Brolucizumab for Diabetic Macular Edema in Participants With/Without Prior Anti-VEGF Exposure: KINGFISHER Study Post Hoc Analysis

OBJECTIVE: To evaluate visual and anatomical outcomes of brolucizumab 6 mg versus aflibercept 2 mg in subgroups of participants with/without prior anti-VEGF 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%) were 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 mean [standard error]) from baseline to week 52 in best-corrected visual acuity (BCVA) and central subfield thickness, proportion of study eyes with absence of both subretinal fluid and intraretinal 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. Central subfield thickness 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 2 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. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.