Long-term outcomes of brolucizumab in diabetic macular edema revealed in 100-week trials
The 100-week outcomes from the KESTREL and KITE trials demonstrated the long-term efficacy and durability of brolucizumab in improving visual and anatomical outcomes in patients with diabetic macular edema.
The KESTREL and KITE trials, both double-masked, active-controlled, and randomized, sought to assess the potential of brolucizumab, administered at 2 different doses (3 mg/6 mg) as BRO3/BRO6, compared to aflibercept (2 mg), a standard treatment for DME. In KESTREL, a total of 566 patients were randomized, while KITE included 360 patients.
The treatment regimen for patients in the BRO3/BRO6 arms consisted of 5 loading doses every 6 weeks, followed by dosing every 12 weeks, with an option to adjust to every 8 weeks at predefined disease activity assessment visits. In KITE, at Week 72, the treatment intervals could be extended by 4 weeks in the BRO6 arm, based on the disease stability assessment. In contrast, patients in the aflibercept (AFL) arms received five monthly loading doses followed by fixed dosing every 8 weeks.
At the 100-week mark, the results showcased the positive impact of brolucizumab on visual acuity and anatomical improvements. In the KESTREL trial, the change from baseline in best-corrected visual acuity (BCVA) was reported to be +8.8 letters for BRO6 and +10.6 letters for AFL. Similarly, in the KITE trial, the change from baseline in BCVA was +10.9 letters for BRO6 and +8.4 letters for AFL.
The trials also found that fewer patients in the BRO6 arms experienced intraretinal fluid and/or subretinal fluid compared to those in the AFL arms, indicating the potential superiority of brolucizumab in managing DME-related fluid buildup in the retina.
The safety profile of brolucizumab remained consistent throughout the 100-week duration of the trials. In terms of intraocular inflammation rates, 4.2% of patients in the BRO6 arm experienced this side effect in KESTREL, while in KITE, the rate was 2.2%, compared to 1.1% and 1.7% in the AFL arms of KESTREL and KITE, respectively. Notably, the incidence of retinal vasculitis was observed to be 0.5% for BRO6 patients in KESTREL, with no cases reported in KITE.
Reference
Wykoff CC, Garweg JG, Regillo C, et al. KESTREL and KITE Phase 3 studies: 100-week results with brolucizumab in patients with diabetic macular edema. Am J Ophthalmol. 2023;S0002-9394(23)00291-X. doi: 10.1016/j.ajo.2023.07.012. Epub ahead of print. PMID: 37460036.
