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. 2022 Jul 12;7(7):CD010834.
doi: 10.1002/14651858.CD010834.pub4.

Anti-IL-5 therapies for asthma

Hugo A Farne  1 , Amanda Wilson  2 , Stephen Milan  3 , Emma Banchoff  4 , Freda Yang  5 , Colin Ve Powell  6
Affiliations

Anti-IL-5 therapies for asthma

Hugo A Farne et al. Cochrane Database Syst Rev. .

Abstract
in English, Spanish

Background: This is the second update of previously published reviews in the Cochrane Library (2015, first update 2017). Interleukin-5 (IL-5) is the main cytokine involved in the proliferation, maturation, activation and survival of eosinophils, which cause airway inflammation and are a classic feature of asthma. Studies of monoclonal antibodies targeting IL-5 or its receptor (IL-5R) suggest they reduce asthma exacerbations, improve health-related quality of life (HRQoL) and lung function in appropriately selected patients, justifying their inclusion in the latest guidelines.

Objectives: To compare the effects of therapies targeting IL-5 signalling (anti-IL-5 or anti-IL-5Rα) with placebo on exacerbations, health-related quality-of-life (HRQoL) measures and lung function in adults and children with chronic asthma, and specifically in those with eosinophilic asthma refractory to existing treatments.

Search methods: We searched CENTRAL, MEDLINE, Embase, and two trials registers, manufacturers' websites, and reference lists of included studies. The most recent search was 7 February 2022.

Selection criteria: We included randomised controlled trials comparing mepolizumab, reslizumab and benralizumab versus placebo in adults and children with asthma.

Data collection and analysis: Two review authors independently extracted data and analysed outcomes using a random-effects model. We used standard methods expected by Cochrane.

Main results: Seventeen studies on about 7600 participants met the inclusion criteria. Six used mepolizumab, five used reslizumab, and six used benralizumab. One study using benralizumab was terminated early due to sponsor decision and contributed no data. The studies were predominantly on people with severe eosinophilic asthma, which was similarly but variably defined. One was in children aged 6 to 17 years; nine others included children over 12 years but did not report results by age group separately. We deemed the overall risk of bias to be low, with all studies contributing data of robust methodology. We considered the certainty of the evidence for all comparisons to be high overall using the GRADE scheme, except for intravenous (IV) mepolizumab and subcutaneous (SC) reslizumab because these are not currently licensed delivery routes. The anti-IL-5 treatments assessed reduced rates of 'clinically significant' asthma exacerbation (defined by treatment with systemic corticosteroids for three days or more) by approximately half in participants with severe eosinophilic asthma on standard care (at least medium-dose inhaled corticosteroids (ICS)) with poorly controlled disease (either two or more exacerbations in the preceding year or Asthma Control Questionnaire (ACQ) score of 1.5 or more), except for reslizumab SC. The rate ratios for these effects were 0.45 (95% confidence interval (CI) 0.36 to 0.55; high-certainty evidence) for mepolizumab SC, 0.53 (95% CI 0.44 to 0.64; moderate-certainty evidence) for mepolizumab IV, 0.43 (95% CI 0.33 to 0.55; high-certainty evidence) for reslizumab IV, and 0.59 (95% CI 0.52 to 0.66; high-certainty evidence) for benralizumab SC. Non-eosinophilic participants treated with benralizumab also showed a significant reduction in exacerbation rates, an effect not seen with reslizumab IV, albeit in only one study. No data were available for non-eosinophilic participants treated with mepolizumab. There were improvements in validated HRQoL scores with all anti-IL-5 agents in severe eosinophilic asthma. This met the minimum clinically important difference (MCID) for the broader St. George's Respiratory Questionnaire (SGRQ; 4-point change) for benralizumab only, but the improvement in the ACQ and Asthma Quality of Life Questionnaire (AQLQ), which focus on asthma symptoms, fell short of the MCID (0.5 point change for both ACQ and AQLQ) for all of the interventions. The evidence for an improvement in HRQoL scores in non-eosinophilic participants treated with benralizumab and reslizumab was weak, but the tests for subgroup difference were negative. All anti-IL-5 treatments produced small improvements in mean pre-bronchodilator forced expiratory flow in one second (FEV1) of between 0.08 L and 0.15 L in eosinophilic participants, which may not be sufficient to be detected by patients. There were no excess serious adverse events with any anti-IL-5 treatment; in fact, there was a reduction in such events with benralizumab, likely arising from fewer asthma-related hospital admissions. There was no difference compared to placebo in adverse events leading to discontinuation with mepolizumab or reslizumab, but significantly more discontinued benralizumab than placebo, although the absolute numbers were small (42/2026 (2.1%) benralizumab versus 11/1227 (0.9%) placebo). The implications for efficacy or adverse events are unclear.

Authors' conclusions: Overall this analysis supports the use of anti-IL-5 treatments as an adjunct to standard care in people with severe eosinophilic asthma and poor symptom control. These treatments roughly halve the rate of asthma exacerbations in this population. There is limited evidence for improved HRQoL scores and lung function, which may not meet clinically detectable levels. The studies did not report safety concerns for mepolizumab or reslizumab, or any excess serious adverse events with benralizumab, although there remains a question over adverse events significant enough to prompt discontinuation. Further research is needed on biomarkers for assessing treatment response, optimal duration and long-term effects of treatment, risk of relapse on withdrawal, non-eosinophilic patients, children (particularly under 12 years), comparing anti-IL-5 treatments to each other and, in patients meeting relevant eligibility criteria, to other biological (monoclonal antibody) therapies. For benralizumab, future studies should closely monitor rates of adverse events prompting discontinuation.

Antecedentes: Esta la segunda actualización de una revisión publicada anteriormente en la Biblioteca Cochrane (2015, primera actualización en 2017). La interleucina 5 (IL‐5) es la principal citoquina implicada en la proliferación, maduración, activación y supervivencia de los eosinófilos, que provocan la inflamación de las vías respiratorias y son una característica típica del asma. Los estudios sobre los anticuerpos monoclonales dirigidos a la IL‐5 o a su receptor (IL‐5R) indican que estos reducen las exacerbaciones del asma, mejoran la calidad de vida relacionada con la salud (CdVRS) y la función pulmonar en pacientes adecuadamente seleccionados, lo cual justifica su inclusión en las últimas guías.

Objetivos: Comparar los efectos de los tratamientos dirigidos a la señalización de la IL‐5 (anti‐IL‐5 o anti‐IL‐5Rα) con placebo, con respecto a las exacerbaciones, las medidas de calidad de vida relacionada con la salud (CdVRS) y la función pulmonar en adultos y niños con asma crónica, y específicamente en los que presentan asma eosinofílica resistente a los tratamientos existentes. MÉTODOS DE BÚSQUEDA: Se hicieron búsquedas en CENTRAL, MEDLINE, Embase, y en dos registros de ensayos clínicos, sitios web de fabricantes y listas de referencias de los estudios incluidos. La búsqueda más reciente se realizó el 7 de febrero de 2022. CRITERIOS DE SELECCIÓN: Se incluyeron ensayos controlados aleatorizados que compararon mepolizumab, reslizumab y benralizumab versus placebo en adultos y niños con asma. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión de forma independiente extrajeron los datos y analizaron los desenlaces mediante un modelo de efectos aleatorios. Se utilizaron los métodos estándar previstos por Cochrane.

Resultados principales: Diecisiete estudios con unos 7600 participantes cumplieron los criterios de inclusión. Seis administraron mepolizumab, cinco proporcionaron reslizumab y seis benralizumab. Un estudio que utilizó benralizumab finalizó antes de tiempo por decisión de los patrocinadores y no proporcionó datos. Los estudios se realizaron principalmente en personas con asma eosinofílica grave, que se definió de forma parecida aunque variable. Uno de ellos se realizó en niños de seis a 17 años; otros nueve incluyeron a niños mayores de 12 años, pero no informaron de los resultados por grupos de edad por separado. Se consideró que el riesgo general de sesgo fue bajo, ya que todos los estudios que aportaron datos tuvieron una metodología sólida. La certeza de la evidencia para todas las comparaciones fue en general alta al utilizar el método GRADE, con la excepción del mepolizumab intravenoso (IV) y subcutáneo (SC) porque se trata de vías de administración no autorizadas en la actualidad. Los tratamientos con inhibidores de la IL‐5 evaluados redujeron las tasas de exacerbación del asma "clínicamente significativa" (definida por el tratamiento con corticosteroides sistémicos durante tres días o más) en aproximadamente la mitad de los participantes con asma eosinofílica grave que recibían atención estándar (al menos una dosis media de corticosteroides inhalados [CSI]) con un control deficiente de la enfermedad (dos o más exacerbaciones en el año anterior o una puntuación de 1,5 o más según el Asthma Control Questionnaire [ACQ]). Los cocientes de tasas para estos efectos fueron de 0,45 (intervalo de confianza [IC] del 95%: 0,36 a 0,55; evidencia de certeza alta) para mepolizumab SC, 0,53 (IC del 95%: 0,44 a 0,64; evidencia de certeza moderada) para mepolizumab IV, 0,43 (IC del 95%: 0,33 a 0,55; evidencia de certeza alta) para reslizumab IV y 0,59 (IC del 95%: 0,52 a 0,66; evidencia de certeza alta) para benralizumab SC. Los participantes que no presentaban asma eosinofílica tratados con benralizumab también mostraron una reducción significativa de las tasas de exacerbaciones, un efecto que no se observó con reslizumab IV, aunque solo en un estudio. No hubo datos sobre los participantes que no presentaban asma eosinofílica tratados con mepolizumab. Hubo mejorías moderadas en las puntuaciones validadas de la CdVRS con todos los inhibidores de la IL‐5 en el asma eosinofílica grave. Se alcanzó la diferencia mínima clínicamente importante (DMCI) del George's Respiratory Questionnaire (SGRQ; cambio de 4 puntos) para benralizumab, pero la mejoría en el ACQ y el Asthma Quality of Life Questionnaire (AQLQ), que se centran en los síntomas del asma, no alcanzó la DMCI (cambio de 0,5 puntos tanto en el ACQ como en el AQLQ) para todas las intervenciones. La evidencia fue débil en cuanto a la mejoría en las puntuaciones de la CdVRS en los participantes que no presentaban asma eosinofílica tratados con benralizumab y reslizumab, pero los análisis de las diferencias de subgrupos obtuvieron resultados negativos. Todos los tratamientos con inhibidores de la IL‐5 produjeron pequeñas mejorías en el flujo espiratorio forzado prebroncodilatador en un segundo (VEF1) de entre 0,08 y 0,15 l en los participantes con asma eosinofílica, las cuales podrían no ser suficientes para que los pacientes las detecten. No hubo un exceso de eventos adversos graves con ningún tratamiento inhibidor de la IL‐5; de hecho, hubo una reducción de tales eventos con benralizumab, probablemente derivada de un menor número de ingresos hospitalarios relacionados con el asma. No hubo diferencias en comparación con placebo en los eventos adversos que provocaran la suspensión del tratamiento con mepolizumab o reslizumab, pero hubo significativamente más interrupciones con el benralizumab que con placebo, aunque los números absolutos fueron pequeños (42/2026 [2,1%] benralizumab versus 11/1227 [0,9%] placebo). No están claras las implicaciones con respecto a la eficacia o los eventos adversos.

Conclusiones de los autores: En general este análisis apoya la administración de los tratamientos inhibidores de la IL‐5 como complemento a la atención estándar en las personas con asma eosinofílica grave y un control deficiente de los síntomas. Estos tratamientos reducen a cerca de la mitad la tasa de exacerbaciones del asma en esta población. Hay evidencia limitada de mejorías en las puntuaciones de la CdVRS y en la función pulmonar, aunque es posible que no alcancen niveles clínicamente detectables. Los estudios no informaron de problemas de seguridad con el mepolizumab ni el reslizumab, ni eventos adversos graves excesivos con benralizumab, aunque se mantiene la duda sobre qué eventos adversos son lo suficientemente significativos para la suspensión inmediata. Se necesitan estudios de investigación adicionales sobre los marcadores biológicos para evaluar la respuesta al tratamiento, la duración óptima y los efectos a largo plazo del tratamiento, el riesgo de recurrencia al retirarlo, los pacientes que no presentan asma eosinofílica, los niños (especialmente menores de 12 años), que comparen los tratamientos inhibidores de la IL‐5 entre sí y, en pacientes que cumplan criterios de elegibilidad relevantes, con otros tratamientos biológicos (anticuerpos monoclonales). En el caso del benralizumab, los estudios futuros deben vigilar atentamente las tasas de eventos adversos que provocan la interrupción inmediata.

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Conflict of interest statement

HF: none known

AW: none known

CP: none known

FY: none known

SM: none known

EB: none known

Figures

1
1
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 1: Rate of exacerbations requiring systemic corticosteroids
1.2
1.2. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 2: At least one clinically significant exacerbation
1.3
1.3. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 3: Rate of exacerbations requiring admission
1.4
1.4. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 4: Rate of exacerbations requiring ED treatment or admission
1.5
1.5. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 5: Health‐related quality of life (ACQ)
1.6
1.6. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 6: Health‐related quality of life (SGRQ)
1.7
1.7. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 7: Pre‐bronchodilator FEV 1 (litres)
1.8
1.8. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 8: Serious adverse events
1.9
1.9. Analysis
Comparison 1: Mepolizumab (SC) versus placebo, Outcome 9: Adverse events leading to discontinuation
2.1
2.1. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 1: Rate of clinically significant exacerbations
2.2
2.2. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 2: Rate of exacerbations requiring emergency department treatment or admission
2.3
2.3. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 3: Rate of exacerbations requiring admission
2.4
2.4. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 4: People with one or more exacerbations
2.5
2.5. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 5: Health‐related quality of life (AQLQ)
2.6
2.6. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 6: Health‐related quality of life (ACQ)
2.7
2.7. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 7: Health‐related quality of life (SGRQ)
2.8
2.8. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 8: Pre‐bronchodilator FEV 1 (litres)
2.9
2.9. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 9: Serious adverse events
2.10
2.10. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 10: Adverse events leading to discontinuation
2.11
2.11. Analysis
Comparison 2: Mepolizumab (IV) versus placebo, Outcome 11: Blood eosinophil level (cells/μL)
3.1
3.1. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 1: Rate of exacerbations requiring systemic corticosteroids
3.2
3.2. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 2: Rate of exacerbations requiring emergency department treatment or admission
3.3
3.3. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 3: Health‐related quality of life (AQLQ)
3.4
3.4. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 4: Health‐related quality of life (ACQ)
3.5
3.5. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 5: Pre‐bronchodilator FEV 1 (litres)
3.6
3.6. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 6: Serious adverse events
3.7
3.7. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 7: Adverse events leading to discontinuation
3.8
3.8. Analysis
Comparison 3: Reslizumab (IV) versus placebo, Outcome 8: Blood eosinophil level (cells/μL)
4.1
4.1. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 1: Rate of exacerbations requiring systemic corticosteroids
4.2
4.2. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 2: Rate of exacerbations requiring emergency department treatment or admission
4.3
4.3. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 3: Health‐related quality of life (AQLQ mean difference)
4.4
4.4. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 4: Health‐related quality of life (ACQ mean difference)
4.5
4.5. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 5: Health‐related quality of life (SGRQ mean difference)
4.6
4.6. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 6: Pre‐bronchodilator FEV 1 (litres)
4.7
4.7. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 7: Serious adverse events
4.8
4.8. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 8: Adverse events leading to discontinuation
4.9
4.9. Analysis
Comparison 4: Reslizumab (SC) versus placebo, Outcome 9: Blood eosinophil level (cells × 10⁹/litre)
5.1
5.1. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 1: Rate of exacerbations requiring systemic corticosteroids
5.2
5.2. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 2: Rate of exacerbations requiring emergency department treatment or admission
5.3
5.3. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 3: Health‐related quality of life (AQLQ mean difference)
5.4
5.4. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 4: Health‐related quality of life (ACQ mean difference)
5.5
5.5. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 5: Health‐related quality of life (SGRQ mean difference)
5.6
5.6. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 6: Pre‐bronchodilator FEV 1 (litres)
5.7
5.7. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 7: Serious adverse events
5.8
5.8. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 8: Adverse events leading to discontinuation
5.9
5.9. Analysis
Comparison 5: Benralizumab (SC) versus placebo, Outcome 9: Blood eosinophil level (% change from baseline)
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References

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FitzGerald 2016 {published data only}
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    1. NCT01914757. A multicentre, randomized, double-blind, parallel group, placebo controlled, phase 3 study to evaluate the efficacy and safety of benralizumab in asthmatic adults and adolescents inadequately controlled on inhaled corticosteroid plus long-acting beta 2agonist (CALIMA). clinicaltrials.gov/show/NCT01914757 (first received 31 July 2013).
Haldar 2009 {published data only}
    1. EUCTR2005-001932-61-GB. Mepolizumab and exacerbation frequency in refractory eosinophilic asthma. A randomised, double blind, placebo controlled, parallel group trial. clinicaltrialsregister.eu/ctr-search/search?query=EUCTR2005-001932-61-GB (first received 16 November 2005).
    1. Gupta S, Halder P, Hargadon B, Sousa A, Marshall RP, Wardlaw AJ, et al. Assessment of changes in airways dimensions with mepolizumab treatment in refractory eosinophilic asthma. In: American Thoracic Society International Conference; 2009 May 15-20 San Diego. 2009:A3641. 4900100000024535
    1. Haldar P, Brightling C, Hargadon B, Gupta S, Monteiro W, Sousa A, et al. Mepolizumab (anti-IL5) and exacerbation frequency in refractory eosinophilic asthma. American Journal of Critical Care and Respiratory Medicine 2009;179:A3638. 4900100000024597
    1. Haldar P, Brightling CE, Hargadon B, Gupta S, Monteiro W, Sousa A, et al. Mepolizumab and exacerbations of refractory eosinophilic asthma. New England Journal of Medicine 2009;360(10):973-84. 4900100000023473 - PMC - PubMed
    1. Haldar P, Brightling CE, Singapuri A, Hargadon B, Gupta S, Monteiro W, et al. Outcomes after cessation of mepolizumab therapy in severe eosinophilic asthma: a 12-month follow-up analysis. Journal of Allergy and Clinical Immunology 2014;133(3):921-3. [EMBASE: 2014156329] [PMID: ] - PubMed
Harrison 2020 {published data only}
    1. Canonica GW, Harrison TW, Chanez P, Menzella F, Louis R. Benralizumab efficacy for severe, eosinophilic asthma with a diagnosis of nasal polyposis: results from the phase IIIb ANDHI trial. European Journal of Allergy and Clinical Immunology 2020;75(109):114.
    1. Harrison TW, Chanez P, Menzella F, Canonica GW, Louis R, Cosio BG, et al. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial. Lancet Respiratory Medicine 2021;9(3):260-74. - PubMed
    1. Kreindler J, Chanez P, Bourdin A, Burden A, Gil EG. Comprehensive response to benralizumab by patients with nasal polyposis and severe, eosinophilic asthma. Annals of Allergy, Asthma and Immunology 2020;125(5):S29.
    1. NCT03170271. A study of the safety and effectiveness of benralizumab to treat patients with severe uncontrolled asthma (ANDHI) [A multicenter, randomized, double-blind, parallel group, placebo controlled, phase 3b study to evaluate the safety and efficacy of benralizumab 30 mg SC in patients with severe asthma uncontrolled on standard of care treatment]. www.clinicaltrials.gov/ct2/show/NCT03170271 (first received 31 May 2017).
Jackson 2022 {published data only}
    1. Altman M, Bacharier L, Villarreal M, Gill M, Liu A, Gruchalla R, et al. Distinct airway inflammatory pathways associated with asthma exacerbations are modulated by mepolizumab therapy in children. In: Journal of Allergy and Clinical Immunology. Vol. 149 Suppl 2. 2022:AB146.
    1. Jackson D, Bacharier L, Gergen P, Gagalis L, Villarreal M, Gill M, et al. Phenotype-directed therapy with mepolizumab for urban children with exacerbation-prone asthma. Journal of Allergy and Clinical Immunology 2022;149(2):AB146.
    1. NCT03292588. A trial of mepolizumab adjunctive therapy for the prevention of asthma exacerbations in urban children (MUPPITS-2). https://clinicaltrials.gov/ct2/show/NCT03292588 (first received 29 March 2022).
Moore 2022 {published data only}
    1. Bel EH, Moore WC, Kornmann O, Poirier C, Kaneko N, Smith SG, et al. Continued long-term mepolizumab in severe eosinophilic asthma protects from asthma worsening versus stopping mepolizumab: COMET trial. European Respiratory Journal 2020;56:5280.
    1. Liu M, Bel E, Kornmann O, Humbert M, Kaneko N, Martin N, et al. Clinician/patient perception: asthma severity decreases and response increases with continuing versus stopping long-term mepolizumab (COMET). Annals of Allergy, Asthma & Immunology 2020;125(5):S30.
    1. Liu M, Bel E, Kornmann O, Humbert M, Kaneko N, Martin N, et al. Clinician/patient perception: asthma severity decreases and response increases with continuing versus stopping long-term mepolizumab (COMET). Annals of Asthma, Allergy and Immunology 2020;201:A4211.
    1. Moore WC, Kornmann O, Humbert M, Poirier C, Bel EH, Kaneko N, et al. Outcomes following continuation or stopping long-term mepolizumab treatment in patients with severe eosinophilic asthma: the randomized COMET trial. ATS Journals 2020;201(1):Meeting Abstracts A421.
    1. Moore WC, Kornmann O, Humbert M, Poirier C, Bel EH, Kaneko N, et al. Stopping versus continuing long-term mepolizumab treatment in severe eosinophilic asthma (COMET study). European Respiratory Journal 2022;59:2100396. - PMC - PubMed
NCT01947946 {published data only}
    1. NCT01947946. Efficacy and safety study of benralizumab added to medium-dose inhaled corticosteroid plus LABA in patients with uncontrolled asthma. clinicaltrials.gov/show/NCT01947946 (first received 11 September 2013).
Ortega 2014 {published data only}
    1. Albers FC, Lugogo N, Gilson MJ, Price R, Yancey SW. Long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma. Journal of Allergy and Clinical Immunology 2016;137(2 Suppl 1):AB14. [CENTRAL: 1135293] [EMBASE: 72196801]
    1. Albers FC, Price R, Ortega H, Yancey SW, Nelsen LM. Effect of mepolizumab in severe eosinophilic asthma patients in relation to their baseline ACQ-5 and SGRQ scores. European Journal of Allergy and Clinical Immunology 2016;71:257-8.
    1. Albers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. Journal of Allergy and Clinical Immunology 2017;140(5):1464-6. - PubMed
    1. Basu A, Dalal A, Canonica GW, Forshag M, Yancey SW, Nagar S, et al. Economic analysis of the phase III MENSA study evaluating mepolizumab for severe asthma with eosinophilic phenotype. Expert Review of Pharmacoeconomics and Outcomes Research 2017;17(2):121-31. - PubMed
    1. Forshag M, Dalal AA, Ortega H, Yancey S, Gunsoy NB, Canonica G. Healthcare resource use associated with exacerbations in patients with severe eosinophilic asthma. American Journal of Respiratory and Critical Care Medicine 2015;191:A4174. [CENTRAL: 1107017] [EMBASE: 72052049]
Park 2016 {published data only}
    1. Adachi M, Kim M-K, Imai N, Nakanishi T, Ohta K, Tohda Y, et al. A phase 2a study of benralizumab for patients with eosinophilic asthma in South Korea and Japan. American Journal of Respiratory and Critical Care Medicine 2015;191(Meeting Abstracts):A2495. [CENTRAL: 1101040] [EMBASE: 72050330]
    1. NCT01412736. A phase IIa study of KHK4563 (4563-003) [A phase IIa, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy and safety of KHK4563 in adults with uncontrolled, suspected eosinophilic asthma]. clinicaltrials.gov/show/NCT01412736 (first received 7 August 2011).
    1. Park HS, Kim MK, Imai N, Nakanishi T, Adachi M, Ohta K, et al. A phase 2a study of benralizumab for patients with eosinophilic asthma in South Korea and Japan. International Archives of Allergy and Immunology 2016;169(3):135-45. [CENTRAL: 1152856] [EMBASE: 20160326586] [PMID: ] - PubMed
Pavord 2012a {published data only}
    1. NCT01000506. Dose ranging efficacy and safety with mepolizumab in severe asthma (DREAM) [A multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to determine the effect of mepolizumab on exacerbation rates in subjects with severe uncontrolled refractory asthma]. clinicaltrials.gov/ct2/show/NCT01000506 (accessed 16 January 2015). 4900126000001337
    1. Ortega H, Chupp G, Bardin P, Bourdin A, Garcia G, Hartley B, et al. The role of mepolizumab in atopic and nonatopic severe asthma with persistent eosinophilia. European Respiratory Journal 2014;44(1):239-41. - PubMed
    1. Ortega H, Li H, Suruki R, Albers F, Gordon D, Yancey S. Cluster analysis and characterization of response to mepolizumab: a step closer to personalized medicine for patients with severe asthma. Annals of the American Thoracic Society 2014;11(7):1011-7. [PMID: ] - PubMed
    1. Ortega HG, Chupp G, Bardin P, Bourdin A, Hartley B, Humbert M. The role of mepolizumab in atopic and non-atopic patients with refractory eosinophilic asthma. American Journal of Respiratory and Critical Care Medicine 2013;187:A3861. [CENTRAL: 1129378] [EMBASE: 71983360]
    1. Pavord I, Korn S, Howarth P, Bleecker E, Buhl R, Keene O, et al. Mepolizumab (anti-IL-5) reduces exacerbations in patients with refractory eosinophilic asthma. European Respiratory Journal 2012;40 Suppl 56:36s [349]. 4900100000068022

References to studies excluded from this review

Albers 2016 {published data only}
    1. Albers F, Cockle S, Gunsoy N, Shin JY, Nelsen L, Muellerova H. Eligibility for mepolizumab, omalizumab and reslizumab in the EU population: The IDEAL study [PA4216]. In: European Respiratory Society 26thAnnual Congress; 2016 Sep 3-7; London. 2016.
Albers 2020 {published data only}
    1. Albers FC, Hozawa S, Bratton DJ, Yancey SW, Prazma CM, Mumbert M, et al. Mepolizumab treatment in patients with severe eosinophilic asthma and prior omalizumab use. Allergy 2020;75(4):942-6. - PMC - PubMed
Alvarez‐Cuesta 1994 {published data only}
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Armentia 1992 {published data only}
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Austin 2016 {published data only}
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Austin 2016a {published data only}
    1. Austin D, Pouliquen I, Keene O, Yancey S. Blood eosinophil dose response to oral corticosteroids in a population of patients with severe asthma. European Respiratory Journal 2016;48:PA1110.
Ayres 2004 {published data only}
    1. Ayres JG, Higgins B, Chilvers ER, Ayre G, Blogg M, Fox H. Efficacy and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate-to-severe) allergic asthma. Allergy 2004;59(7):701-8. 4900100000017042 - PubMed
Bardford 2018 {published data only}
    1. Bardford E, Nelsen L, Bratton D, Albers F, Taille C, Magnan A. Efficacy of mepolizumab in patients with severe eosinophilic asthma who had previously received omalizumab treatment. Pneumologie 2018;72:S17.
Bel 2014 {published data only}
    1. Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene O, Yancey SW, et al. Oral corticosteroid-sparing effect of mepolizumab in severe eosinophilic asthma: The SIRIUS study. European Respiratory Journal 2014;44 Suppl 58:2907. [CENTRAL: 1053369]
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Berger 2003 {published data only}
    1. Berger W, Gupta N, McAlary M, Fowler-Taylor A, McAlary M, Fowler-Taylor A. Evaluation of long-term safety of the anti-IgE antibody, omalizumab, in children with allergic asthma. Annals of Allergy, Asthma and Immunology 2003;91(2):182-8. 4900102000000524 [4900102000000524] - PubMed
Bernstein 2020a {published data only}
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Bjermer 2017 {published data only}
    1. Bjermer L, Garin M, Sun SX. Clinically meaningful improvements with reslizumab in patient-reported outcomes and lung function in a sub-population defined by the EU indication with >=3 exacerbations. European Respiratory Journal 2017;50:PA4687.
Blanken 2012 {published data only}
    1. Blanken M, Rovers M, Sanders E, Bont L. Ethical considerations and rationale of the MAKI trial: a multicenter double-blind randomized placebo-controlled trial into the preventive effect of palivizumab on recurrent wheezing associated with respiratory syncytial virus infection in children with a gestational age of 33-35 weeks. Contemporary Clinical Trials 2012;33(6):1287-92. 4900100000067009 - PubMed
Blanken 2013 {published data only}
    1. Blanken MO, Rovers MM, Molenaar JM, Winkler-Seinstra PL, Meijer A, Kimpen JL, et al. Respiratory syncytial virus and recurrent wheeze in healthy preterm infants. New England Journal of Medicine 2013;368(19):1791-9. 4900100000077900 [4900100000077900] - PubMed
Bleecker 2018a {published data only}
    1. Bleecker E, McDonald M, Garin MC. Decreases in blood eosinophil levels correlate with lung function improvement with reslizumab treatment. American Journal of Respiratory and Critical Care Medicine 2018;197:A1362.
Bleecker 2018b {published data only}
    1. Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. European Respiratory Journal 2018;52(4):1800936. - PMC - PubMed
Boulet 1997 {published data only}
    1. Boulet LP, Chapman KR, Cote J, Kalra S, Bhagat R, Swystun VA, et al. Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response. American Journal of Respiratory and Critical Care Medicine 1997;155(6):1835-40. 4900100000005712 - PubMed
Bourdin 2018 {published data only}
    1. Bourdin A, McDonald M, Vanlandingham R. Reslizumab is effective in asthma patients with or without allergen specific IgE. European Journal of Allergy and Clinical Immunology 2018;73(105):202-3.
Bourdin 2020 {published data only}
    1. Bourdin A, Husereau D, Molinari N, Golam S, Siddiqui MK, Lindner L, et al. Matching-adjusted comparison of oral corticosteroid reduction in asthma: systematic review of biologics. Clinical and Experimental Allergy 2020;50(4):442-52. - PMC - PubMed
Bousquet 2004 {published data only}
    1. Bousquet J, Wenzel S, Holgate S, Lumry W, Freeman P, Fox H. Predicting response to omalizumab, an anti-IgE antibody, in patients with allergic asthma. Chest 2004;125(4):1378-86. 4900100000016325 - PubMed
Bousquet 2011 {published data only}
    1. Bousquet J, Siergiejko Z, Swiebocka E, Humbert M, Rabe KF, Smith N, et al. Persistency of response to omalizumab therapy in severe allergic (IgE-mediated) asthma. Allergy 2011;66(5):671-8. 4900100000026344 - PubMed
Brightling 2014 {published data only}
    1. Brightling CE, She D, Ranade K, Piper E. Efficacy and safety of tralokinumab, an anti-il-13 monoclonal antibody, in a phase 2b study of uncontrolled severe asthma. American Journal of Respiratory and Critical Care Medicine 2014;189:A6670. [CENTRAL: 1035526] [EMBASE: 72047302]
Brown 2007 {published data only}
    1. Brown R, Turk F, Dale P, Bousquet J. Cost-effectiveness of omalizumab in patients with severe persistent allergic asthma. Allergy 2007;62(2):149-53. 4900100000019948 [4900100000019948] - PubMed
Brusselle 2016 {published data only}
    1. Brusselle G, McElhattan J, Canvin J, Buhl R. Reslizumab (RES) in asthma patients (pts) with severe eosinophilic asthma stratified by GINA asthma steps 4 and 5: analysis of two phase 3, placebo (PBO)-controlled trials [PA4107]. In: European Respiratory Society 26thAnnual Congress; 2016 Sep 3-7; London. 2016.
Brusselle 2017 {published data only}
    1. Brusselle G, Canvin J, Weiss S, Sun SX, Buhl R. Stratification of eosinophilic asthma patients treated with reslizumab and GINA Step 4 or 5 therapy. ERJ Open Research 2017;3:00004-2017. - PMC - PubMed
Bryant 1975a {published data only}
    1. Bryant DH, Burns MW, Lazarus L. The correlation between skin tests, bronchial provocation tests and the serum level of IgE specific for common allergens in patients with asthma. Clinical Allergy 1975;5(2):145-57. 4900100000023985 - PubMed
Bryant 1975b {published data only}
    1. Bryant DH, Burns MW, Lazarus L. Identification of IgG antibody as a carrier of reaginic activity in asthmatic patients. Journal of Allergy and Clinical Immunology 1975;56(6):417-28. 4900100000024002 - PubMed
Buhl 2000a {published data only}
    1. Buhl R, Kunkel G, Soler M, Bensch G, Wolfe J, Noga O, et al. RhuMAb-25 improves asthma-specific quality of life in patients with allergic asthma. European Respiratory Journal 2000;16 Suppl 31:465s. 4900100000013847
Buhl 2000b {published data only}
    1. Buhl R, Soler M, Fox H, Ashby M, McAlary M, Cooper J, et al. Recombinant humanized monoclonal antibody (rhuMAb) E25 in the prevention of serious asthma exacerbations. European Respiratory Journal 2000;16 Suppl 31:277s. 4900100000013848
Buhl 2002 {published data only}
    1. Buhl R, Soler M, Matz J, Townley R, O'Brien J, Noga O, et al. Omalizumab provides long-term control in patients with moderate-to- severe allergic asthma. European Respiratory Journal 2002;20(1):73-8. 4900100000012867 - PubMed
Bush 1985 {published data only}
    1. Bush RK, Taylor SL, Nordlee JA, Busse WW. Soybean oil is not allergenic to soybean-sensitive individuals. Journal of Allergy and Clinical Immunology 1985;76(2 Pt 1):242-5. 4900100000001757 - PubMed
Busse 2001 {published data only}
    1. Busse WW, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Della Cioppa G, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. Journal of Allergy and Clinical Immunology 2001;108(2):184-90. 4900100000010636 [4900100000010636] - PubMed
Busse 2008 {published data only}
    1. Busse WW, Israel E, Nelson HS, Baker JW, Charous BL, Young DY, et al. Daclizumab improves asthma control in patients with moderate to severe persistent asthma: a randomized, controlled trial. American Journal of Respiratory and Critical Care Medicine 2008;178(10):1002-8. 4900100000022833 - PubMed
Busse 2015 {published data only}
    1. Busse WW, Wang M, Gibson J, Gottlow M, Braddock M, Colice G. TROPOS: designing a clinical trial to evaluate the oral corticosteroid-sparing effect of a biologic in severe asthma. Clinical Investigation 2015;5(8):723-30. [CENTRAL: 1096145] [EMBASE: 2015401568]
Buttner 2003 {published data only}
    1. Buttner C, Lun A, Splettstoesser T, Kunkel G, Renz H. Monoclonal anti-interleukin-5 treatment suppresses eosinophil but not T-cell functions. European Respiratory Journal 2003;21(5):799-803. 4900100000015258 - PubMed
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Caffarelli 2000 {published data only}
    1. Caffarelli C, Sensi LG, Marcucci F, Cavagni G. Preseasonal local allergoid immunotherapy to grass pollen in children: a double-blind, placebo-controlled, randomized trial. Allergy 2000;55(12):1142-7. 4900100000009985 - PubMed
Canvin 2016 {published data only}
    1. Canvin J, Noble R, Djukanovic R, Curran M, Weiss S. Early identification of responders to reslizumab at 16 weeks using an algorithm derived from the pivotal clinical studies of severe eosinophilic asthma (SEA) patients [OA2998]. In: European Respiratory Society 26th Annual Congress; 2016 Sep 3-7; London. 2016.
Carr 2017 {published data only}
    1. Carr W, McDonald M, Meizlik P. Reslizumab improves spirometric lung age in patients with severe eosinophilic asthma. Annals of Allergy, Asthma and Immunology 2017;119(5):S57. - PubMed
Carr 2019 {published data only}
    1. Carr WW, McDonald M, Meizlik P. Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma. Allergy and Asthma Proceedings 2019;40(4):240-9. - PubMed
Castro 2011 {published data only}
    1. Castro M, Mathur S, Hargreave F, Boulet LP, Xie F, Young J, et al. Reslizumab for poorly controlled, eosinophilic asthma: a randomized, placebo-controlled study. American Journal of Respiratory and Critical Care Medicine 2011;184(10):1125-32. 4900100000056192 - PubMed
    1. Castro M, Mathur S, Hargreave F, Xie F, Young J, Wilkins HJ, et al. Reslizumab in the treatment of poorly controlled asthma in patients with eosinophilic airway inflammation. Annals of Allergy, Asthma and Immunology 2010;105(5 Suppl):A43. 4900100000054093
    1. Mathur S, Castro M, Hargreave F, Xie F, Wilkins HJ, Henkel T, et al. Efficacy of reslizumab in patients with poorly controlled eosinophilic asthma: subgroup analysis of patients with nasal polyps. Journal of Allergy and Clinical Immunology 2011;127(2 Suppl 1):AB84. 4900100000026800
    1. NCT00587288. Efficacy and safety study of reslizumab to treat poorly controlled asthma [An efficacy and safety study of reslizumab in the treatment of poorly controlled asthma in subjects with eosinophilic airway inflammation]. clinicaltrials.gov/show/NCT00587288 (first received 7 January 2008).
Castro 2014 {published data only}
    1. Castro M, Teper A, Wang L, Pirozzi G, Radin A, Graham N, et al. Responder analysis for FEV1 improvement with dupilumab in patients with persistent asthma and elevated eosinophil levels. American Journal of Respiratory and Critical Care Medicine 2014;189:A1321. [CENTRAL: 1131453] [EMBASE: 72043771]
Castro 2018 {published data only}
    1. Castro M, Adir Y, Chanez P, Mcdonald M, Hickey L, Garin M. Consistent efficacy across endpoints with reslizumab despite short term variability in blood eosinophil levels. European Respiratory Journal 2018;52:PA1043.
Chandra 1989 {published data only}
    1. Chandra RK, Singh G, Shridhara B. Effect of feeding whey hydrolysate, soy and conventional cow milk formulas on incidence of atopic disease in high risk infants. Annals of Allergy 1989;63(2):102-6. 4900100000002896 - PubMed
Chanez 2017 {published data only}
    1. Chanez P, Garin M, McDonald M, Humbert M. Reslizumab reduces severe exacerbations associated with emergency department visit or hospitalization and improves measures of lung function in patients on maintenance oral corticosteroids (OCS). European Respiratory Journal 2017;50:PA4691.
Chanez 2017a {published data only}
    1. Chanez P, McDonald M, Garin M, Murphy K. Early decreases in blood eosinophil levels with reslizumab. American Journal of Respiratory and Critical Care Medicine 2017;195:A3190. - PubMed
Chanez 2018 {published data only}
    1. Chanez P, Adir Y, Castro M, Pahus L, Mcdonald M, Hickey L, et al. Intravenous (IV) reslizumab improves asthma control, symptoms, and quality of life in patients with historically elevated blood eosinophils. European Respiratory Journal 2018;52:PA600.
Chanez 2019 {published data only}
    1. Chanez P, Hickey L, Garin M, Castro M. Evaluation of eosinophilic asthma patients without blood eosinophil (EOS) response to intravenous (IV) reslizumab in a post-hoc analysis of 52-week placebo-controlled phase 3 studies. Journal of Allergy and Clinical Immunology 2019;143(2):AB97.
Chauhan 2017 {published data only}
    1. Chauhan A, Garin M, Sun S. Efficacy of reslizumab in adults with severe eosinophilic asthma with >=3 exacerbations in the previous year: analyses at weeks 16 and 52 of two placebo-controlled phase 3 trials. European Respiratory Journal 2017;50:PA2626.
Chervinsky 2003 {published data only}
    1. Chervinsky P, Casale T, Townley R, Tripathy I, Hedgecock S, Fowler-Taylor A, et al. Omalizumab, an anti-IgE antibody, in the treatment of adults and adolescents with perennial allergic rhinitis. Annals of Allergy, Asthma and Immunology 2003;91(2):160-7. 4900100000015346 [4900100000015346] - PubMed
Chipps 2017 {published data only}
    1. Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Efficacy of benralizumab for patients with severe, uncontrolled atopic asthma by serum immunoglobulin E concentrations. Pneumologie 2018;72:S14. - PubMed
Chipps 2018 {published data only}
    1. Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Demographics, clinical characteristics, and response to benralizumab treatment for patients with severe, eosinophilic asthma and fixed airflow obstruction. American Journal of Respiratory and Critical Care Medicine 2018;197:A2489.
Chipps 2019 {published data only}
    1. Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Annals of Allergy and Asthma Immunology 2020;124(1):79-86. - PubMed
Chipps 2020 {published data only}
    1. Chipps B, Corren J, Israel E, Barker P, Kreindler J, Newbold P. Influence of key clinical baseline characteristics on benralizumab response for patients with severe, uncontrolled asthma and moderate blood eosinophilia. Journal of Allergy and Clinical Immunology 2020;145(2):AB22.
Clavel 1998 {published data only}
    1. Clavel R, Bousquet J, Andre C. Clinical efficacy of sublingual-swallow immunotherapy: a double-blind, placebo-controlled trial of a standardized five-grass-pollen extract in rhinitis. Allergy 1998;53(5):493-8. 4900100000023536 - PubMed
Corren 2003 {published data only}
    1. Corren J, Casale T, Deniz Y, Ashby M. Omalizumab, a recombinant humanized anti-IgE antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma. Journal of Allergy and Clinical Immunology 2003;111(1):87-90. 4900100000015187 - PubMed
Corren 2010 {published data only}
    1. Corren J, Busse W, Meltzer EO, Mansfield L, Bensch G, Fahrenholz J, et al. A randomized, controlled, phase 2 study of AMG 317, an IL-4Ralpha antagonist, in patients with asthma. American Journal of Respiratory and Critical Care Medicine 2010;181(8):788-96. 4900100000024877 - PubMed
Cullell‐Young 2002 {published data only}
    1. Cullell-Young M, Bayes M, Leeson PA. Omalizumab: treatment of allergic rhinitis, treatment of asthma. Drugs of the Future 2002;27(6):537-45. 4900100000050549
Dasgupta 2016 {published data only}
    1. Dasgupta A, Kjarsgaard M, Capaldi D, Radford K, Aleman F, Parraga G, et al. Mepolizumab in COPD with eosinophilic bronchitis: a randomized clinical trial [PA305]. In: European Respiratory Society 26th Annual Congress; 2016 Sep 3-7; London. 2016.
De Boever 2014 {published data only}
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Djukanovic 2004 {published data only}
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Maspero 2018 {published data only}
    1. Maspero J, Harrison T, Werkstrom V, Wu Y, Gopalan G, Zangrilli J. Clinical efficacy of benralizumab in patients with severe, uncontrolled eosinophilic asthma and nasal polyposis: pooled analysis of the SIROCCO and CALIMA trials. Journal of Allergy and Clinical Immunology 2018;141(2):AB12.
Maspero 2019 {published data only}
    1. Maspero JF, Hickey L, Garin MC. Multiple components contribute to greater improvements in quality of life with iv reslizumab in the most eosinophilic asthma patients compared with the overall patient population. American Journal of Respiratory and Critical Care Medicine 2019;199:A7085.
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NCT00802438 {published data only}
    1. NCT00802438. Eosinophilic airway inflammation and mepolizumab. clinicaltrials.gov/ct2/show/NCT00802438 (first received 4 December 2008). 4900126000001344
NCT01290887 {published data only}
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NCT01366521 {published data only}
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NCT01471327 {published data only}
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NCT01520051 {published data only}
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NCT01691859 {published data only}
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NCT01842607 {published data only}
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NCT02020889 {published data only}
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NCT02075255 {published data only}
    1. NCT02075255. Efficacy and safety study of benralizumab to reduce OCS use in patients with uncontrolled asthma on high dose inhaled corticosteroid plus LABA and chronic OCS therapy. clinicaltrials.gov/show/NCT02075255 (first received 14 February 2014).
NCT02135692 {published data only}
    1. NCT02135692. A Phase 3a, repeat dose, open-label, long-term safety study of mepolizumab in asthmatic subjects. clinicaltrials.gov/show/NCT02135692 (first received 8 May 2014).
NCT02258542 {published data only}
    1. NCT02258542. A safety extension study to evaluate the safety and tolerability of benralizumab (MEDI-563) in asthmatic adults and adolescents on inhaled corticosteroid plus LABA (BORA). clinicaltrials.gov/show/NCT02258542 (first received 14 September 2014).
NCT02293265 {published data only}
    1. NCT02293265. Cross-sectional study for identification and description of severe asthma patients. clinicaltrials.gov/show/NCT02293265 (first received 27 October 2014).
NCT02377427 {published data only}
    1. NCT02377427. Pharmacokinetics and pharmacodynamics of mepolizumab administered subcutaneously in children. clinicaltrials.gov/ct2/show/NCT02377427 (first received 26 February 2015).
NCT02417961 {published data only}
    1. NCT02417961. Study to assess functionality, reliability, and performance of a pre-filled syringe with benralizumab administered at home. clinicaltrials.gov/show/NCT02417961 (first received 12 March 2015).
NCT02501629 {published data only}
    1. NCT02501629. An efficacy and safety study of reslizumab subcutaneous in patients with oral corticosteroid dependent asthma and elevated blood eosinophils. clinicaltrials.gov/show/NCT02501629 (first received 14 July 2015).
NCT02559791 {published data only}
    1. NCT02559791. Anti-interleukin-5 (IL5) monoclonal antibody (MAb) in prednisone-dependent eosinophilic asthma. clinicaltrials.gov/ct2/show/NCT02559791 (first received 22 September 2015).
NCT02594332 {published data only}
    1. NCT02594332. Effects of mepolizumab compared to placebo on airway physiology in patients with eosinophilic asthma: MEMORY study (MEMORY). clinicaltrials.gov/show/NCT02594332 (first received 31 August 2015).
NCT02654145 {published data only}
    1. NCT02654145. Omalizumab to mepolizumab switch study in severe eosinophilic asthma patients. clinicaltrials.gov/ct2/show/NCT02654145 (first received 11 January 2016).
NCT02808819 {published data only}
    1. NCT02808819. A safety extension study with benralizumab for asthmatic adults on inhaled corticosteroid plus long-acting beta 2 agonist (MELTEMI). clinicaltrials.gov/show/NCT02808819 (first received 7 June 2016).
NCT02814643 {published data only}
    1. NCT02814643. Study to evaluate the potential effect of benralizumab on the humoral immune response to the seasonal influenza vaccination in adolescent and young adult patients with severe asthma (ALIZE). clinicaltrials.gov/show/NCT02814643 (first received 15 June 2016).
NCT02821416 {published data only}
    1. NCT02821416. Study to evaluate the effect of benralizumab on allergen-induced inflammation in mild, atopic asthmatics (ARIA). clinicaltrials.gov/show/NCT02821416 (first received 17 June 2016).
NCT02869438 {published data only}
    1. NCT02869438. A study to evaluate the onset of effect and time course of change in lung function with benralizumab in severe, uncontrolled asthma patients with eosinophilic inflammation. clinicaltrials.gov/ct2/show/NCT02869438 (first received 16 August 2016).
NCT02937168 {published data only}
    1. NCT02937168. An imaging study using PET/CT to characterize the effect of intravenous reslizumab on airway inflammation. clinicaltrials.gov/show/NCT02937168 (first received 14 October 2016).
NCT02968914 {published data only}
    1. NCT02968914. Pharmacokinetic comparability of benralizumab using accessorized pre-filled syringe or autoinjector in healthy volunteers. clinicaltrials.gov/show/NCT02968914 (first received 28 October 2016).
NCT03014674 {published data only}
    1. NCT03014674. A study to compare the pharmacokinetics of mepolizumab as a liquid drug in a safety syringe or an autoinjector versus lyophilised drug. clinicaltrials.gov/show/NCT03014674 (first received 15 December 2016).
NCT03021304 {published data only}
    1. NCT03021304. Study of mepolizumab safety syringe in asthmatics. clinicaltrials.gov/ct2/show/NCT03021304 (first received 12 January 2017).
NCT03476109 {published data only}
    1. NCT03476109. Study of magnitude and prediction of response to omalizumab and mepolizumab in adult severe asthma (PREDICTUMAB) [Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: a pragmatic multicenter trial in Belgium]. clinicaltrials.gov/ct2/show/NCT03476109 (first received 23 March 2018).
NCT04617171 {published data only}
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    1. NCT04710134. Efficacy of reslizumab dose escalation in patients with severe asthma. https://ClinicalTrials.gov/show/NCT04710134 ( first received 14 January 2022).
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