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Lebrikizumab improved asthma exacerbations vs. placebo

SAN DIEGO — A subset of patients with severe asthma are inadequately controlled despite treatment with inhaled corticosteroids and a second controller, according to data from a late-breaking abstract presentation here.

“As we all know, uncontrolled asthma is a major issue and despite the fact we have good drugs, many patients still have symtpoms. We also know a majority of asthmatics Th2 cytokines play a major role; whether they are IL-13, IL-5 and IL-4, and contirbute to airway inflammation and hyper responsiveness in many patients with asthma,” Nicola A. Hanania, MD, associate professor of medicine and director of the Asthma Clinical Research Center at Baylor College of Medicine, said during a presentation at the 2014 American Academy of Allergy, Asthma & Immunology annual meeting.

According to Hanania, lebrikizumab is a humanized antibody to interleukin (IL)-13. Previous Phase 2 data indicated lebrikizumab increased forced expiratory volume in one second (FEV1), particularly among those with greater blood periostin levels.

Hanania and colleagues conducted two multicenter, double blind studies which randomly assigned patients (n=463) with uncontrolled asthma to lebrikizumab 37.5-mg (n=117), 125-mg (n=112), 250-mg (n=118), or placebo (n=116) in a 1:1:1:1 fashion, every four weeks, according to data.

The primary endpoint was the rate of exacerbations, and secondary endpoints included changes to FEV1, Hanania said.

The exacerbation rate was reduced by 62% (95% CI, 23-83) in patients assigned to 37.5-mg; 35% (95% CI, –17-65) in those assigned 125-mg, and 11% (95% CI, –54-49) in patients assigned to 250-mg, according to data.

In those with greater blood periostin levels (≥50 ng/mL), exacerbations were reduced by 81% (95% CI, 35-97) in those assigned to 37.5-mg; 77% (95% CI, 26-95) in those assigned to 125-mg; and 22% (95% CI, –62-63) in patients assigned to 250-mg, according to data.

Twelve-week data indicated improvements to FEV1 levels compared with placebo, especially in those with high periostin levels. No significant safety concerns were reported, according to data.

“The difference beween lebrikizumab treatment and placebo is that lebrikizumab reduced the rate of exacerbations and increased FEV1 in periostin-high patients with uncontrolled asthma who are treated with ICS and a second controller. These results were consistent with a previous phase 2 study published two years ago,” he said.

Currently, phase 3 trials are being initiated at multiple centers around the world, according to Hanania. – by Samantha Costa

For more information:

Hanania NA. #L16. Presented at the American Academy of Allergy, Asthma & Immunology annual meeting; Feb. 28-March 4, 2014; San Diego.

Disclosure: Hanania reports financial ties with NIH, AstraZeneca, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Mylan, and Pearl.