Prescribing information

 

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▼Beovu® (brolucizumab) is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD) and visual impairment due to diabetic macular oedema (DMO).1,2

Beovu: REDEFINING FLUID CONTROL for your patients with visual impairment due to diabetic macular oedema (DMO)1,2

The efficacy and safety was studied in 2 head-to-head trials vs. aflibercept in more than 900 patients with visual impairment due to DMO in 30+ countries: the KESTREL and KITE clinical trials.3

The primary efficacy endpoint was to demonstrate non-inferiority of Beovu vs. aflibercept in mean change from baseline in BCVA at Week 52, measured by ETDRS letters.3

Disease activity was based on functional and anatomical parameters and evaluated by a masked investigator to determine if Beovu® patients could remain on q12w3

*Disease activity was assessed at various timepoints by a masked investigator.3
More frequent treatment was determined by functional and anatomical parameters.3
Assessed at Week 72; option to extend the current treatment interval by 4 weeks, ie, extend q12w to q16w and q8w to q12w.4
§q16w regimen is not an approved posology. After the loading doses q6w for 5 doses, the recommended dosing intervals can be extended to q8w or q12w, based on the physician’s judgment of the disease activity. Please refer to Beovu Summary of Product Characteristics for full posology here for GB and here for NI.
Aflibercept was dosed on a fixed q8w regimen as per KESTREL and KITE study design

 

Beovu: Comparable vision gains vs. aflibercept at Week 52*†3

Mean change in VA with Beovu vs. aflibercept from baseline – at Year 1

Line graph to show the Mean change in VA with Beovu vs aflibercept from baseline – at Year 1 with Beovu

Adapted from Brown DM, et al. 2022.

*Only compared to a fixed q8w aflibercept regimen as studied in KESTREL & KITE
Two fewer median injections as compared to aflibercept at Week 52.3
The primary endpoint was to demonstrate non-inferiority of Beovu® vs. aflibercept in mean change from baseline in BCVA at Week 52, measured by ETDRS letters.3
§One-sided p value referring to the non-inferiority hypothesis with a non-inferiority margin of 4 letters.3

% of patients with fluid resolution (absence of IRF and/or SRF) with Beovu vs. aflibercept*3

Two histograms to show patients with fluid resolution (absence of SRF and/or IRF) with Beovu vs aflibercep at week 32 and 52 in KESTREL and KITE

Adapted from Brown DM, et al. 2022.

*Statistical significance was not tested.3
Median injection number at 52 weeks.3

More Beovu® patients experienced CSFT <280 μm at
Week 52 vs. aflibercept*3

54% and 58% (KESTREL & KITE respectively) of patients on Beovu® achieved CSFT reduction vs. aflibercept at Year 1.3

 

Two histograms to show the proportion of patients treated with Beovu® who achieved absence of DMO (CST <280 µm)

 

Prespecified secondary endpoint: Patients with CST <280 µm at Week 32 and Week 52§3

*Statistical significance was not tested.
CSFT reduction of <280 μm.3
Median number of injections at Week 32 and Week 52.3
§
Secondary endpoint in KESTREL and KITE. Not prespecified for hypothesis testing. No statistical significance conclusions can be drawn.3

Beovu-treated patients exhibited an overall well-tolerated safety profile in KESTREL & KITE3

 

 

Table showing the adverse event profile of Beovu and aflibercept in KESTREL and KITE

  • In KESTREL, 1 subject in the Beovu 6 mg arm had both retinal vasculitis and retinal vascular occlusion. Both events resolved without treatment and BCVA at Week 52 had increased by 14 letters compared with baseline3
  • In KITE, both RO events (one in the Beovu® arm, one in the aflibercept arm) were reported as retinal artery occlusion and were not associated with IOI or retinal vasculitis3

*A patient with multiple occurrences of an AE for a preferred term or system organ class was counted only once in each specific category.
Percentages of subjects with IOI and percentages of subjects with retinal vasculitis cannot be added up; all cases of vasculitis are considered in the IOI events.3
Includes reported cases of retinal vascular occlusion, retinal artery occlusion, and retinal vein thrombosis. Neither case in KITE was associated with IOI.3

Discover real patient cases from the KITE-trial to see how Beovu could help benefit your patients with visual impairment due to DMO.

Treatment-naive patient: q12w regimen after initial 5 loading doses

Preview of case study document available to download

Age: 70, sex: male, race: Caucasian5

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Treatment-naive patient: q8w regimen after initial 5 loading doses

Preview of case study document available to download

Age: 76, sex: male, race: Caucasian6

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Flow diagram to show the loading and maintenance doses for Beovuover 56 weeks

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Disease activity = decreased visual acuity or increasing CST. Determination by visual acuity or morphological criteria.

The recommended dose is 6 mg brolucizumab (0.05 ml solution), which is given as an intravitreal injection every 6 weeks for the first 5 doses. After that, the doctor can determine the treatment intervals individually based on the disease activity, which is determined on the basis of visual acuity and/or anatomical parameters. In patients without disease activity, treatment every 12 weeks (3 months) should be considered. In patients with disease activity, a treatment every 8 weeks (2 months) should be considered, but do not dose less frequently than 8 weekly during the maintenance therapy.1,2

AE, adverse event; BCVA, best corrected visual acuity; CSFT, central subfield thickness; DRSS, diabetic retinopathy severity score; ETDRS, early treatment diabetic retinopathy study; HTN, hypertension; DAA, disease activity assessment; DMO, diabetic macular oedema; IRF, intraretinal fluid; LS, least squares; NPDR, non-proliferative diabetic retinopathy; OD, right eye; RO, retinal vascular occlusion; SE, standard error; SRF, subretinal fluid; q4w, treatment every 4 weeks; q6w, treatment every 6 weeks; q12w, every 12 weeks; q16w, treatment every 16 weeks.

References:

  1. Novartis Pharmaceuticals UK Ltd. Beovu® (brolucizumab) Summary of Product Characteristics, Great Britain, April 2022.
  2. Novartis Pharmaceuticals UK Ltd. Beovu® (brolucizumab) Summary of Product Characteristics, Northern Ireland, March 2022.
  3. Brown DM, et al. Am J Ophthalmol 2022;238:157–172.
  4. Regillo C. Brolucizumab for the treatment of DMO: 100-week results from the two pivotal Phase III KESTREL and KITE studies. Presented at: Angiogenesis, 2022.
  5. Novartis UK data on file: BRO007 2022.
  6. Novartis UK data on file: BRO006, 2022.
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UK | June 2022 | 210792-1
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]