A new study has found that using biologic therapy to reduce lung inflammation enabled 92% of people with severe asthma to reduce their dose of daily inhaled steroid without exacerbating their symptoms. The findings may mean that severe asthmatics can minimize the risk of adverse effects associated with long-term steroid use.
Of the almost 300 million people in the world with asthma, around 3% to 5% have severe asthma, suffering from daily breathlessness, chest tightness and cough that frequently leads to hospitalization. Most have a subtype called eosinophilic asthma, marked by high levels of immune cells (eosinophils) in the blood that cause uncontrolled airway swelling and inflammation.
The recommended treatment for eosinophilic asthma, according to the Global Initiative for Asthma (GINA), is a daily combination of budesonide, an inhaled corticosteroid (ICS) to manage inflammation, and formoterol, a long-acting bronchodilator to relax and open the airways. ICS-formoterol is preferred over short-acting ‘rescue’ inhalers because of its dual anti-inflammatory/bronchodilatory effect. However, the long-term use of ICS can be problematic, being associated with oral thrush, bone density loss and osteoporosis, diabetes, a weakened immune system, and cataracts.
A study led by researchers at King’s College London has examined whether treatment with benralizumab, a biologic therapy, allowed people with severe eosinophilic asthma to reduce their ICS dose without loss of asthma control.
“Biological therapies such as benralizumab have revolutionized severe asthma care in many ways, and the results of this study show for the first time that steroid-related harm can be avoided for the majority of patients using this therapy,” said David Jackson, lead and corresponding author of the study.
Benralizumab, sold as Fasenra, is an anti-IL-5 receptor alpha monoclonal antibody that induces rapid, direct, almost complete depletion of eosinophils. It’s administered by subcutaneous injection once every four weeks for the first three doses, then once every eight weeks.
The current study was conducted across 22 sites in four countries: the UK, France, Italy, and Germany. The researchers recruited 208 adult patients with controlled severe eosinophilic asthma on high-dose ICS following the initiation of benralizumab. The mean age of participants was 57.7; 47% were male, and 75% were White.
During a 32-week reduction period, participants were randomly assigned to either the treatment-reduction group (eight-weekly benralizumab 30 mg plus decreasing doses of ICS-formoterol and reliever as needed) or the reference group (eight-weekly benralizumab 30 mg plus a continuous high dose of ICS-formoterol and reliever as needed). This was followed by a 16-week maintenance period. In the treatment-reduction group, participants were categorized according to their use of ICS-formoterol into high-, medium-, and low-dose and use as needed.
Overall, 92% of participants reduced their ICS-formoterol dose: 15% to medium-dose, 17% to low-dose, and 61% to as-needed only. In 96%, reductions were maintained to week 48, and 91% of participants in the treatment-reduction group had zero exacerbations of their symptoms during tapering.
Rates of adverse events were similar between the two study groups. 73% of participants in the treatment-reduction group had adverse events, and 83% in the reference group.
The researchers say that the study’s findings demonstrate that exposure to high-dose ICS can be minimized by targeting eosinophils using benralizumab.
The study was published in the journal The Lancet.
Source: King’s College London
