Switching from one biologic to benralizumab in patients with severe eosinophilic asthma: An ANANKE study post hoc analysis

Abstract

BackgroundSevere asthma is a heterogeneous inflammatory disease driven by eosinophilic inflammation in the majority of cases. Despite biologic therapy patients may still be sub-optimally controlled, and the choice of the best biologic is a matter of debate. Indeed, switching between biologics is common, but no official guidelines are available and real-world data are limited.Materials and methodsIn this post hoc analysis of the Italian, multi-center, observational, retrospective study, ANANKE. Patients with severe eosinophilic asthma treated with benralizumab were divided in two groups based on history of previous biologic therapy (biologic-experienced [suboptimal response] vs naïve). Baseline clinical and laboratory characteristics were collected in the 12 months prior to benralizumab treatment. Change over time in blood eosinophils, annualized exacerbation rate (AER), asthma control (ACT), lung function and oral corticosteroid (OCS) use following benralizumab initiation were collected in the two groups.ResultsA total of 147 biologic-naïve and 58 biologic-experienced (34 omalizumab, 19 mepolizumab, and 5 omalizumab-mepolizumab) patients were enrolled. Biologic-experienced patients were more likely to be atopic and have a higher AER despite more frequent OCS use. Similar reductions in AER (>90% in both groups), OCS use (≥49% reduction in dosage and ≥41% able to eliminate OCS), ACT improvement (≥7 points gained in 48 weeks) and lung function (≥300 mL of FEV1 improvement in 48 weeks) were observed after benralizumab introduction within the two groups. There were no registered discontinuations of benralizumab for safety reasons.ConclusionIn this post hoc analysis, patients who were switched to benralizumab because of suboptimal control with a previous biologic therapy were more likely to be atopic and more often treated with omalizumab. Benralizumab is effective in both naïve patients and those previously treated with a biologic.

Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study

“…Demographic characteristics at index date were similar between naïve and bio-experienced patients, while clinical characteristics showed some differences between the two groups (Additional file 5 : Table S5). In agreement with the post hoc data reported by Caruso et al [ 24 ], naïve population had a shorter median duration of SEA (1.6 years naïve patients vs 3.5 years bio-experienced patients, IQR 1.0–3.0 vs 1.6–6.5, respectively), the bio-experienced group had a greater proportion of atopic patients (45.2% naïve patients vs 55.3% bio-experienced patients) and a higher frequency of OCS-related conditions (35.5% naïve patients vs 52.6% bio-experienced patients). Accordingly, OCS use appeared to be slightly higher in the bio-experienced group (24.2% naïve patients vs 28.9% bio-experienced patients) while BEC was slightly lower (median BEC: 605 cells/mm 3 IQR 440–915 in naïve patients vs 550 cells/mm 3 IQR 300–756 in bio-experienced patients).…”

“…Patients also experienced an overall improvement in lung function and asthma control, resulting in a decreased utilization of healthcare resources [ 22 ]. Additional post hoc analyses were carried out and revealed that benralizumab maintained its efficacy independently of presence of atopy, body mass index (BMI) [ 22 ], presence of nasal polyps [ 23 ], use of previous biologics [ 24 ] and BEC [ 25 ].…”

Sustained Effectiveness of Benralizumab in Naïve and Biologics-Experienced Severe Eosinophilic Asthma Patients: Results from the ANANKE Study

“…A new post hoc analysis has been conducted from the real-life ANANKE study, in which the clinical characteristics and outcomes in naïve and bio-experienced SEA patients treated with benralizumab were described for up to 96 weeks. The findings here support earlier research with a shorter treatment duration (median of 9.8 months) 36 and demonstrate the sustained response of benralizumab in patients characterized by an eosinophilic-driven SA phenotype which failed to respond to previous biologics. Novel data have also been generated by analyzing bio-experienced patients split into omalizumab and mepolizumab groups.…”

“…The long-term OCS dose reduction shown in this study exceeds the results previously communicated by Caruso et al, in which naïve and bio-experienced patients reached median daily OCS doses of 4.5 mg and 8.6 mg, respectively, after a median period of 9.8 months (reductions of 61.9% and 49.1%, respectively). 36 Indeed, at 48 and 96 weeks, naïve patients maintained a median OCS dose of 0 mg/daily, while bio-experienced patients had a slight increase in median OCS dose from 0 to 1.9 mg/daily. As already explained above, such a modest increment was not caused by an actual increase in OCS dosage but rather by the low number of bio-experienced patients, which further decreased at 96 weeks.…”

“…A number of post hoc analyses have been conducted so far; among these, Caruso et al examined the differences between patients who received benralizumab as the first-choice biologic (naïve patients) and patients switching to benralizumab after they received other biologics (bio-experienced patients). 36 The results revealed that benralizumab was highly efficacious in both naïve and bio-experienced groups; clinical outcomes were comparable even though bio-experienced patients were characterized by higher severe AER and a protracted duration of SEA compared to naïve patients. More recently, we confirmed the durable effectiveness of benralizumab in reducing any and severe AER by more than 90% in both naïve and bio-experienced patients, up to 96 weeks of treatment.…”