ATLANTA — Patients with asthma who were treated with Xolair reported fewer exacerbations and other improvements, according to findings presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology.
“Real-world data are important to supplement clinical trial data in heterogeneous diseases like asthma,” Bradley W. Chipps, MD, of the Capital Allergy and Respiratory Disease Center, Sacramento, California, and colleagues wrote. “We report the results of a U.S.-based, multicenter, prospective, 48-week observational registration of patients with allergic asthma using [omalizumab (Xolair, Genentech, Novartis)].”
Bradley W. Chipps
Chipps and colleagues reported the efficacy of Xolair, the first biologic drug approved for asthma treatment, from the Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab, or PROSPERO.
They enrolled patients that were identified as omalizumab candidates by their treating physicians and who had access to the treatment through insurance or another funding source. All participants were aged 12 and older, and the mean age of the participants was 47.3 years. Sixty-four percent were female, 70% were white and 16% were black. According to the researchers, before PROSPERO, these patients reported a mean of three asthma exacerbations in the previous year that required hospitalization, an ED visit or oral corticosteroid use, with 61% of participants having two or more, and 22% reporting one or more. Of the 806 patients who started the study, 77% completed PROSPERO.
The researchers found that at month 12, a mean of 0.8 exacerbations was recorded among remaining participants, with 19% reporting two or more and 4% reporting one or more. They also wrote that predictors of experiencing an exacerbation included lower forced expiratory volume1, higher fractional exhaled nitric oxide and an exacerbation in the past year at baseline, and that the baseline elevation of a type 2 biomarker was associated with forced expiratory volume1,improvement (+70 to 90 mL in patients aged 18 years and older).
Chipps and colleagues also reported that adverse events were consistent with those on omalizumab’s label during PROSPERO. According to the drug’s website, these include viral upper and upper respiratory tract infection, cough, nausea, arthralgia, sinusitis, headache, and nasopharyngitis; these were reported in 2% or more of patients during clinical studies.
Another presentation at this year’s annual meeting of the American Academy of Allergy Asthma & Immunology showed what researchers called the first-ever data on use trends involving omalizumab. The drug was the first asthma biologic when it went on the market in 2003. – by Janel Miller
Chipps, BW, et al. Abstract 25. Presented at: American Academy of Allergy, Asthma and Immunology Annual Meeting; March 3-6, 2017; Atlanta.
http://www.xolair.com/ciu/hcp/adverse-reactions-safety.html (accessed 02-24-17)
Disclosure: Chipps reports disclosures related to Merck, Boehringer Ingelheim, Novartis, AstraZeneca, Genentech, Meda and the American Academy of Allergy, Asthma & Immunology. Healio Family Medicine was unable to confirm the other researchers’ disclosures prior to publication.