Male, female patients experience similar asthma improvements with tezepelumab

Key takeaways:

• Asthma is more prevalent and severe in women than in men.
• Similar improvements with tezepelumab included exacerbations, lung function, asthma control and health-related quality of life.

WASHINGTON — Male and female patients experienced similar improvements in their severe, uncontrolled asthma with tezepelumab over a 52-week period, according to data presented at the American Thoracic Society International Conference.

“Sex-related differences in asthma prevalence and severity are well documented,” Monica Kraft, MD, Murray M. Rosenberg Professor of Medicine and system chair of the department of medicine at Icahn School of Medicine at Mount Sinai, said during her presentation.

“Asthma is more prevalent and severe in women than in men, which may be due to variations in genetics and epigenetics, immune responses, hormones and environmental and sociocultural factors,” Kraft said.

As a human monoclonal antibody, tezepelumab (Tezspire, Amgen/AstraZeneca) targets thymic stromal lymphopoietin, or TSLP, which is an epithelial cytokine implicated in asthma pathogenesis.

Monica Kraft

Kraft and colleagues specifically looked at differences in the biologic’s impact on male and female patients in the phase 3 NAVIGATOR multicenter, randomized, double-blind, placebo-controlled study. The cohort included 1,059 patients aged 12 to 80 years (36.5% male, 63.5% female) with physician-diagnosed asthma.

“Before the date of informed consent, they had to have been receiving medium- or high-dose inhaled corticosteroids equivalent to fluticasone greater than 500 µg or equivalent for at least 12 months and one more additional controller medication with or without oral steroids for at least 3 months,” Kraft said.

Also, these patients had experienced at least two exacerbations in the previous 12 months.

Patients were randomly assigned to receive 210 mg of tezepelumab or a placebo subcutaneously every 4 weeks for 52 weeks. The male group included 193 on tezepelumab and 194 on placebo. The female group included 335 on tezepelumab and 337 on placebo.

Using a repeated measures analysis, the researchers examined changes from baseline to week 52 in prebronchodilator FEV₁, percent predicted FEV₁, Asthma Control Questionnaire (ACQ) scores and Asthma Quality of Life Questionnaire for patients aged 12 years and older (AQLQ(S)+12) overall scores.

“Of note, baseline mean prebronchodilator FEV₁ was higher in males, 2.2 L, vs. females, 1.6 L,” Kraft said.

Male patients also had higher median serum total IgE levels at 288.4 IU/mL than female patients at 157 IU/mL.

“A higher proportion of male patients than female was sensitized to at least one perennial aeroallergen, 69% vs. 61.3%,” Kraft continued.

Further, 19.1% of the male patients and 13.5% of the female patients had comorbid nasal polyps.

Compared with placebo, reductions in annualized asthma exacerbation rates among patients on tezepelumab over the study period included 55% (95% CI, 37%-67%) for male patients and 57% (95% CI, 45%-66%) for female patients, which the researchers called similar.

Annualized asthma exacerbation rates in the placebo group included 2.35 (95% CI, 2-2.75) for female patients and 1.69 (95% CI, 1.36-2.09) for male patients.

The male patients had numerically greater improvements in prebronchodilator FEV₁ by absolute volume change than female patients (least-squares [LS] mean difference, 0.19 L; 95% CI, 0.11-0.28 vs. 0.1 L; 95% CI, 0.04-0.16), both compared with placebo.

“However, improvements in percent predicted prebronchodilator FEV₁ with tezepelumab compared with placebo were similar between male patients and female participants,” Kraft said.

Male patients had an LS mean difference of 5.6% (95% CI, 2.96%-8.25%), and female patients had an LS mean difference of 4.35% (95% CI, 2.35%-6.35%).

LS mean changes in ACQ-6 scores among patients on tezepelumab compared with placebo included –1.53 (standard error [SE], 0.08) for male patients and –1.54 (SE, 0.06) for female patients, which the researchers called similar as well.

Finally, LS mean changes in AQLQ(S)+12 scores among patients on tezepelumab compared with placebo included 1.45 (SE, 0.08) for male patients and 1.49 (SE, 0.06) for female patients, which the researchers also considered similar.

“In conclusion, tezepelumab reduced exacerbations while improving lung function, asthma control and health-related quality of life compared with placebo to similar degrees in male and female participants over 52 weeks,” Kraft said. “These results further support the efficacy of tezepelumab in a broad population of patients with severe, uncontrolled asthma.”