Late Breaking Abstract - Effectiveness and safety of mepolizumab in real-world clinical practice: the REALITI-A study

Harrison, Tim; Canonica, Giorgio Walter; Gemzoe, Kim; Maxwell, Aoife C.; Yang, Shibing; Joksaite, Sandra; O’Reilly, Ronan; Dyke, Melissa Van; Albers, Frank C.; Kwon, Namhee

doi:10.1183/13993003.congress-2019.oa2104

Cited by 5 publications

(8 citation statements)

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“…Improvements in disease outcomes with mepolizumab are in accordance with reports from clinical trials and previous observational studies and support the real-world efficacy of mepolizumab in treating patients with severe asthma. 2,[34][35][36][37][38]40,41 They are also consistent with several previous post hoc meta-analyses of phase IIb and III randomized clinical trials, which have indicated reductions of at least 50% with mepolizumab treatment in the rate of clinically significant exacerbations across a range of comorbidities, 39 patient weights, 51 and IgE concentrations. 36 Beyond this, improved asthma control is associated with decreased risk of anxiety and depression, which in turn can lead to further improvements in asthma control.…”

Section: Discussionsupporting

confidence: 89%

“…Previous insurance claims-based and observational cohort studies have revealed the treatment benefits of mepolizumab in general populations of patients with severe eosinophilic asthma. 2,40,41 Nevertheless, none of these real-world studies (each involved fewer patients than the current analysis) evaluated the impact of mepolizumab in subgroups of patients with specific comorbidities that can complicate disease management. A post hoc meta-analysis of 4 randomized clinical trials evaluated the efficacy of mepolizumab in patients with and without a self-reported history of comorbid upper airways disease, defined as allergic rhinitis, sinusitis, or nasal polyposis.…”

Section: Discussionmentioning

confidence: 99%

“…39 In real-world clinical practice, several studies have revealed the benefits of mepolizumab in a general population of patients with severe eosinophilic asthma. 2,40,41 Nevertheless, the real-world effectiveness of mepolizumab in patients with specific comorbidities has not yet been determined. These data would be valuable given the disease burden and complexities of managing patients with asthma and associated comorbidities in real-world clinical practice, wherein treatment responses and subsequent care are based primarily on a comparison with an individual patient's history.…”

Section: Introductionmentioning

confidence: 99%

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Real-world effectiveness of mepolizumab in patients with severe asthma and associated comorbidities

Casale

Molfino

Silver

et al. 2021

Annals of Allergy, Asthma & Immunology

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Background: Patients with severe asthma frequently have associated comorbidities, which can compound existing symptoms, complicating asthma management. Objective: To describe the real-world effectiveness of mepolizumab in patients with severe asthma stratified by common overlapping comorbidities. Methods: This was a retrospective analysis of patients with asthma from the MarketScan Commercial and Medicare Supplemental Database initiating mepolizumab treatment (index date). Eligible patients had more than or equal to 1 claim (excluding claims for diagnostic tests) with a diagnosis code for more than or equal to 1 of 7 comorbidities (atopic disease, nasal polyps, chronic sinusitis, obesity, respiratory infections, chronic obstructive pulmonary disease, and depression/anxiety) during the 12-month preindex baseline period; these were used to stratify patients into 7 nonmutually exclusive subgroups. Outcomes included asthma exacerbations and exacerbation-related health care resource utilization during the 12-month baseline and follow-up periods. Each patient acted as their own control. Results: Of the 639 patients included, the most common comorbidities were atopic diseases (73.2%), respiratory infections (55.6%), and chronic sinusitis (45.1%). Across all 7 comorbidity subgroups, there were significant (P < .05) reductions of 38% to 55% and 57% to 83% in exacerbations and exacerbations requiring hospitalization, respectively, during the follow-up vs baseline period, except for exacerbations requiring hospitalization in the nasal polyp subgroup, owing to the small subgroup sample size. During the follow-up vs baseline periods, mean number of oral corticosteroids claims was significantly (P < .001) reduced by 29% to 38%; 39% to 47% of patients achieved greater than or equal to 50% oral corticosteroids dose reduction. Significant reductions in exacerbationrelated health care resource utilization were also observed. Conclusion: Mepolizumab treatment provided real-world clinical benefits in patients.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Real-world effectiveness of mepolizumab in patients with severe asthma and associated comorbidities

Casale

Molfino

Silver

et al. 2021

Annals of Allergy, Asthma & Immunology

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“…The results of this analysis are in line with a previous post hoc analysis of MENSA and MUSCA, which demonstrated that mepolizumab reduced the rate of clinically significant exacerbations and improved SGRQ total and ACQ-5 scores, compared with placebo, in patients with severe eosinophilic asthma across all body weight and body mass index categories [ 16 ]. With regards to real-world evidence, results from an interim analysis of the ongoing prospective, observational, global REALITI-A study (which includes patients with severe eosinophilic asthma newly prescribed mepolizumab in routine care) demonstrated that mepolizumab effectively reduces exacerbations in a real-world setting [ 17 ]. In addition, reductions in exacerbation rates were observed with mepolizumab among patients with especially severe eosinophilic asthma enrolled in a French early access programme [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials

Lemière

Taillé

Lee³

et al. 2021

Respir Res

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Background Severe asthma is associated with a broad range of phenotypes and clinical characteristics. This analysis assessed whether select baseline patient characteristics could prognosticate mepolizumab efficacy in severe eosinophilic asthma. Methods This was a post hoc meta-analysis of data from the Phase III MENSA (NCT01691521/MEA115588) and MUSCA (NCT02281318/200862) studies. Patients aged ≥ 12 years with severe eosinophilic asthma and a history of exacerbations were randomised to receive placebo (MENSA/MUSCA), mepolizumab 75 mg intravenously (MENSA) or 100 mg subcutaneously (SC) (MENSA/MUSCA) every 4 weeks for 32 (MENSA) or 24 (MUSCA) weeks. The primary endpoint was the annual rate of clinically significant exacerbations; other outcomes included the proportion of patients with no exacerbations and changes from baseline in pre-bronchodilator forced expiratory volume in 1 s (FEV1), St George’s Respiratory Questionnaire (SGRQ) total score and Asthma Control Questionnaire (ACQ)-5 score. Analyses were performed by baseline age of asthma onset (< 18 years; 18–40 years; ≥ 40 years); lung function (% predicted FEV1 ≤ 60; 60–80; > 80); airway reversibility (reversible [≥ 12% change in FEV1]; non-reversible [< 12% change in FEV1]); perennial and/or seasonal allergen sensitivity (yes/no); asthma control (uncontrolled [ACQ-5 score ≥ 1.5]; partial/complete control [ACQ-5 score < 1.5]). Results Overall, 936 patients received mepolizumab 100 mg SC or placebo. Across age at asthma onset, lung function and airway reversibility subgroups, mepolizumab reduced the rate of clinically significant exacerbations by 49–63% versus placebo. Improvements in lung function, SGRQ total score and ACQ-5 score were also seen with mepolizumab versus placebo across most age and lung function subgroups. Clinically significant exacerbations were reduced with mepolizumab versus placebo irrespective of season or allergen sensitivity; SGRQ total and ACQ-5 scores were generally improved across seasons. Conclusions Mepolizumab efficacy was consistent for patients with varying age at asthma onset, lung function, airway reversibility and allergen sensitivities at baseline. Our results indicate that mepolizumab is likely to be beneficial for patients with severe eosinophilic asthma with a broad range of baseline clinical characteristics; large-scale real-world studies are needed to confirm the external validity of these findings. Trial registration Post hoc meta-analysis of data from MENSA (NCT01691521/MEA115588) and MUSCA (NCT02281318/200862)

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“…Three monoclonal antibodies against IL-5 or its receptor have been granted market access: mepolizumab in 2014 [40][41][42], reslizumab in 2016 [43][44][45][46] and benralizumab in 2017 [47][48][49][50]. Some of these biologics have shown great potential, with mepolizumab showing significant reductions in exacerbations and use of oral corticosteroids in REALITI-A, a 2-year, "real-world" cohort study of patients with severe eosinophilic asthma; better outcomes than were seen in earlier clinical trials [51]. Just recently, the anti-IL-4/13 receptor antibody dupilumab was also approved for use in patients with severe asthma [52][53][54].…”

Section: Asthma Guidelines Updatementioning

confidence: 99%

ERS International Congress, Madrid, 2019: highlights from the Airway Diseases, Asthma and COPD Assembly

et al. 2020

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The European Respiratory Society (ERS) International Congress 2019 in Madrid, Spain, was a platform for scientific discussion of the highest quality scientific research, cutting-edge techniques and innovative new therapies within the respiratory field. This article discusses some of the high-quality research studies presented at that Congress, with a focus on airway diseases, including asthma, COPD, small airways, bronchiectasis and cough, presented through the Airway Diseases, Asthma and COPD Assembly (Assembly 5) of the ERS. The authors establish the key take-home messages of these studies, compare their findings and place them into context of current understanding.

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Late Breaking Abstract - Effectiveness and safety of mepolizumab in real-world clinical practice: the REALITI-A study

Cited by 5 publications

References 0 publications

Real-world effectiveness of mepolizumab in patients with severe asthma and associated comorbidities

Real-world effectiveness of mepolizumab in patients with severe asthma and associated comorbidities

Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials

ERS International Congress, Madrid, 2019: highlights from the Airway Diseases, Asthma and COPD Assembly

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