Pulmonology Month in Review: May 2024

In May 2024, a series of notable studies were published in the field of pulmonary health, many of which covered frequently-discussed subjects such as electronic cigarette (e-cigarette) use and chronic obstructive pulmonary disease (COPD). These recent findings allow for

In this Month in Review article, the HCPLive editorial team highlighted several of the most significant stories covered in May in the pulmonology field. Here, new research into COPD treatment options, a potential new medication for curbing e-cigarette use, and the impact of lung abnormalities were covered in depth.

FDA Extends Dupilumab COPD Decision to September 2024

One significant story in May within the pulmonology space was the announcement that the US Food and Drug Administration (FDA) had decided to extend their target action date for the priority review designated for Regeneron Pharmaceutical and Sanofi’s dupilumab (Dupixent) indication as an add-on treatment for adults with uncontrolled COPD.

A press release by Regeneron indicated that FDA officials had not expressed concerns related to dupilumab’s validity in treating patients for this indication, but simply asked for an increase in efficacy analyses from the pivotal BOREAS and NOTUS studies. The newly-determined PDUFA date for the drug’s supplemental Biologic License Application (sBLA) for COPD was shifted from June 27 to September 27 of 2024.

NOTUS Trial Confirms Dupixent Benefit in COPD with Type 2 Inflammation

In another story related to the topic of dupilumab, the drug was found in a recent study to be linked to exacerbation reductions and improved lung function versus placebo among individuals with type 2 inflammation and COPD. This research was drawn from the aforementioned NOTUS trial and the findings presented at the 2024 American Thoracic Society International Conference.

The NOTUS trial investigators found that those with both COPD and a blood eosinophil count of 300 cells per microliter were able to see a 34% reduction of their exacerbation rate. Additionally, the research team noted a statistically significant benefit for patients’ prebronchodilator forced expiratory volume in 1 second (FEV1) change versus that of the placebo arm.

“In NOTUS, dupilumab reduced exacerbations by a magnitude never seen before with an investigational biologic in a phase 3 COPD clinical trial,” coprincipal investigator Surya Bhatt, MD, MSPH, professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama at Birmingham, said in a statement. “These comprehensive results reinforce that, if approved, dupilumab could provide a first-of-its-kind medical advancement for the COPD community.”

Cytisinicline, a Plant-Based Medication, Could Help Curb E-Cigarette Use Among Adults Patients

Another major study covered in May was the ORCA-V1 trial, a study which showed that a plant-based medication known as cytisinicline could potentially improve the condition of adult patients with e-cigarette (vaping) dependence.

The team was led by Nancy Rigotti, MD, the director of the Tobacco Research and Treatment Center at Massachusetts General Hospital and professor of Medicine at Harvard Medical School. Rigotti et al. involed over 150 adult subjects in their research who had reported e-cigarette use, finding that cytisinicline implementation led to a greater proportion of subjects achieving vaping discontinuation relative to placebo.

"Many people who use e-cigarettes want to quit but find it difficult due to nicotine dependence. They need help to stop vaping, yet no FDA-approved medication is currently available to help them do so," Rigotti concluded in a statement. "Cytisinicline has been shown in clinical trials to be effective and safe to help adults stop smoking cigarettes.”

Smokers with Lung Abnormalities More Likely to Report Severe Acute Respiratory Disease Events

New research covered in May also found that cigarette-smokers who had quantitative interstitial abnormalities (QIAs), observed in their CT scans, had been shown to be more likely to have severe acute respiratory disease (ARD) events. The investigators, led by Bina Choi, MD, of Brigham and Women’s Hospital, had sought to evaluate whether QIA progression within subjects’ CT scans had a link to ARD or severe ARD reports among those who have a smoking history.

“Although many ARD events are likely related to airway disease and COPD, some may instead be associated with QIA,” Choi et al. wrote. “Thus, the aim of the current study was to determine whether QIA progression at CT is associated with ARD and severe ARD events in individuals with a history of smoking.”

Vaping Frequency in Teen Years Connected to Risk of Exposure to Toxic Lead, Uranium

In another recent study, led by Andrew Kochvar of the University of Nebraska Medical Center, vaping done in the early period of patients’ lives was shown to potentially increase their metal exposure risk. This was noted by Kochvar et al. as potentially resulting in brain and organ development harms.

While positive links had been previously found between cigarettes and levels of uranium, the investigators of this study noted a lack of objective assessment of metals exposure among adolescents who vaped.

“This study analysed a national probability sample of adolescents aged 13–17 years to assess metal exposure among adolescent e-cigarette users with two primary research questions: (1) Are metal concentration levels positively associated with the frequency of e-cigarette use? (2) Does the metal exposure vary by e-cigarette flavour type used?” Kochvar et al. wrote.