Mepolizumab in Severe Pediatric Asthma: Certainties and Doubts through a Single-Center Experience and Review of the Literature
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Case Series
3.2. Review of the Literature
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Case 1 | Case 2 | Case 3 | Case 4 | |
---|---|---|---|---|
Age at asthma onset | 3 years | 12 years | 8 months | 2 months |
Allergic sensitization | House dust mites, cat dander, Olea europaea, Parietaria judaica | Grass pollen, Artemisia, Olea europaea, Parietaria judaica | House dust mites, cat/dog dander, cow’s milk proteins, egg | House dust mites, Alternaria, Olea europaea, Parietaria judaica |
Symptom burden | Weekly cough, dyspnea, and night awakenings. Frequent asthma attacks requiring systemic steroids, extra ICS, and bronchodilators. | Daily chest tightness, cough, exercise-induced dyspnea. Frequent asthma attacks requiring systemic steroids, extra ICS, and bronchodilators. | Monthly exacerbations with frequent need for systemic steroids, extra ICS, and bronchodilators. | Exacerbations requiring systemic steroids twice a month. Weekly night awakenings due to respiratory symptoms. |
Comorbidity | Obesity, insulin resistance | Nasal polyposis | - | Obesity, insulin resistance |
Treatment at referral | Budesonide (640 µg/d) + Formoterol (18 µg/d) | Budesonide (640 µg/d) + Formoterol (18 µg /d) + Montelukast (10 mg) | Budesonide (640 µg /d) + Formoterol (18 µg/d) + Montelukast (10 mg) | Beclomethasone (200 µg/d) + Formoterol (12 µg/d) + Omalizumab (450 mg/14 d) |
Age at mepolizumab | 14 years | 16 years | 10 years | 14 years |
Case 1 | Case 2 | Case 3 | Case 4 | |||||
---|---|---|---|---|---|---|---|---|
Baseline | 12 Months | Baseline | 12 Months | Baseline | 12 Months | Baseline | 12 Months | |
Blood eosinophils, cells/µL (%) | 1490 (13) | 140 (1.3) | 1470 (19) | 100 (1.4) | 420 (8.2) | 80 (1.8) | 530 (6) | 70 (0.8) |
Decrease in eosinophil count post-mepo (%) | −91 | −93 | −81 | −86 | ||||
FEV1, L (% pred) | 3.7 (125) | 3.1 (89) | 3.3 (84) | 3.0 (86) | 1.5 (94) | 1.5 (89) | 1.6 (37) | 4.3 (99) |
FEF25–75, L/s (% pred) | 2.5 (67) | 2.9 (73) | 3.7 (84) | 2.8 (65) | 1.3 (64) | 0.9 (44) | 0.7 (16) | 4.2 (87) |
Total serum IgE (IU/mL) | 1900 | 1800 | 234 | 250 | 1980 | 1980 | 1560 | 403 |
FeNO | 143 | 117 | 53 | 55 | 68 | 33 | 38 | 12 |
ACT score | 12 | 18 | 15 | 20 | 18 | 21 | 8 | 15 |
No. of exacerbations/year | 18 | 7 | 20 | 9 | 17 | 5 | 18 | 8 |
Current treatment | Mepolizumab + Budesonide (640 µg/d) + Formoterol (18 µg/d) | Mepolizumab + Budesonide (640 µg/d) + Formoterol (18 µg/d) | Mepolizumab + Budesonide (640 µg/d) + Formoterol (18 µg/d) + Montelukast (10 mg) | Mepolizumab + Budesonide (640 µg/d) + Formoterol (18 µg/d) |
Reference | Study Design | Number of Cases and Age | Inclusion Criteria | Mepolizumab Daily Dose/Duration | Main Findings |
---|---|---|---|---|---|
Pavord, 2012 (DREAM) [13] | Randomized, double-blind, controlled, multicenter trial | 616; 12–74 years (156 assigned to mepo 750 mg, 152 to mepo 250 mg, 153 to mepo 75 mg, 155 to placebo) | Sputum EOS > 3%, FENO > 50 ppb, blood EOS >300 cells/μL, or asthma control deteriorating after <25% reduction in maintenance ICS or OCS. Daily treatment with ≥880 μg inhaled fluticasone or equivalent, with or without maintenance OCS, and additional controller drugs. | 750 mg, 250 or 75 mg s.c. every 4 weeks for 48 weeks | Decreased asthma exacerbations (all doses) versus placebo. No FEV1 change. |
Ortega, 2014 (MENSA) [12] | Randomized, double-blind, double-dummy, controlled, multicenter, phase 3b trial | 576; 12–82 years (194 assigned to s.c. mepo 100 mg, 191 to i.v. mepo 75 mg, 191 to placebo) | Blood EOS > 300 cells/μL in the previous year, or >150 cells/μL at screening. >2 exacerbations treated with SCS in the previous year. Daily treatment with ≥880 μg inhaled fluticasone or equivalent and ≥3 months of treatment with an additional controller. FEV1 < 80% pred (age ≥18 years) or <90% pred (age 12–17 years). | 75 mg or 100 mg s.c. every 4 weeks for 32 weeks | Decreased asthma exacerbations. Improvement of FEV1 and QoL with both s.c. and i.v. mepo. |
Bel, 2014 (SIRIUS) [11] | Randomized, double-blind, controlled, parallel-group, multicenter trial | 135; 16–74 years (69 assigned to s.c. mepo 100 mg, 66 to placebo) | Blood EOS > 300 cells/μL in the previous year, or >150 cells/μL at screening. Maintenance SCS therapy >6 months. Treatment with high-dose ICS + an additional controller. | 100 mg s.c. every 4 weeks for 20 weeks | Decreased asthma exacerbations. Steroids-sparing effect. Improved asthma control. Non-significant trend of FEV1 improvement. |
Chupp, 2017 (MUSCA) [10] | Randomized, double-blind, controlled, parallel-group, multicenter, phase 3b trial | 551; ≥12 years (274 assigned to mepo, 277 to placebo) | Blood EOS > 300 cells/μL in the previous year, or >150 cells/μL at screening. >2 exacerbations treated with SCS in the previous year. FEV1 <80% pred (age ≥18 years) or <90% pred (age 12–17 years). | 100 mg s.c. every 4 weeks for 24 weeks | Improved QoL and FEV1. |
Gupta, 2019 [14] | Non-randomized, open-label, repeat-dose, phase 2 study | 36; 6–11 years | Blood EOS ≥150 cells/μL at screening or ≥300 cells/μL in the previous year. ≥2 exacerbations treated with SCS in the previous year. Treatment with >200 μg/d fluticasone propionate or equivalent with/without maintenance OCS and ≥1 controller drug. | 40 mg (<40 kg) or 100 mg (>40 kg) s.c. every 4 weeks for 12 weeks | Trend toward improved asthma control. Favorable safety profile No FEV1 change. |
Jackson, 2022 (MUPPITS-2) [9] | Randomized, double-blind, controlled, parallel-group, multicenter trial | 290; 6–17 years (146 assigned to mepo, 144 to placebo) | Blood EOS ≥150 cells/μL. ≥2 exacerbations treated with SCS in the previous year. Twice-daily therapy with at least fluticasone propionate 250 μg or equivalent (6–11 years), or at least futicasone/salmeterol 250/50 μg or equivalent (12–17 years). | 40 mg (age 6–11 years) or 100 mg (age 12–17 years) s.c. every 4 weeks for 52 weeks | Decreased asthma exacerbations. |
Wetzke, 2022 [15] | Real-life multicenter study | 18; 6–17 years | Uncontrolled asthma despite high ICS/LABA doses and trigger avoidance, or asthma requiring high doses of ICS/LABA to remain controlled | 40 mg (age 6–11 years) or 100 mg (age 12–17 years) s.c. every 4 weeks for 12.3 (median; range, 3–36) months | No significant reduction in exacerbation rate except 4 cases with follow-up >1 year. Improved FEV1. |
Lim, 2024 [16] | Retrospective, single-center study | 16; 7–17 years | Blood EOS >300 cells/μL or FENO > 50 ppb in the previous year. ≥3 exacerbations treated with SCS in the previous year. Treatment with high-dose ICS + an additional controller. | 40 mg (age 6–11 years) or 100 mg (age 12–17 years) s.c. every 4 weeks for 48 weeks | Decreased asthma-related hospitalizations. Reduced OCS dose/day No FEV1 or FEF25–75 change. |
Chen, 2024 [8] | Randomized, double-blind, controlled, parallel-group, multicenter trial | 300; ≥12 years (149 assigned to mepo, 151 to placebo) | Blood EOS ≥ 150 cells/μL at screening or ≥300 cells/μL in the previous year. ≥2 exacerbations treated with SCS in the previous year. FEV1 < 80% pred (age ≥18 years) or <90% pred (age 12–17 years). Treatment with high-dose ICS + an additional controller. | 100 mg s.c. every 4 weeks for 52 weeks | Decreased asthma exacerbations and asthma-related hospitalizations. Improved QoL and FEV1. |
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Maglione, M.; Borrelli, M.; Dorato, A.; Cimbalo, C.; del Giudice, L.A.; Santamaria, F. Mepolizumab in Severe Pediatric Asthma: Certainties and Doubts through a Single-Center Experience and Review of the Literature. Children 2024, 11, 895. https://doi.org/10.3390/children11080895
Maglione M, Borrelli M, Dorato A, Cimbalo C, del Giudice LA, Santamaria F. Mepolizumab in Severe Pediatric Asthma: Certainties and Doubts through a Single-Center Experience and Review of the Literature. Children. 2024; 11(8):895. https://doi.org/10.3390/children11080895
Chicago/Turabian StyleMaglione, Marco, Melissa Borrelli, Alessandro Dorato, Chiara Cimbalo, Luigi Antonio del Giudice, and Francesca Santamaria. 2024. "Mepolizumab in Severe Pediatric Asthma: Certainties and Doubts through a Single-Center Experience and Review of the Literature" Children 11, no. 8: 895. https://doi.org/10.3390/children11080895