Omalizumab for asthma in adults and children.

摘要: Background Asthma is a respiratory (airway) condition that affects an estimated 300 million people worldwide and associated with significant morbidity mortality. Omalizumab monoclonal antibody binds inhibits free serum immunoglobulin E (IgE). It called 'anti-IgE' drug. IgE immune mediator involved in clinical manifestations of asthma. A recent update National Institute for Health Care Excellence (NICE) guidance 2013 recommends omalizumab use as add-on therapy adults children over six years age inadequately controlled severe persistent allergic IgE-mediated asthma who require continuous or frequent treatment oral corticosteroids. Objectives To assess the effects versus placebo conventional children. Search methods We searched Cochrane Airways Group Specialised Register trials potentially relevant studies. The most search was performed June 2013. also checked reference lists included online trial registries drug company websites. Selection criteria Randomised examining anti-IgE administered any manner duration. Trials co-interventions were included, long they same each arm. Data collection analysis Two review authors independently assessed study quality extracted entered data. Three modes administration identified from published literature: inhaled, intravenous subcutaneous injection. main focus updated administration, this route currently used practice. Subgroup by severity. unpublished sources. Main results In all, 25 review, including 11 new studies since last update, total 19 considered efficacy adjunct to For participants moderate receiving background inhaled corticosteroid steroid (ICS) therapy, advantage favoured regard experiencing exacerbation (odds ratio (OR) 0.55, 95% confidence interval (CI) 0.42 0.60; ten studies, 3261 participants). This represents absolute reduction 26% suffering on 16% omalizumab, 16 60 weeks. benefit noted reducing hospitalisations (OR 0.16, CI 0.06 0.42; four 1824 participants), representing risk 3% 0.5% 28 No separate data available subgroup, all these reported diagnosis Participants treated significantly more likely be able withdraw their ICS completely than those 2.50, 2.00 3.13), small but statistically daily dose omalizumab-treated compared given (weighted mean difference (WMD) -118 mcg beclomethasone dipropionate (BDP) equivalent per day, -154 -84). However, no between groups seen number (OCS) 1.18, 0.53 2.63). corticosteroids required rescue beta2-agonist medication (mean (MD) -0.39 puffs -0.55 -0.24; nine 3524 observed both (MD -0.58, -0.84 -0.31) -0.30, -0.49 -0.10) subgroups corticosteroids; however, outcome plus Significantly fewer serious adverse events assigned 0.72, 0.57 0.91; 15 5713 injection site reactions (from 5.6% 9.1% omalizumab). reflect current practice, discussion limited use, involving routes have been archived. Authors' conclusions effective exacerbations adjunctive steroids during tapering phases trials. increasing numbers reduce steroids. generally well tolerated, although omalizumab. Further assessment paediatric populations necessary, direct double-dummy comparison ICS. Although subgroup analyses suggest prednisolone had better control when received it remains tested prospectively whether addition has prednisolone-sparing effect. not clear there threshold level baseline optimum Given high cost drug, identification biomarkers predictive response major importance future research.