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This section focuses on recent advances in the epidemiology, diagnosis, and treatment of various diseases including new therapies’ efficacy and safety from clinical trial data, including newly FDA-approved treatments and indications.

Dupilumab Reduces Type 2 Inflammation, May Offer Clinical Benefits for Multiple Comorbid Diseases

Dupilumab Reduces Type 2 Inflammation, May Offer Clinical Benefits for Multiple Comorbid Diseases

Existing data has already proven the benefits of dupilumab, a fully human monoclonal antibody, for the treatment of atopic dermatitis (AD) but the latest research indicating its success reducing type 2 inflammation could offer expanded clinical benefits for multiple comorbid diseases, including asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and potentially eosinophilic esophagitis (not an official indication, trials are underway).1 

In a recent study, Boguniewicz and colleagues2 sought to assess dupilumab’s impact on asthma and sinonasal conditions in adult patients with moderate to severe AD. Four randomized, double-blind, placebo-controlled trials were conducted—LIBERTY AD SOLO 1 (NCT02277743), SOLO 2 (NCT02755649), CHRONOS (NCT02260986), and CAFÉ (NCT02755649).

In each trial, participants either received a placebo or 300 mg of dupilumab every 2 weeks, or 300 mg of dupilumab weekly. Patients enrolled in the CHRONOS and CAFÉ trials also received concomitant topical corticosteroids.

This post hoc analysis assessed Asthma Control Questionnaire-5 (ACQ-5) scores in patients with asthma, Sino-Nasal Outcome Test-22 (SNOT-22) scores in patients with sinonasal conditions, and AD signs and symptoms in all patients.2

At baseline, 463 of 2444 included patients has asthmas (ACQ-5 ≥ 0.5 [19%]), 1171 had sinonasal conditions (48%); and 311 had both (13%).

According to the study’s findings, ACQ-5 scores at week 16 had improved by 0.27 (0.07) in the placebo group, 0.59 (0.08) in the 300 mg every 2 weeks group, and 0.56 (0.07) in the 300 mg weekly dose group for patients with asthma. SNOT-22 scores improved by 5.1 (0.8), 9.9 (0.9), and 10.8 (0.8), respectively, in patients with sinonasal conditions (P<.01 for all dupilumab vs placebo).

Boguniewicz and colleaguesobserved improvements in ACQ-5 and SNOT-22 in patients with both conditions and dupilumab significantly improved AD signs and symptoms among all subgroups.

“In this first analysis of patients with comorbid moderate to severe AD, asthma, and/or chronic sinonasal conditions, dupilumab improved all three diseases in a clinically meaningful and statistically significant manner (vs placebo), based on validated outcome measures,” concluded researchers.

Rabe and colleagues3 confirmed in a recent analysis that dupilumab was successful at reducing severe exacerbations and improving lung function in patients with uncontrolled, moderate-to-severe asthma with a type 2 phenotype defined by multiple parameters as per GINA guidelines. 

"In the United States and Europe, [dupilumab] is approved for patients 6 years and older with moderate-to-severe atopic dermatitis, patients 12 years and older with moderate-to-severe asthma, and in adults with uncontrolled CRSwNP," states Sanofi in a press release. "[Dupilumab] is also approved in one or more of these indications in more than 60 countries around the world and more than 200,000 patients have been treated globally."1

Further research is being conducted to evaluate the potential of clinical remission in patients with moderate-to-severe diseases with type 2 inflammation. Additionally, clinical investigations are still underway for the use of dupilumab for eosinophilic esophagitis. 

References: 

  1. New Dupixent® (dupilumab) data showcasing improvements across four type 2 inflammatory diseases to be presented at 2021 AAAAI Annual Meeting [press release published February 1, 2021]. Accessed July 14, 2021. https://www.news.sanofi.us/2021-02-01-New-Dupixent-R-dupilumab-data-showcasing-improvements-across-four-type-2-inflammatory-diseases-to-be-presented-at-2021-AAAAI-Annual-Meeting
  2. Boguniewicz M, Beck LA, Sher L, et al. Dupilumab improves asthma and sinonasal outcomes in adults with moderate to severe atopic dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi:10.1016/j.jaip.2020.12.059.
  3. Rabe K, Fitzgerald JM, Castro M, et al. Dupilumab efficacy in GINA-defined difficult-to-treat type 2 asthma patients in the LIBERTY ASTHMA QUEST study. 2021;147(2):AB59. J Allergy Clin Immunol Pract. doi:10.1016/j.jaci.2020.12.237