Name

Premières utilisations du Brolucizumab en pratique de routine en France dans la DMLA néovasculaire

Interim analysis of brolucizumab access program in exudative AMD in France. At 6 months: 306 patients (average age 77.3 years) distributed from 55 centers with an average follow-up of 3.7 months. 58.5% women, median duration of progression of neovascular AMD before inclusion: 2 years.

Retrospective analysis to evaluate in real life the clinical benefit of brolucizumab. 2 subpopulations analyzed: patients in therapeutic impasse, pretreated but naive to brolucizumab (N = 138) and patients from clinical trials treated with brolucizumab (N = 168).

For patients in therapeutic impasse, treatment with brolucizumab allowed with few injections (3.2 on average) a median gain of +2 letters, maximal CSMT decrease of -72.2 µm (mean), maintenance at very low levels of intra-retinal fluid compared to baseline (2.9% vs 1.6%) and a reduction in subretinal fluid (from 26.8% to 19.7%). The last treatment interval was 8 weeks (median) compared to 5 weeks before treatment with brolucizumab.

For patients from clinical trials, brolucizumab allowed with very few injections (2 on average) the maintenance of visual acuity (-1 letter in median), CSMT (-2.7 µm in average), intra-retinal and sub-retinal fluids at low levels compared to baseline (7.9% vs 4.8% and 5% vs 7.1%). The final treatment interval was 10.4 weeks (median 12 weeks at program entry). Patients who only received brolucizumab had better maintenance than those who received another antiVEGF before brolucizumab, with a median treatment interval of 12 vs 10 weeks.

10 months after the start of the access program, 438 patients were treated, the rate of observed intraocular inflammations was 1.3% (6 cases/438): 5 without retinal damage (4 resolved without sequelae and 1 ongoing to be resolved) and 1 vasculitis with retinal vascular occlusion. The 6th patient, suffering from occlusive vasculitis, was currently recovering (68L before and 63L on the day of diagnosis). No cases have been reported in patients from clinical trials pretreated for 1 or 2 years with brolucizumab. The inflammations occurred exclusively in patients newly treated by brolucizumab and within the first 2 months of treatment.

These initial results would be confirmed by the final analysis on 688 patients, over a follow-up period of up to 4 years of treatment (including the duration of the study).

Results confirmed the effectiveness of brolucizumab, its favorable benefit/risk profile and its capacity to reduce the treatment burden for patients insufficiently responding to other anti-VEGF.