Dr. Nick Hanania, associate professor of medicine and director the BCM Asthma Clinical Research Center, and colleagues studied whether lebrikizumab, an antibody to interleukin-13, a protein that plays a major role in the inflammation in the airways of asthmatics, would block the effects of the protein and have an effect on lung function or flare ups in asthmatics.
Better lung function
The phase II clinical trial looked at 219 adults with asthma who were already taking inhaled steroids and continued to suffer from asthma symptoms. After 12 weeks, those who received the once-a-month injection of lebrikizumab had better lung function as measured by a test called forced expiratory volume than those who received a placebo. However, there were no significant effects of this drug on asthma flare ups over the six months of the study.
Researchers also found that patients in the study who had a higher blood level of a biomarker periostin, a protein that reflects high interleukin-13 activity and causes a type of inflammation in asthma patients called eosinophilic inflammation, responded better to the drug than those who had lower levels of this biomarker. These findings suggest that a simple blood test can determine which asthma patients may have a positive response to the study medication.
“This information will be very helpful in the future in better defining the role of periostin in asthma and in differentiating the phenotypes, or the characteristics, of asthma,” said Hanania. “We know that not all asthmatics are the same as there are different types of airway inflammation in this disease, and we have never had a simple test that could help us identify who would and wouldn’t respond to agents like this new drug until now.”
Hanania also notes that the safety of the drug was promising compared to the placebo.
Quality of life
“This is a step forward in treating asthma patients,” said Hanania. “These findings could help the well being and quality of life for those on inhaled steroids who continue to suffer from asthma symptoms. Such symptoms can cause increased hospitalizations and emergency room visits, which result in a high cost for patients and the health care system.”
Lebrikizumab will need to be studied in a larger number of patients before it can be reviewed and approved by FDA and become available to patients.
Others who took part in this study include Dr. Jonathan Corren of Allergy Medical Clinic and Genentech; Dr. Robert F. Lemanske, Jr. of the University of Wisconsin School of Medicine and Public Health; Dr. Phillip E. Korenblat of the Clinical Research Center in St. Louis.Dr. Merdad V. Parsey of 3-V Biosciences; and Drs. Joseph R. Arron, Jeffrey M. Harris, Heleen Scheerens, Lawren C. Wu, Zheng Su, Sofia Mosesova, Mark D. Eisner, Sean P. Bohen and John G. Matthews of Genentech.
Funding for this study came from Genentech, a member of Roche group.