original report of the baseline to 6-month outcomes, bevacizumab, a substantially more affordable off-label treatment, was shown to be non-inferior when compared to aflibercept. The data showed that 65.1% (n = 114) of eyes treated with aflibercept gained ≥15 letters in comparison with 61.3% (n = 106) of those treated with bevacizumab (odds ratio [OR], 0.85; 95% CI, 0.62 to 1.17; P = .89). In total, <2% of both groups experienced a VA letter score decrease of ≥15 in the 6-month analysis—1.7% (n = 3) of both groups.
In months 0 to 6, even among those identified as poor responders to aflibercept and bevacizumab, 70% (n = 49; 95% CI, 59.3 to 80.7) and 75% (n = 51; 95% CI, 64.7 to 85.3), respectively, reported a gain of ≥15 letters in VA score. In the group initially receiving aflibercept, the mean change from baseline VA letter score was 21.43 (95% CI, 16.82 to 26.04) compared to 26.22 (95% CI, 21.69 to 30.75) with bevacizumab.
Coupled with the original SCORE2 data, these results suggest that while the two anti-vascular endothelial growth factor (anti-VEGF) therapies are essentially equivalent in treatment capability, aflibercept is an effective substitute for those who respond poorly to bevacizumab.
The study, “SCORE2 Month 6 to Month 12 Results: 12 Month Outcomes of Treatment Change among Poor Responders at Month 6,” was presented in a symposium at the ASRS’s 36th annual meeting.
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