Efficacy and safety of mepolizumab in a real-world cohort of patients with severe eosinophilic asthma

Pertzov, Barak; Unterman, Avraham; Shtraichman, Osnat; Shitenberg, Dorit; Rosengarten, Dror; Kramer, Mordechai R.

doi:10.1080/02770903.2019.1658208

Cited by 33 publications

(23 citation statements)

References 24 publications

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“…Our results support those from the clinical trials MENSA (NCT01691521) and MUSCA (NCT02281318), where patients receiving mepolizumab (subcutaneous dose) experienced respective 53% and 58% reductions in the rate of CSEs versus placebo, despite the placebo effect observed in both studies [14,15]. Additionally, our data are also consistent with findings from several smaller, observational studies of real-world mepolizumab treatment for severe asthma [23][24][25][26][27].…”

Section: Discussionsupporting

confidence: 89%

“…Approximately one-third of patients discontinued maintenance OCS by Week 53-56. Similar to our results, a 50% reduction in the median OCS dose in patients receiving mepolizumab versus placebo was demonstrated in the SIRIUS trial (NCT01691508), and have also been reported in smaller real-world observational studies [13,[23][24][25][26][27]. These reductions are particularly important in patients with severe asthma given the risk of AEs associated with chronic SCS use, irrespective of dose level, and the additional healthcare costs related to corticosteroid-induced AEs in patients with severe asthma [28,29].…”

Section: Discussionsupporting

confidence: 88%

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Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis

et al. 2020

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BackgroundEfficacy of mepolizumab, an anti-interleukin-5 monoclonal antibody, was demonstrated in randomised, controlled trials; data on its real-world impact in routine clinical practice are starting to emerge. We assessed the effectiveness and safety of mepolizumab prescribed for patients in the real world.MethodsREALITI-A is a global, prospective, observational cohort study, collecting data from routine healthcare visits from patients with asthma. Patients newly prescribed mepolizumab for severe asthma with 12 months' relevant medical history pre-mepolizumab (collected retrospectively) were enrolled. An initial analysis of data from early initiators who had completed 1-year follow-up (as of 28 February 2019) was conducted. The primary objective was to compare the rate of clinically significant exacerbations (CSEs; requiring oral corticosteroids [OCS] and/or hospitalisation/emergency department [ED] visit) before and after mepolizumab; exacerbations requiring hospitalisation/ED visit and change in maintenance OCS use were secondary objectives. Treatment-related adverse events (AEs) were reported.ResultsOverall, 368 mepolizumab-treated patients were included. Rates of CSEs were reduced by 69% from 4.63/person/year pre-treatment to 1.43/person/year during follow-up (p<0.001), as were those requiring hospitalisation and/or ED visits (from 1.14/person/year to 0.27/person/year; 77% reduction). In 159 patients with maintenance OCS dose data available during the pre-treatment period, median daily dose decreased from 10.0 mg·day−1 (pre-treatment) to 5.0 mg·day−1 by Week 21–24 of follow-up, sustained until Week 53–56. No new safety signals were reported.ConclusionThese data demonstrate that the effectiveness of mepolizumab is consistent with clinical trial results under real-world settings, with significant reductions in exacerbations and daily maintenance OCS dose.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 88%

Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis

et al. 2020

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“…Similar data were reported also by Caminati et al [45] during a shorter period of observation, after 6 months mepolizumab decreased the OCS dose by 5 mg/day, and the percentage of patients requiring OCS was reduced to 32.2%. These data were confirmed also by a study of Pertzov et al [49], in which 68% of patients discontinued OCS treatment or reduced the daily dose >50% after 6 months of treatment with mepolizumab. Furthermore, the OCS dose was reduced from 20 mg/day to 5 mg/day.…”

Section: Mepolizumabsupporting

confidence: 70%

“…Of the 1757 potentially relevant records identified in the initial search, 59 real-world studies were deemed eligible for a qualitative analysis. Six studies were carried out on benralizumab [34][35][36][37][38][39], 1 on dupilumab [40], 18 on mepolizumab [41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58], 27 on omalizumab [18,, and 3 on reslizumab [85][86][87]. Four studies investigated different mAbs in the same report [88][89][90][91].…”

Section: Study Characteristicsmentioning

confidence: 99%

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

Calzetta

Aiello

Frizzelli

et al. 2021

IJMS

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Airway inflammation represents an important characteristic in asthma, modulating airflow limitation and symptom control, and triggering the risk of asthma exacerbation. Thus, although corticosteroids represent the cornerstone for the treatment of asthma, severe patients may be dependent on oral corticosteroids (OCSs). Fortunately, the current humanised monoclonal antibodies (mAbs) benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab have been proven to induce an OCS-sparing effect in randomized controlled trials (RCTs), thus overcoming the problem of OCS dependence in severe asthma. Nevertheless, a large discrepancy has been recognized between selected patients enrolled in RCTs and non-selected asthmatic populations in real-world settings. It is not possible to exclude that the OCS-sparing effect of mAbs resulting from the RCTs could be different than the real effect resulting in clinical practice. Therefore, we performed a systematic review and correlation analysis to assess whether mAbs are effective in eliciting an OCS-sparing effect and overcoming the OCS dependence in severe asthmatic patients in real-world settings. Overall, real-world studies support the evidence that OCS dependence is a real condition that, however, can be found only in a small number of really severe asthmatic patients. In most patients, the dependence on OCS can be related to modifying factors that, when adequately modulated, may lead to a significant reduction or suspension of OCS maintenance. Conversely, in severe asthmatics in whom OCS resistance is proved by a high daily dose intake, mAbs allow reversion of the OCS dependence, leading to the suspension of OCS therapy in most patients or >50% reduction in the daily OCS dose.

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“…In MENSA (MEpolizumab as adjunctive therapy iN patients with Severe Asthma) and MUSCA (Mepolizumab adjUnctive therapy in subjects with Severe eosinophiliC Asthma), exacerbation rates were reduced by 53% and 58% following 32 and 24 weeks with mepolizumab (100 mg SC) versus placebo [14,15]. Other studies based on real-world data have also associated mepolizumab with a reduction in exacerbations [24][25][26][27]; in one recent example (n=25), 82.6% of patients experienced fewer exacerbations and 47.8% experienced no exacerbations on-treatment [24]. When we analysed data by blood eosinophil count at inclusion, reductions in exacerbation rate and OCS use/dose were seen across all subgroups (although the sample sizes were small).…”

Section: Discussionmentioning

confidence: 99%

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme

et al. 2020

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BackgroundMepolizumab was available in France as part of an early access programme for patients with severe eosinophilic asthma (nominative autorisation temporaire d'utilisation [temporary use authorisation] (nATU)) before its commercialisation. This study aimed to characterise patients who received mepolizumab in the nATU.MethodsThis retrospective, observational study analysed data from the hospital medical records of patients up to 24 months after treatment initiation. Study objectives were to describe patient baseline characteristics, the evolution of disease severity and treatment modifications during follow-up; safety was also investigated.FindingsOverall, 146 patients who received ≥1 dose of mepolizumab were included. At inclusion, patients had a mean age of 58.2 years with a mean severe asthma duration of 13.4 years, and 37.0% had respiratory allergies. Patients experienced, on average, 5.8 exacerbations per patient per year at baseline, 0.6 and 0.5 of which required hospitalisation and emergency department visits, respectively. These values improved to 0.6, 0.1 and 0.1 exacerbations per patient per year, respectively, at 24 months of follow-up. Most patients (92.8%) were using oral corticosteroids at baseline, compared with 34.7% by 24 months of follow-up. Moreover, mean blood eosinophil counts improved from 722 cells·µL−1 at baseline to 92 cells·µL−1 at 24 months of follow-up; lung function and asthma control followed a similar trend.InterpretationResults confirm findings from clinical trials, demonstrating that mepolizumab is associated with important improvements in several clinically meaningful outcomes and has a favourable safety profile in a population with severe eosinophilic asthma, outside of the controlled environment of a clinical trial.

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Efficacy and safety of mepolizumab in a real-world cohort of patients with severe eosinophilic asthma

Cited by 33 publications

References 24 publications

Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis

Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis

Oral Corticosteroids Dependence and Biologic Drugs in Severe Asthma: Myths or Facts? A Systematic Review of Real-World Evidence

Mepolizumab in a population with severe eosinophilic asthma and corticosteroid dependence: results from a French early access programme

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