Omalizumab may help in severe allergic asthma

January 01, 0001

Omalizumab may help in severe allergic asthma

Inhaled corticosteroids (ICS) and long-acting â2-agonists (LABAs) are recommended in patients with asthma that is not well-controlled; however, many patients continue to have inadequately controlled asthma despite this therapy. The aim of this prospective, multicenter, randomized, parallel- group, double-blind, placebo-controlled trial by researchers from the US was to evaluate the efficacy and safety of omalizumab in patients with inadequately controlled severe asthma who are receiving high-dose ICS and LABAs, with or without additional controller therapy, across 193 investigational sites in the United States and 4 sites in Canada, involving 850 patients aged 12 to 75 years. Omalizumab (n = 427) or placebo (n = 423) was added to existing medication regimens for 48 weeks.

During 48 weeks, the rate of protocol-defined asthma exacerbations was significantly reduced for omalizumab compared with placebo (0.66 vs. 0.88 per patient), representing a 25% relative reduction. Omalizumab improved mean Asthma Quality of Life Questionnaire scores(0.29 point), reduced mean daily albuterol puffs (-0.27 puff/d), and decreased mean asthma symptom score (-0.26) compared with placebo during the 48- week study period. The incidence of adverse events (80.4% vs. 79.5%) and serious adverse events (9.3% vs. 10.5%) were similar in the omalizumab and placebo groups, respectively.

The researchers concluded: "In this study, omalizumab provided additional clinical benefit for patients with severe allergic asthma that is inadequately controlled with high- dose ICS and LABA therapy."

Not widely available and expensive, but there you are.

For the full abstract, click here.

Annals of Internal Medicine 154(9):573-582, 2 May 2011 © 2011 by the American College of Physicians
Omalizumab in Severe Allergic Asthma Inadequately Controlled With Standard Therapy: A Randomized Trial. Nicola A. Hanania, Oral Alpan, Daniel L. Hamilos et al.

Category: R. Respiratory. Keywords: omalizumab, severe, allergic asthma, inadequate control, standard therapy, randomized trial, journal watch.
Synopsis edited by Dr Stephen Wilkinson, Melbourne, Australia. Posted on Global Family Doctor 10 June 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.