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Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial

Andrew Menzies-Gow, Jonathan Corren, Elisabeth H. Bel, Jorge Maspero, Liam G. Heaney, Mark Gurnell, Peter Wessman, Ubaldo J. Martin, Shahid Siddiqui, Esther Garcia Gil
ERJ Open Research 2019 5: 00009-2019; DOI: 10.1183/23120541.00009-2019
Andrew Menzies-Gow
1Royal Brompton Hospital, London, UK
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  • For correspondence: a.menzies-gow@rbht.nhs.uk
Jonathan Corren
2Depts of Medicine and Pediatrics, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
3Allergy Medical Clinic, Los Angeles, CA, USA
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Elisabeth H. Bel
4Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
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Jorge Maspero
5Fudación CIDEA, Buenos Aires, Argentina
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Liam G. Heaney
6Queen's University Belfast, Belfast, UK
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Mark Gurnell
7Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK
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Peter Wessman
8AstraZeneca, Gothenburg, Sweden
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Ubaldo J. Martin
9AstraZeneca, Gaithersburg, MD, USA
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  • ORCID record for Ubaldo J. Martin
Shahid Siddiqui
9AstraZeneca, Gaithersburg, MD, USA
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Esther Garcia Gil
10AstraZeneca, Barcelona, Spain
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  • FIGURE 1
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    FIGURE 1

    PONENTE study design. EOT: end of treatment; OCS: oral corticosteroid; Q4W: every 4 weeks; Q8W: every 8 weeks. #: guided by schema of OCS reduction defined in the study protocol.

  • FIGURE 2
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    FIGURE 2

    OCS down-titration schema until dosage of 5 mg·day−1 is reached, without worsening of asthma. OCS: oral corticosteroid; Q1W: every week; Q2W: every 2 weeks; Q4W: every 4 weeks.

  • FIGURE 3
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    FIGURE 3

    Hypothalamic–pituitary–adrenal axis evaluation and oral corticosteroid down-titration schema from prednisone dosage of 5 mg·day−1. ACTH: adrenocorticotropic hormone; AI: adrenal insufficiency; i.v.: intravenous; Q4W: every 4 weeks.

  • FIGURE 4
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    FIGURE 4

    Rescue down-titration after recovery from asthma exacerbation or deterioration. OCS: oral corticosteroid; Q4W: every 4 weeks.

Tables

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  • TABLE 1

    Comparison of PONENTE study features with published oral corticosteroid (OCS)-sparing studies of other biological treatments for severe asthma

    Study nameStudy typeTrial durationPatientsBiologicOCS inclusion criteriaOCS tapering
    Time frameDosage reduction
    PONENTE (ongoing)Open-label, single-arm>36 weeks (variable personalised OCS tapering period) + 4 weeks follow-upAim: ∼600Benralizumab≥5 mg·day−1 of prednisone (or equivalent)Dose-reduction phase: variable depending on baseline OCS dosage
    Maintenance phase: ∼24–32 weeks
    Follow-up: 4 weeks (Week 36)
    OCS dosages will be reduced by 5 mg either weekly or every 2 weeks or by 2.5 mg every 4 weeks depending on baseline OCS use/loss of asthma control until reaching ≤5 mg·day−1
    Following 4 weeks at ≤5 mg·day−1, further OCS reduction depends on cortisol concentration and AI status (evaluated by HPA axis integrity) assessed by ACTH stimulation testing
    ZONDA [18]RCT28 weeks + 8 weeks follow-up220Benralizumab7.5–40.0 mg·day−1 of prednisone (or equivalent) 5–35 mg·day−1 of prednisone (or equivalent)Dose-reduction phase: 20 weeks (Week 4–24)
    Maintenance phase: 4 weeks
    Follow-up: 8 weeks (Week 36)
    OCS dosage reduced by 2.5–5 mg·day−1 every 4 weeks (until reaching a dosage of 7.5 mg·day−1, then further reduced to 5 mg·day−1, 1.25 mg·day−1, and 0 mg·day−1; only patients with OCS dosage of ≤12.5 mg·day−1 at the end of the run-in phase were eligible for a 100% dose reduction)
    SIRIUS [28]RCT24 weeks135Mepolizumab5–35 mg·day−1 of prednisone (or equivalent)Run-in optimisation phase: 3–8 weeks
    Dose-reduction phase: 16 weeks (Week 4–20)
    Maintenance phase: 4 weeks (Week 24)
    Run-in OCS optimisation phase: OCS reduced weekly until asthma worsening
    Dose-reduction phase: OCS dosage reduced by 1.25–10 mg·day−1 every 4 weeks (based on asthma control and symptoms of AI); reduction only allowed for patients with stable ACQ-5 scores and for whom the investigator deemed appropriate
    VENTURE [29]International RCT24 weeks210Dupilumab5–35 mg·day−1 of prednisone (or equivalent)Dose-reduction phase: 16 weeks (Week 4–20)
    Maintenance phase: 4 weeks
    Follow-up: 12 weeks
    OCS dosage reduced every 4 weeks (protocol-specified algorithm; reduction range 2.5–25 mg·day−1, depending on baseline OCS dosage); no dose adjustments allowed after Week 20

    RCT: randomised controlled trial; AI: adrenal insufficiency; HPA: hypothalamic–pituitary–adrenal; ACTH: adrenocorticotropic hormone; ACQ-5: five-item Asthma Control Questionnaire-5.

    Supplementary Materials

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      Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

      Supplementary material 00009-2019.supp

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    Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial
    Andrew Menzies-Gow, Jonathan Corren, Elisabeth H. Bel, Jorge Maspero, Liam G. Heaney, Mark Gurnell, Peter Wessman, Ubaldo J. Martin, Shahid Siddiqui, Esther Garcia Gil
    ERJ Open Research Jul 2019, 5 (3) 00009-2019; DOI: 10.1183/23120541.00009-2019

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    Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial
    Andrew Menzies-Gow, Jonathan Corren, Elisabeth H. Bel, Jorge Maspero, Liam G. Heaney, Mark Gurnell, Peter Wessman, Ubaldo J. Martin, Shahid Siddiqui, Esther Garcia Gil
    ERJ Open Research Jul 2019, 5 (3) 00009-2019; DOI: 10.1183/23120541.00009-2019
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