Reslizumab Appears Helpful in Refractory Asthma

By David Douglas

October 31, 2019

NEW YORK (Reuters Health) - Intravenous reslizumab (Cinquair, Teva) appears beneficial in patients with inadequately controlled oral-corticosteroid-dependent asthma, according to post-hoc analyses.

"Intravenous reslizumab, a biologic that blocks the interleukin-5 protein, is a very effective treatment for patients with severe asthma associated with raised eosinophil counts," said Dr. Parameswaran Nair of St. Joseph's Healthcare Hamilton, in Canada.

"Unlike the other anti-IL-5 molecules, its efficacy in patients with the most severe form of asthma, i.e. those who require daily oral corticosteroids such as prednisone, has not been previously evaluated in large studies," he told Reuters Health by email.

"In this post-hoc analysis of two large previously published clinical trials," he added, "we demonstrated that the drug is very effective in such patients, not only in reducing the exacerbations but also in reducing the total inhaled and oral corticosteroid burden during the 52 week course of the study."

Reslizumab is indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.

For their study, Dr. Nair and colleagues pooled data on 953 patients aged 12 to 75 years with inadequately controlled, moderate-to-severe asthma.

Of these patients, 477 were randomized to reslizumab and 476 received placebo. The agents were given by injection every four weeks for 52 weeks; 73 patients (15%) in each group were taking oral corticosteroids at baseline and about half of these were on also high-dose inhaled corticosteroids.

At one year, reslizumab "was favored over placebo for all efficacy endpoints in oral corticosteroid-dependent patients, with numerically greater improvements in oral corticosteroid-dependent patients than the overall population," the researchers write in The Journal of Allergy and Clinical Immunology: In Practice, online October 15.

In patients receiving oral corticosteroids at baseline, the probability of not experiencing a clinical asthma exacerbation by week 52 in the active-treatment group was significantly greater than that with placebo (63.8% vs. 35.7%).

Although numerically superior improvements in lung function with reslizumab were also seen, these did not reach statistical significance.

In the whole population, fewer new systemic corticosteroid prescriptions were issued per patient with reslizumab (248) versus placebo (480). In those already taking oral corticosteroids, about half as many new prescriptions above the baseline dose were given to active-treatment patients compared with those on placebo.

There were similar findings in various at-risk subgroups including those with chronic rhinosinusitis.

The researchers conclude that these and other findings suggest a benefit of reslizumab in oral corticosteroid-dependent severe asthma. However, they caution that "these findings have yet to be confirmed in clinical trials of IV reslizumab, and this will require further prospectively designed studies."

Dr. Mario Castro of the University of Kansas School of Medicine, in Kansas City, chief of pulmonary, critical care and sleep medicine, told Reuters Health by email, "This is an important advance in our knowledge of the effect of reslizumab, a monoclonal antibody against IL-5, approved to treat patients with severe uncontrolled eosinophilic asthma."

"This analysis confirms that reslizumab reduces exacerbations and enable oral steroids to be reduced in severe asthma patients requiring chronic oral steroids, a treatment that is unacceptable given the numerous side-effects steroids have," said Dr. Castro, who was not involved in the study.

The original studies were funded by Teva Pharmaceuticals Inc who also had a role in the current study. Dr. Nair has relationships with Teva as do other authors, a number of whom are company employees.

SOURCE: https://bit.ly/365vBHI

J Allergy Clin Immunol Pract 2019.

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