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. 2017 Sep 21;2017(9):CD010834. doi: 10.1002/14651858.CD010834.pub3

Summary of findings 3.

Reslizumab intravenous (IV) compared to placebo for asthma

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)