USA: In patients with diabetic macular edema (DME), brolucizumab 6mg exhibited significant visual and anatomical improvements, as well as a favorable benefit/risk profile, points out an article published in the American Journal of Ophthalmology.
This study was conducted by David M. Brown and the team with the intention of comparing the effectiveness and safety of brolucizumab and aflibercept on individuals with diabetic macular edema (DME).
This was a 100-week, multicenter, active-controlled, randomized experiment that was double-masked. In KESTREL (N=566), subjects were randomized 1:1:1 to brolucizumab 3mg/6mg or aflibercept 2mg, while in KITE (N=360), they were randomized 1:1 to brolucizumab 6mg or aflibercept 2mg. Brolucizumab groups got 5 loading doses every 6 weeks (q6w), then q12w dosing, with the possibility of increasing to q8w if disease activity was detected at predefined assessment visits; aflibercept groups received 5xq4w, then q8w dosing. The primary goal was the change in best-corrected visual acuity (BCVA) from baseline at Week 52; supplementary endpoints included the proportion of individuals who were still on q12w dosage, change in DRSS score, and anatomical and safety outcomes.
The key findings of this study are as follow:
1. Brolucizumab 6mg was shown to be noninferior (NI margin 4 letters) to aflibercept in mean change in BCVA from baseline (KESTREL: +9.2 letters versus +10.5 letters; KITE: +10.6 letters versus +9.4 letters), more subjects achieved central subfield thickness (CSFT) 280m, and fewer had persisting subretinal and/or intraretinal fluid versus aflibercept at Week 52,
2. In KITE, brolucizumab 6mg outperformed aflibercept in terms of change in CSFT from baseline from Week 40 to Week 52.
3. In KESTREL, the incidence of ocular serious adverse events was 3.7% (brolucizumab 3mg), 1.1% (brolucizumab 6mg), 2.1% (aflibercept), and 2.2% (brolucizumab 6mg), 1.7% (aflibercept).
4. In KITE, the incidence was 2.2% (brolucizumab 6mg), 1.7% (aflibercept).
In conclusion, according to the findings of these investigations, brolucizumab could be considered a therapeutic option for DME patients.
Reference:
David M. Brown, Andres Emanuelli, Francesco Bandello, Jose Juan Escobar Barranco, Joao Figueira, Eric Souied, Sebastian Wolf, Vishali Gupta, Nor Fariza Ngah, Gerald Liew, Raman Tuli, Ramin Tadayoni, Dilsher Dhoot, Lixin Wang, Emmanuel Bouillaud, Ying Wang, Lidija Kovacic, Nicolas Guerard, Justus G. Garweg, KESTREL and KITE: 52-week results from two Phase III pivotal trials of brolucizumab for diabetic macular edema, American Journal of Ophthalmology, 2022, https://doi.org/10.1016/j.ajo.2022.01.004.