BATTLE TESTED
IN EOS DISEASE

NUCALA—the only FDA-approved therapy for EGPA—offered patients more time in remission and a lower daily OCS dose

NUCALA—the only FDA-approved therapy for EGPA—offered patients more time in remission and a lower daily OCS dose

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*IQVIA National Prescription Audit from August 2022 to July 2023 for all indications combined.
 

NUCALA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Choose NUCALA for EGPA

Increased time in remission

2.8x

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as many patients
achieved remission1†§

NUCALA, 53% (n=36/68)
vs placebo, 19% (n=13/68)

Subanalysis. Results are descriptive.

Reduced daily OCS dose

1in5

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patients ELIMINATED daily steroids
in the last 4 weeks of treatment1

NUCALA, 18% (n=12/68)
vs placebo, 3% (n=2/68)

Results are descriptive from secondary endpoint.

Decreased relapse rate

50%

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reduction in annualized
relapse rate1†ll

NUCALA, 1.14 vs placebo, 2.27;
rate ratio: 0:50; 95% CI: 0.36, 0.70

Other endpoint. These results are descriptive
and not adjusted for multiplicity.

Pivotal trial design: 52-week, phase 3, randomized, placebo-controlled, double-blind study comparing 300 mg of NUCALA every 4 weeks plus standard of care (SOC) (n=68) vs placebo plus SOC (n=68); follow-up Weeks 52-60. Co-primary endpoints: NUCALA patients spent more time in remission§ over 52 weeks (OR: 5.9; 95% CI: 2.7, 13.0; P<0.001). More NUCALA patients were in remission§ at both Week 36 and Week 48 (OR: 16.7; 95% CI: 3.6, 77.6; P<0.001). Secondary endpoint: NUCALA patients achieved lower daily steroid dose during the last 4 weeks of treatment (OR: 0.20; 95% Cl: 0.09, 0.41).1

SOC was defined as OCS +/– immunosuppressants. After Week 4, OCS (prednisolone or prednisone) dose could be tapered, per physician judgment or a suggested protocol.

Remission was defined as Birmingham Vasculitis Activity Score (BVAS)=0 (no active vasculitis) plus OCS dose ≤4 mg/day.

Relapse was defined as a worsening related to vasculitis, asthma, or sinonasal symptoms requiring an increase in dose of corticosteroids, increase in dose or addition of immunosuppressive therapy, or hospitalization.

ACR/VF recommendations include NUCALA as
a treatment for appropriate patients with EGPA2

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NUCALA is conditionally recommended as an add-on treatment option for patients with EGPA who meet specific criteria in the 2021 ACR/VF Guideline for the Management of ANCA-Associated Vasculitis. All EGPA recommendations in the Guideline are conditional due in part to the lack of multiple randomized controlled trials and/or low-quality evidence supporting the recommendations.2

 

ACR=American College of Rheumatology; ANCA=Antineutrophil Cytoplasmic Antibody; CI=confidence interval; OCS=oral corticosteroid; OR=odds ratio; VF=Vasculitis Foundation.

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About EGPA

Description, clinical
manifestations, and more

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Eosinophil reduction
and mechanism of action (MOA)

See the results of NUCALA
on eosinophil reduction