CLINICAL TRIAL RESULTS
XOLAIR clinical study
XOLAIR helped significantly reduce allergic reactions, including anaphylaxis, in individuals with one or more food allergies.
How the study was done:
Allergens included:
Clinical study results:
After 16 to 20 weeks of treatment with XOLAIR or placebo, people were able to consume at least:
Percentage of people
Primary goals:
XOLAIR protected 68% of patients vs 5% of patients treated with placebo from moderate to severe allergic symptoms.
This means they did not have moderate to severe allergic symptoms; no more than mild skin, respiratory, or gastrointestinal symptoms.
After taking XOLAIR for 16 to 20 weeks, 17% of people were still not able to eat more than half of a peanut (100 mg) without moderate to severe allergic symptoms.*
Data is from a double-blind, placebo-controlled food challenge. This means that both participants and researchers were unaware which participants received XOLAIR or the placebo. The maximum amount of peanut tolerated at the start of the study was 100 mg. By the end of 16 to 20 weeks, more people taking XOLAIR could tolerate 600 mg of peanut compared with people taking the placebo.
*This means they did not have moderate to severe allergic symptoms; no more than mild skin, respiratory, or gastrointestinal symptoms occurred.
Secondary goals:
18%, 22%, and 41% of people were not able to consume more than 2 teaspoons of 1% milk (300 mg), 1/12th of an egg (300 mg), or 1 cashew (300 mg), respectively, without moderate to severe allergic symptoms.*
*This means they did not have moderate to severe allergic symptoms; no more than mild skin, respiratory, or gastrointestinal symptoms occurred.
Results of additional secondary goals:
These additional endpoints were measured in a post hoc analysis. A post hoc analysis is a review of clinical trial data that was not planned before data collection was started and it is not designed to prove cause and effect. Therefore, conclusions should not be drawn based on this information.
Each person in the study was tested with peanuts plus 2 more allergens, including cashews, walnuts, hazelnuts, milk, eggs, or wheat.
Percentage of people who could consume at least:
Open-label extension study:
Of the children taking XOLAIR, 38 continued their treatment for an additional 24 to 28 weeks. The improvements seen at 16 to 20 weeks for all foods studied were maintained at 28 weeks.*
*Data is from an uncontrolled open-label study and does not establish efficacy.
Patient Characteristics
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About the clinical study
To learn how XOLAIR might help people with food allergy, medical teams conducted research. People who visited their doctor for food allergy took part—this is known as a clinical study. Researchers wanted to know if XOLAIR could increase:
- The amount of food that could be consumed
- The number of foods that could be consumed
All people are unique, and each person’s food allergy is different. The study looked at people with a peanut allergy plus 2 more food allergies.
What is a placebo?
People were split into 2 groups. One group of people received XOLAIR and the other group received a placebo. A placebo is a look-alike treatment with no active medicine. Because XOLAIR is an injection, the placebo treatment was also an injection. This way, neither the patients nor the researchers knew what each person received.
You’ve got a whole support network on your side
From diagnosis to treatment, everyone’s food allergy experience is unique. The Support For You program is designed with YOU in mind. Access free 1-on-1 sessions and learn about programs that may help you save on XOLAIR.