Study Design Secondary Endpoint About Nucala
COLUMBA (4.5-year open-label study)5,6
*Patients continued in COLUMBA until a protocol-defined stopping criterion was met.
4.5-year, multicenter, open-label, long-term study assessing the safety, immunogenicity, and efficacy of NUCALA in 347 patients ≥12 years of age with severe eosinophilic asthma (SEA) previously treated in DREAM† at least 12 months prior and met eligibility criteria. All patients received NUCALA added to asthma controller therapy.
Long-term safety, including adverse events (AEs), serious adverse events (SAEs), and immunogenicity. Most frequent AEs (≥20%): viral upper respiratory tract infection, 49%; headache, 29%; asthma‡, 27%; upper respiratory tract infection, 23%; bronchitis, 21%. Two SAEs occurred in ≥1% of patients: asthma, 10%; and pneumonia, 2%. A total of 8% of patients had a positive anti-drug antibody result, but all were negative for neutralizing antibodies.
Frequency of exacerbations§, asthma control (ACQ-5 score), and lung function (FEV1). Exacerbations: The annualized exacerbation rate was 0.68 (95% CI; 0.60 to 0.78). Asthma Control: The mean change from baseline in ACQ-5 score was -0.47 points at both Week 12 and end of study. Lung Function: The mean change from baseline in pre-bronchodilator FEV1 at Week 12 was 124 mL, and gradually declined to approximate baseline values at end of study.
Results are descriptive.
- †DREAM 52-week study comparing mepolizumab IV to placebo IV added to SOC in 616 patients ≥12 years of age with severe asthma. Primary Endpoint/Results: Exacerbations/year 1.24 for mepolizumab 75 mg vs 2.40 for placebo (48% reduction, P<0.0001).8
- ‡Asthma reported as an AE means worsening or exacerbation of asthma.
- §Exacerbations of asthma were defined as the worsening of asthma that required use of oral/systemic corticosteroids and/or hospitalization and/or emergency department (ED) visits; for patients on maintenance oral/systemic corticosteroids, exacerbations were defined as requiring at least double the existing maintenance dose for at least 3 days.
- ACQ=Asthma Control Questionnaire; FEV1=forced expiratory volume in 1 second; IV=intravenous.