AstraZeneca drug reduces lung disease flare-ups in late-stage trials

A drug being developed by AstraZeneca **AZN.L** significantly reduced flare-ups of chronic obstructive pulmonary disease in two late-stage trials, researchers reported on Tuesday at the medical meeting in Barcelona. Patients receiving Astra's tozorakimab during the year-long studies experienced about 29% to 34% fewer moderate-to-severe COPD exacerbations than those receiving a placebo, the researchers reported. Overall rates of moderate or severe exacerbations among former and current smokers in the two trials were 1.41 and 1.44 events, respectively, in patients receiving tozorakimab compared with 2.00 and 2.03 events, respectively, in those receiving a placebo. "Reducing exacerbations is one of the most important goals in the treatment of COPD because flare-ups have a profound impact on patients' health, quality of life and long-term outcomes," study leader Dr. Frank Sciurba of the University of Pittsburgh said in a statement. The trials involved 1,750 current or former smokers with COPD flares during the previous year. They all received standard therapy plus either tozorakimab or a placebo. Tozorakimab, a monoclonal antibody injected under the skin every four weeks, targets interleukin-33, a protein involved in airway inflammation and mucus production. The AstraZeneca drug was effective regardless of patients’ smoking status, severity of lung impairment, or levels of eosinophils, a type of blood cell that contributes to COPD symptoms, according to the researchers. Overall safety profiles were generally similar, the studies also found. “Our study data and results will now be under consideration by the U.S. Food and Drug Administration for approval to use... outside of a clinical trial,” Sciurba said. “It is encouraging to have an additional, safe therapy for patients who often struggle to breathe.” The data was also published in *The New England Journal of Medicine* to coincide with the presentation. People with a form of severe asthma show subtle differences in the structure of their brains compared with patients whose asthma is well-controlled, investigators reported in Barcelona at the respiratory meeting. Severe type-2 asthma is driven by an overactive immune response that causes persistent inflammation, frequent asthma attacks and breathing difficulties. Many patients require multiple medications, and sometimes even intensive therapy is ineffective. About 5% to 10% of people with asthma have severe asthma, and about 70% of those have type 2 asthma, previous research has found. For the new study, 50 people with severe type-2 asthma and 25 with well-controlled mild or moderate type-2 asthma underwent a special type of magnetic resonance imaging that can reveal the microscopic structure of the brain’s white matter pathways, which act as its communication network, connecting different regions. People with severe asthma had less-well-organized white matter than those with well-controlled asthma. The degree of white matter change was linked to levels of inflammation, suggesting a possible connection between inflammation associated with severe asthma and changes in the brain. The team also identified differences in the size of specific structures, such as the hippocampus, and brain regions such as the temporal lobes, in people with severe type-2 asthma. While this study cannot prove that inflammation caused these changes, it does suggest there may be a biological link that deserves further investigation, the researchers said. "One of the most important questions is whether these brain changes can be prevented or reversed,” study leader James Dodd of the University of Bristol in the UK said in a statement. “We hope our ongoing work will help answer that." The benefit of the high-dose influenza vaccine for older people in general also extends to those with chronic lung disease, lessening the risk of hospitalization, according to a new analysis. In two large randomized trials of patients above age 65, those with asthma, bronchitis, lung transplants, or other pulmonary conditions who received the high-dose flu shots had lower risks of hospitalization for flu or pneumonia than similar patients who received the standard vaccine, researchers reported at the European respiratory meeting. One trial ran in Denmark over three recent flu seasons and one ran in Spain over two flu seasons. Analysis of these trials has already shown that the high-dose vaccine, which delivers four times more of the active ingredient than the standard shot, is beneficial in older people overall. Altogether, the two trials involved nearly 470,000 volunteers, including nearly 32,000 with chronic lung diseases, who are known to be at particularly high risk for complications of respiratory infections. “Although high-dose flu vaccines are designed to produce a stronger immune response in older adults, there has been limited randomized evidence specifically showing whether they provide better protection against serious illness in people with chronic lung disease,” study leader Dr. Lisa Steen Duus from Gentofte Hospital in Copenhagen said in a statement. The high-dose vaccine reduced hospital admissions for flu or pneumonia by 8.8% compared with the standard-dose vaccine. The high-dose vaccine also reduced hospitalizations for other conditions compared to the standard-dose vaccine, the researchers found. “For older people with chronic lung disease and their families, these findings provide reassurance that high-dose flu vaccination can offer better protection against serious illness requiring hospital treatment than a standard-dose vaccine,” Duus said.

AstraZeneca drug reduces lung disease flare-ups in late-stage trials

Experimental drug reduces lung-disease flares

Severe asthma linked with structural brain changes

Older lung-disease patients should get high-dose flu shot

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