Comparing Baseline Characteristics of Patients with Chronic Rhinosinusitis with Nasal Polyps with and without Asthma in the AROMA Registry
Bibliographic record
Abstract
Anju T Peters,1 Enrico Heffler,2,3 Kathleen M Buchheit,4 Shigeharu Fujieda,5 Scott Nash,6 Changming Xia,6 Micah W Johnson,6 Mark Corbett,7 Lucia De Prado Gomez,8 Juby A Jacob-Nara,7 Amr Radwan9 1Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; 2Personalized Medicine, Asthma and Allergy, Humanitas Research Hospital, Milan, Italy; 3Department of Biomedical Sciences - Humanitas University, Pieve Emanuele, Milan, Italy; 4AERD Center, Division of Allergy and Clinical Immunology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; 5Department of Otorhinolaryngology, Head and Neck Surgery, University of Fukui, Fukui, Japan; 6Immunology & Inflammation, Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA; 7Global Medical Immunology, Sanofi, Morristown, NJ, USA; 8Global Medical Immunology, Sanofi, Madrid, Spain; 9Immunology & Inflammation, Regeneron Pharmaceuticals Inc., Uxbridge, United KingdomCorrespondence: Anju T Peters, Feinberg School of Medicine, Northwestern University, McGaw Pavilion Suite M-316, 240 E Huron, Chicago, IL, 60611, USA, Tel +1-312-695-4000, Email anjupeters@northwestern.eduBackground: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease of the nose and paranasal sinuses. Asthma is a common coexisting condition, associated with more severe sinus disease and reduced quality of life. Treating patients with uncontrolled CRSwNP and coexisting asthma is currently challenging.Objective: To compare baseline characteristics and disease burden in patients with CRSwNP with and without coexisting asthma in AROMA.Methods: AROMA is a prospective global registry study recruiting adult patients with severe CRSwNP who initiate dupilumab and follows them for up to 36 months. All patients entering the registry were assessed for baseline demographics and disease characteristics.Results: As of February 2023, the study had enrolled 303 patients, with 210 (69.3%) patients reporting coexisting asthma. Of the patients with asthma, 11.0% reported ongoing oral/systemic corticosteroid use at baseline, and 29.0% had at least 1 severe asthma exacerbation in the year before screening.Conclusion: More than two-thirds of adults with CRSwNP who initiated dupilumab in AROMA have coexisting asthma. Of these patients, one-third reported at least 1 severe asthma exacerbation in the past year.Plain Language Summary: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition that causes partial or complete blockage of the nose, making it difficult to breathe. This has a negative effect on many aspects of a person’s life, and a person with severe CRSwNP is more likely to be affected by diseases such as asthma. People with asthma and CRSwNP are more likely to have severe forms of both diseases, making both conditions challenging to treat. A drug called dupilumab, which is injected under the skin every other week, has been approved for treating people with both CRSwNP and asthma. This article presents initial findings from a large study called AROMA, which observed people with severe CRSwNP for 3 years after beginning dupilumab treatment. The study also looked at the characteristics of patients with CRSwNP and asthma before they began dupilumab treatment. The initial findings showed that 1 in 3 people with CRSwNP and asthma had at least 1 severe asthma attack in the year before beginning dupilumab treatment. People in the study with CRSwNP and asthma were more likely to take steroids than people with just CRSwNP. Keywords: asthma, chronic rhinosinusitis with nasal polyps, dupilumab, real-world evidence, type 2 inflammation
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".