Abstract
BackgroundOmalizumab is approved for treating severe allergic asthma from age 6, but the definition of severe asthma including a systematic assessment to rule out difficult-to-treat asthma has changed since the drug was approved in 2003.MethodsWe conducted a systematic review and meta-analysis of two critical (exacerbation rate, oral corticosteroid (OCS) treatment) and eight important clinical outcomes in children, adolescents and adults, and specifically searched papers for systematic assessment of severe asthma.ResultsAdults: seven studies (n = 2159) ascertaining exacerbation rate showing a 37% (95% CI 21–50) reduction in favor of omalizumab, larger than the pre-specified minimal clinically important difference (MCID) of 25%. Only one open-label study (n = 82) was identified assessing the percentage of patients experiencing reduction of OCS-maintenance treatment showing a significantly greater decrease in the omalizumab group (− 45% vs. + 18.3%, p = 0.002). Children and adolescents: four studies (n = 1551) reported data on exacerbations (no meta-analysis conducted), showed overall improvements in exacerbation rate and some passed MCID. No OCS studies were identified. No included studies provided systematic assessment of severe asthma according to current guidelines.ConclusionsOmalizumab provides clinically relevant improvements in exacerbation rate among children, adolescents, and adults and in OCS-reduction among adults. New studies incorporating a guideline-approached definition of severe asthma are warranted.
Highlights
Omalizumab is approved for treating severe allergic asthma from age 6, but the definition of severe asthma including a systematic assessment to rule out difficult-to-treat asthma has changed since the drug was approved in 2003
After removal of duplicates, screening and assessment for eligibility a total of 28 papers were included for further analysis
We found a statistically significant lower risk of serious adverse events (SAEs) in the omalizumab group compared to placebo: rate ratios (RR) 0.40, which was above the predefined minimal clinically important difference (MCID) (Additional file 1: Figure S3b)
Summary
Omalizumab is approved for treating severe allergic asthma from age 6, but the definition of severe asthma including a systematic assessment to rule out difficult-to-treat asthma has changed since the drug was approved in 2003. After systematic assessment to optimize asthma care [4, 5], including assessment of triggers, comorbidities and obstacles to asthma control, approximately 5–15% of the asthmatics remain to have severe asthma [6], which is associated with an increased morbidity and mortality and possess a significant socioeconomic burden [7]. A previous Cochrane review from 2014 pooled paediatric and adult data and found favourable effects of omalizumab on the risk of exacerbations and reduction of ICS in severe allergic asthmatics [9]. No previous review has included preomalizumab workup as part of the assessment of level of evidence
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