Summary of findings 5. Benralizumab subcutaneous (SC) compared to placebo for asthma.
| Benralizumab (SC) compared to placebo for asthma | ||||||
| Patient or population: people with asthma Setting: community Intervention: benralizumab (SC) Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with benralizumab (SC) | |||||
| Rate of clinically significant exacerbations requiring systemic corticosteroids Follow‐up: range 24‐56 weeks | The mean rate in the placebo group was 1.2 events per participant per yeara | The mean rate in the intervention groups was 0.49 fewer events per participant per year (0.58 fewer to 0.41 fewer) | Rate ratio 0.59 (0.52 to 0.66) | 3112 (4 RCTs) |
⊕⊕⊕⊕ High | |
| Rate of exacerbations requiring emergency department treatment or admission Follow‐up: range 48‐56 weeks | The mean rate in the placebo group was 0.11 events per participant per yearb | The mean rate in the intervention groups was 0.04 fewer events per participant per year (0.06 fewer to 0.002 fewer) | Rate ratio 0.68 (0.47 to 0.98) | 1537 (2 RCTs) | ⊕⊕⊕⊝ Moderatec | There is greater heterogeneity (I² = 43%) owing to inclusion of participants with less severe asthma in FitzGerald 2016 (a larger proportion who had only suffered 1 exacerbation the previous year, with correspondingly less potential for exacerbation) |
| Health‐related quality of life (AQLQ) Scale from: 1‐7 (higher is better) Follow‐up: range 48‐56 weeks | The mean change in the placebo group ranged from 0.98 to 1.31 units | MD 0.23 higher (0.11 higher to 0.35 higher)d | ‐ | 1541 (3 RCTs) | ⊕⊕⊕⊕ High | A change of ≥ 0.5 points is considered the MCID |
| Health‐related quality of life (ACQ) Scale from: 0‐6 (lower is better) Follow up: range 24‐56 weeks | The mean change in the placebo group ranged from −1.19 to −0.76 units | MD ‐0.26 lower (‐0.34 lower to ‐0.17 lower)e | ‐ | 2791 (4 RCTs) |
⊕⊕⊕⊕ High | A change of ≥ 0.5 points is considered the MCID |
| Pre‐bronchodilator FEV1 (L) Follow‐up: range 24‐56 weeks | The mean change in the placebo group ranged from ‐0.01 L to 0.239 L | MD 0.11 L higher (0.08 L higher to 0.15 L higher) | ‐ | 2786 (4 RCTs) |
⊕⊕⊕⊕ High | |
| Serious adverse events Follow‐up: range 24‐56 weeks | 130 per 1000 | 109 per 1000 (81 to 121) | Risk ratio 0.76 (0.62 to 0.93) | 3304 (5 RCTs) | ⊕⊕⊕⊕ High | |
| Clinically significant adverse events leading to discontinuation Follow‐up: range 48‐56 weeks | 9 per 1000 | 18 per 1000 (9 to 36 ) | Risk ratio 2.04 (1.03 to 4.03) |
3253 (4 RCTs) | ⊕⊕⊕⊕ High | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ACQ: Asthma Control Questionnaire; AQLQ: Asthma Quality of Life Questionnaire; CI: confidence interval; FEV1: forced expiratory volume in 1 second; IV: intravenous; MCID: minimum clinically significant difference; MD: mean difference | ||||||
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GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
aRounded mean of the rate in the placebo group of the eosinophilic and non‐eosinophilic arms (as applicable) or the three studies: 1.33, 1.21, 0.68, 0.49, 0.93, 1.21. bRounded mean of the rate in the placebo group of the two studies: 0.18 and 0.04. cOne point deducted to reflect the level of heterogeneity on this outcome.