Long-Term Clinical Remission on Benralizumab Treatment in Severe Eosinophilic Asthma: A Four-Year Real-Life Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Asthma Control Test (ACT)
2.2. Pulmonary Function Tests
2.3. Inflammatory Markers
2.4. Definition of Clinical Remission
2.5. Statistical Analysis
3. Results
3.1. Patients’ Characteristics at Baseline
3.2. Effect of Benralizumab on Individual Outcomes That Comprise the Definition of Clinical Remission
3.2.1. Effect of Benralizumab in Reducing Exacerbation
3.2.2. Effect of Benralizumab in Reducing OCS Dependence
3.2.3. Effect of Benralizumab in Improving Respiratory Function
3.2.4. Effect of Benralizumab in the Asthma Control Test (ACT) Score
3.3. Effects of Benralizumab on Markers of Asthma-Related T2 Inflammation
3.4. Clinical Remission Rates After Biological Therapy with Benralizumab
3.5. Baseline Predictors of SEA Complete Clinical Remission After 48 Months of Treatment with Benralizumab
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristics | Results (n = 23) |
---|---|
Age, years (mean ± SD) | 58.30 ± 10.26 |
Females, n (%) | 16 (69.6%) |
Males, n (%) | 7 (30.4%) |
Smokers (ex or current), n (%) | 5 (21.7%) |
BMI, kg/m2 (mean ± SD) | 27.25 ± 5.00 |
Asthma onset, years (mean ± SD) | 34.26 ± 12.95 |
Childhood onset, n (%) | 6 (26.1%) |
Adult onset, n (%) | 17 (73.9%) |
Atopy, n (%) | 17 (73.9%) |
Nasal polyposis, n (%) | 14 (60.9%) |
Gastroesophageal reflux, n (%) | 10 (43.5%) |
ASA sensitivity, n (%) | 3 (13.0%) |
Bronchiectasis, n (%) | 8 (34.8%) |
Anxiety and/or depression, n (%) | 3 (13.0%) |
Osteoporosis, n (%) | 12 (52.2%) |
OSAS, n (%) | 2 (8.7%) |
Atopic dermatitis, n (%) | 2 (8.7%) |
Exacerbation patients, n (%) | 21 (91.3%) |
Exacerbation/year, n (mean ± SD) | 2.61 ± 1.33 |
OCS-dependent patients, n (%) | 13 (56.5%) |
OCS dosage, mg (mean ± SD) | 18.48 ± 12.85 |
ACT score (mean ± SD) | 14.57 ± 2.45 |
FEV1%pre-bd, (mean ± SD) | 66.52 ± 15.94 |
FEV1 Lpre-bd (mean ± SD) | 1.95 ± 0.62 |
FEF25–75% (mean ± SD) | 36.83 ± 11.50 |
Eosinophils, cell/mcL (mean ± SD) | 670.87 ± 237.26 |
Eosinophils > 300 cell/mcL, n (%) | 22 (95.6%) |
FeNO50, ppb (mean ± SD) | 48.43 ± 14.79 |
FeNO50 > 50 ppb, n (%) | 9 (39.1%) |
Total IgE, kU/L (mean ± SD) | 235.18 ± 219.65 |
Clinical Outcomes | T0 | T12 | T24 | T36 | T48 |
---|---|---|---|---|---|
Exacerbations; mean ± SD (range) | 2.61 ± 1.33 (0–6) | 0.30 ± 0.45 (0–2) | 0.22 ± 0.34 (0–2) | 0.09 ± 0.16 (0–1) | 0.13 ± 0.23 (0–1) |
p-value (T0 vs. T12) < 0.0001 * | |||||
p-value (T0 vs. T24) < 0.0001 * | |||||
p-value (T0 vs. T36) < 0.0001 * | |||||
p-value (T0 vs. T48) < 0.0001 * | |||||
Exacerbation patients (n, %) | 21 (91.3%) | 4 (17.4%) | 3 (23.1%) | 1 (4.3%) | 3 (23.1%) |
p-value (T0 vs. T12) < 0.0001 * | |||||
p-value (T0 vs. T24) < 0.0001 * | |||||
p-value (T0 vs. T36) < 0.0001 * | |||||
p-value (T0 vs. T48) < 0.0001 * | |||||
Prednisone dose, mg; mean ± SD | 18.48 ± 12.85 | 3.48 ± 5.75 | 2.17 ± 3.97 | 1.09 ± 2.08 | 1.61 ± 2.94 |
p-value (T0 vs. T12) 0.0002 * | |||||
p-value (T0 vs. T24) < 0.0001 * | |||||
p-value (T0 vs. T36) < 0.0001 * | |||||
p-value (T0 vs. T48) < 0.0001 * | |||||
Patients requiring OCS (n, %) | 13 (56.5%) | 4 (17.4%) | 3 (13.0%) | 1 (4.3%) | 2 (8.7%) |
p-value (T0 vs. T12) 0.01 * | |||||
p-value (T0 vs. T24) 0.0045 * | |||||
p-value (T0 vs. T36) 0.0002 * | |||||
p-value (T0 vs. T48) 0.001 * | |||||
FEV1pre-bd %; mean ± SD | 66.52 ± 15.94 | 81.30 ± 15.44 | 81.35 ± 17.81 | 85.39 ± 14.93 | 87.14 ± 15.32 |
p-value (T0 vs. T12) 0.02 * | |||||
p-value (T0 vs. T24) 0.02 * | |||||
p-value (T0 vs. T36) 0.002 * | |||||
p-value (T0 vs. T48) 0.0008 * | |||||
FEV1 gain, mL; mean ± SD | - | 296 ± 257 | 617 ± 273 | 891 ± 270 | 1145 ± 258 |
p-value (T0 vs. T12) 0.07 * | |||||
p-value (T0 vs. T24) 0.03 * | |||||
p-value (T0 vs. T36) 0.002 * | |||||
p-value (T0 vs. T48) < 0.0001 * | |||||
FEF25–75%; mean ± SD | 36.83 ± 11.50 | 53.55 ± 24.28 | 59.95 ± 26.04 | 63.05 ± 19.78 | 66.21 ± 20.79 |
p-value (T0 vs. T12) 0.02 * | |||||
p-value (T0 vs. T24) 0.006 * | |||||
p-value (T0 vs. T36) < 0.0001 * | |||||
p-value (T0 vs. T48) < 0.0001 * | |||||
ACT score; mean ± SD | 14.57 ± 2.45 | 22.30 ± 2.00 | 23.35 ± 1.58 | 24.39 ± 0.79 | 24.52 ± 0.75 |
p-value (T0 vs. T12) < 0.0001 * | |||||
p-value (T0 vs. T24) < 0.0001 * | |||||
p-value (T0 vs. T36) < 0.0001 * | |||||
p-value (T0 vs. T48) < 0.0001 * |
Markers | T0 | T12 | T24 | T36 | T48 |
---|---|---|---|---|---|
Eosinophils, cell/mcL; mean ± SD | 670.87 ± 237.26 | 52.57 ± 89.12 | 3.91 ± 6.81 | 0.87 ± 1.66 | 0.87 ± 1.66 |
p-value (T0 vs. T12) < 0.0001 * | |||||
p-value (T0 vs. T24) < 0.0001 * | |||||
p-value (T0 vs. T36) < 0.0001 * | |||||
p-value (T0 vs. T48) < 0.0001 * | |||||
FeNO50, ppb; mean ± SD | 48.43 ± 14.79 | 28.83 ± 11.93 | 21.38 ± 7.83 | 16.75 ± 4.76 | 14.61 ± 4.76 |
p-value (T0 vs. T12) 0.002 * | |||||
p-value (T0 vs. T24) < 0.0001 * | |||||
p-value (T0 vs. T36) < 0.0001 * | |||||
p-value (T0 vs. T48) < 0.0001 * | |||||
Total IgE, kU/L; mean ± SD | 235.18 ± 219.65 | 114.19 ± 109.20 | 65.17 ± 43.84 | 52.88 ± 36.97 | 37.78 ± 22.87 |
p-value (T0 vs. T12) 0.21 | |||||
p-value (T0 vs. T24) 0.06 | |||||
p-value (T0 vs. T36) 0.04 * | |||||
p-value (T0 vs. T48) 0.02 * |
Characteristics at T0 | Complete Remission at T48 | OR | 95% CI | p-Value | ||
---|---|---|---|---|---|---|
Yes (n = 15) | No (n = 6) | |||||
Females | 8 (53.3%) | 6 (100.0%) | 0.09 | 0.01 | 1.82 | 0.06 |
Males | 7 (46.7%) | 0 (0.0%) | 11.47 | 0.55 | 239.80 | 0.06 |
Smokers (past or current) | 2 (13.3%) | 2 (33.3%) | 0.31 | 0.03 | 2.94 | 0.54 |
BMI > 30 kg/m2 | 4 (26.7%) | 2 (33.3%) | 0.36 | 0.04 | 3.52 | 0.56 |
Adult-onset asthma | 11 (73.3%) | 4 (66.7%) | 1.37 | 0.18 | 10.66 | 1.00 |
Atopy | 11 (73.3%) | 4 (66.7%) | 1.37 | 0.18 | 10.66 | 1.00 |
Gastroesophageal reflux | 6 (40.0%) | 4 (66.7%) | 0.33 | 0.04 | 2.43 | 0.36 |
Nasal polyposis | 12 (80.0%) | 1 (16.7%) | 20.00 | 1.65 | 241.90 | 0.01 * |
Anxiety and/or depression | 2 (13.3%) | 1 (16.7%) | 0.77 | 0.06 | 10.50 | 1.00 |
ASA sensitivity | 2 (12.3%) | 1 (16.7%) | 0.77 | 0.06 | 10.50 | 1.00 |
Osteoporosis | 11 (73.3%) | 1 (16.7%) | 13.75 | 1.21 | 156.70 | 0.04 * |
OSAS | 2 (13.3%) | 0 (0.0%) | 2.41 | 0.10 | 57.78 | 1.00 |
Bronchiectasis | 8 (53.3%) | 0 (0.0%) | 14.73 | 0.70 | 308.10 | 0.04 * |
Atopic dermatitis | 0 (0.0%) | 1 (16.7%) | 0.12 | 0.01 | 3.26 | 0.28 |
≥2 exacerbations/year | 11 (73.3%) | 5 (83.3%) | 0.55 | 0.05 | 6.27 | 1.00 |
OCS dependency | 11 (73.3%) | 1 (16.7%) | 13.75 | 1.21 | 156.70 | 0.04 * |
FEV1%pre-bd ≥ 80% | 14 (93.3%) | 3 (50.0%) | 14.00 | 1.06 | 185.60 | 0.05 * |
FEF25–75% < 65% | 15 (100.0%) | 3 (50.0%) | 31.00 | 1.28 | 747.60 | 0.01 * |
Eosinophils > 300 cell/mcL | 15 (100.0%) | 5 (83.3%) | 8.45 | 0.30 | 240.00 | 0.28 |
FeNO50 > 50 ppb | 7 (46.7%) | 2 (33.3%) | 1.75 | 0.24 | 12.65 | 0.66 |
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Quarato, C.M.I.; Tondo, P.; Lacedonia, D.; Soccio, P.; Pescatore, D.; Baccellieri, M.L.; Lepore, G.; Foschino Barbaro, M.P.; Scioscia, G. Long-Term Clinical Remission on Benralizumab Treatment in Severe Eosinophilic Asthma: A Four-Year Real-Life Study. J. Clin. Med. 2025, 14, 2075. https://doi.org/10.3390/jcm14062075
Quarato CMI, Tondo P, Lacedonia D, Soccio P, Pescatore D, Baccellieri ML, Lepore G, Foschino Barbaro MP, Scioscia G. Long-Term Clinical Remission on Benralizumab Treatment in Severe Eosinophilic Asthma: A Four-Year Real-Life Study. Journal of Clinical Medicine. 2025; 14(6):2075. https://doi.org/10.3390/jcm14062075
Chicago/Turabian StyleQuarato, Carla Maria Irene, Pasquale Tondo, Donato Lacedonia, Piera Soccio, Dalila Pescatore, Maria Lisa Baccellieri, Giorgia Lepore, Maria Pia Foschino Barbaro, and Giulia Scioscia. 2025. "Long-Term Clinical Remission on Benralizumab Treatment in Severe Eosinophilic Asthma: A Four-Year Real-Life Study" Journal of Clinical Medicine 14, no. 6: 2075. https://doi.org/10.3390/jcm14062075
APA StyleQuarato, C. M. I., Tondo, P., Lacedonia, D., Soccio, P., Pescatore, D., Baccellieri, M. L., Lepore, G., Foschino Barbaro, M. P., & Scioscia, G. (2025). Long-Term Clinical Remission on Benralizumab Treatment in Severe Eosinophilic Asthma: A Four-Year Real-Life Study. Journal of Clinical Medicine, 14(6), 2075. https://doi.org/10.3390/jcm14062075