TABLE 1.
Targeted treatments for severe asthma: effect on exacerbations, oral corticosteroid (OCS) dose reduction, OCS withdrawal, symptoms, quality of life (QoL), lung function and prediction of response
| Biologic agent | Exacerbations | OCS dose reduction | OCS withdrawal | Symptoms | QoL | FEV1 | Prediction of response |
| Omalizumab | |||||||
| Humbert et al. [ 37 ] (INNOVATE)# | 26% reduction | NA | NA | p=0.039 | AQLQ +0.45 | p=0.043 | NA |
| Busse et al. [ 36 ]# | 27% reduction | NA | NA | ns | NA | ns | BEC >300 mm−3 |
| Sorkness et al. [ 38 ]# | 50% reduction | NA | NA | p<0.01 | NA | NA | High FENO, blood eosinophils and BMI >25 kg·m−2 |
| Hanania et al. [ 39 ]# | 53% reduction | NA | NA | p<0.05 | p<0.05 | NA | FENO >20 ppb, BEC >260 mm−3, high periostin |
| Hanania et al. [ 27 ]# | 25% reduction | NA | NA | p<0.05 | AQLQ +0.29 | NA | NA |
| Vignola et al. [ 40 ]# | 30% reduction | NA | NA | p=0.023 | p<0.001 | NA | NA |
| Adachi et al. [ 29 ]¶ | 44% reduction | 80% reduction | NA | NA | NA | NA | NA |
| Casale et al. [ 34 ]¶ | 39% reduction | NA | NA | ACT +4.4 | NA | ns | NA |
| Cazzola et al. [ 30 ]¶ | 78% reduction | 71% reduction | NA | NA | NA | NA | NA |
| Yorgancıoğlu et al. [ 31 ]¶ | 71% reduction at 5 years | NA | NA | p<0.001 | NA | NA | NA |
| Humbert et al. [ 28 ]¶ | 78.5% had a ≥40% reduction | NA | NA | NA | NA | NA | Not BEC |
| Frix et al. [ 33 ]¶ | 83% reduction at 5 years | p<0.05 | NA | ACQ −0.8 after 5 years | AQLQ +1.5 after 5 years | FEV1 +6% at 1 year | NA |
| Brusselle et al. [32]¶ | 65% reduction at week 52 | ns | NA | NA | 84% had AQLQ increase >0.5 | NA | NA |
| Mepolizumab | |||||||
| Pavord et al. [ 44 ] (DREAM)# | 48% reduction (75 mg i.v.) | NA | NA | ACQ −0.16 (ns) | AQLQ +0.08 (ns) | FEV1 +61 mL | Baseline BEC and history of exacerbations |
| Ortega et al. [ 45 ] (MENSA)# | 53% reduction (100 mg s.c.) | NA | NA | ACQ −0.44 | SGRQ −7 | FEV1 +98 mL(p=0.03) | NA |
| Chupp et al. [ 46 ] (MUSCA)# | 58% reduction | NA | NA | NA | SGRQ −7.7 | NA | NA |
| Bel et al. [ 49 ] (SIRIUS)# | 32% reduction | 50% reduction | OR 1.67 (p=0.41) | ACQ −0.52 | SGRQ −5.8 at week 24 (p=0.02) | pre-BD FEV1 +114 mL (ns) | NA |
| Harrison et al. [ 48 ] (REALITI-A)¶ | 69% reduction at 5 years | 52% reduction at week 49 | 34% reduction | NA | NA | NA | NA |
| Schleich et al. [ 47 ]¶ | 85% reduction | 75% at 30 months | NA | ACQ −1.13 | AQLQ +1.24 | FEV1 +190 mL | NA |
| Reslizumab | |||||||
| Bjermer et al. [ 53 ]# | NA | NA | NA | ACQ −0.36 (p=0.03) | AQLQ +0.36 (p=0.02) | FEV1 +160 mL | NA |
| Castro et al. [ 51 ]# | 67% reduction (ns) | NA | NA | ACQ −0.38 (ns) | NA | FEV1 +240 mL (p=0.002) | Nasal polyposis – improvement in ACQ |
| Corren et al. [ 52 ]# | NA | NA | NA | ACQ-7 −0.195 (p<0.05) | NA | FEV1 +68 mL | NA |
| Benralizumab | |||||||
| Bleecker et al. [ 54 ] (SIROCCO)# | 51% reduction | NA | NA | ACQ −0.25 | NA | FEV1 +159 mL | NA |
| FitzGerald et al. [ 57 ] (CALIMA)# | 28% reduction | NA | NA | ACQ-6 –0.25 | AQLQ +0.24 | pre-BD FEV1 +116 mL | BEC >300 mm−3 |
| Nair et al. [ 56 ] (ZONDA)# | 70% reduction | 75% reduction | 52% reduction | ns at week 28 | ns at week 28 | ns at week 28 | NA |
| Harrison et al. [ 55 ] (ANDHI)# | 49% reduction | NA | NA | ACQ-6 –0.36 | SGRQ −8.11 | FEV1 +160 mL | NA |
| Kavanagh et al. [ 58 ]¶ | 72.8% reduction | Median reduction of 100% | 51.4% | ACQ-6 −0.75 | AQLQ +0.89 | post-BD FEV1 +140 mL | Higher BEC, adult-onset, nasal polyposis |
| Dupilumab | |||||||
| Castro et al. [ 60 ]# | 48% reduction | NA | NA | ACQ-5 −0.22 (week 52) | AQLQ +0.26 (week 52) | FEV1 +140 mL | BEC >300, FENO >25 ppb: better improvement in lung function and exacerbations |
| Rabe et al. [ 62 ]# | 59% reduction | 28% reduction | 52% versus 29% in placebo group | ACQ-5 −0.47 | NA | FEV1 +220 mL | BEC >300, higher FENO |
| Corren et al. [ 61 ]# | 45% reduction | NA | NA | ACQ-5 −0.26 (allergic asthma) and ns in nonallergic asthma | NA | FEV1 +130 mL | Elevated type 2 biomarkers |
| Sher et al. [ 63 ]# | 66% reduction | 41–89% | 0.41 | ACQ-5 −1.06–−1.25 | NA | FEV1 +250–360 mL | |
| Dupin et al. [66]¶ | 75% reduction | Reduction from 20 mg to 5 mg prednisolone | NA | ACT +7 | NA | FEV1 +10% | NA |
| Tezepelumab | |||||||
| Corren et al. [ 69 ]# | 66–78% reduction | NA | NA | NA | NA | FEV1 +150 mL | Irrespective of allergic status |
| Menzies-Gow et al. [ 68 ]# | 66% reduction | NA | NA | ACQ-6 −0.33 | AQLQ +0.34 | FEV1 +130 mL | High blood eosinophils, high FENO |
| Corren et al. [ 71 ]# | NA | NA | NA | Significant improvement in ACQ-6 (OR 1.94) | Significant improvement in AQLQ (OR 1.96) | NA | NA |
| Corren et al. [ 70 ]# | 62–71% reduction | NA | NA | ACQ-6 −0.29 | AQLQ +0.20 ns | FEV1 +120–150 mL | Irrespective of blood eosinophils |
ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality Of Life Questionnaire; BD: bronchodilator; BEC: blood eosinophil count; BMI: body mass index; FENO: exhaled nitric oxide fraction; FEV1: forced expiratory volume in 1 s; NA: not available; ns: nonsignificant; SGRQ: St George's Respiratory Questionnaire. #: Randomised controlled trial. ¶: Real-word evidence study.