Biologics (mepolizumab and omalizumab) induced remission in severe asthma patients

Abstract

BackgroundAsthma remission has emerged as a potential treatment goal. This study evaluated the effectiveness of two biologics (mepolizumab/omalizumab) in achieving asthma remission.MethodsThis observational study included 453 severe asthma patients (41% male; mean age ± SD 55.7 ± 14.7 years) from two real‐world drug registries: the Australian Mepolizumab Registry and the Australian Xolair Registry. The composite outcome clinical remission was defined as zero exacerbations and zero oral corticosteroids during the previous 6 months assessed at 12 months and 5‐item Asthma Control Questionnaire (ACQ‐5) ≤1 at 12 months. We also assessed clinical remission plus optimization (post‐bronchodilator FEV1 ≥80%) or stabilization (post‐bronchodilator FEV1 not greater than 5% decline from baseline) of lung function at 12 months. Sensitivity analyses explored various cut‐offs of ACQ‐5/FEV1 scores. The predictors of clinical remission were identified.Results29.3% (73/249) of AMR and 22.8% (37/162) of AXR cohort met the criteria for clinical remission. When lung function criteria were added, the remission rates were reduced to 25.2% and 19.1%, respectively. Sensitivity analyses identified that the remission rate ranged between 18.1% and 34.9% in the AMR cohort and 10.6% and 27.2% in the AXR cohort. Better lung function, lower body mass index, mild disease and absence of comorbidities such as obesity, depression and osteoporosis predicted the odds of achieving clinical remission.ConclusionBiologic treatment with mepolizumab or omalizumab for severe asthma‐induced asthma remission in a subgroup of patients. Remission on treatment may be an achievable treatment target and future studies should consider remission as an outcome measure.

Long-Term Clinical and Sustained REMIssion in Severe Eosinophilic Asthma treated with Mepolizumab: The REMI-M study

“…In contrast, remission was more likely in patients with AERD and a better baseline lung function. Notably, these determinants concur with findings from previous studies on clinical remission after 12 months (37,44,46,47), thus confirming their influence also in the long-term.…”

“…We also explored the most used composite criteria for defining clinical and sustained remission from a research/clinician point of view to ensure adequate reproducibility and allow for direct comparison with prior studies (26). Specifically, according to the lung function parameter adopted, the percentage of patients achieving clinical remission at 12 months ranged from 28.6% to 35.8%, in concordance with the already available evidence (29,37,44). However, the clinical remission rate after one year in our study was higher compared to the Danish (19%) and UK (18.3%) national registry cohorts (46,47).…”

“…In terms of clinical remission, to date, only a few studies have investigated the effects of mepolizumab, with two studies assessing its effectiveness after one year of treatment (29,44), one study evaluating the super-response to anti-IL-5/Rα biologics after 2 years (45).…”

Evaluation of Clinical Remission in Best-Performing Severe Asthmatic Patients Treated for Three Years with Mepolizumab

“…One reason may be that we included only patients who continued the therapy for the entire period and not those who discontinued it for ineffectiveness or other reasons, so that our cohort was predisposed to experience some effect. In their Australian registry study of patients with severe asthma treated with mepolizumab and omalizumab, Thomas et al [28] reported a 1-year remission rate of 29.3% (or 25.2% when the respiratory function parameter was also considered), as compared with 39% to 52% in our patients at the same time point. To try to clarify possible reasons for this difference, we considered the predisposing factors for remission identified in that study and compared them with the baseline data from our cohort (Table 4).…”

“…Compared with previously published findings, our cohort of patients was more likely to be in remission by the end of the study [5,28]. One reason may be that we included only patients who continued the therapy for the entire period and not those who discontinued it for ineffectiveness or other reasons, so that our cohort was predisposed to experience some effect.…”