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Prescribing Information Tezspire®▼(tezepelumab)
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TEZSPIRE® (tezepelumab): efficacy & clinical trials
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TEZSPIRE® (tezepelumab): efficacy & clinical trials

See full indication

TEZSPIRE is the first & only licensed biologic that treats across phenotypes and irrespective of key biomarker levels1-10

Patients enrolled with high and low key clinical biomarker levels (bEOS, IgE, or FeNO).1*

Relative Risk Reductions In Exacerbations2,3

 

AAER reduction vs placebo†

 

TEZSPIRE 0.93 (n=528) vs placebo 2.1 (n=531)
(RR=0.44, 95% CI: 0.37–0.53; P<0.001);

ARR=1.17




Primary endpoint of NAVIGATOR

 

 

See data

 

AAER reduction vs placebo in patients with baseline eos <300 cells/µl†

TEZSPIRE 1.02 (n=309) vs placebo 1.73 (n=309)

(RR=0.59, 95% CI: 0.46–0.75; P<0.001);

ARR=0.71





Primary endpoint of NAVIGATOR

 

 

See data

Hospitalisation2,3

 

 

Relative risk reduction in AAER with hospitalisation or ED visit vs placebo

 

TEZSPIRE 0.06 (n=528) vs placebo 0.28 (n=531)

(RR=0.21, 95% CI: 0.12–0.37);

ARR=0.22





Additional secondary endpoint of NAVIGATOR

 

 

See data

Quality of life2,3

 

 

Observed improvements in asthma control, health-related quality of life and asthma symptoms vs placebo



Key secondary endpoints of NAVIGATOR

 

See data

Lung function1,2

 

lung_function_panel_image

 

130ml LS Mean Difference from Placebo. Lung function improvement was observed at Week 2 and maintained over 52 weeks of treatment.

(230mL improvement with TEZSPIRE at Week 52 compared
with baseline vs 100mL for placebo, 130mL difference;
95% CI: 0.08–0.18; P<0.001)

Key secondary endpoint of NAVIGATOR

See data

 

*No restrictions across eosinophilic and non-eosinophilic, allergic and non-allergic phenotypes, eosinophils, IgE, and FeNO biomarkers.

†,All patients received SOC (MD or HD ICS + additional controller).1,3

Reductions across key clinical biomarker levels1,3

Additional secondary endpoint of NAVIGATOR: change from baseline in bEOS, FeNO and IgE3

biomarker_data
biomarker_data

Adapted from Menzies-Gow A, et al. NEJM. 2021 (Supplementary)

 

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TEZSPIRE mode of action

Blocking TSLP with TEZSPIRE has been shown to reduce a broad spectrum of 
biomarkers and cytokines associated with airway inflammation1,3

Explore MOA

TEZSPIRE (tezepelumab) is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment1

AAER=annualised asthma exacerbation rate; ARR=absolute risk reduction; bEOS=blood eosinophils; CI=confidence interval; ED=emergency department; FeNO=fractional exhaled nitric oxide; HD=high dose; ICS=inhaled corticosteroid; IgE=immunoglobulin E; MD=medium dose; MOA=mode of action; RR=rate ratio; SOC=standard of care; TSLP=thymic stromal lymphopoietin.

 

  1. Tezspire (tezepelumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/14064/smpc (last accessed: November 2024).
  2. Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809.
  3. Menzies-Gow A, Corren J, Bourdin A, et al. Supplementary Appendix. Tezepelumab in adults and adolescents with severe, uncontrolled asthma. N Engl J Med. 2021;384(19):1800-1809.
  4. Corren J, Parnes JR, Wang L, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377(10):936-946.
  5. Nucala (mepolizumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/10563/smpc (last accessed: November 2024).
  6. Cinqaero (reslizumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/4370/smpc (last accessed: November 2024).
  7. Fasenra (Benralizumab). Summary of Product Characteristics. 2023. Available at: https://www.medicines.org.uk/emc/product/10559/smpc (last accessed: November 2024).
  8. Dupixent (dupilumab). Summary of Product Characteristics. 2023. Available at: https://www.medicines.org.uk/emc/product/8553/smpc (last accessed: November 2024).
  9. Xolair (omalizumab). Summary of Product Characteristics. 2022. Available at: https://www.medicines.org.uk/emc/product/4725/smpc (last accessed: November 2024).
  10. Corren J et al. Efficacy of tezepelumab in patients with severe, uncontrolled asthma: a pooled analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR studies. Poster presented at: AAAAI 2022 (Poster 044).

GB-56753 | November 2024

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