Patients with severe eosinophilic asthma taking benralizumab may reduce high-dose inhaled corticosteroids/formoterol while maintaining symptom control.

After 32 weeks, a reduction of high-dose inhaled corticosteroids/formoterol (HD ICS/F) was possible in 92% of patients, who had been stable on benralizumab. This lower dosage was maintained to week 48 by 95.8%. These findings were presented at the 2023 ERS International Congress.

The open-label, active-controlled, phase 4 open SHAMAL study investigated the possibility of a successful reduction of HD ICS/F in patients with severe eosinophilic asthma, well-controlled with add-on benralizumab. A total of 168 adults were randomly assigned 1:3 to either continue their benralizumab dose at 30 mg every 8 weeks plus HD ICS/F as before or taper HD ICS/F from medium to low dose and further down to maintenance of anti-inflammatory reliever (AIR). The primary endpoint was defined as the proportion of patients reducing HD ICS/F to medium or low dose or the as-needed regimen only at the end of the initial period over 32 weeks. David J. Jackson, MBBS, MRCP, MSc, PhD, stressed that there was a maintenance phase of a further 16 weeks to make sure that these can maintain that lower level.

The overall baseline parameters showed a mean age of 57.7 years, 53% women, a mean fractional exhaled nitric oxide (FeNO) of 27.0 ppb, a mean Asthma Control Questionnaire (ACQ)-5 score of 0.53, and 2.9 exacerbations within the last year before starting benralizumab. At week 32, nearly all participants (92%) were able to reduce HD ICS/F, with 15% tapering to medium dose, 17% to low dose, and 61% to AIR only. This corresponded to an overall 73% lesser mean daily dose of HD ICS/F in the tapering arm. Furthermore, 95.8% were able to maintain their reduced doses to week 48. In terms of changes in lung function measured by FEV₁ and FeNO, only the group of participants who tapered down to AIR experienced a decline in FEV₁ and a rise in FeNO and these changes from baseline were significantly correlated (P=0.0003 at week 32 and P=0.0241 at week 48). “Very interestingly, this was not seen with exacerbations,” Dr. Jackson said, revealing that almost all the participants remained completely exacerbation-free, as only 8% had one exacerbation over the study year. These results were also mirrored by the absence of a clinically meaningful decrease in symptom control in ACQ-5.

“Most patients with severe eosinophilic asthma adequately controlled on benralizumab and background therapy can reduce ICS/formoterol dose from high dose, whilst maintaining asthma control,” Dr. Jackson concluded.

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