Novel Agent for Severe Asthma Halves Exacerbation Rates Across Respiratory Comorbidities

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In a broad population of patients with severe, uncontrolled asthma and common respiratory comorbidities, annual asthma exacerbations were reduced by more than 50% in patients treated with the novel thymic stromal lymphopoietin (TSLP) inhibitor tezepelumab vs placebo.

These findings were presented during a poster session at the 2022 American Academy of Asthma, Allergy, & Immunology Annual Meeting, held February 25-28, in Pheonix, AZ, and virtually.

The results follow a post hoc analysis of the efficacy of tezepelumab in patients from the NAVIGATOR phase 3 clinical trial who had specific respiratory comorbidities.

Patients in the NAVIGATOR study, a multicenter, randomized, double-blind, placebo-controlled trial, ranged in age from 12 to 80 years old and had severe, uncontrolled asthma. Participants were randomized 1:1 to receive subcutaneous tezepelumab 210 mg or a placebo injection every 4 weeks for 52 weeks. The current post hoc analysis assessed the annualized asthma exacerbation rate (AAER) in patients with and without chronic sinusitis, rhinitis, aspirin sensitivity and non-steroidal anti-inflammatory drug (NSAID) sensitivity, based on self-report.

A total of 1059 patients were randomized, 528 to receive tezepelumab 210 mg and 531 to receive placebo. Distribution of comorbidities of interest among patients was chronic sinusitis 259, rhinitis 724, aspirin sensitivity 76, and NSAID sensitivity 64.

When tezepelumab-treated patients were compared with those given placebo, the AAER was reduced over 52 weeks by 54% (95% CI, 33-68) in those with chronic sinusitis and 56% (95% CI, 46-65) in those without chronic sinusitis; by 58% (95% CI, 47-67) in patients with rhinitis and by 50% (95% CI, 30-64), in patients without rhinitis.

In patients with aspirin sensitivity, the AAER was reduced by 79% (95% CI, 54-91) and in those without aspirin sensitivity by 54% (95% CI, 44-62). Patients with NSAID sensitivity treated with tezepelumab experienced an AAER of 85% (95% CI, 66-94) and those without the sensitivity, an AAER of 53% (95% CI, 43-61).

The authors emphasize that the efficacy of tezepelumab in patients with severe difficult-to-control asthma extends to reduction of AAER regardless of specific respiratory comorbidities.

Reference: Carr T, Bernstein J, Cook B, et al. Efficacy of tezepelumab in patients with severe, uncontrolled asthma with respiratory comorbodities: results from the phase 3 NAVIGATOR Study. Presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) 2022 Annual Meeting; February 25–28, 2022; Phoenix, AZ. Abstract 458.