AI Article Synopsis
- The study investigates the combined effects of subcutaneous immunotherapy (SCIT) and Dupilumab on patients with seasonal allergic rhinitis (SAR) who are unresponsive to standard treatments.
- Although SCIT+Dupilumab did not significantly reduce nasal symptoms compared to SCIT alone, it demonstrated improved treatment tolerability, with fewer patients needing epinephrine rescue and higher rates of achieving the maintenance dose.
- The results suggest that adding Dupilumab to SCIT may enhance overall patient adherence and comfort without significantly improving immediate allergy response symptoms.
Article Abstract
Background: Subcutaneous immunotherapy (SCIT) has been proven as an effective therapy against some allergens for seasonal allergic rhinitis (SAR) patients unresponsive to intranasal corticosteroids and/or antihistamines but carries risk of systemic allergic reactions. Dupilumab blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation in multiple diseases.
Objective: To evaluate the efficacy and safety of SCIT+dupilumab vs SCIT alone.
Methods: This phase 2a, multicenter, double-blind, placebo-controlled parallel-group study conducted in 103 adults with grass pollen-induced SAR (NCT03558997) randomized patients 1:1:1:1 to SCIT, dupilumab (300 mg every 2 weeks), SCIT+dupilumab, or placebo. SCIT was administered using an 8-week cluster protocol followed by 8 weeks of maintenance injections. Primary endpoint was change from pre-treatment baseline in area under the curve (AUC) in total nasal symptom score (TNSS) 0-1 h following nasal allergen challenge (NAC) with timothy grass extract at Week 17.
Results: Although 16 weeks of treatment with SCIT+dupilumab did not significantly improve TNSS AUC (0-1 h) following NAC at Week 17 vs SCIT (least squares mean -56.76% vs -52.03%), a higher proportion of SCIT+dupilumab-treated patients (61.5%) achieved SCIT maintenance dose vs SCIT (46.2%). A lower proportion of SCIT+dupilumab-treated patients (7.7%) required epinephrine rescue treatment vs SCIT (19.2%). There were significantly fewer withdrawals in the SCIT+dupilumab group than in the SCIT group (n = 2 [7.7%] vs n = 8 [30.8%]; = 0.0216); the majority of SCIT group withdrawals were due to SCIT-related intolerability, compared with no discontinuations from the SCIT+dupilumab group.
Conclusion: In SAR patients, 16 weeks of SCIT+dupilumab may improve SCIT tolerability but did not incrementally reduce post-allergen challenge nasal symptoms compared with SCIT alone.
Clinical Study Number: NCT03558997.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8379710 | PMC |
| http://dx.doi.org/10.2147/JAA.S318892 | DOI Listing |
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