Abstract
ABSTRACTBackground: New, complex, and expensive therapies targeting Interleukin-5 (IL-5) to treat severe eosinophilic asthma are emerging.Objective: To assess efficacy, adverse events, and inter-drug comparison of mepolizumab and reslizumab for treating severe eosinophilic asthma.Design: A systematic review and meta-analysis on randomized, placebo-controlled, clinical trials elucidating two critical (exacerbation rate and oral corticosteroid (OCS) use) and six important clinical outcomes on the efficacy and safety of mepolizumab and reslizumab.Results: Five studies (N = 2197) contributed with data for exacerbation rate, showing a reduction of 53% (95% CI 46; 59) in favour of anti-IL-5, corresponding to –0.94 annual exacerbations (95% CI –1.08;–0.82), thus exceeding the predefined minimal clinical important difference (MCID) of 25% reduction of the estimated ≥2 annual exacerbations. Quality of evidence was considered moderate, with low heterogeneity in study findings (I2 = 0%). One study (N = 135) contributed with data on percentage of patients experiencing ≥50% reduction inoral corticosteroid treatment, showing an effect of 20% (95% CI 2.3;47) in favour of anti-IL-5 treatment (mepolizumab), thus exceeding the predefined MCID of 10%. Quality of evidence was considered low.Compared to placebo, anti-IL-5 showed significant improvements in lung function, asthma control, and asthma-related quality of life, but below the MCIDs. No differences were observed for serious adverse events and number of patients, who dropped out. No studies evaluating sickleave or head-to-head comparisons were identified. By indirect comparison, we found no significant difference between mepolizumab and reslizumab in any ofthe predefined clinical outcomes. OCS treatment reduction could not be compared due to lack of reslizumab studies investigating this outcome.Conclusions: Mepolizumab and reslizumab provide significant and clinically relevant improvements in exacerbation rate and OCS reduction. Indirect, inter-study comparisons revealed no differences between the anti-IL-5 drugs in efficacy or safety measures.
Highlights
New, complex, and expensive therapies targeting Interleukin-5 (IL-5) to treat severe eosinophilic asthma are emerging
Primary literature The systematic literature search identified four randomised controlled trials which examined the efficacy of mepolizumab [22–25], and five trials which examined the efficacy of reslizumab [26– 28]
We found an absolute difference of FEV1 of 112.93 ml in favour of the antiIL-5 treatment compared to placebo (Figure 7), which is below the minimal clinically important difference
Summary
Complex, and expensive therapies targeting Interleukin-5 (IL-5) to treat severe eosinophilic asthma are emerging. Asthma is a common chronic inflammatory airway disorder affecting 300 million people worldwide [1]. The prevalence of severe asthma is estimated. 3–15% of all patients with asthma, depending on the method of identification [4] and is associated with a significant negative impact on quality of life for the affected patients [5], as well as an increased risk of morbidity and mortality [6]. The uncontrolled severe asthma patient is a smaller part of the severe asthma patients, estimated onethird of all severe asthma patients [7]. Asthma has traditionally been categorised as either allergic- or non-allergic. It is increasingly recognised that asthma is a heterogeneous syndrome
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