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Résultats d’un programme français d'accès au brolucizumab dans la DMLA exsudative pour les patients déjà traités par le brolucizumab dans les essais cliniques

Analysis of a French brolucizumab access program in neovascular AMD for 239 patients already treated with brolucizumab in a clinical trial and eligible for post-trial access in France. The median duration since their diagnosis of neovascular AMD was 1.57 years.

Retrospective analysis evaluating the clinical and anatomical benefits of brolucizumab treatment continuation in a close-to-real-life condition, in patients already treated with brolucizumab. 

Two subpopulations were analyzed. The first group included 100 brolucizumab pre-treated patients, from OCTOPUS or TALON studies, who had not received other anti-VEGF treatments before brolucizumab. The second group of 139 patients were switched to brolucizumab in SWIFT or TALON Ext trials, and had previously received at least one anti-VEGF treatment. 

Overall, the maximum treatment duration with brolucizumab was 48,2 months, the median treatment duration with brolucizumab was 24,5 months and the median treatment duration with brolucizumab in the MAP was 10.2 months. 

Results showed maintained efficacy on functional and anatomical criteria (ETDRS, CSMT, fluids) and extended intervals: the median final treatment interval was 12.4 weeks at M18 vs 12 weeks at baseline. Especially, 7.3% of patients with Q8 interval and 58.9% of patients with Q12 interval at baseline had extension at 18 months.  

No cases of adverse drug reactions were reported in these patients issued from clinical trials pretreated for a minimum of 1,8 months with brolucizumab (with a maximum of 20 months and a median of 9,8 months)  

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Results demonstrated that patients who were exposed to brolucizumab for up to 4 years (median: 26,5 months) continued to benefit in a close-to-real life condition: maintained efficacy, extension of intervals, without any adverse drug reaction.