Meta-Analysis Supports Omalizumab Therapy for Asthma

Omalizumab therapy reduces exacerbations in severe allergic asthma patients.

A 2016 meta-analysis of data from "real-life" studies of omalizumab add-on therapy with inhaled corticosteroid (ICS) treatment for patients with severe allergic asthma confirmed positive results from clinical trials.

Using data from 25 "real-life" clinical studies of omalizumab as an add-on therapy for patients with severe allergic asthma, Alohossan Abdulaziz, PharmD, with colleagues from the University of Arizona, Tucson, and the Oregon Health and Science University in Portland, Oregon, found that "real-life" results of Omalizumab "mirror, complement, and extend the efficacy data from randomized controlled trials”.

Abdulaziz said that omalizumab therapy has also been linked to "improvements across the full spectrum of objective and subjective indicators" for asthma improvement in 25 isolated real-life studies of patients. The study sought to compile and assess that data to determine the effects of omalizumab treatment response in "real-life" populations.

Omalizumab, a "recombinant monoclonal anti-IgE antibody that inhibits IgE binding sites" reducing inflammation in asthma patients, is increasingly used as an add-on therapy to ICS. It’s specifically been shown in clinical trials to improve asthma symptoms and quality of life while reducing exacerbations in patients with severe allergic asthma.

The study drew data from 25 "real life" effectiveness studies on omalizumab add-on use published between 2008 and 2015. The international studies included 9213 patients from 32 countries. Abdulaziz reported that although the 25 studies differed in outcomes measured, the raw data produced on treatment effectiveness (via Global Evaluation of Treatment Effectiveness scale), quality of life (via Asthma-related Quality-of-Life Questionnaire), asthma control (via standard Asthma Control Test and FEV1 [Forced Air Volume] testing), corticosteroid use levels, exacerbations, and hospitalizations could be successfully extracted to produce data on mean improvements in asthma control and quality of life.

The meta-analysis study covered outcomes for omalizumab patients under non-controlled, heterogeneous populations, and determined that, in line with results from clinical trials, omalizumab therapy was an effective treatment for 77.2% of patients with severe allergic asthma.

Data showed significant improvements in FEV1 levels, quality of life, and asthma control in response to omalizumab therapy. Data also revealed a significant decrease in oral and inhaled corticosteroid requirements and asthma exacerbations in patients, and a small but significant reduction in asthma-related hospitalizations among patients.

The study also determined positive improvements varied across treatment length. Patients who received 4-6 months of treatment benefited from omalizumab, but an even larger improvement was seen in patients with 12 months of treatment. Abdulaziz and colleagues reported that outcome data available for patients at 24 months were "similar in size to those observed at 12 months, suggesting stabilization in asthma status”.

Overall, the study concluded that omalizumab was positively associated with "significant improvements in subjective and objective outcomes" among heterogeneous patients in real-life clinical settings worldwide, "without the controls and constraints inherent to randomized controlled trials." According to Abdulaziz and colleagues, the study also confirmed the effectiveness of omalizumab therapy for adult patients with severe allergic asthma.

The article “Real-life” Effectiveness Studies of Omalizumab in Adult Patients with Severe Allergic Asthma: Meta-analysis" appeared online in March 2017 for The American Academy of Allergy, Asthma & Immunology and will printed in the May 2017 issue.

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