Real-World Effectiveness of Reslizumab in Patients With Severe Eosinophilic Asthma – First Initiators and Switchers

Hashimoto, Simone; Kroes, Johannes A.; Eger, Katrien; Mau-Asam, Pearl; Hofstee, Hendrik B.; Nederveen-Bendien, S A van; Braunstahl, Gert‐Jan; Broeders, M.E.A.C.; Imming, Leonie M.; Langeveld, Bas; Zee, Anke H. Maitland‐van der; Oud, Karen TM.; Patberg, Kornelis W.; Smeenk, Frank W.J.M.; Romme, Elisabeth Anna Petronella; Bezouw, Maarten Johannes van; Ven, M J Van De; Veen, Anneke van; Velzen, Edwin van; Veen, Ilonka H. van; Weersink, Els J.M.; Brinke, Anneke ten; Sont, Jacob K.; Bel, Elisabeth H.

doi:10.1016/j.jaip.2022.04.014

Cited by 13 publications

(2 citation statements)

References 19 publications

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“…First, since treatment decision-making is based on different factors, including disease characteristics, effectiveness, patient preference, adherence, and socioeconomic status, real-world studies can offer the opportunity to investigate factors related to treatment initiation, dose adjustment or discontinuation and to examine switching patterns. Biological treatment discontinuation or switch is frequent in patients with SA, and RWD may help to understand patient factors or clinical outcomes associated with the treatment changes [98][99][100][101][102]. Some patients who did not respond to one biological agent may achieve a significant clinical improvement with other biologics [103].…”

Section: Opportunities For Real-world Studies In Severe Asthmamentioning

confidence: 99%

Roles of real-world evidence in severe asthma treatment: challenges and opportunities

Lee

Park

et al. 2022

ERJ Open Res

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Recent advances in asthma research have led to the development of novel biologics that hinder the pathologic actions of key molecules in severe asthma (SA). Traditional randomised controlled studies (RCTs), the gold standard for evaluating the efficacy and safety of medical interventions with excellent internal validity, have proven the clinical benefits and favourable safety profiles of type 2-biologics in SA. However, RCTs are not always ideal because of shortcomings such as limited external validity and practical issues in the management of SA that could not be solved through strictly designed clinical trials. Thus, the applicability of their findings may be questioned for asthmatic patients because treatment adherence is frequently poor in the real world. Real-world evidence (RWE) includes a wide range of real-world data (RWD) collected from multiple sources in clinical practice, such as electronic medical records, healthcare insurance claims, and retrospective or prospective patient registries. It may help clinicians make decisions about the management of patients with SA. RWE is also gaining attention to address clinical questions not answered by traditional RCTs. Since there are various types of RWD with different possibilities and limitations, and thus it is important to decide which type of RWD could be “fit for purpose” to address a specific question. This narrative review is to discuss the challenges and opportunities of RWD for evaluating the effectiveness and clinical outcomes of biological treatments for SA.

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Section: Opportunities For Real-world Studies In Severe Asthmamentioning

confidence: 99%

Roles of real-world evidence in severe asthma treatment: challenges and opportunities

Lee

Park

et al. 2022

ERJ Open Res

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“…Reslizumab is an IgG subclass 4 κ mAb, given intravenously, which targets IL-5 in patients with severe eosinophilic asthma (SEA) (6). It has been shown in both clinical trials and realworld studies to reduce exacerbation frequency and oral corticosteroid (OCS) use in severe asthmatics (7)(8)(9).…”

Section: Introductionmentioning

confidence: 99%

Real-World clinical outcomes of asthma patients switched from reslizumab to mepolizumab or benralizumab

et al. 2023

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IntroductionApproximately 3%–10% of asthma patients will remain uncontrolled despite maximum, optimal conventional therapy. Treatment of severe refractory asthma often involves the use of targeted biological therapy. Randomised controlled trials have shown improvements in clinical parameters with these treatments but real-world data is lacking.MethodsThe clinical parameters, frequency of exacerbations, number of hospital admissions, asthma control questionnaire score (ACQ), forced expiratory volume in one second (FEV1) and maintenance oral corticosteroid (OCS) dose of twenty asthma patients switched from reslizumab to benralizumab or mepolizumab at 1 year prior and 6 months after switching were compared, with adjustments for time.ResultsThe mean frequency of exacerbations (0.35 v 0.3) and the mean ACQ were essentially unchanged (1.6 v 1.5) following the switch. The number of hospital admissions was one in the 6 months post switch compared to one in 1-year pre switch. 25% of patients were on maintenance OCS before and after switching but one patient required an increased dose post switch resulting in an increase in the mean maintenance OCS dose (1.6 mg to 2.4 mg). The mean FEV1 was unchanged (80% v 77.9%) six months post switching. Regarding asthma control (n = 19), 47.4% were controlled pre and post switch (ACQ < 1.5), 36.8% remained uncontrolled despite switching, 10.5% improved control while 5.3% disimproved.ConclusionWe present real-world clinical outcomes of asthma patients switched from reslizumab to either benralizumab or mepolizumab without a loss of clinical effectiveness in the majority.

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Development and characterization of anti-IL-5 monoclonal antibody Fab fragment for blocking IL-5/IL-5Rα binding

Li,

Wang,

Fordjour

et al. 2023

International Immunopharmacology

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Real-World Effectiveness of Reslizumab in Patients With Severe Eosinophilic Asthma – First Initiators and Switchers

Cited by 13 publications

References 19 publications

Roles of real-world evidence in severe asthma treatment: challenges and opportunities

Roles of real-world evidence in severe asthma treatment: challenges and opportunities

Real-World clinical outcomes of asthma patients switched from reslizumab to mepolizumab or benralizumab

Development and characterization of anti-IL-5 monoclonal antibody Fab fragment for blocking IL-5/IL-5Rα binding

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