Tezepelumab improves asthma outcomes regardless of prior omalizumab use
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Key takeaways:
- 65% of patients who had used omalizumab and 38% of those who had not had more than two exacerbations in the previous year.
- Patients who had used omalizumab had higher annualized asthma exacerbation rates.
WASHINGTON — Tezepelumab reduced annualized asthma exacerbation rates compared with placebo among patients with severe, uncontrolled asthma regardless of prior omalizumab use, according to study results.
The findings from the post-hoc analysis were presented at the American Thoracic Society International Conference.
“A common question with any biologic for severe asthma is how well it works in patients previously treated with other biologics,” Jean-Pierre Llanos Ackert, MD, executive medical director, global medical affairs, Amgen, and Chris Ambrose, MD, MBA, franchise head, U.S. Medical, Respiratory, at AstraZeneca, told Healio in a statement.
The phase 3 NAVIGATOR study found that tezepelumab (Tezspire, Amgen/AstraZeneca) significantly reduced exacerbations and improved lung function, asthma control and health-related quality of life in 1,059 patients aged 12 to 20 years with severe, uncontrolled asthma.
“The randomized, placebo-controlled NAVIGATOR study enrolled a small number of patients who had been previously treated with omalizumab,” Llanos Ackert and Ambrose continued. “As a result, we conducted a post hoc analysis to describe the efficacy and safety of tezepelumab in that population.”
Eighty-one (8%) of the patients in NAVIGATOR had used omalizumab (Xolair; Genentech, Novartis) previously, including 45 who then used tezepelumab and 36 who used a placebo during the study.
In the previous 12 months, 65% (n = 53) of patients with prior omalizumab use and 38% (n = 371) who had not used omalizumab experienced more than two exacerbations.
Also, patients with prior omalizumab use had an annualized asthma exacerbation rate (AAER) of 3.09, whereas those who had not used omalizumab had an AAER of 2.02 in the placebo group.
Compared with placebo, tezepelumab reduced AAER by 51% (95% CI, 8%-74%) among patients who had used omalizumab and by 57% (95% CI, 47%-64%) among those who had not over the 52-week trial.
“This post-hoc analysis demonstrated that tezepelumab reduced exacerbations compared with placebo in patients with severe, uncontrolled asthma, to similar degrees in those with and without prior omalizumab use,” Llanos Ackert and Ambrose said.
Adverse event frequencies also were similar in tezepelumab recipients compared with placebo recipients, regardless of prior omalizumab use, Llanos Ackert and Ambrose continued.
These findings further demonstrate the efficacy and safety of tezepelumab in patients with severe, uncontrolled asthma, including those who previously received omalizumab, Llanos Ackert and Ambrose said.
“These results, in combination with previously published analyses describing tezepelumab’s efficacy in patients with allergic asthma, inform specialists that tezepelumab can be considered an effective biologic option with an established safety profile for patients with severe, uncontrolled asthma including those with allergic phenotype,” they said.
Research is ongoing.
“Looking ahead, we plan to further examine the efficacy and effectiveness of tezepelumab across clinically relevant subgroups of patients with severe, uncontrolled asthma, with a particular focus on patients with allergic and eosinophilic asthma who may particularly benefit from the multiple beneficial effects of blocking TSLP with tezepelumab,” Llanos Ackert and Ambrose said.