Baseline disease characteristics in patients maintaining q12 and q16 dosing with aflibercept 8 mg versus patients with shortened treatment intervals: A Phase 3 PULSAR post hoc analysis

Abstract

Purpose : In the ongoing double-masked, 96-week, Phase 3 PULSAR trial in treatment-naïve neovascular age-related macular degeneration (nAMD), 83% of patients receiving aflibercept 8 mg completed Week 48 on treatment intervals ≥12 weeks. This analysis describes baseline characteristics of patients maintained on their original randomized dosing regimens versus those who had shortened intervals according to prespecified dose regimen modification criteria denoting disease activity.

Methods : Patients were randomly assigned 1:1:1 to receive intravitreal aflibercept 8 mg every 12 (8q12) or 16 weeks (8q16) or aflibercept 2 mg every 8 weeks (2q8), each after three initial monthly injections. In Year 1, from Week 16, treatment intervals could be shortened to a minimum of 8 weeks in 8q12 or 8q16 groups. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at Week 48.

Results : The primary endpoint was met with aflibercept 8q12 vs 2q8 and 8q16 vs 2q8 (non-inferiority margin at 4 letters). Overall, 79% of patients in the 8q12 group (n=316) maintained 12-week treatment intervals, and 77% of patients in the 8q16 group (n=312) maintained 16-week treatment intervals through Year 1. Mean±SD baseline BCVA was 59.4±13.7 letters in 251 patients who were maintained on 8q12 at Week 48, 60.8±12.0 letters in 239 patients maintained on 8q16 at Week 48, and 59.6±13.9 letters in 105 patients who shortened to q8 dosing from either 8q12 or 8q16. Baseline central subfield retinal thickness was 372±128 µm (8q12), 353±127 (8q16) and 397±140 µm (shortened to q8 dosing), respectively. Baseline total choroidal neovascularization lesion area was 6.0±4.7 mm² in patients maintained on 8q12, 6.4±5.4 mm² in those maintained on 8q16, and 6.4±5.8 mm² in patients with shortened to q8 treatment intervals.

Conclusions : The vast majority of patients with nAMD treated with intravitreal aflibercept 8 mg were maintained on q12 or q16 treatment intervals. As the investigated disease characteristics at baseline were similar in patients who maintained 8q12 or 8q16 dosing and those who had shortened treatment intervals, we conclude the need for treatment intervals shorter than q12 or q16 does not appear to be influenced by baseline characteristics, including lesion size, in patients with nAMD.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.