Trelegy Ellipta Approval Expanded to Patients with Asthma

By Jessica Pyhtila, PharmD, BCGP, BCPS

The three-agent COPD medication Trelegy Ellipta, which contains fluticasone, umeclidinium and vilanterol, was recently approved by the FDA for an expanded indication of asthma use. The drug is available in two doses, a lower dose of fluticasone 100 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg and a higher dose of fluticasone 200 mcg/umeclidinium 62.5 mcg/vilanterol 25 mcg.

In a double-blind, active-controlled, parallel-group, multicenter study the FDA used to evaluate its efficacy in asthma, Trelegy was compared head-to-head against Breo Ellipta, which contains fluticasone and vilanterol. Participants were eligible if they had poorly controlled asthma while receiving inhaled steroid and long-acting beta agonist therapy for at least 12 weeks. The median age of participants was 53 years, and the baseline mean percent predicted FEV1 was 68%.

The study followed patients for 24 to 52 weeks. Versus low-dose Breo, low-dose Trelegy was linked to a statistically significant 110mL improvement in FEV1 at week 24. Similarly, the high dose was linked to a statistically significant 92mL improvement in FEV1 at week 24 versus high-dose Breo.

Trelegy is a dry powder inhaler. It is meant to be inhaled once on a daily basis and should be taken at the same time every day. The manufacturer recommends starting with low-dose Trelegy and subsequently uptitratring if necessary to the high dose. The top three most common side effects were similar in both low-dose and high-dose Trelegy and included pharyngitis/nasopharyngitis, impacting up to 17% of patients, headache, impacting up to 9% of patients, and upper respiratory infection, affecting up to 7% of patients.

Patients should be counseled that Trelegy is not a rescue inhaler and that they should use a short-acting beta agonist for asthma exacerbations. Further, since Trelegy contains the steroid fluticasone, patients should be educated to rinse their mouths with plain water and spit after every dose to avoid candidiasis. Because Trelegy contains milk proteins, it may not be appropriate for patients with a severe milk allergy.

References:

U.S. National Library of Medicine. “Trelegy Ellipta.” September 9, 2020. Accessed November 7, 2020. Retrieved from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e

GlaxoSmithKline. “Trelegy is now approved for adult asthma patients aged 18 and older.” September 2020. Accessed November 7, 2020. Retrieved from: https://gskpro.com/en-us/products/trelegy/asthma?cc=ps_PITGR63URP676589&mcm=110016&gclid=CjwKCAiAqJn9BRB0EiwAJ1SztazExbaEYzc_hnTCwWlLaNFxI6osWFAzCviBgIdnDxaeO4cUsZm0SxoCGdIQAvD_BwE&gclsrc=aw.ds