Just 16 months after the FDA approved AstraZeneca’s Fasenra for a severe form of asthma, investigators at the NIH have found that the drug appears to hold great promise for treating rare chronic immune disorders called hypereosinophilic syndromes, or HES.
The team led by Amy Klion, chief of the Human Eosinophil Section in the NIAID Laboratory of Parasitic Disease, followed a familiar path with this drug, which has already proved its ability to flag eosinophils for destruction, warranting the approval in the fall of 2017 for severe asthma associated with eosinophils in the lungs.
In HES, patients suffer from an overabundance of eosinophils in blood and tissue, affecting hearts, lungs and other organs.
Recruiting 20 HES patients, who have no specifically approved therapy for their condition, the researchers first divided the group into a drug arm and a placebo segment, then provided the drug for all 20 during the next phase of the study.
They found that in the first part of the study, 9 of 10 HES patients on Fasenra came out with undetectable levels of eosinophils, compared to a drop of 50% or more in 3 patients in the placebo arm. In the second phase of the study, 17 of 19 patients had undetectable levels of eosinophils (1 patient dropped out for “logistical” reasons) and after the third phase 14 of the patients continued to benefit.
Nine of those 14 participants (64 percent) were able to taper off other HES therapies during the third phase. The 14 participants continued taking benralizumab for another year after completing the third phase.
The investigators say they need to run a large study to confirm the data.
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