Study Suggests Biologics Safe to Recommend for Treatment of IgE-Mediated Food Allergy

A recent systematic review and meta-analysis published in the World Allergy Organization Journal highlights the increasing role of biologics, particularly omalizumab — known under the brand name Xolair — in managing IgE-mediated food allergy. While oral immunotherapy (OIT) has been a traditional approach for desensitization, its limitations, such as lack of standardization and adverse effects, have opened doors for alternative treatments. Biologics offer a broader applicability by targeting the underlying immunological pathways responsible for allergic reactions, with omalizumab being the most extensively studied in this domain.

The research team, led by Ulugbek Nurmatov, MD, PhD, highlighted that biologics, whether used alone or together with OIT, represent a cutting-edge approach for food allergy management. However, they also recognized that more research is needed to fully understand the best way to use these therapies. Important factors such as the ideal timing, treatment duration, effective combination strategies, and the cost-effectiveness of biologics in food allergy treatment still need thorough investigation.

To conduct their systematic review, investigators rigorously searched several medical databases, including Cochrane Library, EMBASE, and ISI Web of Science. They specifically looked for randomized controlled trials (RCTs) that examined biologics as a monotherapy or combined with OIT. The inclusion criteria ensured that studies involved patients of all ages with confirmed IgE-mediated food allergy, had appropriate control groups, and reported on primary outcomes such as desensitization and adverse reactions, as well as secondary immunological and quality of life outcomes.

From an initial pool of 7791 papers, the researchers meticulously filtered down to 13 RCTs and 2 US National Clinical Trials (NCTs) that met their strict inclusion criteria. These studies collectively included 1010 patients ranging from 1 to 60 years old. A significant portion of the included RCTs (9 out of 13) were assessed as having a low risk of bias, bolstering the reliability of the findings.

The meta-analysis, which combined data from 10 of the included RCTs, demonstrated a clear benefit of omalizumab. It showed an increased likelihood of patients tolerating 2 grams of protein from common allergens like peanuts and cow’s milk when treated with omalizumab, either alone or with OIT, compared to control groups. Furthermore, omalizumab significantly increased food tolerance thresholds and notably reduced the risk of allergic reactions without increasing other adverse or severe reactions, including skin-related issues. The study also observed a decrease in hypersensitivity and a reduction in allergic and inflammatory responses.

Despite these promising findings, the investigators acknowledged certain limitations, including the heterogeneity of patient populations, interventions, and outcomes across the studies. They stressed the need for more research, particularly studies with long-term follow-up, to firmly establish the long-term effectiveness, tolerability, and safety of biologics. They also called for standardized definitions and reporting of adverse events and allergic reactions to facilitate more comprehensive analyses and comparisons, along with further research into the cost-effectiveness and quality of life impacts to guide patient-centered care.