Dupilumab, a fully human monoclonal antibody, blocks the receptors for interleukins 4/13, key and central drivers of type 2 inflammation. Clinical trials demonstrated the safety and efficacy of dupilumab in patients with moderate-to-severe asthma. Here, we aim to describe baseline characteristics of patients initiating dupilumab for asthma, to characterize its safety and effectiveness in real-world clinical practice. REVEAL (pRospEctiVe charactErization of asthma patients treated with dupilumAb in a reaL-world setting; NCT04550962) is a longitudinal, prospective, 3-year observational study of patients aged ≥12 years prescribed dupilumab for asthma in Latin America, the Middle East, Russian Federation, and Singapore per country-specific prescribing information. Of 376 patients enrolled, 374 were included in the effectiveness analysis set. Most were female (62.6%), white (50.3%), and non-Hispanic or Latino (51.3%). Mean (standard deviation SD) age was 47.8 (13.89) years. Tobacco use was rare; 312 (83.4%) patients were never smokers. Most were classified as Global Initiative for Asthma step 4 (17.8%) or 5 (69.5%). Mean (SD) number of prior-year severe exacerbations was 2.0 (4.53) (n = 374). Mean (SD) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) was 2.2 L (0.83) (n = 306) and 2.3 L (0.86) (n = 212), respectively. Mean (SD) pre-bronchodilator FEV1/forced vital capacity (FVC) ratio was 0.7 (0.13) (n = 301). 242 (64.7%); 231 (61.8%) patients reported allergic rhinitis and chronic rhinosinusitis with nasal polyposis history. Median (Q1–Q3) blood eosinophil counts were 390.0 cells/µL (185.0–700.0) (n = 348) and fractional exhaled nitric oxide levels were 34.0 parts per billion (19.0–60.0) (n = 314). Patients prescribed dupilumab in routine clinical practice were predominantly adult women with severe asthma. Frequent severe exacerbations, high prevalence of coexisting type 2 inflammatory conditions, and elevated type 2 inflammatory biomarkers suggest disease burden is high among patients initiating dupilumab for asthma. ClinicalTrials.gov Identifier, NCT04550962. Standard asthma treatments do not always prevent asthma attacks or improve breathing. Dupilumab is a newer prescription medicine used to treat patients with moderate-to-severe asthma who have an overreaction of their immune system called type 2 inflammation. In clinical trials, dupilumab reduced asthma attacks and improved breathing in patients with moderate-to-severe asthma. The REVEAL registry is a study observing how patients with asthma in the Middle East, Latin America, Russian Federation, and Singapore respond to dupilumab outside of clinical trial settings. The average patient had uncontrolled, severe asthma on enrollment. We summarized the characteristics of 374 enrolled patients before they started dupilumab; 60% were from the Middle East, nearly 60% were women, and half were white. More than 80% reported no history of smoking and, on average, patients were overweight. In the year before REVEAL, despite taking their medicine, patients had an average of two severe asthma attacks. Breathing tests showed moderate asthma in most patients. Most (72%) had high numbers of blood eosinophils (an inflammatory white blood cell) and 55% had elevated fractional exhaled nitric oxide (FeNO; a marker of lung inflammation in breath), indicating presence of type 2 inflammation, common in many people with asthma. Several patients had other health problems related to type 2 inflammation, most commonly allergic rhinitis (runny nose, sneezing, and itchy eyes caused by allergies), seen in 65% of patients. Overall, patients starting dupilumab in the real world had features of uncontrolled, severe asthma, including frequent asthma attacks and type 2 inflammation.
Máspero et al. (Wed,) studied this question.