Er zijn diverse publicaties van en met RAPSODI data verschenen, voor artikelen geldt dat deze op basis van de hieronder genoemde titel(s) of auteur(s) in pubmed opgezocht kunnen worden om deze in zijn geheel in te kunnen zien. Indien aanwezig wordt hieronder een abstract getoond.
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– Characteristics and treatment regimens across ERS SHARP severe asthmaregistries
– Treatment Eligibility of Real-LifeMepolizumab-Treated Severe Asthma Patients
– Long-Term Therapy Response to Anti-IL-5 Biologics in Severe Asthma-A Real-Life Evaluation
– Poor outcome of SARS-CoV-2 infection in patients with severe asthma on biologic therapy
– Real-World Effectiveness of Reslizumab in Patients With Severe Eosinophilic Asthma – First Initiators and Switchers
– Cumulative Corticosteroid Sparing Effect of Anti-Interleukin-5/5Ra In Eosinophilic Asthma
– RAPSODI Team. Anti-IL-5/5Ra biologics improve work productivity and activity in severe asthma: a RAPSODI registry-based cohort study
– Long-Term Weight Changes After Starting Anti-IL-5/5Ra Biologics in Severe Asthma: The Role of Oral Corticosteroids
– Real-World Effectiveness of IL-5/5Ra Targeted Biologics in Severe Eosinophilic Asthma With Comorbid Bronchiectasis
– Clinical response to benralizumab can be predicted by combining clinical outcomes at 3 months with baseline characteristics
Characteristics and treatment regimens across ERS SHARP severe asthmaregistries
J.J.M. van Bragt. Eur Respir J. 2020 Jan 9;55(1):1901163. doi: 10.1183/13993003.01163-2019, link naar PDF van abstract
Little is known about the characteristics and treatments of patients with severe asthma across
Europe, but both are likely to vary. This is the first study in the European Respiratory Society
Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical
Research Collaboration and it is designed to explore these variations. Therefore, we aimed to
compare characteristics of patients in European severe asthma registries and treatments
before starting biologicals.This was a cross-sectional retrospective analysis of aggregated
data from 11 national severe asthma registries that joined SHARP with established patient
databases.Analysis of data from 3236 patients showed many differences in characteristics and
lifestyle factors. Current smokers ranged from 0% (Poland and Sweden) to 9.5% (Belgium),
mean body mass index ranged from 26.2 (Italy) to 30.6 kg·m-2 (the UK) and the largest
difference in mean pre-bronchodilator forced expiratory volume in 1 s % predicted was
20.9% (the Netherlands versus Hungary). Before starting biologicals patients were treated
differently between countries: mean inhaled corticosteroid dose ranged from 700 to 1335
μg·day-1 between those from Slovenia versus Poland when starting anti-interleukin (IL)-5
antibody and from 772 to 1344 μg·day-1 in those starting anti-IgE (Slovenia versus Spain).
Maintenance oral corticosteroid use ranged from 21.0% (Belgium) to 63.0% (Sweden) and
from 9.1% (Denmark) to 56.1% (the UK) in patients starting anti-IL-5 and anti-IgE,
respectively.The severe asthmatic population in Europe is heterogeneous and differs in both
clinical characteristics and treatment, often appearing not to comply with the current
European Respiratory Society/American Thoracic Society guidelines definition of severe
asthma. Treatment regimens before starting biologicals were different from inclusion criteria
in clinical trials and varied between countries.
Copyright ©ERS 2020.
Treatment Eligibility of Real-LifeMepolizumab-Treated Severe Asthma Patients
L.B. Richards. J Allergy Clin Immunol Pract. 2020 Oct;8(9):2999-3008.e1. doi: 10.1016/j.jaip.2020.04.029, link naar PDF van abstract.
Background: Patients with severe asthma not meeting the strict trial eligibility criteria for
mepolizumab are now routinely treated with this biological in clinical practice, but it remains
unclear whether these ineligible patients respond differently to mepolizumab treatment.
Objective: This study investigated the extent and reasons for trial ineligibility of real-life,
mepolizumab-treated patients with severe asthma and compared the characteristics of these
patients with trial populations. Subsequently, therapeutic response in ineligible patients was
assessed on the basis of oral corticosteroid (OCS) reduction.
Methods: Trial eligibility, population differences, and therapeutic response were assessed
using the baseline characteristics of mepolizumab-receiving patients with severe asthma
treated in the Amsterdam University Medical Centres and OCS dose at 6 months for OCS-
dependent patients extracted from patients’ electronic health records. Eligibility criteria and
population characteristics from trials investigating mepolizumab were extracted from their
Results: A total of 82.4% of 119 mepolizumab-receiving, real-life patients with severe
asthma were ineligible for trial inclusion, wherein 42.9% and 39.5% were excluded on the
basis of inclusion and exclusion criteria, respectively. The clinical care population was older,
more often male and demonstrating a better lung function under lower OCS maintenance
dosages in comparison with trial populations. A total of 50% of 66 ineligible, OCS-dependent
mepolizumab-treated patients were able to reduce their maintenance OCS dosage to ≤5 mg
Conclusions: A large proportion of the real-life, mepolizumab-treated population with severe
asthma would be excluded from trial participation, and significant differences in population
characteristics exist. Regardless, a large fraction of ineligible patients in clinical care can
reduce maintenance OCS dosage under mepolizumab therapy.
Keywords: Anti-IL-5; Asthma; Biologicals; Real-life evidence; Type 2 asthma.
Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by
Elsevier Inc. All rights reserved.
Long-Term Therapy Response to Anti-IL-5 Biologics in Severe Asthma-A Real-Life Evaluation
K.A.B. Eger. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1194-1200. doi: 10.1016/j.jaip.2020.10.010.
Background: Patients with severe eosinophilic asthma show different responses to various anti-IL-5 biologics, ranging from super response to nonresponse. Residual disease manifestations observed in partial responders may prompt physicians to switch between biologics. More data on response, switches, and residual disease manifestations are needed to improve personalized treatment.
Objective: To assess (1) prevalences and predictors of super, partial, and nonresponders to long-term anti-IL-5 treatment, (2) frequency and reasons for switches between anti-IL-5 biologics, and (3) nature of residual disease manifestations.
Methods: In this 2-year follow-up study, patients with severe asthma were included who initiated an anti-IL-5 biologic (mepolizumab, reslizumab, benralizumab) (n = 114). Patient characteristics (clinical, functional, inflammatory) and comorbidities were collected at baseline and 2-year follow-up. “Super responders” showed no residual disease manifestations at 2-year follow-up, “partial responders” experienced residual disease manifestations, and “nonresponders” discontinued anti-IL-5 treatment after less than 2 years because of clinical worsening.
Results: After 2-year anti-IL-5 treatment, 14% of patients were super responders, 69% partial responders, and 11% nonresponders. Super response was predicted by shorter asthma duration and higher FEV1, and tended to be associated with adult-onset asthma, absence of nasal polyps, and lower body mass index. Switches between anti-IL-5 biologics occurred frequently (41%). After 2-year treatment, most common residual disease manifestations included impaired lung function (59%), uncontrolled sinonasal disease (58%), and uncontrolled asthma symptoms (48%).
Conclusions: After 2 years of anti-IL-5 treatment, a favorable response was found in 83% of patients with severe asthma, including a super response in 14%. Most partial responders show impaired lung function or uncontrolled sinonasal disease, causing physicians to switch between biologics.
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
Poor outcome of SARS-CoV-2 infection in patients with severe asthma on biologic therapy
K.A.B. Eger. Respir Med. 2020 Dec 24;177:106287. doi: 10.1016/j.rmed.2020.106287.
Background: It is unclear whether asthma and asthma medications increase or decrease the risk of severe COVID-19, and this is particularly true for patients with severe asthma receiving biologics.
Objectives: The aim of this study was to assess incidence and disease course of COVID-19 in patients with severe asthma on biologic therapy (omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab), as compared with COVID-19 data from the general Dutch population.
Methods: COVID-19 cases were identified through a prospective ongoing survey between March 17 and April 30, 2020 among all severe asthma specialists from 15 hospitals of the Dutch Severe Asthma Registry RAPSODI. From these cases, data was collected on patient characteristics, including co-morbidities, COVID-19 disease progression and asthma exacerbations. Findings were then compared with COVID-19 data from the general Dutch population.
Results: Of 634 severe asthma patients who received biologic therapy in RAPSODI, 9 (1.4%) were diagnosed with COVID-19. Seven patients (1.1%) required hospitalization for oxygen therapy, of which 5 were admitted to the intensive care for intubation and mechanical ventilation. One patient died (0.16%). All intubated patients had ≥1 co-morbidities. Odds (95%CI) for COVID-19 related hospitalization and intubations were 14 (6.6–29.5) and 41 (16.9–98.5) times higher, respectively, compared to the Dutch population. One patient presented with an asthma exacerbation.
Conclusion: Patients with severe asthma using biologic therapy showed to have a more severe course of COVID-19 compared to the general population. This may be due to co-morbidities, the severity of asthmatic airway inflammation, the use of biologics, or a combination of these.
Copyright © 2020 The Authors. Published by Elsevier Ltd. All rights reserved.
Real-World Effectiveness of Reslizumab in Patients With Severe Eosinophilic Asthma – First Initiators and Switchers
S. Hashimoto. J Allergy Clin Immunol Pract. 2022 Apr 26:S2213-2198(22)00362-2. doi: 10.1016/j.jaip.2022.04.014.
Background: Reslizumab, a biologic targeting IL-5, has been shown to reduce asthma exacerbations and maintenance oral corticosteroid use in randomized controlled trials and pre-post studies in patients with severe eosinophilic asthma. However, real-world effectiveness data of reslizumab are scarce, and it is unknown whether reslizumab has added value after switching from another type 2 biologic.
Objective: To evaluate (1) the real-world effectiveness of reslizumab on severe asthma exacerbations, maintenance oral corticosteroid use, and overall treatment response, both in biologic-naive patients who initiated reslizumab and in those who switched from another type 2 biologic; and (2) physicians’ experience with reslizumab treatment.
Methods: This observational real-world study evaluated data from 134 adults with severe eosinophilic asthma included in the Dutch severe asthma registry (RAPSODI), who initiated reslizumab treatment (4-weekly infusions, 0.3 mg/kg) before April 2020 and had follow-up data for 6 months and greater. Clinical asthma experts completed surveys on their experience with reslizumab treatment.
Results: Overall, reslizumab reduced the exacerbation rate (odds ratio [95% CI] = 0.10 [0.05-0.21]; P < .001), oral corticosteroid use (OR [95% CI], 0.2 [0.0-0.5]; P < .001), and maintenance dose (median [CI], 5.0 [0.0-10.0] to 0.0 [0.0-5.0]; P < .001), with comparable results in biologic-naive reslizumab initiators and switchers. The overall response to reslizumab was graded good or excellent in 59.2% of patients. The additive effectiveness of reslizumab after switching from another biologic was reflected in physicians’ surveys.
Conclusions: Real-world data show that reslizumab reduces severe asthma exacerbations and oral corticosteroid use in patients with severe eosinophilic asthma, both in biologic-naive reslizumab initiators and in those who switched from another type 2 biologic. This additional value of reslizumab was recognized by clinical asthma experts.
Copyright © 2022 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Cumulative Corticosteroid Sparing Effect of Anti-Interleukin-5/5Ra In Eosinophilic Asthma
J.A. Kroes. Eur Respir J. 2022 May 20:2102983. doi: 10.1183/13993003.02983-2021.
Introduction: Anti-interleukin-5/5Ra therapy has shown to reduce maintenance oral corticosteroid dose in severe eosinophilic asthma. However, the effect on cumulative oral corticosteroid exposure is currently unknown. Neither is it known how prior oral corticosteroid exposure affects response to anti-interleukin-5/5Ra treatment. We aimed primarily to compare the cumulative oral corticosteroid exposure over a 2-year period before and after anti-interleukin-5/5Ra initiation, and secondarily to investigate whether duration and cumulative oral corticosteroid exposure prior to anti-interleukin-5/5Ra influence the ability to discontinue oral corticosteroids within 2 years of anti-interleukin-5/5Ra therapy.
Methods: This real-world nationwide observational registry-based study evaluated all dispensed oral corticosteroids from 389 adults with severe eosinophilic asthma included in the Dutch severe asthma registry (RAPSODI) 2 years before and 2 years after initiating anti- interleukin-5/5Ra. Wilcoxon-signed rank test and multivariable regression analyses were used.
Results: Median (IQR) cumulative oral corticosteroid exposure in the 2 years before and after anti-interleukin-5/5Ra initiation decreased from 2.715 g (1.150–5.539) to 1.050 g (0.300–3.640), p<0.001. Fifty-two percent of patients were able to discontinue oral corticosteroids within 2 years anti-interleukin-5/5Ra therapy, which was independently predicted by lower and shorter prior oral corticosteroid exposure.
Conclusion: This real-world study showed that anti-interleukin-5/5Ra therapy leads to a significant reduction in cumulative oral corticosteroid exposure over a 2-year period. Patients with lower and shorter oral corticosteroids exposure were more likely to completely eliminate oral corticosteroids. Since cumulative exposure increased progressively prior to anti-interleukin-5/5Ra initiation, our data suggest that early intervention leads to a better long-term prognosis in patients with severe eosinophilic asthma.
RAPSODI Team. Anti-IL-5/5Ra biologics improve work productivity and activity in severe asthma: a RAPSODI registry-based cohort study
van der Valk JPM, Hekking PP, Rauh SP, Patberg KW, van Veen IA, Van Huisstede A, Smeenk FWJM, van de Ven MJT, Broeders MEAC, Hilvering B, van Exsel J, Oud KTM, Langeveld B, Fieten KB, van Veen A, Hashimoto S, Sont JK, Ten Brinke A, Braunstahl GJ;
J Asthma. 2023 Oct;60(10):1869-1876. doi: 10.1080/02770903.2023.2196563. Epub 2023 Apr 21. PMID: 6976568
Long-Term Weight Changes After Starting Anti-IL-5/5Ra Biologics in Severe Asthma: The Role of Oral Corticosteroids
Ten Have L, Visser E, Meulmeester FL, Bendien SA, Braunstahl GJ, Broeders MEAC, Fieten KB, Hashimoto S, van Huisstede A, Langeveld B, Oud KTM, Patberg KW, Smeenk FWJM, van Veen A, van Veen IH, van de Ven MJT, Weersink EJM, de Jong K, Sont JK, Kroes JA, Ten Brinke A.
J Allergy Clin Immunol Pract. 2023 Jul 1:S2213-2198(23)00718-3. doi: 10.1016/j.jaip.2023.06.054. Epub ahead of print. PMID: 37399945.
Real-World Effectiveness of IL-5/5Ra Targeted Biologics in Severe Eosinophilic Asthma With Comorbid Bronchiectasis
Bendien SA, Kroes JA, van Hal LHG, Braunstahl GJ, Broeders MEAC, Oud KTM, Patberg KW, Smeenk FWJM, van Veen IHPAA, Weersink EJM, Fieten KB, Hashimoto S, van Veen A, Sont JK, van Huisstede A, van de Ven MJT, Langeveld B, Maitland-van der Zee AH, Ten Brinke A; Registry of Adult Patients With Severe Asthma for Optimal Disease Management Team.
J Allergy Clin Immunol Pract. 2023 Jun 7:S2213-2198(23)00640-2. doi: 10.1016/j.jaip.2023.05.041. Epub ahead of print. PMID: 37295671.
Clinical response to benralizumab can be predicted by combining clinical outcomes at 3 months with baseline characteristics.
Kroes JA, de Jong K, Hashimoto S, Zielhuis SW, van Roon EN, Sont JK, Ten Brinke A.
ERJ Open Res. 2023 Apr 11;9(2):00559-2022. doi: 10.1183/23120541.00559-2022. PMID: 37057095; PMCID: PMC10086738.
– Poster van J.A. Kroes van de ROSA studie
– NYA Poster van S. Hashimoto van de CORA studie.
– NYA Poster van S. van Nederveen-Bendies van de SABEBIO studie.
– NYA Poster ZonMW 2022 van E.H.Bel & J.K.Sont “RAPSODI- ‘Best-practice’ register voor ernstig astma in Europa”.
In samenwerking met SHARP
The effect of the COVID-19 pandemic on severe asthma care in Europe – will care change for good?
ERJ Open Res. 2022 May 16;8(2):00065-2022. doi: 10.1183/23120541.00065-2022
What bothers severe asthma patients most? A paired patient-clinician study across seven European countries.
Ainsworth B, Chatburn E, Bansal AT, Fulton O, Hamerlijnck D, Coleman C, Eger K, Hyland M, Holmes J, Heaney L, Sedlák V, Škrgat S, Edelbaher N, Ten Brinke A, Porsbjerg C, Gaga M, Loureiro C, Djukanovic R, Berret E, Kwon N.
ERJ Open Res. 2023 May 30;9(3):00717-2022. doi: 10.1183/23120541.00717-2022. PMID: 37260457; PMCID: PMC10227631.
Characteristics of severe asthma patients on biologics: a real-life European registry study.
Principe S, Richards LB, Hashimoto S, Kroes JA, Van Bragt JJMH, Vijverberg SJ, Sont JK, Scichilone N, Bieksiene K, Ten Brinke A, Csoma Z, Dahlén B, Gemicioglu B, Grisle I, Kuna P, Lazic Z, Mihaltan F, Popović-Grle S, Škrgat S, Marcon A, Caminati M, Djukanovic R, Porsbjerg C, Maitland Van Der Zee AH. ERJ Open Res. 2023 May 2;9(3):00586-2022. doi: 10.1183/23120541.00586-2022. PMID: 37143845; PMCID: PMC10152256.
Evaluation of real-world mepolizumab use in severe asthma across Europe: the SHARP experience with privacy-preserving federated analysis.
Kroes JA, Alfonso-Cristancho R, Bansal AT, Berret E, Bieksiene K, Bourdin A, Brussino L, Canhoto D, Cardini C, Celik G, Csoma Z, Dahlén B, Damadoglu E, Eger K, Gauquelin L, Gemicioglu B, Goksel O, Graff S, Heffler E, Hofstee HB, Howarth P, Jakes RW, Jaun F, Kalinauskaite-Zukauske V, Kopač P, Kwon N, Loureiro CC, Lozoya García V, Masoli M, Rezelj MP, Pérez De Llano L, Popović-Grle S, Ramos-Barbón D, Sà Sousa A, Samitas K, Schleich F, Sirena C, Skrgat S, Zervas E, Zichnalis G, Bel EH, Sont JK, Hashimoto S, Ten Brinke A.
ERJ Open Res. 2023 Apr 3;9(2):00745-2022. doi: 10.1183/23120541.00745-2022. PMID: 37020841; PMCID: PMC10068512
Heterogeneity in the use of biologics for severe asthma in Europe: a SHARP ERS study.
Frix AN, Heaney LG, Dahlén B, Mihaltan F, Sergejeva S, Popović-Grle S, Sedlak V, Lehtimäki L, Bourdin A, Korn S, Zervas E, Csoma Z, Lúðvíksdóttir D, Butler M, Canonica GW, Grisle I, Bieksiene K, Ten Brinke A, Kuna P, Chaves Loureiro C, Nenasheva NM, Lazic Z, Škrgat S, Ramos-Barbon D, Leuppi J, Gemicioglu B, Bossios A, Porsbjerg CM, Bel EH, Djukanovic R, Louis R.
ERJ Open Res. 2022 Oct 24;8(4):00273-2022. doi: 10.1183/23120541.00273-2022. PMID: 36299366; PMCID: PMC9589318.
SHARP: enabling generation of real-world evidence on a pan-European scale to improve the lives of individuals with severe asthma.
van Bragt JJMH, Hansen S, Djukanovic R, Bel EHD, Ten Brinke A, Wagers SS, Maitland-van der Zee AH, Porsbjerg C.
ERJ Open Res. 2021 Apr 19;7(2):00064-2021. doi: 10.1183/23120541.00064-2021. PMID: 33898615; PMCID: PMC8053907.
SHARP Clinical Research Collaboration; Members of the SHARP Clinical Research Collaboration are. Characteristics and treatment regimens across ERS SHARP severe asthma registries.
van Bragt JJMH, Adcock IM, Bel EHD, Braunstahl GJ, Ten Brinke A, Busby J, Canonica GW, Cao H, Chung KF, Csoma Z, Dahlén B, Davin E, Hansen S, Heffler E, Horvath I, Korn S, Kots M, Kuna P, Kwon N, Louis R, Plaza V, Porsbjerg C, Ramos-Barbon D, Richards LB, Škrgat S, Sont JK, Vijverberg SJH, Weersink EJM, Yasinska V, Wagers SS, Djukanovic R, Maitland-van der Zee AH;
Eur Respir J. 2020 Jan 9;55(1):1901163. doi: 10.1183/13993003.01163-2019. PMID: 31601713.