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Treatment with interleukin (IL)-5/IL-5 receptor antibodies in patients with severe eosinophilic asthma and COPD

Nora Drick, Jan Fuge, Benjamin Seeliger, Milan Speth, Jens Vogel-Claussen, Tobias Welte, Hendrik Suhling
ERJ Open Research 2022 8: 00207-2022; DOI: 10.1183/23120541.00207-2022
Nora Drick
1Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany
2Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany
4These authors contributed equally
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Jan Fuge
1Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany
2Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany
4These authors contributed equally
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  • For correspondence: fuge.jan@mh-hannover.de
Benjamin Seeliger
1Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany
2Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany
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Milan Speth
3Institute for Diagnostic and Interventional Radiology, Hannover Medical School, Hannover, Germany
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Jens Vogel-Claussen
2Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany
3Institute for Diagnostic and Interventional Radiology, Hannover Medical School, Hannover, Germany
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Tobias Welte
1Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany
2Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany
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Hendrik Suhling
1Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany
2Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany
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  • FIGURE 1
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    FIGURE 1

    Flowchart of patient inclusion. COPD: chronic obstructive pulmonary disease; PS: propensity score; SEA: severe eosinophilic asthma.

  • FIGURE 2
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    FIGURE 2

    Change of parameters from baseline to follow-up by group. SEA: severe eosinophilic asthma; COPD: chronic obstructive pulmonary disease; ACT: asthma control test; EOS: eosinophils; FEV1: forced expiratory volume in 1 s; RV: residual volume; QoL-VAS: quality of life – visual analogue scale; PO2: oxygen tension.

Tables

  • Figures
  • TABLE 1

    Baseline demographics

    ItemAllSEA and COPDSEAp-value
    Subjects8442 (50)42 (50)
    Age years61 (55–66)61 (55–65)61 (55–66)0.917
    Sex
     Female34 (41)17 (41)17 (41)1.000
     Male50 (59)25 (59)25 (59)
    BMI kg·m−229 (25–34)28 (25–34)29 (25–34)0.512
    Therapy
     Anti-IL-5 (mepolizumab)35 (42)23 (55)12 (29)0.015#
     Anti-IL-5Rα (benralizumab)49 (58)19 (45)30 (71)
     OCS43 (51)23 (55)20 (48)0.513#
     ICS, medium–high dose100 (100)42 (100)42 (100)1.000#
    IL-5 responder64 (76)32 (76)32 (76)1.000#
    Smoking
     Never28 (33)0 (0)28 (67)<0.001#
     Former56 (67)42 (100)14 (33)
    Pack-years20 (9–30)20 (15–30)7 (4–9)<0.001
    PFT
      DLCO % predicted79 (72–97)74 (70–90)94 (75–101)0.116
      KCO % predicted107 (89–115)93 (80–112)112 (105–117)0.005
     FEV1/FVC post-BDT66 (54–73)66 (58–73)68 (51–73)0.785
    Positive bronchodilator test¶21 (38)13 (43)8 (31)0.333#
    Total IgE IU·mL−1177 (74–751)446 (87–1442)126 (41–259)0.040
    CT imaging, mean±sd+
     Total lung volume mL5878±14796041±14615681±15150.427
     LAA-950 cc188±379271±49488±1010.113
     LAA-950 %2.8±5.23.9±6.71.4±1.60.099
    Comorbidities
     Obesity (BMI ≥30 kg m−2)33 (39)36 (38)17 (41)0.823#
     CRSwNP2 (2)1 (2)1 (2)1.000#
     CRSsNP14 (17)4 (10)10 (24)0.079#
     ASA intolerance4 (5)2 (5)2 (5)1.000#
     Atopic dermatitis4 (5)1 (2)3 (7)0.305#
     Cardiovascular diseases11 (13)6 (14)5 (12)0.746#
     Diabetes3 (4)0 (0)3 (7)0.078#
     Reflux5 (6)2 (5)3 (7)0.645#
     Allergic rhinitis2 (2)0 (0)2 (5)0.152#

    Data are presented as n (%) or median (interquartile range), unless otherwise stated. p-values were derived using t-test, if not indicated otherwise. SEA: severe eosinophilic asthma; BMI: body mass index; IL: interleukin; OCS: oral corticosteroids; ICS: inhaled corticosteroids; PFT: pulmonary function testing; DLCO: diffusing capacity for carbon monoxide; KCO: carbon monoxide transfer coefficient; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; BDT: bronchodilator test; CT: computed tomography; LAA: low-attenuation areas; CRSwNP: chronic rhinosinusitis with nasal polyps; CRSsNP: chronic rhinosinusitis without nasal polyps; ASA: acetylsalicylic acid. #: Chi squared test; ¶: data from n=56 patients available; +: data from n=45 patients available. Significant values are marked as bold.

    • TABLE 2

      Comparison of baseline and follow-up visits (delta)

      ItemΔ totalΔ SEA and COPDΔ SEAp-value
      Δ of lung function
       FVC % predicted8 (−2–18)6 (−1–16)12 (−2–23)0.216
       FEV1 % predicted11 (3–22)11 (5–18)15 (−3–23)0.637
       RV % predicted−10 (−23–6)−11 (−24–5)−10 (−22–12)0.472
       TLC % predicted0 (−6–7)−1 (−6–5)0 (−6–10)0.128
       eNO ppb−6 (−30–9)−3 (−25–10)−7 (−32–8)0.612
      Δ of blood gases
       PO2 mmHg1 (−4–8)−2 (−5–10)2 (−3–7)0.740
       PCO2 mmHg1 (−1–2)0 (−1–1)1 (−1–3)0.229
      Δ of laboratory
       Eosinophils 103·µL−1−6 (−10– −4)−6 (−10– −4)−6 (−12– −3)0.571
      Δ of OCS therapy
       OCS dosage mg−5 (−11–0)−3 (−6–0)−5 (−20– −1)0.070
       OCS therapy, n (%)−9 (11)−3 (7)−6 (14)0.069#
      Δ of quality-of-life scores
       QoL-VAS1 (0–3)0 (−1–3)2 (0–3)0.019
       ACT score4 (0–8)3 (0–6)6 (1–11)0.097
       Stair climbing (flights of stairs)0 (0–1)0 (0–1)0 (0–1)0.274¶
       Annual exacerbations, mean±sd−1.4±2.4−1.1±2.3−1.5±2.60.505
      Δ of subjective condition, n (%)
       Worsened12 (14)4 (11)8 (22)0.453
       Stable41 (49)17 (47)16 (44)
       Improved31 (37)15 (42)12 (33)

      Data are presented as median (interquartile range), unless otherwise stated. p-values were derived using t-test, if not indicated otherwise. SEA: severe eosinophilic asthma; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; RV: residual volume; TLC: total lung capacity; eNO: exhaled nitric oxide; PO2: oxygen tension; PCO2: carbon dioxide tension; OCS: oral corticosteroids; QoL-VAS: quality of life visual analogue scale; ACT: asthma control test. #: Chi squared test; ¶: Mann–Whitney U-test. Significant values are marked as bold.

      • TABLE 3

        Comparison of baseline and follow-up visits (absolute)

        ItemSEA and COPDSEA
        BaselineFollow-upp-valueAdjusted p-valueBaselineFollow-upp-valueAdjusted p-value
        Lung function
         FVC % predicted81 (73–92)92 (76–99)<0.001<0.00177 (60–92)89 (74–102)<0.001<0.001
         FEV1 % predicted56 (42–69)70 (53–81)<0.001<0.00162 (44–75)75 (55–91)<0.001<0.001
         RV % predicted141 (112–179)134 (110–168)0.0050.011138 (105–159)128 (104–151)0.0690.080
         TLC % predicted104 (95–110)104 (95–114)0.5020.50299 (84–113)102 (93–110)0.1560.169
        Blood gases
         PO2 mmHg71 (65–77)71 (67–79)0.2750.35874 (66–79)73 (67–80)0.3340.334
         PCO2 mmHg39 (36–41)38 (36–41)0.5720.62038 (35–39)40 (37–41)0.0310.040
        Laboratory
         Eosinophils 103·µL−10.6 (0.4–0.8)0.01 (0–0.08)<0.001<0.0010.5 (0.2–0.8)0 (0–0.06)<0.001<0.001
        OCS therapy
         OCS dosage mg10 (5–15)8 (4–18)0.6650.66510 (5–20)5 (3–6)0.0020.003
         OCS therapy, n (%)23 (55)20 (48)<0.250#<0.271#20 (48)14 (33)<0.109#<0.177#
        QoL scores
         QoL-VAS5 (4–7)7 (4–8)0.0470.0765 (3–6)7 (5–9)<0.001<0.001
         ACT score14 (11–19)19 (13–23)<0.0010.00312 (9–18)20 (17–23)<0.001<0.001
         Stair climbing (flights of stairs)1 (1–2)2 (1–3)0.1830.2642 (1–2)2 (1–3)0.008¶0.012
         Annual exacerbations, mean±sd2.0±2.80.9±1.80.0110.0201.9±2.50.4±0.70.0010.002

        Data are presented as median (interquartile range), unless otherwise stated. p-values were derived using paired t-test, if not indicated otherwise. SEA: severe eosinophilic asthma; FVC: forced vital capacity; FEV1: forced expiratory volume in 1 s; RV: residual volume; TLC: total lung capacity; PO2: oxygen tension; PCO2: carbon dioxide tension; OCS: oral corticosteroids; QoL-VAS: quality of life – visual analogue scale; ACT: asthma control test. #: McNemar test; ¶: Wilcoxon signed-rank test. Significant values are marked as bold.

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        Treatment with interleukin (IL)-5/IL-5 receptor antibodies in patients with severe eosinophilic asthma and COPD
        Nora Drick, Jan Fuge, Benjamin Seeliger, Milan Speth, Jens Vogel-Claussen, Tobias Welte, Hendrik Suhling
        ERJ Open Research Oct 2022, 8 (4) 00207-2022; DOI: 10.1183/23120541.00207-2022

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        Treatment with interleukin (IL)-5/IL-5 receptor antibodies in patients with severe eosinophilic asthma and COPD
        Nora Drick, Jan Fuge, Benjamin Seeliger, Milan Speth, Jens Vogel-Claussen, Tobias Welte, Hendrik Suhling
        ERJ Open Research Oct 2022, 8 (4) 00207-2022; DOI: 10.1183/23120541.00207-2022
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