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

• Published in: Journal of asthma and allergy Vol. 14; pp. 1045 - 1063
• Main Authors: Corren, Jonathan, Saini, Sarbjit S, Gagnon, Remi, Moss, Mark H, Sussman, Gordon, Jacobs, Joshua, Laws, Elizabeth, Chung, Elinore S, Constant, Tatiana, Sun, Yiping, Maloney, Jennifer, Hamilton, Jennifer D, Ruddy, Marcella, Wang, Claire Q, O’Brien, Meagan P
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2021; Taylor & Francis Ltd; Dove; Dove Medical Press
• Subjects: Allergens; Allergic rhinitis; Allergies; Antihistamines; Asthma; Clinical outcomes; Clinical trials; Corticosteroids; Dosage; Drug dosages; Drug therapy; dupilumab; Epinephrine; Hay fever; Histamine; Immunotherapy; Interleukin 13; Interleukin 4; Interleukins; International organizations; Monoclonal antibodies; nasal allergen responses; Original Research; Patients; Pharmaceutical industry; Pharmacists; Placebos; Respiratory agents; Rhinitis; seasonal allergic rhinitis; Sinusitis; Steroids; subcutaneous immunotherapy; France; Canada; United Kingdom; nasal allergen responses; seasonal allergic rhinitis; subcutaneous immunotherapy; dupilumab
• ISSN: 1178-6965; 1178-6965
• DOI: 10.2147/JAA.S318892

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. To evaluate the efficacy and safety of SCIT+dupilumab vs SCIT alone. 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. 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. 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. NCT03558997.