Mepolizumab in Hypereosinophilic Syndrome: A Systematic Review and Meta-analysis

Júnior, José Mario Alves; Prota, Francisco Eduardo; Villagelin, Danilo; Bley, Fernanda; Bernardo, Wanderley Marques

doi:10.6061/clinics/2021/e3271

Cited by 3 publications

(2 citation statements)

References 17 publications

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“…Again, observations in real life have shown the efficacy of the drug in other diseases such as eosinophilic esophagitis [ 67 , 68 , 69 ]. Mepolizumab was approved for two orphan diseases, namely, EGPA [ 70 , 71 , 72 ] and HES [ 73 , 74 , 75 ]. Concerning benralizumab, the effect on the reduction in exacerbations and the need for systemic corticosteroids was confirmed in randomized clinical trials [ 76 ].…”

Section: T2 Targeted Therapies In Asthmamentioning

confidence: 99%

Personalized and Precision Medicine in Asthma and Eosinophilic Esophagitis: The Role of T2 Target Therapy

Bagnasco,

Savarino,

Yacoub

et al. 2023

Pharmaceutics

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The role of type 2 inflammation has been progressively associated with many diseases, including severe asthma, atopic dermatitis, nasal polyposis, eosinophilic granulomatosis with polyangiitis, and, recently, eosinophilic esophagitis. Despite this, the association between asthma and esophagitis is still poorly known, and this is probably because of the low prevalence of each disease and the even lower association between them. Nonetheless, observations in clinical trials and, subsequently, in real life, have allowed researchers to observe how drugs acting on type 2 inflammation, initially developed and marketed for severe asthma, could be effective also in treating eosinophilic esophagitis. For this reason, clinical trials specifically designed for the use of drugs targeted to type 2 inflammation were also developed for eosinophilic esophagitis. The results of clinical trials are presently promising and envisage the use of biologicals that are also likely to be employed in the field of gastroenterology in the near future. This review focuses on the use of biologicals for type 2 inflammation in cases of combined severe asthma and eosinophilic esophagitis.

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Section: T2 Targeted Therapies In Asthmamentioning

confidence: 99%

Personalized and Precision Medicine in Asthma and Eosinophilic Esophagitis: The Role of T2 Target Therapy

Bagnasco,

Savarino,

Yacoub

et al. 2023

Pharmaceutics

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“…The response rate of imatinib was only 23% in PDGFRα -negative HES patients. Mepolizumab, a monoclonal antibody targeting interkulin5 ( IL-5 ), could control AEC, relieve disease symptoms, and reduce the prednisone dosage in HES patients ( Roufosse et al, 2020 ; Alves Júnior et al, 2021 ; Pane et al, 2022 ). Nonetheless, its high cost limits its application.…”

Section: Introductionmentioning

confidence: 99%

Case Report: Off-label treatment of idiopathic hypereosinophilic syndrome with Omalizumab

2023

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Idiopathic hypereosinophilic syndrome (IHES) is a rare disease characterized by causeless persistent hypereosinophilia and eosinophilia-associated end-organ damage. Current treatment modalities don’t meet the needs due to adverse events of steroids as first-line therapy and the limited efficacy of second-line treatments, underscoring the need for new therapeutic strategies. Here we presented two cases of IHES with different clinical manifestations that were both refractory to corticosteroids. Patient #1 experienced rashes, cough, pneumonia, and steroid-induced side effects. Patient #2 had severe gastrointestinal symptoms attributed to hypereosinophilia. They both had high levels of serum IgE, didn’t respond well to second-line treatments of interferon-α (IFN-α) and imatinib, and Mepolizumab was not accessible. We then innovatively switched to Omalizumab, an anti-IgE monoclonal antibody approved for allergic asthma and chronic idiopathic urticaria. Patient #1 was treated with Omalizumab 600 mg per month for 20 months; his absolute eosinophil count (AEC) decreased significantly and has stabilized at around 1.0×109/L for 17 months, with complete relief from erythra and cough. Patient #2 recovered promptly from severe diarrhea with a sharp drop in AEC after 3 months of treatment with omalizumab at 600 mg per month. Therefore, we concluded that Omalizumab may be a seminal therapeutic strategy for IHES patients who are refractory to corticosteroids, whether as long-term management of AEC or as an urgent intervention to address severe symptoms caused by eosinophilia.

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Is the United Kingdom (UK) medicines pricing policy failing patients? The impact of terminated National Institute for Health and Care Excellence (NICE) appraisals for multi-indication products on patients

Mitchell,

Xin,

Hide

et al. 2024

Preprint

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BackgroundNational Institute for Health and Care Excellence (NICE) data regarding manufacturer-driven terminations indicate that some patients in the United Kingdom (UK) are unable to access treatments that are available in other European countries, which may result in reduced survival and quality of life (QoL). This study aims to quantify the health impact of NICE appraisals for multi-indication products terminated for reasons not related to clinical trial failure on the UK population.MethodsTerminated NICE appraisals (2014–2023) for multi-indication products were identified and a targeted literature search was conducted to identify data on the health impact of the interventions. The potential incremental quality-adjusted life year (QALY) loss and impact on overall survival (OS), progression-free survival (PFS), and QoL was calculated.ResultsOver 16,000 QALYs/year were potentially lost (with one QALY equal to one year of life in perfect health) across approximately 829,000 patients in the UK due to NICE appraisals for multi-indication products being terminated for reasons not related to clinical trial failure. Across oncology indications (approximately 18,900 patients), OS and PFS may have been reduced by over 9,400 years and 9,000 years, respectively. The potential impact of the treatments for non-oncology indications for which NICE appraisals were terminated on QoL was an incremental improvement of 13% (weighted average).ConclusionsDue to the increasing number of NICE terminations for multi-indication products, patients cannot access therapies that could lengthen their lives and increase their QoL. As the UK uniform pricing policy is likely to influence manufacturer-driven terminations, introducing alternative reimbursement arrangements such as indication-based pricing (IBP) agreements to ensure that prices remain commensurate with therapeutic value could improve access to therapies in the UK, thereby improving public health.HighlightsNational Institute for Health and Care Excellence (NICE) termination data indicate that some patients in the United Kingdom (UK) are unable to access treatments available in other European countries, which could potentially prolong their lives and improve their quality of life (QoL)Across approximately 829,000 patients in the UK, over 16,000 quality-adjusted life years (QALYs) per year (with one QALY equal to one year of life in perfect health) are potentially lost as a result of NICE appraisals for multi-indication products that have been terminated for reasons not related to clinical trial failureAssessing reimbursement options such as indication-based pricing (IBP) agreements for treatments that would typically not meet NICE’s cost-effectiveness criteria at the current price provides an opportunity to improve access to therapies in the UK, thereby improving public health

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Mepolizumab in Hypereosinophilic Syndrome: A Systematic Review and Meta-analysis

Cited by 3 publications

References 17 publications

Personalized and Precision Medicine in Asthma and Eosinophilic Esophagitis: The Role of T2 Target Therapy

Personalized and Precision Medicine in Asthma and Eosinophilic Esophagitis: The Role of T2 Target Therapy

Case Report: Off-label treatment of idiopathic hypereosinophilic syndrome with Omalizumab

Is the United Kingdom (UK) medicines pricing policy failing patients? The impact of terminated National Institute for Health and Care Excellence (NICE) appraisals for multi-indication products on patients

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