Efficacy and Safety of Mepolizumab in Uncontrolled Patients with Severe Eosinophilic Asthma Following a Switch from Omalizumab (OSMO Study): Exacerbation and Safety Outcomes

Galkin, Dmitry; Liu, Mark C.; Chipps, Bradley E.; Muñoz, Xavier; Bergna, Miguel; Azmi, Jay; Mouneimne, Dalal; Joksaite, Sandra; Albers, Frank C.

doi:10.1016/j.jaci.2017.12.965

Cited by 14 publications

(18 citation statements)

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“…In accordance with already published data, 5–7 our study showed a significant decrease in peripheral blood eosinophil count after switching from omalizumab to mepolizumab. This was an expected result when considering the direct action of mepolizumab on IL-5, namely the main eosinophil survival factor.…”

Section: Discussionsupporting

confidence: 93%

“…The main result of our study, highly consistent with OSMO 6 and the similar trial performed by Bagnasco et al, 7 is that patients with severe eosinophilic asthma, not optimally controlled by omalizumab, displayed a significant improvement in asthma control following a direct switch to mepolizumab, as reflected by the important reduction in the rate of both severe and mild-tomoderate exacerbations. In the OSMO study, among 145 patients who were switched to mepolizumab, the rate of clinically significant exacerbations during the 32-week study period decreased by 64% compared with the year prior to study enrollment 6 . After 1 year of mepolizumab treatment, Bagnasco et al 7 registered a decrease in the mean exacerbation rate of 81% in their 27 patients.…”

Section: Discussionmentioning

confidence: 99%

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Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

Carpagnano

Pelaia

D’Amato

et al. 2020

Ther Adv Respir Dis

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Background: Current availability of several biologic treatments for severe asthma makes it possible to choose the most appropriate for each patient. Sometimes a good percentage of patients with severe asthma may be eligible for biologics that target either the allergic phenotype or the eosinophilic one, but not all respond to that selected as first choice. The aim of our real-life study was to assess whether, for patients with severe eosinophilic allergic asthma, not previously controlled by the anti-IgE omalizumab, the shift to another biologic targeting interleukin-5, such as mepolizumab, may represent a good therapeutic choice. Methods: A total of 41 consecutive patients with severe, persistent allergic, eosinophilic asthma, uncontrolled despite treatment with omalizumab, were enrolled in seven certified Clinical Respiratory Units of Southern Italy (Catania, Catanzaro, Foggia, Bari, Palermo, and two University Respiratory Units of Naples) and shifted to mepolizumab without a wash-out period. Data at baseline, after at least 12 months of therapy with omalizumab, and after at least 12 months of treatment with mepolizumab were collected. Results: After at least 12 months of therapy with mepolizumab, patients experienced a significant decrease in the number of exacerbations/year (5.8 ± 1.8 versus 0.7 ± 0.9, p < 0.0001), an increment of asthma control test score (12 ± 2.7 versus 21.9 ± 2.7, p < 0.0001), an increase in pre-bronchodilator forced expiratory volume in 1 s (1.56 ± 0.45 l versus 1.86 ± 0.52 l, p < 0.0001), and a reduction of blood eosinophils (584 ± 196 cells/µl versus 82 ± 56 cells/µl, p < 0.0001). The percentage of patients who were dependent on corticosteroids significantly decreased from 46% at baseline to 5% during treatment with mepolizumab. Conclusion: Results of our real-life multicentric experience confirms that the shift to mepolizumab could be a good therapeutic strategy in severe eosinophilic allergic asthma not previously controlled by omalizumab. The reviews of this paper are available via the supplemental material section.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

Carpagnano

Pelaia

D’Amato

et al. 2020

Ther Adv Respir Dis

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“…Addition of mepolizumab was also associated with improvements vs placebo in asthma control, HRQoL and OCS use irrespective of prior omalizumab use 28. More recently, a prospective, single-arm study confirmed that patients who are suboptimally controlled on omalizumab and who switch directly to mepolizumab add-on treatment can achieve significant improvement in exacerbation rates, lung function, health status, and asthma control, with 77% of patients experiencing the minimal clinically important difference of ≥0.5-point reduction in Asthma Control Questionnaire-5 score 19,20. Together, these data suggest that mepolizumab could be a suitable option for those patients who exhibit severe uncontrolled asthma with both allergic and eosinophilic phenotype markers and are, therefore, eligible for both mepolizumab and omalizumab.…”

Section: Discussionmentioning

confidence: 96%

“…Indirect comparisons using network meta-analyses have indicated broadly similar efficacy and safety profiles in patients with severe asthma, although population differences and high rates of outcome heterogeneity precluded any definitive conclusions 17,18. More recently, a single-arm study showed that patients not optimally controlled with omalizumab who were switched directly to mepolizumab and followed for 32 weeks achieved clinically meaningful improvements from baseline in exacerbation rates, asthma control, HRQoL, and lung function, with no new safety issues identified 19,20…”

Section: Introductionmentioning

confidence: 99%

<p>Real-world characteristics and disease burden of patients with asthma prior to treatment initiation with mepolizumab or omalizumab: a retrospective cohort database study</p>

Llanos¹,

Bell²,

Packnett³

et al. 2019

JAA

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PurposePatients with severe asthma are eligible for asthma-specific biologics as add-on therapies, such as mepolizumab and omalizumab, when optimized controller therapies are unable to control their symptoms. However, few real-world data are available to describe the characteristics and associated economic burden of patients considered to be candidates for mepolizumab or omalizumab therapy.MethodsThis retrospective cohort study investigated patients with asthma (≥12 years of age) identified at the time of first mepolizumab or omalizumab administration (index date) in the MarketScan™ Commercial Database. Data were collected during the 12-month period before the index date (baseline period) for two mutually exclusive patient groups (patients prescribed mepolizumab and omalizumab, respectively). Baseline demographics, history of exacerbations, healthcare resource utilization (HCRU), and medical costs were investigated.ResultsIn total, 413 and 1,834 patients who had been prescribed mepolizumab or omalizumab, respectively, were identified. During the baseline period, patients prescribed mepolizumab experienced more exacerbations (81.4% vs 57.5%, P<0.001), had higher asthma-related HCRU for outpatient services (all P<0.01), and had higher total asthma-related healthcare costs (US$11,000 vs US$7,400, P<0.001) compared with patients prescribed omalizumab. Allergic rhinitis, atopic dermatitis, and chronic idiopathic urticaria were more common among patients prescribed omalizumab vs mepolizumab. In contrast, sinusitis, nasal polyps, and comorbid COPD were more common among patients prescribed mepolizumab vs omalizumab. Prescriptions of fixed-dose inhaled corticosteroids (ICSs) with long-acting β2-agonists (LABAs) and ICS/LABA/long-acting muscarinic antagonist triple therapy during the baseline period were higher among patients prescribed mepolizumab vs omalizumab (80.4% vs 56.8% and 27.1% vs 14.4%, respectively, both P<0.001).ConclusionIn the 12 months prior to initiation of asthma-specific biologics, patients prescribed mepolizumab had a different prevalence of certain comorbidities, higher disease burden, higher HCRU, and higher healthcare costs compared with patients prescribed omalizumab.

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“…Еще одной клинической ситуацией в которой может быть эффективно использован меполизумаб является рефрактерность к терапии омализумабом, которая может развиваться на фоне применения данного лекарственного препарата [37]. Соответственно, целью другого КЭИ может являться определение экономических последствий переключения с омализумаба на меполизумаб в случаях развития рефрактерности к проводимой терапии.…”

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Cost-Effectiveness Analysis of Treatment for Severe Eosinophilic Asthma in Adults: Mepolizumab and Omalizumab

Толкушин¹,

Погудина²,

Ivanov

et al. 2019

Medical Technologies. Assessment and Choice (Медицинские Технологии. Оценка И Выбор)

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Objective: Based on the cost-effectiveness analysis (CEA) to determine economic and clinical consequences of using mepolizumab instead of omalizumab in adults with severe eosinophilic asthma, when omalizumab is administered once every 2 weeks or mepolizumab is administered once every 4 weeks. Methods: Effectiveness and safety analysis was conducted based on the published network meta-analysis, because head-to-head clinical trials of omalizumab versus mepolizumab were not identified during targeted scientific literature search. Direct medical costs were calculated using information from the register of manufacturers` maximum selling prices for vital and essential drugs (VED), instructions for medical use, the unit cost of healthcare services. Results: Effectiveness and safety of the compared drugs were determined based on the results of the network meta-analysis. Frequency of clinically significant asthma exacerbations (risk ratio = 0,19; 95% CI: 0,02–2,32) and withdrawals due to adverse events (risk ratio = 0,05; 95% CI: 0,002–0,95). Therefore, despite the tendency to mepolisumab benefits, it was concluded that there are no statistically significant differences in the effectiveness and safety of the compared drugs due to the insufficient statistical power of the result. Direct medical costs were 870130 rubles and 1852063 rubles for mepolizumab and omalizumab respectively. Saving of direct medical costs for mepolizumab treatment was 959170 rubles per patient per year or 52%. Conclusion: treatment with mepolizumab versus omalizumab in patients with severe eosinophilic asthma, when omalizumab is administered once every 2 weeks or mepolizumab is administered once every 4 weeks, leads to saving of direct medical costs for drug treatment.

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Efficacy and Safety of Mepolizumab in Uncontrolled Patients with Severe Eosinophilic Asthma Following a Switch from Omalizumab (OSMO Study): Exacerbation and Safety Outcomes

Cited by 14 publications

References 0 publications

Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

Switching from omalizumab to mepolizumab: real-life experience from Southern Italy

<p>Real-world characteristics and disease burden of patients with asthma prior to treatment initiation with mepolizumab or omalizumab: a retrospective cohort database study</p>

Cost-Effectiveness Analysis of Treatment for Severe Eosinophilic Asthma in Adults: Mepolizumab and Omalizumab

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