GSK announces results of indirect treatment comparisons of Nucala to benralizumab and reslizumab for severe eosinophilic asthma
Nucala demonstrated greater reduction in exacerbations and improved asthma control.
Issued: London UK
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced results from an indirect treatment comparison of the licensed doses of Nucala (mepolizumab), versus benralizumab and reslizumab in patients with severe eosinophilic asthma. The data, published today in?The Journal of Allergy and Clinical Immunology (JACI),?showed that in patients with similar blood eosinophil counts, mepolizumab significantly reduced clinically significant exacerbations and improved asthma control compared with both benralizumab and reslizumab.
Dr William Busse, Professor of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Department at the University of Wisconsin Medical School in Madison, Wisconsin, said: ?This analysis was undertaken to try to dissect an important clinical question: how can the various anti-IL5 approaches be evaluated??As a consequence, this study helps improve our understanding of the relative efficacy of the three available anti-IL5 pathway directed treatments for patients with severe eosinophilic asthma when grouped by patients? blood eosinophil counts, which are known to influence treatment effect. Only licensed doses used in clinical practice were included and patients were matched according to blood eosinophil counts and asthma control scores. This approach ensured a robust comparison, which will help inform doctors when making clinical decisions about treating their patients.?
Results from the primary data analysis demonstrated that patients treated with Nucala experienced a reduction in clinically significant exacerbations compared to both benralizumab and reslizumab across all eosinophil levels in the adjusted analysis. Reduction of exacerbations is important because this sudden worsening results in greater difficulty breathing, which in the worst cases can be life-threatening and lungs can suffer long-term damage:
- Mepolizumab reduced clinically significant exacerbations by 34%?45%?versus benralizumab across subgroups (=400cells/?L- 45%, =300cells/?L-39%, =150cells/?L-34%, p<0.05)
- Mepolizumab reduced clinically significant exacerbations by 45%?versus reslizumab in the =400cells/?L subgroup (p<0.007)
Study design and primary endpoint results
This indirect treatment comparison used data from 11 separate studies identified through a Cochrane review process of anti-IL5 pathway directed therapies and additional literature searches. ?Eligible studies were randomised, controlled trials in patients aged =12 years with severe eosinophilic asthma that met predefined selection criteria (see publication for more details). The comparison employed robust methodology, following ISPOR guidelines, to account?for differences in trial populations. The analysis was limited to only the licensed presentation and doses of each anti-IL5 pathway-directed treatment, with the aim of evaluating the clinical effects of the three treatments available in clinical practice. Furthermore, the comparisons were carried out on patient populations grouped by baseline blood eosinophil count, which is known to influence treatment effect, and matched according to baseline ACQ score to allow like-for-like comparisons between treatments. Endpoints included annualised rate of clinically significant exacerbations, change from baseline in ACQ score and FEV1. An indirect treatment comparison (ITC) was performed in all patients with ACQ =1.5 and stratified by baseline blood eosinophil counts.? Mepolizumab 100mg SC was compared to:- Reslizumab 3mg/kg for eosinophilic subgroup =400 cells/?L
- Benralizumab 30 mg for eosinophilic subgroups =150, =300, =400 cells/?L