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J Asthma Allergy. 2021 Aug 16;14:1045-1063. doi: 10.2147/JAA.S318892. eCollection 2021.

Short-Term Subcutaneous Allergy Immunotherapy and Dupilumab are Well Tolerated in Allergic Rhinitis: A Randomized Trial.

Journal of asthma and allergy

Jonathan Corren, Sarbjit S Saini, Remi Gagnon, Mark H Moss, Gordon Sussman, Joshua Jacobs, Elizabeth Laws, Elinore S Chung, Tatiana Constant, Yiping Sun, Jennifer Maloney, Jennifer D Hamilton, Marcella Ruddy, Claire Q Wang, Meagan P O'Brien

Affiliations

  1. Departments of Medicine and Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  2. Department of Internal Medicine, Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center, Baltimore, MD, USA.
  3. Clinique Spécialisée en Allergie de la Capitale, Québec, QC, Canada.
  4. Departments of Medicine and Pediatrics, Division of Allergy, Pulmonary and Critical Care, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
  5. Department of Medicine, University of Toronto, Toronto, ON, Canada.
  6. Allergy and Asthma Clinical Research, Inc, Walnut Creek, CA, USA.
  7. Sanofi, Bridgewater, NJ, USA.
  8. Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA.

PMID: 34429614 PMCID: PMC8379710 DOI: 10.2147/JAA.S318892

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%];

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.

© 2021 Corren et al.

Keywords: dupilumab; nasal allergen responses; seasonal allergic rhinitis; subcutaneous immunotherapy

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