Ophthalmology. Retina · 2025
Brolucizumab for Diabetic Macular Edema in Participants with/without prior Anti-VEGF Exposure: KINGFISHER Study Post Hoc Analysis.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Ip Michael, Chaudhary Varun, He Fanyin, Bouillaud Emmanuel, Kim Yongsoo, Igwe Franklin, Singer Michael
Аннотация
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.
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.
Предметные рубрики MeSH
HumansDiabetic RetinopathyMacular EdemaIntravitreal InjectionsMaleRecombinant Fusion ProteinsFemaleVisual AcuityReceptors, Vascular Endothelial Growth FactorMiddle AgedTomography, Optical CoherenceVascular Endothelial Growth Factor AAngiogenesis InhibitorsTreatment OutcomeAntibodies, Monoclonal, HumanizedFollow-Up StudiesAgedMacula LuteaDouble-Blind MethodDose-Response Relationship, DrugFluorescein AngiographyFundus Oculi