Summary of findings 5. Benralizumab 30 mg compared with placebo for chronic obstructive pulmonary disease.
| Benralizumab 30 mg compared with placebo for chronic obstructive pulmonary disease | ||||||
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Patient or population: individuals with COPD Settings: outpatient Intervention: benralizumab 30 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 30 mg | |||||
| Rate of moderate or severe exacerbations Eosinophils ≥ 220/μL | 1.20 moderate or severe exacerbations per year | 1.20 (1.07 to 1.37) moderate or severe exacerbations per year | Rate ratio 1.00 (0.89 to 1.13) | 1523 (2 RCTs) | ⊕⊕⊕⊖ Moderatea |
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| Rate of moderate or severe exacerbations Eosinophils < 220/μL | 1.24 moderate or severe exacerbations per year | 1.33 (1.13 to 1.57) moderate or severe exacerbations per year | Rate ratio 1.07 (0.91 to 1.27) | 711 (2 RCTs) | ⊕⊕⊕⊖ Moderatea |
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| Rate of severe exacerbations requiring hospitalisation Eosinophils ≥ 220/μL |
0.29 severe exacerbations requiring hospitalisation per year | 0.28 (0.22 to 0.35) severe exacerbations requiring hospitalisation per year | Rate ratio 0.96 (0.75 to 1.22) | 1523 (2 RCTs) | ⊕⊕⊕⊖ Moderatea |
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| Serious adverse events | 334 serious adverse events out of 1118 participants | 328 serious adverse events out of 1117 participants | Odds ratio 0.98 (0.81 to 1.17) | 2235 (2 RCTs) | ⊕⊕⊕⊖ 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 −1.42 lower (−3.13 to 0.29). | ‐ | 1333 (2 RCTs) | ⊕⊕⊕⊖ Moderatea |
A change of ≥ 4 is considered the minimum clinically significant difference. |
| Lung function (FEV₁) Eosinophils ≥ 220/μL |
‐ | There was no MD −0.00 (−0.03 to 0.03). | ‐ | 1312 (2 RCTs) | ⊕⊕⊕⊖ 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 due to imprecision. The confidence intervals include the possibility of a small or no effect and important benefit or harm.