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Inflammation intraoculaire, vascularite et vascularite occlusive sous brolucizumab chez des patients atteints de DMLA néovasculaire naïfs et prétraités : premiers enseignements des études OCTOPUS et SWIFT

This analysis presents preliminary descriptive insights from the OCTOPUS and SWIFT studies on the incidence, clinical features, management, and outcomes of IOI, vasculitis and occlusive vasculitis with brolucizumab treatment in naive and pretreated  neovascular age-related macular degeneration (nAMD) patients, diagnosed < 18 months, and only 1 previous anti-VEGF drug with a 4 or 8-week interval treatment.

OCTOPUS (NCT04239027) and SWIFT (NCT04264819) studies are prospective Phase IIIb single-arm, open-label, multicenter studies assessing brolucizumab in both treatment naive (OCTOPUS) and pretreated (SWIFT) patients with nAMD. Interim pre-specified analysis on efficacy endpoint was an opportunity to analyze IOI-related safety. Of 505 brolucizumab-treated eyes / patients with median brolucizumab treatment of 8.8 months, 54 eyes demonstrated at least one1 IOI-related adverse event (AE). Reports of IOI-related AEs were reviewed and AE images and clinical features and outcomes of each case were analyzed by an independent committee.

The incidence of overall IOI-related AEs was 10.7%;  the incidence of IOI only was 7.3%; the incidence of retinal vasculitis without occlusion was 1.8%; and the incidence of vasculitis with occlusion was 1.6%. Incidence was similar in naive and pretreated patients. Before the onset of the first IOI-related AE, eyes received a mean number of 2.6 brolucizumab injections; 79.6% of IOI-related AEs occurred during the loading phase. IOI-related AEs occurred a median number of 24.4 days from the last brolucizumab injection (range, 1-88 days). At AEs onset, most frequently reported symptoms were floaters (51.9%) and blurred or decreased vision (31.5%). Of the 54 AEs, 44 (81.5%) were treated, most with topical corticosteroids (45.5%); systemic and intraocular corticosteroids were used for 14 and 5 AEs each. No severe vision loss was reported for the 10 non-treated AEs. Overall, the mean +/- SD best corrected visual acuity (BCVA) change at IOI-related AEs resolution from baseline was 0.0 +/- 0.0 letters, 2 patients with occlusive vasculitis had BCVA loss &ge; 15 letters due to IOI-related AEs. All eyes permanently discontinued brolucizumab after the first IOI-related AE. 26 (48.1%) patients were treated with another aVEGF after IOI resolution.

Inflammatory complications have been accurately reported during both prospective studies and are consistent with those reported in the literature.

This analysis highlights the need for monitoring and educating patients for any signs of IOI-related events when being treated with brolucizumab, to immediately stop brolucizumab exposure at any signs of IOI, and to treat all signs of IOIs promptly and intensely with corticosteroids.