GlaxoSmithKline pleased with recent Nucala results

GlaxoSmithKline announced results on Monday from an indirect treatment comparison of the licensed doses of Nucala (mepolizumab), compared to benralizumab and reslizumab, in patients with severe eosinophilic asthma.

The FTSE 100 pharmaceuticals giant said the data, published 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.

It explained that 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 was important, GSK said, because that sudden worsening resulted in greater difficulty breathing, which in the worst cases could be life-threatening and lungs could suffer long-term damage.

Mepolizumab reduced clinically significant exacerbations by between 34% and 45% versus benralizumab across subgroups, and by 45% compared to reslizumab in the ≥400cells/µL subgroup.

It also demonstrated “significantly greater improvements” in asthma control as assessed by the asthma control questionnaire (ACQ) score, compared with reslizumab and benralizumab in the adjusted analysis by baseline blood eosinophils.

GSK said there were “no significant differences” between mepolizumab and benralizumab or reslizumab in lung function, measured by change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) or on reducing exacerbations requiring emergency room visits or hospitalisation.

“This analysis was undertaken to try to dissect an important clinical question - how can the various anti-IL5 approaches be evaluated?,” explained Dr William Busse, professor of medicine at the division of allergy, pulmonary and critical care medicine at the University of Wisconsin Medical School.

“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.”

Dr Busse said 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.”

Severe eosinophilic asthma was described by the company as a clinically recognised phenotype of severe asthma, characterised by recurrent exacerbations, poor disease control and eosinophilic inflammation.

Eosinophil proliferation, maturation, and activation are controlled by the cytokine interleukin 5 (IL5).

Three anti-IL5 pathway-directed therapies have been developed and approved for use in patients with severe eosinophilic asthma.

GSK said mepolizumab and reslizumab are monoclonal antibodies that target IL5, and the monoclonal antibody benralizumab binds to the IL5 receptor.