Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma with fungal sensitization
© 2023 Sanofi. Clinical & Experimental Allergy published by John Wiley & Sons Ltd..
BACKGROUND: Fungal sensitization (FS) exacerbates asthma in patients who have elevated type 2 inflammatory response. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, key and central drivers of type 2 inflammation in multiple diseases.
OBJECTIVE: This post hoc analysis, funded by the manufacturers of dupilumab, was conducted to assess dupilumab efficacy in patients from the phase 3 LIBERTY ASTHMA QUEST trial (NCT02414854) and TRAVERSE open-label extension (NCT02134028) study who had uncontrolled, moderate-to-severe asthma with type 2 inflammatory phenotype (defined as blood eosinophil count ≥150 cells/μL or FeNO ≥25 ppb) and with FS (defined as IgE specific to Alternaria alternata, Aspergillus fumigatus or Cladosporium herbarum >0.35 IU/mL).
METHODS: We evaluated annualized rate of severe exacerbations (AER), change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 s (FEV1 ), asthma control (per 5-item Asthma Control Questionnaire [ACQ-5]) and biomarker levels (blood eosinophil count, fractional exhaled nitric oxide [FeNO], total IgE, fungal-specific IgEs, thymus and activation-regulated chemokine [TARC] and eotaxin-3).
RESULTS: Dupilumab vs. placebo reduced AER, improved pre-BD FEV1 and asthma control (ACQ-5), and reduced serum IgE levels, blood eosinophil count, TARC, eotaxin-3 and FeNO in patients both with and without FS after 52 weeks of treatment in QUEST. Reductions in asthma exacerbation rates and improvements in all other variables were sustained over the TRAVERSE open-label extension study.
CONCLUSION: Dupilumab demonstrated efficacy during prolonged treatment in patients with uncontrolled, moderate-to-severe asthma with FS.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:53 |
|---|---|
| Enthalten in: |
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology - 53(2023), 10 vom: 17. Okt., Seite 1020-1030 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Corren, Jonathan [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
37341-29-0 |
|---|
| Anmerkungen: |
Date Completed 09.10.2023 Date Revised 10.10.2023 published: Print-Electronic ClinicalTrials.gov: NCT02414854, NCT02134028 Citation Status MEDLINE |
|---|
| doi: |
10.1111/cea.14389 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM362489548 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM362489548 | ||
| 003 | DE-627 | ||
| 005 | 20231226091342.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1111/cea.14389 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1208.xml |
| 035 | |a (DE-627)NLM362489548 | ||
| 035 | |a (NLM)37752621 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Corren, Jonathan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma with fungal sensitization |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 09.10.2023 | ||
| 500 | |a Date Revised 10.10.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02414854, NCT02134028 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 Sanofi. Clinical & Experimental Allergy published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Fungal sensitization (FS) exacerbates asthma in patients who have elevated type 2 inflammatory response. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, key and central drivers of type 2 inflammation in multiple diseases | ||
| 520 | |a OBJECTIVE: This post hoc analysis, funded by the manufacturers of dupilumab, was conducted to assess dupilumab efficacy in patients from the phase 3 LIBERTY ASTHMA QUEST trial (NCT02414854) and TRAVERSE open-label extension (NCT02134028) study who had uncontrolled, moderate-to-severe asthma with type 2 inflammatory phenotype (defined as blood eosinophil count ≥150 cells/μL or FeNO ≥25 ppb) and with FS (defined as IgE specific to Alternaria alternata, Aspergillus fumigatus or Cladosporium herbarum >0.35 IU/mL) | ||
| 520 | |a METHODS: We evaluated annualized rate of severe exacerbations (AER), change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 s (FEV1 ), asthma control (per 5-item Asthma Control Questionnaire [ACQ-5]) and biomarker levels (blood eosinophil count, fractional exhaled nitric oxide [FeNO], total IgE, fungal-specific IgEs, thymus and activation-regulated chemokine [TARC] and eotaxin-3) | ||
| 520 | |a RESULTS: Dupilumab vs. placebo reduced AER, improved pre-BD FEV1 and asthma control (ACQ-5), and reduced serum IgE levels, blood eosinophil count, TARC, eotaxin-3 and FeNO in patients both with and without FS after 52 weeks of treatment in QUEST. Reductions in asthma exacerbation rates and improvements in all other variables were sustained over the TRAVERSE open-label extension study | ||
| 520 | |a CONCLUSION: Dupilumab demonstrated efficacy during prolonged treatment in patients with uncontrolled, moderate-to-severe asthma with FS | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a asthma | |
| 650 | 4 | |a dupilumab | |
| 650 | 4 | |a fungal sensitization | |
| 650 | 7 | |a dupilumab |2 NLM | |
| 650 | 7 | |a 420K487FSG |2 NLM | |
| 650 | 7 | |a Chemokine CCL26 |2 NLM | |
| 650 | 7 | |a Anti-Asthmatic Agents |2 NLM | |
| 650 | 7 | |a Immunoglobulin E |2 NLM | |
| 650 | 7 | |a 37341-29-0 |2 NLM | |
| 700 | 1 | |a Hanania, Nicola A |e verfasserin |4 aut | |
| 700 | 1 | |a Busse, William W |e verfasserin |4 aut | |
| 700 | 1 | |a Sher, Lawrence D |e verfasserin |4 aut | |
| 700 | 1 | |a Altincatal, Arman |e verfasserin |4 aut | |
| 700 | 1 | |a Hardin, Megan |e verfasserin |4 aut | |
| 700 | 1 | |a Mannent, Leda P |e verfasserin |4 aut | |
| 700 | 1 | |a Amin, Nikhil |e verfasserin |4 aut | |
| 700 | 1 | |a Lederer, David J |e verfasserin |4 aut | |
| 700 | 1 | |a Soler, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a Jacob-Nara, Juby A |e verfasserin |4 aut | |
| 700 | 1 | |a Rowe, Paul J |e verfasserin |4 aut | |
| 700 | 1 | |a Deniz, Yamo |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology |d 1990 |g 53(2023), 10 vom: 17. Okt., Seite 1020-1030 |w (DE-627)NLM012617121 |x 1365-2222 |7 nnns |
| 773 | 1 | 8 | |g volume:53 |g year:2023 |g number:10 |g day:17 |g month:10 |g pages:1020-1030 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1111/cea.14389 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 53 |j 2023 |e 10 |b 17 |c 10 |h 1020-1030 | ||