Mepolizumab COLUMBA Study Reports Consistent 3-Plus Year Benefits

Sumita Khatri, MD

New data from the longest anti-interleukin 5 (IL-5) biologic therapy trial in severe eosinophilic asthma ever reported has found mepolizumab (Nucala) consistently improves exacerbation reduction and asthma control in patients with the condition.

Data from the open-label COLUMBA study, presented at the 2018 American Thoracic Society (ATS) International Conference in San Diego, CA, reported the results of patients with severe eosinophilic asthma who were treated with mepolizumab for a mean 3.5 years and up to 4.5 years. Along with consistent clinical efficacy, patients treated with the drug reported safety profiles similar with previous studies.

Mepolizumab, from GlaxoSmithKline (GSK), was previously approved by the US Food and Drug Administration (FDA) for the treatment of severe asthma is patients aged 12 years or older who suffer from an eosinophilic phenotype, in November 2015. Last year, it received an expanded indication to treat adults with rare autoimmune disease eosinophilic granulomatosis with polyangiitis (EGPA).

The monoclonal antibody binds to and inhibits the IL-5 cytokine from binding on the surface of eosinophil white blood cells — an element involved in the role of asthma-associated inflammation.

The open-label, phase 3 trial tested mepolizumab in patients with severe eosinophilic asthma who had also participated in the 12-month DREAM study at least 1 year ago from study’s start. It featured 347 patients, who were administered 100 mg subcutaneous mepolizumab once every 4 weeks, plus standard care, for an average of 3.5 years. Researchers noted that, due to the study’s longevity, there were notably fewer patients in the later stage of COLUMBA than in its first 2—3 years.

Results showed that patients reported a 61% decrease in annual exacerbation rate at the end of the study, dropping from 1.74 events per year at enrollment to 0.68 (95% CI; 0.60-0.78). Annual exacerbation rates in patients immediately fell to within that range, and was maintained over time (0.71 in year 1; 0.82 in year 2; 0.71 in year 3).

Frank Albers, MD, PhD, Global Medical Affairs Lead, Mepolizumab, GSK, sat down with MD Magazine at ATS to discuss the surprising results of mepolizumab in the COLUMBA study.

Patients also reported a 78% reduction in blood eosinophils by week 4, which was also sustained until the end of the study. Lung function, via forced expiratory volume in 1 second (FEV1), made an early improvement in patients that gradually decreased over the study period. However, researchers noted such a decline was expected in the patient population.

Asthma control, as gauged by the 5-point Asthma Control Questionnaire (ACQ5), improved by an average of -0.47 from first assessment at week 12 through study’s end. Mepolizumab’s safety and immunogenicity profiles as a long-term therapy were similar to those found in previous studies for patients with severe asthma.

Sumita Khatri, MD, principal COLUMBA investigator and associate professor of medicine at the Cleveland Clinic in Ohio, said there has always been an effort by patients with severe eosinophilic asthma to seek better methods of control on their condition, either by inhaled or oral therapies.

“We know this may be achieved with biologic therapy and are excited to see the long-term effectiveness of the anti-IL-5 therapy, Nucala, balanced with a long-term safety profile,” Khatri said.

Dave Allen, head of the Respiratory Therapy Area of Research and Development for GSK, said the data is indicative of mepolizumab’s enduring benefit to this patient population.

“The findings show the sustained exacerbation reduction and asthma control delivered by this medicine over a substantial length of time, with no new safety findings,” Allen said.

GSK recently filed a supplemental Biologics License Application (sBLA) for mepolizumab as a treated in patients with chronic obstructive pulmonary disease (COPD), and it is currently being investigated for the treatment of severe hypereosinophilic syndrome and nasal polyposis.

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