Objective:

To evaluate the efficacy of tezepelumab in reducing maintenance oral corticosteroid doses in adult patients with severe oral corticosteroid-dependent asthma while maintaining asthma control.

Approach:

• Study Design: Phase 3 SUNRISE trial with 122 adults aged 18 to 80 years, randomly assigned to receive either tezepelumab 210 mg or placebo every 4 weeks for 28 weeks.
• Participants: Eligible participants were on medium- or high-dose inhaled corticosteroids and long-acting beta-2 agonists, with specific blood eosinophil counts.
• Endpoints: Primary endpoint assessed the reduction in daily maintenance oral corticosteroid dose by week 28 without loss of asthma control.

Key Findings:

• At week 28, 36% of tezepelumab patients achieved a 90-100% reduction in oral corticosteroid dose vs 21% in placebo.
• 69% of tezepelumab patients achieved at least a 50% reduction vs 44% in placebo.
• Complete discontinuation occurred in 35% vs 21%, respectively.
• An oral corticosteroid dose of 5 mg or less was reached in 59% vs 38%, respectively.

Interpretation:

The results of the SUNRISE trial show the potential of tezepelumab to reduce maintenance oral corticosteroid use while maintaining asthma control.

Limitations:

• Study terminated early due to recruitment challenges, resulting in a smaller sample size.
• Baseline imbalances in blood eosinophil counts and oral corticosteroid doses between treatment groups.
• Not powered to assess statistical significance within subgroups.

Conclusion:

The SUNRISE trial indicates the potential of tezepelumab to reduce maintenance oral corticosteroid use while maintaining asthma control.

Sources:

• The Lancet Respiratory Medicine