Baseline Composite Score for 12-Month Clinical Remission in Biologic-Treated Severe Asthma: Development of the Base4Score
Abstract
1. Introduction
2. Methods
2.1. Study Design and Population
2.2. Construction of the Empirical Baseline Score (Base4Score)
- Poor symptom control (ACT < 20);
- ≥1 severe exacerbation in the previous 12 months;
- Maintenance oral corticosteroid (OCS) use;
- Airflow limitation (FEV1 < 80% predicted).
2.3. Statistical Analysis
2.4. Ethics Considerations
3. Results
3.1. Baseline Characteristics
3.2. Domain-Specific Remission Probabilities and Empirical Weights
- Among patients with ≥1 severe exacerbation in the prior year, 35/76 (46.1%) had no severe exacerbations during follow-up.
- Among those on maintenance OCS, 22/36 (61.1%) were able to discontinue OCS by 12 months.
- Among patients with poor symptom control (ACT < 20) at baseline, 48/73 (65.8%) achieved ACT ≥ 20.
- In contrast, only 10/57 (17.5%) of those with FEV1 < 80% predicted at baseline reached FEV1 ≥ 80% at 12 months.
3.3. Distribution of the Base4Score
- Low severity: score <5 (20/77, 26.0%).
- Intermediate severity: 5 to <9 (17/77, 22.1%).
- High severity: ≥9 (40/77, 51.9%).
3.4. Association Between Baseline Score and 12-Month Strict Clinical Remission in the 4 Domains
3.5. Exploratory Analyses of Inflammatory Remission
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
References
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| Baseline Domain | Abnormal at Baseline (%) | 12-Month Improvement (%) | 1/p | Weight |
|---|---|---|---|---|
| FEV1 < 80% | 58/92 (63.0%) | 10/57 (17.5%) | 5.7 | 5.7 |
| ACT < 20 | 76/85 (89.4%) | 48/73 (65.8%) | 1.5 | 1.5 |
| ≥1 exacerbation | 78/92 (84.8%) | 35/76 (46.1%) | 2.2 | 2.2 |
| Maintenance OCS | 38/93 (40.9%) | 22/36 (61.1%) | 1.6 | 1.6 |
| Variable | Total (n = 93) | Basal Included * (n = 81) | 12-Month Valid Paired Data (n = 77) |
|---|---|---|---|
| Age (y) | 55.88 ± 14.95 | 57.05 ± 14.40 | 57.09 ± 14.57 |
| Female | 66 (70.97%) | 56 (66.67%) | 51 (66.23%) |
| BMI (kg/m2) | 30.42 ± 6.45 | 30.33 ± 6.18 | 30.31 ± 6.28 |
| Smoking: never (%) | 58 (62.37) | 49 (60.49%) | 47 (61.04%) |
| Phenotypic characteristics | |||
| T2-low biomarkers | 31 (33.33%) | 28 (34.57%) | 26 (33.77%) |
| Naïve T2-low biomarkers | 25 (26.88%) | 22 (78.57%) | 21 (80.77%) |
| Biologic-switch T2-low biomarkers | 6 (6.45%) | 6 (21.43%) | 5 (19.23%) |
| T2-high | 62 (66.67%) | 53 (65.43%) | 51 (66.23%) |
| Naïve T2-high | 26 (41.94%) | 21(39.62%) | 19 (37.25%) |
| Biologic-switch T2-high | 36 (58.06%) | 32 (60.38%) | 32 (62.75%) |
| Allergic | 31 (33.33%) | 27 (50.94%) | 25 (32.47%) |
| Eosinophilic | 31 (33.33%) | 26 (49.06%) | 26 (33.77%) |
| Adult-onset | 65 (69.89%) | 57 (70.37%) | 55 (71.43%) |
| Comorbidities | |||
| Obesity | 50 (53.76%) | 44 (54.32%) | 42 (54.55%) |
| Bronchiectasis | 21 (22.58%) | 20 (24.69%) | 18 (23.38%) |
| COPD | 11 (11.83%) | 10 (12.35%) | 9 (11.69%) |
| Medication | |||
| Patients with long-term OCS therapy | 38 (40.86%) | 33 (40.74%) | 30 (38.96%) |
| ICS low | 4 (4.3%) | 2 (2.47%) | 2 (2.6%) |
| ICS medium | 9 (9.68%) | 9 (11.11%) | 9 (11.69%) |
| ICS high | 79 (84.95%) | 69 (85.19%) | 66 (85.71%) |
| LABA | 92 (98.92%) | 80 (98.77%) | 77 (100%) |
| LAMA | 88 (94.62%) | 76 (93.83%) | 73 (94.81%) |
| Montelukast | 46 (49.46%) | 40 (49.38%) | 39 (50.56%) |
| Macrolides | 35 (37.63%) | 35 (43.21%) | 33 (42.86%) |
| Previous biologic treatments | |||
| Biologic-naïve | 51 (54.84%) | 43 (53.09%) | 40 (51.95%) |
| Previous Omalizumab | 9 (9.68%) | 8 (9.88%) | 8 (10.39%) |
| Previous Mepolizumab | 9 (9.68%) | 9 (11.11%) | 9 (11.69%) |
| Previous Benralizumab | 10 (9.30%) | 9 (11.11%) | 7 (9.09%) |
| Previous Dupilumab | 13 (13.98%) | 13 (16.05%) | 12 (15.58%) |
| Previous Tezepelumab | 1 (1.08%) | 1 (1.23%) | 1 (1.30%) |
| ORc | 95% | CI | Linear p Trend | ORa | 95% | CI | Linear p-Trend | |
|---|---|---|---|---|---|---|---|---|
| Base4Score(range 1.5–11.0) | 1.21 | 1.01 | 1.45 | 0.043 | 1.22 | 1.00 | 1.49 | 0.047 |
| Base4Score standardised to 1–4 | 1.83 | 1.02 | 3.29 | 0.043 | 1.91 | 1.01 | 3.63 | 0.047 |
| Unweighted 1–4 score | 1.68 | 0.89 | 3.16 | 0.11 | 1.88 | 0.95 | 3.72 | 0.068 |
| ORc | 95% | CI | p Value | ORa | 95% | CI | p Value | |
|---|---|---|---|---|---|---|---|---|
| Base4Score (range 1.5–11.0 points) | ||||||||
| <5 | 1 | 1 | ||||||
| >4 to <9 | 3.11 | 0.67 | 14.44 | 0.147 | 4.67 | 0.57 | 38.20 | 0.151 |
| ≥9 | 4.67 | 1.28 | 17.05 | 0.02 | 6.77 | 1.40 | 32.84 | 0.018 |
| Linear p trend | 0.022 | 0.021 |
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García-Rivero, J.L.; Anaaoui, A.H.; Pallarés-Sanmartín, A.; Blanco-Aparicio, M.; García-Hernáez, R.; Sanz, V.G.-G.; Calvo-Álvarez, U.; Carazo-Fernández, L.; Hermida-Valverde, T.; Dorronsoro, S.; et al. Baseline Composite Score for 12-Month Clinical Remission in Biologic-Treated Severe Asthma: Development of the Base4Score. Biomedicines 2026, 14, 747. https://doi.org/10.3390/biomedicines14040747
García-Rivero JL, Anaaoui AH, Pallarés-Sanmartín A, Blanco-Aparicio M, García-Hernáez R, Sanz VG-G, Calvo-Álvarez U, Carazo-Fernández L, Hermida-Valverde T, Dorronsoro S, et al. Baseline Composite Score for 12-Month Clinical Remission in Biologic-Treated Severe Asthma: Development of the Base4Score. Biomedicines. 2026; 14(4):747. https://doi.org/10.3390/biomedicines14040747
Chicago/Turabian StyleGarcía-Rivero, Juan Luis, Adil Hannaoui Anaaoui, Abel Pallarés-Sanmartín, Marina Blanco-Aparicio, Raquel García-Hernáez, Victoria García-Gallardo Sanz, Uxío Calvo-Álvarez, Luis Carazo-Fernández, Tamara Hermida-Valverde, Silvia Dorronsoro, and et al. 2026. "Baseline Composite Score for 12-Month Clinical Remission in Biologic-Treated Severe Asthma: Development of the Base4Score" Biomedicines 14, no. 4: 747. https://doi.org/10.3390/biomedicines14040747
APA StyleGarcía-Rivero, J. L., Anaaoui, A. H., Pallarés-Sanmartín, A., Blanco-Aparicio, M., García-Hernáez, R., Sanz, V. G.-G., Calvo-Álvarez, U., Carazo-Fernández, L., Hermida-Valverde, T., Dorronsoro, S., Carrascosa-Anguiano, I., Astiárraga, I. L., Santos, I. d. l., Rodríguez, A. I. E., Pérez de Llano, L., Álvarez Vega, P., Abascal-Bolado, B., & Santibañez, M. (2026). Baseline Composite Score for 12-Month Clinical Remission in Biologic-Treated Severe Asthma: Development of the Base4Score. Biomedicines, 14(4), 747. https://doi.org/10.3390/biomedicines14040747

