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• W3092753436 abstract "SESSION TITLE: Updates in the Management of Severe Asthma SESSION TYPE: Original Investigations PRESENTED ON: October 18-21, 2020 PURPOSE: Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin, an epithelial cytokine implicated in asthma pathogenesis. In the phase 2b PATHWAY study (NCT02054130), tezepelumab significantly reduced annualized asthma exacerbation rates (AAER) by up to 71% versus placebo in adults with severe, uncontrolled asthma. This post hoc analysis evaluated the effect of tezepelumab on AAER and forced expiratory volume in 1 second (FEV1) in patients from PATHWAY taking medium-dose (MD) or high-dose (HD) inhaled corticosteroids (ICS) at baseline. METHODS: Adults (18–75 years) with severe, uncontrolled asthma were randomized to receive subcutaneous tezepelumab (70mg every 4 weeks [Q4W], 210mg Q4W, 280mg every 2 weeks) or placebo for 52 weeks. AAER and FEV1 were determined in patients taking MD (250–500μg/day of fluticasone propionate [FP] or equivalent) or HD (>500μg/day FP or equivalent) ICS at baseline. Data are reported for tezepelumab 210mg and pooled tezepelumab doses. RESULTS: Overall, 550 patients were randomized to placebo (n=138) or tezepelumab 70mg (n=138), 210mg (n=137) or 280mg (n=137). Patients taking HD ICS (n=269) had more exacerbations in the prior year (mean: 2.6 vs 2.2), higher fractional exhaled nitric oxide levels (median: 24.3 vs 20.5 ppb) and lower post-bronchodilator FEV1 reversibility (median: 287.0 vs 340.0 mL) at baseline than those taking MD ICS (n=281), and higher occurrence of nasal polyps (18.6% vs 11.4%) and maintenance oral corticosteroid (OCS) use (18.6% vs 0.4%). Over 52 weeks, AAER in placebo-treated patients was higher in the HD ICS group than in the MD ICS group (1.12 [95% confidence interval (CI): 0.76–1.66] vs 0.38 [95% CI: 0.24–0.61], respectively). For tezepelumab 210mg, AAER was reduced by 77% (95% CI: 54–89) and 60% (95% CI: 8–83) versus placebo in the HD and MD ICS groups, respectively. Results were similar for pooled tezepelumab doses versus placebo (HD ICS, 74% [95% CI: 57–84]; MD ICS, 52% [95% CI: 12–73]). Compared with placebo, the least squares mean change from baseline in FEV1 at week 52 was 160mL (95% CI: 10–300) and 140mL (95% CI: 0–280) in patients taking HD and MD ICS, respectively, in the tezepelumab 210mg group, and 190mL (95% CI: 70–310) and 120mL (95% CI: 10–230), respectively, in the pooled tezepelumab dose group. CONCLUSIONS: Patients with severe, uncontrolled asthma taking HD ICS had more exacerbations in the prior year and higher baseline maintenance OCS use than those taking MD ICS, which is consistent with patients taking HD ICS having more severe disease. Treatment with tezepelumab reduced exacerbations and improved FEV1 versus placebo in both ICS dose groups, with a trend of greater effects in patients taking HD ICS. CLINICAL IMPLICATIONS: This study further supports the potential benefits of tezepelumab treatment in patients with severe, uncontrolled asthma, irrespective of pre-treatment maintenance ICS dose. DISCLOSURES: Employee relationship with AstraZeneca Please note: >$100000 Added 04/03/2020 by Christopher Ambrose, source=Web Response, value=Salary Employee relationship with AstraZeneca Please note: >$100000 Added 04/15/2020 by gene colice, source=Web Response, value=Ownership interest Employee relationship with AstraZeneca Please note: >$100000 Added 04/15/2020 by gene colice, source=Web Response, value=Salary Advisory Committee Member relationship with AstraZeneca Please note: $1001 - $5000 Added 04/14/2020 by Jonathan Corren, source=Web Response, value=Honoraria Consultant relationship with AstraZeneca Please note: $1001 - $5000 Added 04/14/2020 by Jonathan Corren, source=Web Response, value=Consulting fee Removed 04/14/2020 by Jonathan Corren, source=Web Response Speaker/Speaker's relationship with AstraZeneca Please note: $5001 - $20000 Added 04/14/2020 by Jonathan Corren, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Genetech Please note: $5001 - $20000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Honoraria Research funds relationship with Genetech Please note: $5001 - $20000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Grant/Research Support Research funds relationship with AstraZeneca Please note: $5001 - $20000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Grant/Research Support Board Member relationship with Novartis Please note: $1001 - $5000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Honoraria Research funds relationship with Novartis Please note: $5001 - $20000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Regeneron/Sanofi Please note: $5001 - $20000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Honoraria Board Member relationship with Regeneron/Sanofi Please note: $1001 - $5000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Honoraria Research funds relationship with Regeneron/Sanofi Please note: $5001 - $20000 Added 04/15/2020 by Jonathan Corren, source=Web Response, value=Grant/Research Support Employee relationship with Amgen Please note: >$100000 Added 04/23/2020 by Jane Parnes, source=Web Response, value=Salary Employee relationship with Amgen Please note: >$100000 Added 04/23/2020 by Jane Parnes, source=Web Response, value=Stock and stock options Employee relationship with AstraZeneca Pharma Poland Please note: $20001 - $100000 Added 05/26/2020 by Kinga Sałapa, source=Admin input, value=Salary" @default.
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• W3092753436 date "2020-10-01" @default.
• W3092753436 modified "2023-09-25" @default.
• W3092753436 title "THE EFFECT OF TEZEPELUMAB ON EXACERBATIONS IN PATIENTS WITH SEVERE, UNCONTROLLED ASTHMA ACCORDING TO BASELINE INHALED CORTICOSTEROID DOSE: RESULTS FROM THE PHASE 2B PATHWAY STUDY" @default.
• W3092753436 doi "https://doi.org/10.1016/j.chest.2020.08.070" @default.
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