Clinical Characteristics and Outcomes of Eyes with Intraocular Inflammation after Brolucizumab: Post Hoc Analysis of HAWK and HARRIER.
This analysis of the pivotal phase III HAWK and HARRIER trials aimed to provide insights on the timing of presentation, management, and outcomes of intraocular inflammation (IOI)-related adverse events (AEs), as reported by investigators in these trials.Post hoc analysis of investigator-reported IOI-related AEs in HAWK and HARRIER.Of 1088 brolucizumab-treated eyes (3 mg or 6 mg), 49 eyes experienced at least 1 IOI-related AE and were included in this analysis.Reports of IOI-related AEs were analyzed and descriptive statistics were provided for outcome measures.Incidence and description of eyes with IOI-related AEs, timing of presentation, management, clinical outcomes, and brolucizumab treatment after the first IOI-related AE.A total of 70 IOI-related AEs were reported in 49 eyes. Prior to the onset of first IOI-related AE, eyes received a mean (standard deviation [SD]) of 3.9 (2.2) brolucizumab injections. Median (25th-75th percentile) time to first IOI-related AE from the last administered brolucizumab injection was 18.0 (4.0-29.0) days. Of the 70 AEs, 61 (87.1%) were treated, the majority with topical corticosteroids; systemic and intraocular corticosteroids were used for 3 AEs each. Overall, inflammation resolved completely in 39 (79.6%) eyes, resolved with sequelae in 5 (10.2%) eyes, and did not resolve in 5 (10.2%) eyes by end-of-study. Overall, mean (SD) best-corrected visual acuity (BCVA) change from baseline to end-of-study, before AE to the lowest BCVA in 3 months after AE, and from before AE to end-of-study were -0.84 (20.6), -16.31 (17.6), and -0.22 (18.9) ETDRS letters, respectively. Of the 36 (73.5%) eyes that continued on brolucizumab after first IOI-related AE, 24 completed the trials and 12 discontinued; mean (SD) BCVA change in these eyes was 2.6 (17.6), 7.8 (13.2), and -7.7 (21.3) ETDRS letters, respectively, from baseline to end-of-study. The remaining 13 (26.5%) eyes were not treated with brolucizumab after first IOI-related AE and had mean (SD) BCVA change of -10.4 (25.5) ETDRS letters from baseline to end-of-study.Findings of this analysis highlight the need for continued vigilance and monitoring for any signs of IOI-related events in patients receiving brolucizumab.
Authors: Michael Singer, Thomas A Albini, András Seres, Caroline R Baumal, Soumil Parikh, Richard Gale, Peter K Kaiser, Iryna Lobach, Nicolas Feltgen, Mayur R Joshi, Focke Ziemssen, Bahram Bodaghi