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  1. Article ; Online: Population Pharmacokinetic Modeling and Exposure-Efficacy and Body Weight-Response Analyses for Tezepelumab in Patients With Severe, Uncontrolled Asthma.

    Zheng, Yanan / Abuqayyas, Lubna / Quartino, Angelica / Guan, Ye / Gao, Yuying / Liu, Lu / Hellqvist, Åsa / Colice, Gene / MacDonald, Alexander

    Journal of clinical pharmacology

    2024  

    Abstract: Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin. This analysis assessed the suitability of a fixed-dose regimen of tezepelumab 210 mg every 4 weeks (Q4W) in adults and adolescents with severe, ... ...

    Abstract Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin. This analysis assessed the suitability of a fixed-dose regimen of tezepelumab 210 mg every 4 weeks (Q4W) in adults and adolescents with severe, uncontrolled asthma. A population pharmacokinetic model was developed using data from 1368 patients with asthma or healthy participants enrolled in 8 clinical studies (phases 1-3). Tezepelumab exposure-efficacy relationships were analyzed in the phase 3 NAVIGATOR study (NCT03347279), using asthma exacerbation rates over 52 weeks and changes in pre-bronchodilator forced expiratory volume in 1 s at week 52. Tezepelumab pharmacokinetics were well characterized by a 2-compartment linear disposition model with first-order absorption and elimination following subcutaneous and intravenous administration at 2.1-420 and 210-700 mg, respectively. There were no clinically relevant effects on tezepelumab pharmacokinetics from age (≥12 years), sex, race/ethnicity, renal or hepatic function, disease severity (inhaled corticosteroid dose level), concomitant asthma medication use, smoking history, or anti-drug antibodies. Body weight was the most influential covariate on tezepelumab exposure, but no meaningful differences in efficacy or safety were observed across body weight quartiles in patients with asthma who received tezepelumab 210 mg subcutaneously Q4W. There was no apparent relationship between tezepelumab exposure and efficacy at this dose regimen, suggesting that it is on the plateau of the exposure-response curve of tezepelumab. In conclusion, a fixed-dose regimen of tezepelumab 210 mg subcutaneously Q4W is appropriate for eligible adults and adolescents with severe, uncontrolled asthma.
    Language English
    Publishing date 2024-04-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 188980-1
    ISSN 1552-4604 ; 0091-2700 ; 0021-9754
    ISSN (online) 1552-4604
    ISSN 0091-2700 ; 0021-9754
    DOI 10.1002/jcph.2433
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  2. Article: Tezepelumab Reduces Exacerbations Across All Seasons in Patients with Severe, Uncontrolled Asthma: A Post Hoc Analysis of the PATHWAY Phase 2b Study.

    Corren, Jonathan / Karpefors, Martin / Hellqvist, Åsa / Parnes, Jane R / Colice, Gene

    Journal of asthma and allergy

    2021  Volume 14, Page(s) 1–11

    Abstract: Introduction: Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine implicated in airway inflammation in asthma, from binding to its heterodimeric receptor. In the PATHWAY phase 2b study, ... ...

    Abstract Introduction: Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine implicated in airway inflammation in asthma, from binding to its heterodimeric receptor. In the PATHWAY phase 2b study, tezepelumab significantly reduced exacerbation rates compared with placebo in adults with severe, uncontrolled asthma, irrespective of baseline disease characteristics.
    Objective: To evaluate the effect of tezepelumab on asthma exacerbations on a seasonal basis.
    Methods: This was a post hoc analysis of the PATHWAY study (NCT02054130). Adults (N=550) with severe, uncontrolled asthma were randomized 1:1:1:1 to receive subcutaneous tezepelumab 70 mg every 4 weeks (Q4W), 210 mg Q4W or 280 mg every 2 weeks (Q2W), or placebo Q2W, for 52 weeks. The annualized asthma exacerbation rate (AAER), total number of days with an exacerbation, proportion of patients with at least one exacerbation or 0, 1 or ≥2 exacerbations, and proportion of patients experiencing an exacerbation per day were evaluated by season and over the year, by treatment in the overall study population and in subgroups according to baseline blood eosinophil count (≥300 cells/µL or <300 cells/µL) or atopic asthma status (fluoro-enzyme immunoassay [FEIA]+ or FEIA-).
    Results: Seasonal variations in exacerbation rates were found, with peaks observed in fall and winter, and greater variations in patients with high blood eosinophil counts (≥300 cells/µL). Tezepelumab treatment consistently reduced exacerbation rates across all seasons compared with placebo. Furthermore, there was a trend, which was not significant, toward a reduction in the total number of days with exacerbations and in the proportion of patients with exacerbations during each season in patients treated with tezepelumab compared with those who received placebo, irrespective of blood eosinophil count or atopic asthma status.
    Conclusion: Tezepelumab reduced exacerbations across all seasons, irrespective of evaluated baseline disease characteristics. These data support the efficacy of tezepelumab in a broad population of patients with severe, uncontrolled asthma.
    Language English
    Publishing date 2021-01-11
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2494877-9
    ISSN 1178-6965
    ISSN 1178-6965
    DOI 10.2147/JAA.S286036
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  3. Article: Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma with and without Nasal Polyposis: A

    Emson, Claire / Corren, Jonathan / Sałapa, Kinga / Hellqvist, Åsa / Parnes, Jane R / Colice, Gene

    Journal of asthma and allergy

    2021  Volume 14, Page(s) 91–99

    Abstract: Background: Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial cytokine implicated in asthma pathogenesis, from binding to its heterodimeric receptor. In the phase 2b PATHWAY study, tezepelumab ... ...

    Abstract Background: Tezepelumab is a human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial cytokine implicated in asthma pathogenesis, from binding to its heterodimeric receptor. In the phase 2b PATHWAY study, tezepelumab significantly reduced annualized asthma exacerbation rates (AAERs) versus placebo, irrespective of baseline disease characteristics, and improved lung function and symptom control, in adults with severe, uncontrolled asthma. This
    Methods: In this
    Results: At baseline, NP+ patients had higher blood eosinophil counts, higher FeNO levels and higher serum IL-5 and IL-13 levels than NP- patients. Tezepelumab 210 mg reduced the AAER versus placebo to a similar extent in both NP+ and NP- patients (NP+, 75% [95% confidence interval (CI): 15, 93], n=23; NP-, 73% [95% CI: 47, 86], n=112). Patients treated with tezepelumab 210 mg demonstrated greater reductions in blood eosinophil count and levels of FeNO, IL-5 and IL-13 than placebo-treated patients, irrespective of NP status.
    Discussion: Tezepelumab reduced exacerbations and reduced type 2 inflammatory biomarkers in patients with and those without NP, supporting its efficacy in a broad population of patients with severe asthma.
    Language English
    Publishing date 2021-02-03
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2494877-9
    ISSN 1178-6965
    ISSN 1178-6965
    DOI 10.2147/JAA.S288260
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  4. Article ; Online: Efficacy and safety of tezepelumab in patients with uncontrolled disease while receiving maintenance therapy for moderate or severe asthma.

    Corren, Jonathan / Wechsler, Michael E / Chupp, Geoffrey / Roseti, Stephanie L / Hellqvist, Åsa / Martin, Neil / Llanos, Jean-Pierre / Ambrose, Christopher S / Colice, Gene

    The journal of allergy and clinical immunology. In practice

    2022  Volume 11, Issue 3, Page(s) 943–945.e2

    MeSH term(s) Humans ; Asthma/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Anti-Asthmatic Agents/therapeutic use ; Double-Blind Method
    Chemical Substances tezepelumab (RJ1IW3B4QX) ; Antibodies, Monoclonal, Humanized ; Anti-Asthmatic Agents
    Language English
    Publishing date 2022-11-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2843237-X
    ISSN 2213-2201 ; 2213-2198
    ISSN (online) 2213-2201
    ISSN 2213-2198
    DOI 10.1016/j.jaip.2022.10.042
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study.

    Corren, Jonathan / Ambrose, Christopher S / Griffiths, Janet M / Hellqvist, Åsa / Lindsley, Andrew W / Llanos, Jean-Pierre / Colice, Gene / Menzies-Gow, Andrew

    Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology

    2022  Volume 53, Issue 4, Page(s) 417–428

    Abstract: Background: Allergic asthma is the most common phenotype among patients with severe asthma. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with ... ...

    Abstract Background: Allergic asthma is the most common phenotype among patients with severe asthma. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with severe, uncontrolled asthma. This exploratory analysis evaluated the efficacy of tezepelumab in NAVIGATOR participants with evidence of severe allergic asthma.
    Methods: Patients (12-80 years old) receiving medium- or high-dose inhaled corticosteroids and ≥ 1 additional controller medication, with or without oral corticosteroids, were randomized to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks in NAVIGATOR. In this analysis, the AAER, forced expiratory volume in 1 second (FEV
    Results: Of 1059 patients who received treatment in NAVIGATOR, 680 (64%) had perennial aeroallergen sensitivity and 318 (30%) had confirmed symptomatic allergy; 379 (36%) and 359 (34%) patients were OMA-US- and OMA-EU-eligible, respectively. Tezepelumab reduced the AAER over 52 weeks versus placebo by 58% (95% confidence interval [CI]: 47-67) to 68% (95% CI: 55-77) across these subgroups. Among omalizumab-eligible patients, AAERs were reduced in patients across baseline blood eosinophil counts and FeNO levels. Tezepelumab improved FEV
    Conclusions: Tezepelumab was efficacious in patients with severe, uncontrolled asthma with evidence of allergic inflammation, defined by multiple clinically relevant definitions. These findings further support the benefits of tezepelumab in a broad population of patients with severe asthma, including those with severe allergic asthma.
    MeSH term(s) Humans ; Omalizumab/therapeutic use ; Anti-Asthmatic Agents/adverse effects ; Asthma/diagnosis ; Asthma/drug therapy ; Adrenal Cortex Hormones/therapeutic use ; Double-Blind Method
    Chemical Substances tezepelumab (RJ1IW3B4QX) ; Omalizumab (2P471X1Z11) ; Anti-Asthmatic Agents ; Adrenal Cortex Hormones
    Language English
    Publishing date 2022-12-12
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 645204-8
    ISSN 1365-2222 ; 0954-7894 ; 0960-2178
    ISSN (online) 1365-2222
    ISSN 0954-7894 ; 0960-2178
    DOI 10.1111/cea.14256
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  6. Article ; Online: DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma.

    Menzies-Gow, Andrew / Ponnarambil, Sandhia / Downie, John / Bowen, Karin / Hellqvist, Åsa / Colice, Gene

    Respiratory research

    2020  Volume 21, Issue 1, Page(s) 279

    Abstract: Background: Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. The efficacy, safety and oral corticosteroid-sparing potential of tezepelumab are being investigated in two ongoing, ...

    Abstract Background: Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. The efficacy, safety and oral corticosteroid-sparing potential of tezepelumab are being investigated in two ongoing, phase 3, randomized, double-blind, placebo-controlled studies (NAVIGATOR [NCT03347279] and SOURCE [NCT03406078]). DESTINATION (NCT03706079) is a long-term extension (LTE) of these studies.
    Methods: DESTINATION is a randomized, double-blind, placebo-controlled LTE study in adults (18-80 years old) and adolescents (12-17 years old) with severe, uncontrolled asthma who are receiving treatment with medium- or high-dose inhaled corticosteroids plus at least one additional controller medication with or without oral corticosteroids. The study population will comprise patients who complete the 52- and 48-week NAVIGATOR and SOURCE studies, respectively. Patients who were randomized to receive tezepelumab 210 mg every 4 weeks (Q4W) in either predecessor study will continue to receive this regimen for 1 year; those who were previously randomized to receive placebo will be re-randomized (1:1) to receive either tezepelumab 210 mg Q4W or placebo for 1 year. Patients will receive their prescribed controller medications throughout DESTINATION and study physicians will have the opportunity to down- or up-titrate dosage of these medications, if appropriate. The primary objective is to evaluate the long-term safety and tolerability of tezepelumab over 104 weeks (inclusive of the treatment period of either predecessor study). The secondary objective is to assess the long-term effect of tezepelumab on asthma exacerbations. Patients recruited from SOURCE will be followed up post-treatment for 12 weeks. Patients recruited from NAVIGATOR who complete 100 weeks of tezepelumab treatment will be eligible for either 12 weeks of follow-up or a 36-week extended follow-up during which the clinical benefit of tezepelumab after treatment cessation will be investigated.
    Discussion: DESTINATION will evaluate the long-term safety, tolerability and efficacy of tezepelumab versus placebo with continued dosing for up to 2 years. DESTINATION will also evaluate the clinical effect of tezepelumab after treatment cessation. This LTE study aims to elucidate the long-term safety implications of receiving tezepelumab and to assess its potential long-term treatment benefits in patients with severe, uncontrolled asthma.
    Trial registration: NCT03706079 (ClinicalTrials.gov). Registered 15 October 2018.
    MeSH term(s) Administration, Inhalation ; Adolescent ; Adrenal Cortex Hormones/administration & dosage ; Adrenal Cortex Hormones/adverse effects ; Adrenal Cortex Hormones/metabolism ; Adult ; Aged ; Aged, 80 and over ; Anti-Asthmatic Agents/administration & dosage ; Anti-Asthmatic Agents/adverse effects ; Anti-Asthmatic Agents/metabolism ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/metabolism ; Asthma/diagnosis ; Asthma/drug therapy ; Asthma/metabolism ; Cytokines/metabolism ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Severity of Illness Index ; Young Adult
    Chemical Substances Adrenal Cortex Hormones ; Anti-Asthmatic Agents ; Antibodies, Monoclonal, Humanized ; Cytokines ; TSLP protein, human ; tezepelumab (RJ1IW3B4QX)
    Keywords covid19
    Language English
    Publishing date 2020-10-21
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 2041675-1
    ISSN 1465-993X ; 1465-9921
    ISSN (online) 1465-993X
    ISSN 1465-9921
    DOI 10.1186/s12931-020-01541-7
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  7. Article ; Online: Effect of tezepelumab on healthcare utilization in patients with severe, uncontrolled asthma: The NAVIGATOR study.

    Menzies-Gow, Andrew / Bourdin, Arnaud / Chupp, Geoffrey / Israel, Elliot / Hellqvist, Åsa / Hunter, Gillian / Roseti, Stephanie L / Ambrose, Christopher S / Llanos, Jean-Pierre / Cook, Bill / Corren, Jonathan / Colice, Gene

    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

    2023  Volume 131, Issue 3, Page(s) 343–348.e2

    Abstract: Background: Tezepelumab, a human monoclonal antibody, blocks thymic stromal lymphopoietin. In the phase 3 NAVIGATOR study, tezepelumab reduced exacerbations and improved lung function, asthma control, and health-related quality of life compared with ... ...

    Abstract Background: Tezepelumab, a human monoclonal antibody, blocks thymic stromal lymphopoietin. In the phase 3 NAVIGATOR study, tezepelumab reduced exacerbations and improved lung function, asthma control, and health-related quality of life compared with placebo in patients with severe, uncontrolled asthma. However, little is known about the impact of tezepelumab on healthcare utilization (HCU) in these patients.
    Objective: To evaluate to what extent tezepelumab reduces patients' HCU.
    Methods: In NAVIGATOR, patients were randomized to receive subcutaneous tezepelumab 210 mg or placebo, every 4 weeks for 52 weeks. For this analysis, the main outcomes of interest were asthma-related HCU. A blinded, systematic analysis of the symptoms and HCU recorded in the investigator-reported narratives describing exacerbation-related hospitalizations was also conducted; the narratives included blinded ratings of event intensity, recorded as mild, moderate, or severe.
    Results: Recipients of tezepelumab (n = 528) required fewer asthma-related unscheduled specialist visits (tezepelumab, 285 events; placebo, 406 events), telephone calls with a healthcare provider (tezepelumab, 234; placebo, 599), ambulance transports (tezepelumab, 5; placebo, 22), emergency department visits (without subsequent hospitalization; tezepelumab, 16; placebo, 37), hospitalizations (tezepelumab, 14; placebo, 78), and intensive care days (tezepelumab, 0; placebo, 31) than did recipients of placebo (n = 531). Among patients with asthma exacerbation-related hospitalizations, 38% of those hospitalized and receiving tezepelumab (5/13) had an event rated as severe, compared with 82% of those hospitalized and receiving placebo (32/39).
    Conclusion: Tezepelumab substantially reduced HCU across all outcomes measured compared with placebo, in addition to the severity of asthma exacerbations requiring hospitalization. Tezepelumab can reduce the overall burden of disease of severe, uncontrolled asthma.
    Clinical trial registration: ClinicalTrials.gov (https://clinicaltrials.gov/ct2/home), identifier: NCT03347279.
    MeSH term(s) Humans ; Anti-Asthmatic Agents ; Quality of Life ; Asthma ; Patient Acceptance of Health Care ; Double-Blind Method
    Chemical Substances tezepelumab (RJ1IW3B4QX) ; Anti-Asthmatic Agents
    Language English
    Publishing date 2023-05-30
    Publishing country United States
    Document type Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1228189-x
    ISSN 1534-4436 ; 0003-4738 ; 1081-1206
    ISSN (online) 1534-4436
    ISSN 0003-4738 ; 1081-1206
    DOI 10.1016/j.anai.2023.05.028
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  8. Article ; Online: Reply to Lipworth and Chan.

    Ambrose, Christopher S / Israel, Elliot / Bowen, Karin / Llanos, Jean-Pierre / Martin, Neil / Cook, Bill / Hellqvist, Åsa / Korn, Stephanie / Menzies-Gow, Andrew / Roseti, Stephanie L / Molfino, Nestor A / Griffiths, Janet M / Parnes, Jane R

    American journal of respiratory and critical care medicine

    2023  Volume 208, Issue 2, Page(s) 212–213

    Language English
    Publishing date 2023-06-06
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1180953-x
    ISSN 1535-4970 ; 0003-0805 ; 1073-449X
    ISSN (online) 1535-4970
    ISSN 0003-0805 ; 1073-449X
    DOI 10.1164/rccm.202305-0843LE
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  9. Article ; Online: Tezepelumab and Mucus Plugs in Patients with Moderate-to-Severe Asthma.

    Nordenmark, Lars H / Hellqvist, Åsa / Emson, Claire / Diver, Sarah / Porsbjerg, Celeste / Griffiths, Janet M / Newell, John D / Peterson, Samuel / Pawlikowska, Beata / Parnes, Jane R / Megally, Ayman / Colice, Gene / Brightling, Christopher E

    NEJM evidence

    2023  Volume 2, Issue 10, Page(s) EVIDoa2300135

    Abstract: Tezepelumab and Mucus Plugs in Patients with AsthmaMucus plugs in airways of asthma patients are associated with airway obstruction and the activity of inflammatory cytokines. This article reports prespecified and post hoc analyses of the effect of ... ...

    Abstract Tezepelumab and Mucus Plugs in Patients with AsthmaMucus plugs in airways of asthma patients are associated with airway obstruction and the activity of inflammatory cytokines. This article reports prespecified and post hoc analyses of the effect of tezepelumab treatment on mucus plugs identified by computed tomography imaging in patients with moderate-to-severe asthma. At baseline, mucus plug scores correlated positively with levels of inflammatory biomarkers and negatively with lung function measures. Patients treated with tezepelumab had resolution of more mucus plugs than patients taking placebo.
    MeSH term(s) Humans ; Airway Obstruction/complications ; Antibodies, Monoclonal, Humanized/therapeutic use ; Asthma/complications ; Mucus
    Chemical Substances Antibodies, Monoclonal, Humanized ; tezepelumab (RJ1IW3B4QX)
    Language English
    Publishing date 2023-09-20
    Publishing country United States
    Document type Clinical Trial ; Journal Article
    ISSN 2766-5526
    ISSN (online) 2766-5526
    DOI 10.1056/EVIDoa2300135
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  10. Article ; Online: Tezepelumab reduces exacerbations across all seasons in patients with severe, uncontrolled asthma (NAVIGATOR).

    Pavord, Ian D / Hoyte, Flavia C L / Lindsley, Andrew W / Ambrose, Christopher S / Spahn, Joseph D / Roseti, Stephanie L / Cook, Bill / Griffiths, Janet M / Hellqvist, Åsa / Martin, Nicole / Llanos, Jean-Pierre / Martin, Neil / Colice, Gene / Corren, Jonathan

    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

    2023  Volume 131, Issue 5, Page(s) 587–597.e3

    Abstract: Background: Asthma exacerbation frequencies vary throughout the year owing to seasonal triggers. Tezepelumab is a human monoclonal antibody that targets thymic stromal lymphopoietin. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab ... ...

    Abstract Background: Asthma exacerbation frequencies vary throughout the year owing to seasonal triggers. Tezepelumab is a human monoclonal antibody that targets thymic stromal lymphopoietin. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) vs placebo in patients with severe, uncontrolled asthma.
    Objective: To evaluate the effect of tezepelumab on asthma exacerbations across all seasons in NAVIGATOR patients (post hoc).
    Methods: NAVIGATOR was a multicenter, randomized, double-blind, placebo-controlled study. Patients (12-80 years old) were randomized 1:1 to tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. AAER over 52 weeks was assessed by season. Data from patients in the Southern Hemisphere were transformed to align with Northern Hemisphere seasons.
    Results: Tezepelumab reduced the AAER vs placebo by 63% (95% confidence interval [CI], 52-72) in winter, 46% (95% CI, 26-61) in spring, 62% (95% CI, 48-73) in summer, and 54% (95% CI, 41-64) in fall. In matched climates, during the spring allergy season (March 1 to June 15) and ragweed allergy season (September), tezepelumab reduced the AAER vs placebo in patients with seasonal allergy by 59% (95% CI, 29-77) and 70% (95% CI, 33-87), respectively. In patients with perennial allergy and in those with seasonal allergy, tezepelumab reduced the AAER vs placebo across all seasons.
    Conclusion: Tezepelumab reduced exacerbations across all seasons vs placebo in patients with severe, uncontrolled asthma, including patients with seasonal and perennial allergies. These data further support the efficacy of tezepelumab in a broad population of patients with severe, uncontrolled asthma.
    Trial registration: ClinicalTrials.gov Identifier: NCT03347279 (https://clinicaltrials.gov/ct2/show/NCT03347279).
    MeSH term(s) Humans ; Child ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Aged ; Aged, 80 and over ; Seasons ; Anti-Asthmatic Agents/therapeutic use ; Asthma/drug therapy ; Antibodies, Monoclonal, Humanized/therapeutic use ; Double-Blind Method
    Chemical Substances tezepelumab (RJ1IW3B4QX) ; Anti-Asthmatic Agents ; Antibodies, Monoclonal, Humanized
    Language English
    Publishing date 2023-08-23
    Publishing country United States
    Document type Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1228189-x
    ISSN 1534-4436 ; 0003-4738 ; 1081-1206
    ISSN (online) 1534-4436
    ISSN 0003-4738 ; 1081-1206
    DOI 10.1016/j.anai.2023.08.015
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