Summary of findings 3.
Reslizumab (IV) compared to placebo for asthma | ||||||
Patient or population: people with asthma Setting: community Intervention: reslizumab (IV) Comparison: placebo | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with placebo | Risk with reslizumab (IV) | |||||
Rate of exacerbations requiring systemic corticosteroids Follow‐up: 52 weeks | The mean rate in the placebo group was 1.54 events per participant per year | The mean rate in the intervention groups was 0.93 fewer events per participant per year (1.09 fewer to 0.73 fewer) | Rate ratio 0.43 (0.33 to 0.55) | 953 (2 RCTs) | ⊕⊕⊕⊕ High | |
Rate of exacerbations requiring emergency department treatment or admission Follow‐up: 52 weeks | The mean rate in the placebo group was 0.12 events per participant per year | The mean rate in the intervention groups was 0.04 fewer events per participant per year (0.07 fewer to 0.02 more) | Rate ratio 0.67 (0.39 to 1.17) | 953 (2 RCTs) | ⊕⊕⊕⊕ High | |
Health‐related quality of life (AQLQ) Scale from: 1 to 7 (higher is better) Follow ‐p: range 16 weeks to 52 weeks | The mean change in the placebo group ranged from 0.779 to 0.89 units | MD 0.28 higher (0.17 higher to 0.39 higher)a | ‐ | 1164 (3 RCTs) | ⊕⊕⊕⊕ High | A change of ≥ 0.5 is considered the minimum clinically significant difference |
Health‐related quality of life (ACQ) Scale from: 0 to 6 (lower is better) Follow‐up: range 16 weeks to 52 weeks | The mean change in the placebo group ranged from −0.368 to −0.80 units | MD ‐0.25 lower (‐0.33 lower to ‐0.17 lower)b | ‐ | 1652 (4 RCTs) | ⊕⊕⊕⊕ High | A change of ≥ 0.5 is considered the minimum clinically significant difference |
Pre‐bronchodilator FEV1 (L) Follow‐up: range 16 weeks to 52 weeks | The mean change in the placebo group ranged from 0.002 L (± 0.1216 L) to 0.215 (± 0.0484 L) | MD 0.11 L higher (0.07 L higher to 0.15 L higher) | ‐ | 1652 (4 RCTs) | ⊕⊕⊕⊕ High | |
Serious adverse events Follow‐up: range 16 weeks to 52 weeks | 91 per 1000 | 72 per 1000 (51 to 102) | RR 0.79 (0.56 to 1.12) | 1656 (4 RCTs) | ⊕⊕⊕⊕ High | |
Adverse events leading to discontinuation Follow‐up: range 16 weeks to 52 weeks | 58 per 1000 | 38 per 1000 (25 to 59) | RR 0.66 (0.43 to 1.02) | 1659 (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; MD: mean difference; IV: intravenous; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
a The mean difference (0.28) is smaller than the minimum clinically significant difference (a reduction of 0.5 points). b The mean difference (‐0.25) is smaller than the minimum clinically significant difference (a reduction of 0.5 points)