Francis Thien, MD
In adults and children with moderate-to-severe, persistent, allergic asthma, is subcutaneous omalizumab safe and efficacious when added to corticosteroid therapy?
Included studies compared subcutaneous omalizumab with placebo as add-on therapy to corticosteroids in children and adults with allergic asthma. Primary outcomes were reduction in corticosteroid use and asthma exacerbations; secondary outcomes included adverse events.
MEDLINE, EMBASE/Excerpta Medica (to April 2010), Cochrane Controlled Trials Register (first quarter 2010), and Novartis and US Food and Drug Administration databases were searched for randomized, parallel, placebo-controlled trials. 8 trials (n = 3429) met the inclusion criteria. 6 trials included adolescents and adults only (> 12 y), and 2 also included children (≤ 12 y). All trials were sponsored by the pharmaceutical industry. Omalizumab, 0.016 mg/kg/IU/mL every 2 to 4 weeks, was given as add-on therapy to oral or inhaled corticosteroids for 12 to 28 weeks (stable-steroid phase); in 5 trials, this was followed by an 8- to 28-week steroid-reduction phase. 2 trials met ≥ 4 of 5 quality criteria (risk for bias).
Meta-analysis showed that patients allocated to omalizumab had lower rates of asthma exacerbations, including hospitalizations for asthma exacerbations, during both the stable-steroid and steroid-reduction phases (Table). Meta-analyses of trials that included a steroid-reduction phase showed that patients allocated to omalizumab were more likely to completely withdraw from corticosteroid therapy or to reduce the dose by > 50% (Table). The omalizumab and placebo groups did not differ for patients reporting serious adverse events (3.8% vs 5.3%, P = 0.14); however, the omalizumab group had higher rates of suspected treatment-related adverse events (5.0% vs 3.2%, P = 0.03), mainly injection-site reactions (20% vs 13%, P = 0.002)
In adults and children with moderate-to-severe, persistent, allergic asthma, subcutaneous omalizumab added to corticosteroid therapy reduces exacerbations; patients allocated to omalizumab are more likely to completely withdraw from corticosteroid therapy.
Omalizumab (omal) vs placebo (plac) as add-on therapy to corticosteroids in adults and children with persistent, allergic asthma*
*RRR, RBI, NNT, and CI defined in Glossary. All results based on a random-effects model.
†Stable-steroid phase lasted 12 to 28 wk; in 5 trials, a subsequent steroid-reduction phase lasted 8 to 28 wk.
‡Information provided by author.
Thien F. Review: Omalizumab added to corticosteroids reduces exacerbations and corticosteroid use in adults and children with asthma. Ann Intern Med. 2011;154:JC5–11. doi: 10.7326/0003-4819-154-10-201105170-02011
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Published: Ann Intern Med. 2011;154(10):JC5-11.
Asthma, Pulmonary/Critical Care.
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