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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