During the ERS 2018, long-term safety and efficacy data were presented from 2 ‘post-phase 3’ extension studies with approved anti-IL-5 biologics. The first study, COSMEX, evaluated the long-term safety and effectiveness of mepolizumab in an open label extension of the previous phase 3 COSMOS trials . In this study, 339 patients with very severe, life-threatening, eosinophilic asthma received mepolizumab (100 mg every 4 weeks) for additionally up to 172 weeks. Overall, 93% of patients reported on-treatment adverse events (AEs), which occurred with a frequency of >10%, similar to the previous shorter-term placebo-controlled trials. The frequency of serious AEs was low. Effectiveness of mepolizumab treatment was sustained with substantial reductions in exacerbation rates and oral corticosteroids use, for up to 4.5 years.
The second study, BORA, reported on the long-term safety and effectiveness of benralizumab during an extension of the previous phase 3 trials SIROCCO and CALIMA . In this study, 793 patients with uncontrolled severe eosinophilic asthma were enrolled and 512 continued benralizumab (30 mg every 4 weeks or every 8 weeks), while 281 continued placebo for another 52 weeks as in their previous study. In the BORA study, benralizumab treatment showed similar safety and tolerability outcomes to those in the previous phase 3 trials. Only very few serious AEs were reported, leading to discontinuation in 2-3% of patients. Long-term effectiveness was also similar and consistent with preceding studies, with approximately 75% of patients on benralizumab remaining exacerbation-free.
- Albers F, et al. OA3566; ERS 2018; Paris, France.
- Busse BW, et al. OA3567; ERS 2018; Paris, France.
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