Faricimab Versus Standard of Care in Naive Neovascular Age-Related Macular Degeneration Patients: An Indirect Treatment Comparison Using Individual Level Data

Author(s)

Lanzetta P1, Parravano MC2, Nicolò M3, Staurenghi G4, Viola F5, Galeone C6, Bianchino L7, Sicari E7, Villa G7, Vujosevic S8
1Department of Ophthalmology, University of Udine, Udine, Italy, 2IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS, Rome, Italy, 3University Eye Clinic, Ospedale Policlinico San Martino IRCCS, Genoa, Italy, 4Eye Clinic, Department of Biomedical and Clinical Sciences "Luigi Sacco", Luigi Sacco Hospital, University of Milan, Milan, Italy, 5Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy, 6Bicocca-Applied Statistics Center (B-ASC), University of Milano-Bicocca, Milan, Italy, 7Roche S.p.A., Monza, Italy, 8Eye Clinic, IRCCS MultiMedica, Milan, Italy

OBJECTIVES: To evaluate the potential benefit of faricimab, a new targeting vascular endothelial growth factor A (VEGF-A) and Angiopoietin-2, versus the current intravitreal (IV) a-VEGF SoC in nAMD patients.

METHODS: Patient-level data from the companion phase III clinical trials TENAYA and LUCERNE (faricimab; n=513) and the RADIANCE observational study (SoC: n=263; including aflibercept: n=101, bevacizumab: n=53, ranibizumab: n=59) were used. The investigation included naïve nAMD patients with effectiveness data at one year follow-up available. Effectiveness was assessed in terms of change from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST). Propensity score weighting (PSW) was used to balance demographic and clinical patients’ characteristics between the faricimab and the SoC cohorts. Weighted one-way ANOVA was applied to compare changes in BCVA and CST between groups. A sensitivity analysis to adjust for injections’ number was conducted using weighted ANCOVA.

RESULTS: After PSW, mean vision gains in BCVA after 1 year of treatment were 6.5 letters (95% confidence interval, CI: 5.0, 7.9) in the faricimab and 1.0 (95% CI: -0.4, 2.5) in the SoC groups, with a corresponding treatment difference of 5.4 letters (95% CI: 3.4, 7.5, p<0.001) in favour of faricimab. Mean CST change from baseline was -143.2 μm (95% CI: -156.2, -130.1) with faricimab and -71.4 μm (95% CI: -84.3, -58.4) with SoC, with a corresponding treatment difference of -71.8 μm (95% CI: -90.2, -53.4, p<0.001). Results were confirmed in sensitivity analyses: treatment differences in favor of faricimab was +4.0 letters in BCVA and -71.8 μm in CST reduction.

CONCLUSIONS: In naive nAMD patients, first line treatment with faricimab resulted in a greater vision gain and CST reduction compared with current SoC. Despite limitations of indirect treatment comparisons, which call for specific post-marketing real world studies, the present analysis supports potential benefits in nAMD patients treated with faricimab.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

CO71

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)

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