Benralizumab Allows Safe Reduction of Inhaled Corticosteroid Therapy in Patients With Severe Asthma

“Stepwise intensification of inhaled corticosteroids (ICS) is routine for severe eosinophilic asthma, despite some poor responses to high-dose ICS. Dose reductions are recommended in patients responding to biologics, but little supporting safety evidence exists,” researchers of a phase 4 clinical trial published in The Lancet wrote.

Therefore, The SHAMAL study investigated the safety and efficacy of tapering ICS therapy in patients with severe eosinophilic asthma controlled on benralizumab.

Conducted across 22 study sites in 4 countries, the SHAMAL study enrolled adults aged 18 years and older with severe eosinophilic asthma who received at least 3 consecutive doses of benralizumab before screening. Participants, who all exhibited controlled asthma based on a 5-item Asthma Control Questionnaire score below 1.5, were randomly assigned to either taper their high-dose ICS to medium, low, or as-needed doses (reduction group), or to continue their ICS-formoterol therapy (reference group) for 32 weeks, followed by a 16-week maintenance period.

The study, which screened and enrolled patients between November 12, 2019, and February 16, 2023, randomized 168 (74%) patients to the reduction group and 43 (26%) patients to the reference group. Overall, 92% of patients (n=110) in the reduction group successfully decreased their ICS-formoterol dose. Specifically, 15% reduced to a medium dose, 17% to a low dose, and 61% to as-needed only. Reductions were maintained in 96% of patients until week 48, and 91% of those in the reduction group experienced no exacerbations during tapering.

Safety analyses indicated that rates of adverse events (AEs) were similar between the reduction and reference groups, with 73% and 83% of patients reporting AEs, respectively. Serious AEs were infrequent, occurring in 10% of patients in the reduction group and 12% of those in the reference group. No deaths were reported during the study.

Regarding their results, the investigators wrote that, “these findings show that patients controlled on benralizumab can have meaningful reductions in ICS therapy while maintaining asthma control.”