Long-Term Efficacy of Mepolizumab at 3 Years in Patients with Severe Asthma: Comparison with Clinical Trials and Super Responders
Abstract
:1. Introduction
2. Methods
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
ACT | Asthma Control Test |
BMI | Body mass index |
CRSwNP | Chronic Rhinosinusitis with nasal polyps |
FeNO | Fractional exhaled nitric oxide |
FEV1 | Forced expiratory volume 1 s |
Ig | Immunoglobulin |
IL | Interleukin |
MEP | Mepolizumab |
OCS | Oral Corticosteroids |
MCID | Minimal clinically important difference |
RCT | Randomized controlled trials |
RL | Real Life |
SANI | Severe Asthma Network Italy |
SNOT-22 | Sinonasal Outcome Test |
T2 | Type 2 |
Appendix A
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Baseline (n = 157) | 1° Year (n = 151) | p-Value Baseline vs. 1° y | 2° Year (n = 146) | p-Value 1° vs. 2° y | 3° Year (n = 116) | p-Value 2° vs. 3° y | p-Value Baseline vs. 3° | |
---|---|---|---|---|---|---|---|---|
Male (%) | 80 (51) | 76 (50) | 0.864 | 77 (53) | 0.706 | 59 (51) | 0.833 | 0.937 |
Age mean (range) | 59 (21–84) | 59 (22–85) | 0.945 | 59 (23–81) | 0.899 | 60 (24–82) | 0.910 | 0.904 |
Age onset | 41 (15.7) | n.a. | - | n.a. | - | n.a. | - | - |
BMI | 25.8 (8.8) | 26.1 (7.6) | 0.894 | 25.9 (6.4) | 0.903 | 26.0 (6.1) | 0.945 | 0.849 |
CRSwNP (%) | 99 (63) | 95 (63) | 0.901 | 88 (60) | 0.811 | 70 (60) | >0.999 | 0.705 |
Blood Eosinophils + | 718 (579) | 88 (43) | <0.0001 | 91 (23) | >0.999 | 90 (31) | >0.999 | <0.0001 |
OCS dependent (%) | 85 (54) | 31 (21) | <0.0001 | 16 (11) | 0.02 | 7 (6) | 0.19 | <0.001 |
OCS daily dose ° | 15.0 (11) | 9.8 (10) | 0.022 | 7.6 (9) | 0.891 | 6.3 (4) | 0.933 | 0.046 |
OCS cumulative yearly dose (g) | 5.8 (4.0) | 3.6 (3.11) | 0.039 | 2.7 (2.7) | 0.867 | 2.2 (1.3) | 0.822 | 0.049 |
Exacerbations | 3.9 (2.8) | 0.6 (1.2) | <0.0001 | 0.4 (0.9) | 0.656 | 0.2 (0.5) | 0.842 | <0.0001 |
Hospitalizated patients (%) | 35 (22) | 2 (1.3) | <0.0001 | 1 (0.7) | >0.999 | 1 (0.8) | >0.999 | <0.0001 |
Hospitalization § | 1.4 (0.5) | 0.02 (0.18) | <0.0001 | 0.006 (0.08) | >0.999 | 0.03 (0.2) | >0.999 | <0.0001 |
FEV1 % | 70 (33) | 83 (24) | 0.158 | 82 (22) | 0.981 | 84 (20) | 0.933 | 0.206 |
FEV1 L | 2.21 (1.0) | 2.38 ¥ (1.0) | 0.044 | 2.33 (0.86) | >0.999 | 2.39 (0.9) | >0.999 | 0.078 |
FeNO | 58 (42) | 34 (18) | <0.0001 | 38 (14) | 0.443 | 35 (18) | 0.718 | <0.0001 |
ACT | 17 (4) | 23 (2) ¥ | <0.0001 | 23 (2) | 0.898 | 23 (2) | 0.691 | <0.0001 |
SNOT-22 | 51 (15) | 37 (15) ¥ | 0.0002 | 34 (16) | 0.857 | 26 (14) | 0.05 | <0.0001 |
RL vs. COSMEX/COSMOS | RL Cohort | Cosmos 651 | p-Value | Kavanagh 28 | p-Value (Cosmos vs. Kavanagh) | p-Value (RL vs. Kavanagh) |
---|---|---|---|---|---|---|
Exacerbations * | 3.9 (2.8) | 3.67 | 0.305 | 3.57 (2.2) | 0.811 | 0.142 |
OCS dose ° | 15 (11) | 12.5 | <0.005 | 10 | 0.013 | <0.0001 |
BMI | 25.8 (8.8) | 28.1 (6.1) | 0.001 | 28.2 (4.5) | 0.907 | 0.0008 |
FEV1 (L) | 2.21 (1.0) | 1.99 (0.7) | 0.008 | 2.10 (0.65) | 0.378 | 0.171 |
CRSwNP § | 99 (63%) | 24 (7%) | <0.0001 | 19 (67.9) | <0.001 | 0.188 |
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Bagnasco, D.; Nicola, S.; Testino, E.; Brussino, L.; Pini, L.; Caminati, M.; Piccardo, F.; Canevari, R.F.; Melissari, L.; Ioppi, A.; et al. Long-Term Efficacy of Mepolizumab at 3 Years in Patients with Severe Asthma: Comparison with Clinical Trials and Super Responders. Biomedicines 2023, 11, 2424. https://doi.org/10.3390/biomedicines11092424
Bagnasco D, Nicola S, Testino E, Brussino L, Pini L, Caminati M, Piccardo F, Canevari RF, Melissari L, Ioppi A, et al. Long-Term Efficacy of Mepolizumab at 3 Years in Patients with Severe Asthma: Comparison with Clinical Trials and Super Responders. Biomedicines. 2023; 11(9):2424. https://doi.org/10.3390/biomedicines11092424
Chicago/Turabian StyleBagnasco, Diego, Stefania Nicola, Elisa Testino, Luisa Brussino, Laura Pini, Marco Caminati, Federica Piccardo, Rikki Frank Canevari, Laura Melissari, Alessandro Ioppi, and et al. 2023. "Long-Term Efficacy of Mepolizumab at 3 Years in Patients with Severe Asthma: Comparison with Clinical Trials and Super Responders" Biomedicines 11, no. 9: 2424. https://doi.org/10.3390/biomedicines11092424