FDA has cleared Nucala as an add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
The approval is based on data from GSK’s SYNAPSE study which evaluated the effect of Nucala versus placebo in over 400 patients with CRSwNP.
In this trial, Nucala achieved significant improvement in reducing the size of nasal polyps and nasal obstructions.
Out of the SYNAPSE study it was discovered that there was a 57% reduction in the proportion of patients who had surgery in the group treated with Nucala versus placebo.
The number of patients requiring systemic corticosteroid use during the 52-week treatment period was also lower in the group receiving Nucala treatment.
Chronic rhinosinusitis (CRS) is a 12 week or longer condition during which the sinuses get infected or irritated, become swollen, are severely congested and secrete mucus into the throat.
CRS also can cause facial pain, pressure and loss of smell, and in some cases, it may be associated with depression, anxiety, impaired sleep and low quality of life.
Although the factors leading to CRS are unknown, Johns Hopkins Medicine researchers have provided what may be the first evidence that long-term exposure to tiny particulate air pollution is one of them.
“We assessed patients experiencing chronic rhinosinusitis in areas where exposure to environmental air pollution known as PM2.5 — inhalable, particulate matter less than 2.5 micrometers in size [about 30 times smaller than the diameter of a human hair] —may have been high,” says lead author Murugappan “Murray” Ramanathan, M.D., rhinologist and associate professor of otolaryngology–head and neck surgery at the Johns Hopkins University School of Medicine.
According to the U.S. Environmental Protection Agency (EPA), PM2.5 (particulate matter) is the term for a mixture of solid particles and liquid droplets found in the air.
PM2.5 consists of many materials that vary with location, including dust, dirt, soot, smoke, organic compounds and metals.
In this study, the Johns Hopkins Medicine researchers looked at a population of 6,102 patients age 18 and older, including 2,034 with CRS who did not have the disorder for up to five years before it was diagnosed.
Mean PM2.5 exposures were calculated for each patient based on his or her residential address postal code at 12, 24, 36 and 60 months prior to CRS diagnosis.
Out it all, the research team found that patients exposed to higher PM2.5 concentrations over a long period of time were more likely to be diagnosed with CRS, regardless of how the exposure occurred.
For example, exposure over 60 months was associated with an approximately one-and-a-half-fold increase in developing the disorder. There also was a nearly five times greater risk of developing severe pansinusitis (inflammation in all four sinuses).
The Johns Hopkins Medicine team is conducting ongoing research to seek a better understanding of how race and socioeconomic status may contribute to air pollution exposure, and in turn, development of chronic rhinosinusitis.