Summary of findings 4. Benralizumab 10 mg compared with placebo for chronic obstructive pulmonary disease.
| Benralizumab 10 mg compared with placebo for chronic obstructive pulmonary disease | ||||||
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Patient or population: individuals with COPD Settings: outpatient Intervention: benralizumab 10 mg Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Benralizumab 10 mg | |||||
| Rate of moderate or severe exacerbations Eosinophils ≥ 220/μL | 1.17 moderate or severe exacerbations per year | 0.99 (0.83 to 1.19) moderate or severe exacerbations per year | Rate ratio 0.85 (0.71 to 1.02) | 765 (1 RCT) | ⊕⊕⊕⊖ Moderatea |
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| Rate of moderate or severe exacerbations Eosinophils < 220/μL | 1.18 moderate or severe exacerbations per year | 1.23 (0.97 to 1.56) moderate or severe exacerbations per year | Rate ratio 1.04 (0.82 to 1.32) | 365 (1 RCT) | ⊕⊕⊕⊖ Moderatea |
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| Rate of severe exacerbations requiring hospitalisation Eosinophils ≥ 220/μL |
0.32 severe exacerbations requiring hospitalisation per year | 0.22 (0.16 to 0.30) severe exacerbations requiring hospitalisation per year | Rate ratio 0.68 (0.49 to 0.94) | 765 (1 RCT) | ⊕⊕⊕⊖ Moderatea |
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| Serious adverse events | 158 serious adverse events out of 568 participants | 144 serious adverse events out of 561 participants | Odds ratio 0.90 (0.69 to 1.17) | 1129 (1 RCT) | ⊕⊕⊕⊖ Moderatea |
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| Heath‐related quality of life, change in SGRQ total score Scale: 0 to 100 (lower is better) Eosinophils ≥ 220/μL |
‐ | The MD was −0.87 lower (−3.23 to 1.49). | ‐ | 680 (1 RCT) | ⊕⊕⊕⊖ Moderatea |
A change of ≥ 4 is considered the minimum clinically significant difference. |
| Lung function (FEV₁) Eosinophils ≥ 220/μL |
‐ | The MD was 0.01 higher (−0.04 to 0.05). | ‐ | 669 (1 RCT) | ⊕⊕⊕⊖ Moderatea |
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| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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). CI: confidence interval; COPD: chronic obstructive pulmonary disease; FEV₁: forced expiratory volume in 1 second; MD: mean difference; RCT: randomised controlled trial; SGRQ: St George's Respiratory Questionnaire | ||||||
| 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. | ||||||
aDowngraded once as this is a single study. The true effect is likely to be close to the estimate of the effect, but further studies could be substantially different.