A landmark clinical trial has discovered that omalizumab, marketed as Xolair, provides more effective treatment for multiple food allergies than the current standard approach of oral immunotherapy (OIT). This finding represents a significant advancement for individuals who experience allergic reactions to very small amounts of common food allergens, offering new hope for those who struggle with severe dietary restrictions.
The challenge of multiple food allergies
Millions of Americans live with food allergies, but those with multiple severe allergies face particularly difficult challenges. These individuals must constantly guard against accidental exposure to several different foods, a situation that creates significant restrictions in daily life.
Before this study, oral immunotherapy represented the primary treatment option for reducing allergic responses. This approach involves consuming gradually increasing doses of food allergens to build tolerance. However, OIT can cause significant side effects, including allergic reactions during the treatment process itself.
The current research specifically focused on individuals with extreme sensitivity to multiple foods. All participants experienced allergic reactions to less than half a peanut and similarly tiny amounts of at least two other common allergens from a group including milk, egg, cashew, wheat, hazelnut and walnut.
How the medications work differently
The two treatment approaches employ fundamentally different mechanisms to address food allergies:
- Oral immunotherapy works by gradually exposing the immune system to increasing amounts of allergens, essentially training the body to become less reactive through repeated exposure.
- Omalizumab functions by binding to immunoglobulin E (IgE), the antibody responsible for triggering allergic reactions. By neutralizing this antibody in the bloodstream, omalizumab prevents it from activating immune cells that would normally respond to allergens.
The medication’s ability to block allergic responses regardless of the specific food trigger makes it particularly valuable for those with multiple allergies. Rather than requiring separate desensitization for each food, omalizumab potentially provides protection against numerous allergens simultaneously.
The study’s comprehensive approach
The National Institute of Allergy and Infectious Diseases (NIAID) conducted this trial, named Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults (OUtMATCH), at ten locations across the United States.
Researchers enrolled 177 children and adolescents ages 1 to 17 years and three adults ages 18 to 55 years, all with confirmed severe allergies to peanuts and at least two other common foods. This comprehensive approach allowed for thorough evaluation of both treatments across different age groups and allergy combinations.
The study design included a carefully structured comparison between the two treatment approaches:
- All participants initially received omalizumab injections for eight weeks.
- Participants were then randomly divided into two groups: Group A received omalizumab plus multi-allergen OIT for eight weeks, followed by placebo injections with multi-allergen OIT for 44 weeks.
- Group B received omalizumab injections with placebo OIT for the entire 52-week period.
This design allowed researchers to directly compare the effectiveness and tolerability of extended omalizumab treatment versus a hybrid approach using omalizumab as a pretreatment for oral immunotherapy.
Striking differences in treatment outcomes
The research revealed dramatic differences between the treatment groups, particularly regarding side effects and treatment completion rates. In Group A, which received oral immunotherapy, 29 of 59 participants discontinued treatment. Fifteen stopped due to allergic reactions or intolerable symptoms, while fourteen withdrew for other reasons including food aversion or the burden of participation.
In stark contrast, no participants in Group B experienced allergic reactions or side effects from omalizumab severe enough to cause treatment discontinuation. Seven participants in this group left the study, primarily due to the burden of participation rather than medication-related issues.
Overall, 51 percent of Group A completed treatment, compared to 88 percent of Group B. This substantial difference in treatment adherence significantly influenced the final results.
After the treatment period, researchers tested how much of each food allergen participants could consume without reaction. Thirty-six percent of participants who received extended omalizumab could tolerate 2 grams or more of peanut protein (approximately eight peanuts) and two other food allergens. Only 19 percent of participants who received the combination therapy achieved the same level of tolerance.
However, when analyzing only those participants who completed their assigned therapy, both groups showed similar rates of success. This finding suggests that for those who can tolerate oral immunotherapy, it remains an effective option for building food tolerance.
Implications for future treatment approaches
This research provides crucial information for patients and healthcare providers considering treatment options for severe multiple food allergies. The findings indicate that omalizumab is a good alternative treatment because most people tolerate it well, while oral immunotherapy remains an effective option if treatment-related adverse effects are not an issue.
The findings build upon earlier research demonstrating that a 16-week course of omalizumab increased the amount of various allergens that multi-food allergic children as young as 1 year could consume without reaction. This new study extends those findings by directly comparing omalizumab with the current standard treatment approach.
For individuals and families affected by severe food allergies, these results offer new hope for treatment options that may reduce the constant vigilance required to avoid allergic reactions. The research suggests that healthcare providers now have multiple effective approaches to consider, allowing for more personalized treatment plans based on individual needs and tolerance profiles.
