Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 1-year results from the Japan subgroup of the phase 3 TENAYA trial
NCT03823287 | TENAYA Japan Subgroup | Mori R et al. (2023)
Mori R, Honda S, Gomi F, et al. Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 1-year results from the Japan subgroup of the phase 3 TENAYA trial. Japanese Journal of Ophthalmology, 2023; 67:301–310.
Locations
41 sites in Japan
Study Period
Not reported
Study Design
Phase 3, randomized, double-masked, active comparator-controlled, parallel-group, noninferiority trial
Study Population
Experimental Group
Control Group
Follow-up Time: 48 weeks
Outcomes
Durability
The proportions of patients in the faricimab group on Q16W, Q12W, and Q8W dosing intervals in the TENAYA Japan subgroup:
• Q16W: 66.1% (41/62)
• Q12W: 22.6% (14/62)
• Q8W: 11.3% (7/62)
At week 48, 88.7% (55/62) of faricimab-treated patients were on Q12W or Q16W dosing intervals
Vision
Best-Corrected Visual Acuity (BCVA)
The adjusted mean (95% CI) BCVA change at Week 48 (Primary Outcome):
• Faricimab: +7.1 letters (95% CI: 4.6 to 9.7)
• Aflibercept: +7.7 letters (95% CI: 5.2 to 10.1)
• Difference: -0.5 letters (95% CI -4.1 to 3.0).
Other
N/A
Immunognicity
Not reported
Pharmokinetics
Not reported
Anatomic
Central Subfield Thickness (CST)
The adjusted mean (95% CI) CST change at Week 48:
• Faricimab: -140.6 µm (95% CI -154.5 to -126.7)
• Aflibercept: -130.5 µm (95% CI -144.1 to -117.0)
Safety
Ocular AEs
Total events:
• Faricimab: 158
• Aflibercept: 102
Patients with any ocular AE:
• Faricimab: 14 (21.2%)
• Aflibercept: 17 (25.4%)
Patients with any treatment-related ocular AE:
• Faricimab: 2 (3.0%)
• Aflibercept: 2 (3.0%)
Patients with any AEs of intraocular inflammation (IOI):
• Faricimab: 2 (3.0%)
• Aflibercept: 0
Ocular Serious AEs (SAEs)
Total events:
• Faricimab: 14
• Aflibercept: 8
Patients with any ocular SAE:
• Faricimab: 2 (3.0%)
• Aflibercept: 2 (3.0%)
Patients with any treatment-related ocular SAE:
• Faricimab: 0
• Aflibercept: 1 (1.5%)
Non-ocular AEs
• Faricimab: 43 patients (65.2%)
• Aflibercept: 35 patients (52.2%).
Conclusion
The TENAYA Japan subgroup analysis showed that faricimab up to Q16W had sustained efficacy and safety comparable to aflibercept Q8W. These findings align with global TENAYA and LUCERNE results.
Risk of Bias Assessment for Primary Outcome
Randomization Process
Low risk
Note: “Patients were randomized in a 1:1 ratio to faricimab up to Q16W or aflibercept Q8W using identification numbers assigned through an interactive voice- or web-based response system.”
“Baseline characteristics were generally balanced between treatment groups in the TENAYA Japan subgroup.”
Missing Outcome Data
Low risk
Note: The evidence that the primary outcome data analysis was not biased by the missingness: “Results are based on mixed model for repeated measures (MMRM) analysis; missing data were implicitly imputed by MMRM.”
Selection of the Reported Results
Low risk Note: registration with protocol
Deviations from Intended Observations
Low risk Note: This is a double-masked study. “The pre-planned TENAYA Japan subgroup analyses included all patients randomized in the TENAYA trial at sites in Japan.”
Measurement of the Outcome
Low risk Note: This is a double-masked study. “The outcome was averaged over the 3 time points to limit the impact of measurement variability and account for differences in time from the last dose received by patients across treatment groups on different dosing intervals.”
Overall
Low risk
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