Over a 2-year period, no significant differences in visual outcomes were found between treatment with aflibercept monotherapy and treatment with initial bevacizumab with a switch to aflibercept in the case of suboptimal response in patients with moderate vision loss due to diabetic macular edema (DME), according to trial results presented at ASRS 2022 and published in the New England Journal of Medicine.
The efficacy of this form of step therapy has not been previously clear, although many insurance companies require it due to the cost difference between anti-VEGF treatments.
In this trial funded by the National Institutes of Health, 312 eyes (270 adults) were randomized to receive aflibercept monotherapy (n = 158) or bevacizumab first (n = 154). At 12 weeks, eyes in the bevacizumab-first group were switched to aflibercept if protocol-specified criteria were met. Study eyes had best corrected E-ETDRS VA of 20/50 to 20/320 and center-involved diabetic macular edema.
During the 2-year period, 70% of the eyes in the bevacizumab-first group were switched to aflibercept, with more than half switching between 12 and 24 weeks.
There was a mean visual acuity improvement of 15 letters in the aflibercept-monotherapy group and 14 letters in the bevacizumab-first group (adjusted difference, 0.8 letters; 95% confidence interval, −0.9 to 2.5; P = 0.37).
Over the 2 years, there was no overall difference in mean change in vision between groups. Serious adverse events (52% and 26% of patients in the aflibercept-monotherapy group and bevacizumab-first group, respectively) and hospitalizations for adverse events (48% and 32%, respectively) were more common in the aflibercept-monotherapy group.
Reference
Jhaveri CD. Aflibercept Monotherapy vs Initial Bevacizumab Followed by Aflibercept if Needed for Treatment of Center-Involved Diabetic Macular Edema. Presented at ASRS 2022.
Jhaveri CD, Glassman AR, Ferris FL, et al. Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema. New England J of Med. 2022;DOI: 10.1056/NEJMoa2204225
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