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Data from the KITE study shows that ≥50% of brolucizumab patients maintained a 12-week interval schedule through 52 weeks.
Findings from the KITE trial support the efficacy and safety of brolucizumab in patients with diabetic macular edema (DME). Data was presented this week at the Association for Research in Vision and Ophthalmology (ARVO) Virtual Meeting.
David Brown, MD, of Retina Consultants of Houston, and colleagues presented 52-week results from the ongoning prospective, double-blind, multicenter Phase III trial, which compared the safety and efficacy of brolucizumab with aflibercept in DME patients. Another parallel trial, dubbed the KESTREL study, is currently ongoing as well.
Enrolled patients across both studies are ≥18 years of age. The team included those with type 1 or 2 diabetes mellitus, visual impairment due to disease and a BVCA score between 78-23 ETDRS letters, and DME that involved the center of the macula with a central subfield thickness (CST) ≥320µm on SD-OCT in the study eye at screening.
In the KITE study, patients were randomized 1:1 to receive brolucizumab 6 mg or aflibercept 2 mg. In KESTRAL randomization was 1:1 to brolucizumab 6 mg, 3 mg, or aflibercept 2 mg.
As such, patients who received brolucizumab received 5 loading doses every 6 weeks (q6w), which was then followed by followed by every 12-week dosings in the first year. These patients also were given the option to change to every 8 weeks according to predefined disease activity assessment visits. Those who were randomized to aflibercept received 5 loading doses monthly followed by a fixed dosing every 8 weeks.
The primary endpoint sought by the investigators was the change from baseline in best-correct visual acuity (BCVA) at Week 52. Secondary endpoints were the proportion of patients on brolucizumab who maintained a q12w dosing up to week 52 as well as the change from baseline in CST.
According to the presented results from KITE, the primary objective was met — brolucizumab 6 mg was considered non-inferior to aflibercept in regard to the change from baseline in BCVA at week 52.
Further, after the loading phase, ≥50% of brolucizumab patients were maintained on the q12w dosing schedule through week 52.
“Brolucizumab 6mg showed superior improvements versus aflibercept 2mg in the change from baseline in CST over the period of Week 40 through Week 52,” Brown and team reported.
They also indicated that brolucizumab demonstrated a favorable safety profile comparable to aflibercept. Even more, the rate of intraocular pressure inflammation was notably comparable between both treatments.
“Results from the KITE study show that brolucizumab offers the potential for robust vision gains and superior anatomical outcomes with q12w treatment intervals in more than 50% of patients with DME,” the investigators reported.
Results from the KESTREL study are expected later this year, they announced.
The study, “Brolucizumab for the treatment of visual impairment due to diabetic macular edema: 52-week results from the KITE and KESTREL studies,” was presented at ARVO 2021.