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Nucala demonstrates long-term safety, efficacy for asthma

In patients with severe eosinophilic asthma, long-term treatment with Nucala safely reduced exacerbations and improved asthma control, according to findings presented at the American Thoracic Society International Conference.

“People with severe eosinophilic asthma for whom control has not been possible with inhaled or oral therapy have always sought options to improve control,” Sumita Khatri, MD, principal investigator of the COLUMBA study and associate professor of medicine at Cleveland Clinic, said in a press release issued by GlaxoSmithKline. “We know this may be achieved with biologic therapy and are excited to see the long-term effectiveness of the anti-IL-5 therapy, Nucala, balanced with a long-term safety profile.”

Khatri and colleagues enrolled 347 patients with severe eosinophilic asthma into the COLUMBA study to determine the long-term safety and efficacy of Nucala (mepolizumab, GlaxoSmithKline). The researchers administered 100 mg of mepolizumab to participants every 4 weeks in addition to standard care for up to 4.5 years (average duration, 3.5 years).

Data indicated that the exacerbation rate decreased by 61% among participants treated with mepolizumab. About one-third of participants experienced no exacerbations with mepolizumab treatment. Additionally, exacerbation rates remained consistent over the study duration.

As measured by the Asthma Control Questionnaire 5, asthma control improved at week 12 and was sustained for more than 4 years. By week 4, participants demonstrated a reduction in blood eosinophils by 78%, which was maintained throughout the study.

Mepolizumab showed no new safety concerns. Lung function improved with mepolizumab initially, but gradually decreased over time.

“These new data give us evidence that Nucala, a targeted biologic treatment, provides an enduring benefit to patients with severe eosinophilic asthma,” Dave Allen, head of the Respiratory Therapy Area R&D at GlaxoSmithKline, said in the release. “The findings show the sustained exacerbation reduction and asthma control delivered by this medicine over a substantial length of time, with no new safety findings.” – by Alaina Tedesco

Reference:

Ortega H, et al. Long-term safety of mepolizumab in patients with severe eosinophilic asthma: The COLUMBA study. Presented at: American Thoracic Society International Conference. May 18-23, 2018; San Diego.

Disclosure: Allen is an employee of GlaxoSmithKline. Healio Internal Medicine was unable to confirm Khatri’s relevant financial disclosures at the time of publication.