Brolucizumab for Diabetic Macular Edema in Participants with/without prior Anti-VEGF Exposure

OBJECTIVE: To evaluate visual and anatomical outcomes of brolucizumab 6 mg versus aflibercept 2 mg in subgroups of participants with/without prior anti-vascular endothelial growth factor treatment for diabetic macular edema in the KINGFISHER study. DESIGN: Post hoc analysis of the KINGFISHER study PARTICIPANTS: Of 517 participants randomized, 370 (71.6%) treatment-naive (brolucizumab 6 mg [n=251]; aflibercept 2 mg [n=119]) and 147 (28.4%) prior-treated (brolucizumab 6 mg [n=95]; aflibercept 2 mg [n=52]) participants were included. METHODS: Visual and anatomical outcomes were analyzed, and descriptive statistics were provided for outcome measures. MAIN OUTCOME MEASURES: Assessment of the changes (least squares [LS] mean [standard error, SE]) from baseline to Week 52 in best corrected visual acuity (BCVA) and central subfield thickness (CSFT); proportion of study eyes with absence of both sub-retinal fluid and intra-retinal fluid at Week 52; proportion of participants with ≥2-step improvement from baseline to Week 52 in Diabetic Retinopathy Severity Scale (DRSS) score; and incidence of intraocular inflammation (IOI)-related adverse events. RESULTS: The mean BCVA changes from baseline to Week 52 in the prior-treated and treatment-naive subgroups were: brolucizumab 6 mg (+11.0 [1.00] letters) versus aflibercept 2 mg (+8.6 [1.35] letters) and brolucizumab 6 mg (+12.6 [0.58] letters) versus aflibercept 2 mg (+12.2 [0.85] letters), respectively. CSFT reductions from baseline to Week 52 in the prior-treated subgroup were: brolucizumab 6 mg (-255.3 [11.27] μm) versus aflibercept 2 mg (-189.6 [15.32] μm), and in the treatment-naive subgroup were: brolucizumab 6 mg (-231.4 [5.65] μm) versus aflibercept 2 mg (-199.0 [8.21] μm). A higher proportion of participants treated with brolucizumab 6 mg had a fluid-free macula at Week 52 in both subgroups. The proportion of participants with ≥2-step improvement from baseline in DRSS at Week 52 was comparable between the two subgroups and trended higher in the brolucizumab 6 mg arm. The incidence of IOI was: brolucizumab 6 mg (4.2%) versus aflibercept 2 mg (5.8%) in the prior-treated subgroup and was: brolucizumab 6 mg (4.0%) versus aflibercept 2 mg (1.7%) in the treatment-naive subgroup. CONCLUSIONS: These results demonstrate the effectiveness of brolucizumab 6 mg irrespective of the prior treatment status of the participants.