Efficacy and Safety of Anti-Interleukin-5 Therapy in Patients with Asthma: A Systematic Review and Meta-Analysis

<div><p>Background</p><p>Recent trials have assessed the efficacy and safety of novel monoclonal antibodies such as reslizumab and benralizumab. However, the overall efficacy and safety anti—interleukin (IL) 5 treatment in asthma have not been thoroughly assessed.</p><p>Methods</p><p>Randomized controlled trials (RCTs) of anti-IL-5 treatment on patients with asthma published up to October 2016 in PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) that reported pulmonary function, quality of life scores, asthmatic exacerbation rate, blood and sputum eosinophil counts, short-acting β-agonist (SABA) rescue use, and adverse events were included. The pooled mean difference, and relative risks (RR), and 95% confidence intervals (CIs) were calculated using random-effects models.</p><p>Results</p><p>Twenty studies involving 7100 patients were identified. Pooled analysis revealed significant improvements in FEV₁ (first second forced expiratory volume) (MD = 0.09, 95% CI: 0.06–0.12, <i>I</i>^<i>2</i> = 10%), FEV₁% (MD = 3.75, 95% CI: 1.66–5.83, <i>I</i>^<i>2</i> = 19%), Asthma Quality of Life Questionnaire (AQLQ) score (MD = 0.22, 95% CI: 0.15–0.30, <i>I</i>^<i>2</i> = 0%), decreased blood, sputum eosinophils and asthmatic exacerbation (RR = 0.66, 95% CI: 0.59–0.73, <i>I</i>^<i>2</i> = 51%); peak expiratory flow (PEF) (MD = 5.45, 95% CI: -2.83–13.72, <i>I</i>^<i>2</i> = 0%), histamine PC₂₀ (MD = -0.62, 95% CI: -1.92–0.68, <i>I</i>^<i>2</i> = 0%) or SABA rescue use (MD = -0.11, 95% CI: -0.3–0.07, <i>I</i>^<i>2</i> = 30%) were unaffected; adverse events were not increased (RR = 0.93, 95% CI: 0.89–0.98, <i>I</i>^<i>2</i> = 46%). No publication bias was observed (Egger's <i>P</i> = 0.78).</p><p>Conclusions</p><p>Anti-interleukin 5 monoclonal therapies for asthma could be safe for slightly improving FEV₁ (or FEV₁% of predicted value), quality of life, and reducing exacerbations risk and blood and sputum eosinophils, but have no significant effect on PEF, histamine PC20, and SABA rescue use. Further trials required to establish to clarify the optimal antibody for different patients.</p></div

Characteristic of randomized controlled trials included.

<p>Characteristic of randomized controlled trials included.</p

Baseline Characteristics of Patients in the 20 Studies Included.

<p>Baseline Characteristics of Patients in the 20 Studies Included.</p

The effects of anti–interleukin-5 on PEF (L/min).

<p>The effects of anti–interleukin-5 on PEF (L/min).</p

The effect of anti-interleukin 5 versus placebo on FEV₁.

<p>CI = confidence interval; FEV₁ = forced expiratory volume in 1 second; SD = standard derivation; IV = Inverse Variance.</p

Begg’s funnel plot evaluated the effect of anti-interleukin-5 on FEV₁.

<p>Begg’s funnel plot evaluated the effect of anti-interleukin-5 on FEV₁.</p

The effects of anti–interleukin-5 on histamine PC₂₀ (mg/ml).

<p>The effects of anti–interleukin-5 on histamine PC₂₀ (mg/ml).</p

Risk of bias summary.

<p>Risk of bias summary.</p

The effect of anti-interleukin 5 versus placebo on FEV₁% of predicted value.

<p>The effect of anti-interleukin 5 versus placebo on FEV₁% of predicted value.</p

The effects of anti-interleukin-5 on SABA rescue use.

<p>The effects of anti-interleukin-5 on SABA rescue use.</p