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Pravin U Dugel, Gabriele Elisabeth Lang, Sam Razavi, Andreas Weichselberger, Yuichiro Ogura, David M Brown; Predictability of the 12-week dosing status at Week 48 for patients receiving brolucizumab in HAWK and HARRIER. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1455.
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Brolucizumab is a novel single-chain antibody fragment with potent anti-vascular endothelial growth factor attributes. In HAWK and HARRIER, the majority of patients receiving brolucizumab 6mg were maintained on an exclusive 12-week (q12w) interval. The role of the first q12 interval on the identification of q12 dosing suitability will be presented.
HAWK and HARRIER are 96-week, prospective, double-masked, multi-centered phase III studies in which patients were randomized 1:1:1 to brolucizumab 3mg (n=358), brolucizumab 6mg (n=360) or aflibercept 2mg (n=360) (HAWK), or 1:1 with either brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) (HARRIER). Only one eye of each patient was designated as the study eye. After three loading doses, brolucizumab patients were treated every 12 weeks (q12w), with the possibility of adjusting to 8-week dosing (q8w) during the first q12 interval and at each scheduled q12 treatment visit; aflibercept patients were treated on a fixed q8w regimen, as per label. The primary endpoint was non-inferiority of brolucizumab to aflibercept in best corrected visual acuity (BCVA) change from baseline to Week 48. Key secondary endpoints included the proportion of patients on the q12w treatment regimen at Week 48 and the predictive value of the first q12w treatment interval for maintenance of a q12w treatment regimen up to Week 48.
The majority of patients with a need for q8 were identified during the first q12 interval (80% and 78% of brolucizumab 6mg patients in HAWK and HARRIER, respectively). Patients receiving brolucizumab 6mg who successfully completed the first q12w interval had an 87.4% and an 82.5% probability of remaining on q12w treatment until Week 48 in HAWK and HARRIER, respectively (82.6% probability for the 3mg brolucizumab arm (HAWK)).
Brolucizumab patients who were successfully identified as being suitable for the q12w interval dosing in the first q12w interval immediately after loading, were likely to remain on q12w treatment for the remainder of the study. Learning from the first q12 interval can have an essential role in determining suitable treatment intervals for patients and potentially reducing the burden in the management of neovascular age-related macular degeneration.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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