Patients with severe eosinophilic asthma, prior biologic use benefit from benralizumab
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Key takeaways:
- Twelve months prior to benralizumab treatment, 380 patients received at least one biologic.
- Patients without vs. with previous biologic use had a greater relative reduction in annualized exacerbation rate.
Among adults with severe eosinophilic asthma and previous biologic use, benralizumab for 48 weeks aided in reducing exacerbations and improving asthma symptom control, according to results published in European Respiratory Journal.
These outcomes were also found among adults with severe eosinophilic asthma and no previous biologic use, according to researchers.
“There are currently very limited data on biologic-experienced patients due to poor representation in [randomized controlled trials] and currently published smaller real-world analyses,” David J. Jackson, MBBS, MRCP, MSc, PhD, clinical professor of respiratory immunology, School of Immunology & Microbial Sciences, Guy’s Hospital, King’s College London, and colleagues wrote.
“While biologic-experienced patients tended to have less pronounced improvements than biologic-naïve patients, the effectiveness was notable and clinically relevant,” Jackson and colleagues added.
In the multinational, retrospective, observational, real-world XALOC-1 study, Jackson and colleagues evaluated 1,002 adults (mean age, 55.4 years; 58.6% women) with severe eosinophilic asthma treated with benralizumab (Fasenra, AstraZeneca) for 48 weeks to determine if previous biologic use and important clinical characteristics change benralizumab’s ability to improve annualized exacerbation rate, maintenance oral corticosteroid use, asthma symptom control and lung function.
Important clinical characteristics included “maintenance oral corticosteroid use, blood eosinophil count [BEC], exacerbation history, age at asthma diagnosis, fractional exhaled nitric oxide [FeNO] level and presence of atopy and chronic rhinosinusitis with nasal polyps.”
Twelve months prior to benralizumab treatment (baseline), 380 patients received at least one biologic. The most frequent biologic used was mepolizumab (n = 237), followed by omalizumab (n = 171) and reslizumab (n = 31).
Exacerbations
Researchers found a higher proportion of patients who had no asthma exacerbations at week 48 vs. baseline in the total cohort (71.3% vs. 17.2%), and this was also the case when divided into patients with no previous biologic use (74.9% vs. 13.6%) and patients with previous biologic use (65.4% vs. 22.4%).
In the total cohort, the annualized exacerbation rate went down by 82.7% between baseline and week 48. In the subgroup of patients who did not previously use a biologic, there was an 87.7% relative reduction, whereas in the subgroup of patients who did previously use a biologic, there was a 72.9% relative reduction.
Within three of the clinical characteristic subgroups, researchers observed similar decreases in the annualized exacerbation rate from baseline to week 48: chronic rhinosinusitis with nasal polyps (with, 84.9% vs. without, 81.9%), atopic status (positive, 83% vs. negative, 90.8%) and maintenance oral corticosteroid use (with, 81% vs. without, 85.6%).
Patients with a peak baseline BEC less than 300 cells/μL−1 had a smaller relative reduction compared with those with counts of 300 cells/μL−1 or more (67.2% vs. 86.1%) and those with counts of 500 cells/μL−1 or more (87.1%).
A similar pattern was found when dividing the total cohort based on baseline FeNO level, with a smaller relative reduction in the annualized exacerbation rate among those levels less than 20 ppb (78.9%) compared with those with levels of 20 to less than 50 ppb (83.2%) and levels of 50 ppb or higher (85.8%).
Maintenance oral corticosteroids, asthma control
In terms of maintenance oral corticosteroid use, a dose of 0 mg per day at week 48 was achieved by nearly half (47.4%) of those receiving this treatment at baseline, and the daily dose dropped by an average of 51.2%.
Compared with those with previous biologic use, the subgroup of patients without previous biologic use had more patients with a daily maintenance oral corticosteroid dose of 0 mg at week 48 (56.1% vs. 36.5%) and a greater mean decrease in daily dose (63.2% vs. 34.9%).
Researchers highlighted that the daily maintenance oral corticosteroid dose dropped by an average of 31.3% to 69.9% between baseline and week 48 across the clinical characteristic subgroups.
The minimal clinically important difference for the Asthma Control Test and the Asthma Control Questionnaire-6 signaling improvement was met in at least one of these scores by the 48-week mark in 67.8% of patients from the total cohort. A greater proportion of patients without vs. with previous biologic use achieved this outcome (72% vs. 60.9%).
In the clinical characteristic subgroups, researchers said the minimal clinically important difference for either one of the asthma symptom control scores was met by “most patients.”
Between baseline and week 48 of benralizumab treatment, the 263 patients with lung function data had a least-squares mean absolute change in prebronchodilator FEV1 of 0.27 L (95% CI, 0.2-0.34), and this change was similar in the no previous biologic use subgroup (0.27 L; 95% CI, 0.18-0.36) and the previous biologic use subgroup (0.29 L; 95% CI, 0.18-0.39).
Lastly, researchers observed significant elevated odds for benralizumab response at week 48 with two baseline characteristics: more exacerbations (OR = 1.54; 95% CI, 1.15-2.07) and higher peak BEC (OR = 1.48; 95% CI, 1.05-2.08).
“XALOC-1 demonstrates that benralizumab treatment is highly effective, including in patients who have not adequately responded to anti-IgE and/or anti-IL-5 treatments, irrespective of key clinical characteristics such as BEC and FENO level,” Jackson and colleagues wrote.