New England Journal of Medicine publishes Phase III data showing
Xolair significantly reduced allergic reactions across multiple
foods in people with food allergies
- Detailed results from the
NIH-sponsored Phase III OUtMATCH study showed treatment with Xolair
increased the amount of peanuts, tree nuts, egg, milk and wheat
that people as young as 1 year consumed without an allergic
reaction
- The U.S. FDA recently
approved Xolair as the first and only medicine for children and
adults with one or more food allergies
- Allergic reactions can be
life-threatening and it is estimated that food-related anaphylaxis
results in 30,000 medical events treated in emergency rooms in the
U.S. each year1-3
Basel, 25 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today data from Stage 1 of the National Institutes of
Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating
the efficacy and safety of Xolair® (omalizumab) in
patients allergic to peanuts and at least two other common foods
were published in the New England Journal of Medicine (NEJM) and
featured in a late-breaking symposium at the 2024 American Academy
of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The
study showed treatment with Xolair increased the amount of peanuts,
milk, egg, wheat and tree nuts (cashew, hazelnut and walnut) that
it took to cause moderate to severe allergic reactions in
multi-food allergic people as young as 1 year. Safety findings were
consistent with the known safety profile of Xolair across its
approved indications and in previous clinical trials.4
The U.S. Food and Drug Administration (FDA) recently approved the
expanded use of Xolair in children and adults with IgE-mediated
food allergies based on the OUtMATCH data.
“Over the past 35 years, I have seen how debilitating food
allergies can be for patients and their loved ones, as they are
consumed by the fear of accidental exposure,” said Robert Wood,
M.D., director of the Eudowood Division of Allergy, Immunology and
Rheumatology at Johns Hopkins Children's Center, and principal
investigator of the OUtMATCH study. “While allergic reactions to
exposures are common and often severe, there have been limited
treatment advancements for food allergy. The results of the
OUtMATCH study showed that anti-IgE therapy could significantly
reduce the occurrence of allergic reactions across multiple foods
in the event of an accidental exposure.”
“Living with food allergies has a profound impact on patients
and their families, causing significant stress and requiring
constant vigilance,” said R. Sharon Chinthrajah, M.D., associate
professor of medicine, Stanford School of Medicine, Sean N. Parker
Center for Allergy and Asthma Research and OUtMATCH co-lead study
investigator. “The OUtMATCH study demonstrated that anti-IgE
therapy increased most patients’ threshold for an allergic
reaction. This presents an important new treatment option for
patients and families in its potential to reduce the risk of
allergic reactions from accidental exposures they may face in
day-to-day life.”
One hundred eighty patients ages 1 to 55 years old entered Stage
1 of the OUtMATCH study unable to tolerate up to 100 mg of peanut
protein (equivalent to about one third of a peanut), and up to 300
mg of at least two other food proteins among milk, egg, cashew,
walnut, hazelnut and wheat. After 16 to 20 weeks of treatment with
Xolair or placebo, each participant completed four separate blinded
food challenges (including a placebo ingredient) to assess
patients’ ability to consume a single dose of at least 600 mg of
peanut protein (primary endpoint), and a single dose of at least
1,000 mg of milk, egg, wheat, cashew, hazelnut or walnut protein
(secondary endpoints) without experiencing moderate to severe
allergic reactions.
Results showed that, compared to placebo, a statistically
significant (p<0.001) higher proportion of patients receiving
Xolair were able to consume at least 600 mg of peanut protein and
at least 1,000 mg of milk, egg and cashew protein without
experiencing moderate to severe allergic reactions. Additionally,
compared to placebo, a higher proportion of patients receiving
Xolair were also able to consume at least 1,000 mg of walnut,
hazelnut and wheat protein without experiencing moderate to severe
allergic reactions. Detailed results are included in the table
below.
OUtMATCH Primary and Secondary Endpoints Results in
Paediatric Population (n=177)
Percentage of Patients Successfully Consuming Predefined
Threshold Dose of Seven Foods
|
Approximate Equivalents5 |
Xolair Treated Patients |
Placebo Treated Patients |
Number of Patients |
Primary Endpoint |
Peanut (≥600 mg)
95% CI for difference: 47 to 70; p<0.001 |
2.5 peanuts
or
1/2 teaspoon of regular peanut butter |
67% |
7% |
177 |
Key Secondary Endpoints |
Cashew (≥1,000 mg)
95% CI for difference: 19 to 52; p<0.001 |
3.5 cashews |
41% |
3% |
99 |
Egg (≥1,000 mg)
95% CI for difference: 46 to 79; p<0.001 |
1/4 of an egg |
67% |
0% |
71 |
Milk (≥1,000 mg)
95% CI for difference: 30 to 74; p<0.001 |
2 tablespoons
of 1% milk |
66% |
10% |
62 |
Additional Secondary Endpoints |
Walnut (≥1,000 mg)
95% CI for difference: 27 to 68 |
3 walnut halves |
64% |
13% |
78 |
Hazelnut (≥1,000 mg)
95% CI for difference: -2 to 78 |
4.5 hazelnuts |
65% |
14% |
24 |
Wheat (≥1,000 mg)
95% CI for difference: 13 to 88 |
3.5 saltine crackers |
75% |
13% |
20 |
Additionally, out of three adult OUtMATCH participants, two
completed Stage 1 of the study; the adult who received Xolair met
the primary endpoint compared to the placebo-enrolled adult
patient.
Adverse event rates in the study were similar between Xolair and
placebo. The most common adverse event in Xolair-treated children
and adolescents was injection site reaction (9%).
“The Phase III OUtMATCH results represent a major advance and
reinforce our commitment to addressing critical gaps in care for
conditions like food allergy,” said Levi Garraway, M.D., Ph.D.,
Roche’s Chief Medical Officer and Head of Global Product
Development. “Now recently FDA-approved, Xolair provides a new way
to help manage food allergies for children and adults who live with
the constant fear of life-threatening allergic reactions.”
While efficacy cannot be established from uncontrolled,
open-label studies, for 38 children who continued Xolair for 24-28
weeks in an open-label extension, the percentage of patients who
were able to consume 600 mg or more of peanut protein and 1,000 mg
or more of egg, milk and/or cashew protein without moderate to
severe dose-limiting symptoms was maintained.
About 3.4 million children and 13.6 million adults in the U.S.
will have been diagnosed with IgE-mediated food allergies, based on
estimates for 2024.1,2 Food allergy prevalence has been
on the rise for the past 20 years.6 There are 160
different foods that cause IgE-mediated food allergy.7
Allergic reactions can range from mild to moderate, including hives
and swelling, to severe and life-threatening, such as
anaphylaxis.3 More than 40% of children and more than
half of adults with food allergies have experienced a severe
reaction at least once, and it is estimated that food-related
anaphylaxis results in 30,000 medical events treated in emergency
rooms in the U.S. each year.1-3
On 16 February, 2024, the FDA approved Xolair for the reduction
of allergic reactions, including anaphylaxis, that may occur with
accidental exposure to one or more foods in adult and paediatric
patients aged 1 year and older with IgE-mediated food allergy.
People taking Xolair for food allergies should continue to avoid
all foods they are allergic to (commonly referred to as “food
allergen avoidance”). Xolair should not be used for the emergency
treatment of any allergic reactions, including anaphylaxis. Xolair
is the first and only FDA-approved medicine to reduce allergic
reactions in people with one or more food allergies.
In the U.S., Genentech, a member of the Roche Group, and
Novartis Pharmaceuticals Corporation work together to develop and
co-promote Xolair.
About the OUtMATCH Study
The Omalizumab as Monotherapy and as Adjunct Therapy to
Multi-Allergen Oral Immunotherapy in Food Allergic Children and
Adults (OUtMATCH; NCT03881696) study is an NIH-sponsored,
three-stage, multicentre, randomised, double-blind,
placebo-controlled study evaluating Xolair safety and efficacy in
patients aged 1 to 55 years who are allergic to peanuts and at
least two other common foods.
Stage 1 included 180 patients (177 children and adolescents; 3
adults) who were randomly assigned to receive placebo or Xolair
injections either every two weeks or every four weeks for 16 to 20
weeks. The Xolair dose and dosing interval were determined by total
serum IgE level and body weight at baseline.
After 16 to 20 weeks of treatment with Xolair or placebo, each
participant completed four separate blinded food challenges where
they were given gradually increasing amounts of peanut protein, two
other food proteins they were allergic to, and a placebo
ingredient. The food challenges were conducted in a carefully
controlled setting with investigators looking for signs and
symptoms of allergic reaction to assess patients’ ability to
consume a single dose of at least 600 mg of peanut protein (primary
endpoint), and a single dose of at least 1,000 mg of milk, egg,
wheat, cashew, hazelnut or walnut protein (secondary endpoints)
without experiencing dose-limiting symptoms, which were defined as
moderate to severe allergic reactions, including skin, respiratory
or gastrointestinal symptoms.
The OUtMATCH study is being sponsored and funded by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
NIH, and conducted by the NIAID-funded Consortium for Food Allergy
Research (CoFAR) at 10 clinical sites across the U.S. led by Johns
Hopkins Children's Center and co-led by Stanford School of
Medicine. The study is also supported by Genentech and Novartis
Pharmaceuticals Corporation.
About Xolair
Xolair is the only approved antibody designed to target and block
immunoglobulin E (IgE). By reducing free IgE, down-regulating
high-affinity IgE receptors and limiting mast cell degranulation,
Xolair minimises the release of mediators throughout the allergic
inflammatory cascade.
About Roche in Immunology
The Roche Group’s immunology medicines include:
Actemra®/RoActemra® (tocilizumab) for
rheumatoid arthritis, polyarticular juvenile idiopathic arthritis
(pJIA), systemic juvenile idiopathic arthritis (sJIA) and giant
cell arteritis (GCA) and for the treatment of severe or
life-threatening chimeric antigen receptor (CAR) T cell-induced
cytokine release syndrome (CRS);
Rituxan®/MabThera® (rituximab) for rheumatoid
arthritis granulomatosis with polyangiitis and microscopic
polyangiitis and for pemphigus vulgaris (PV);
Xolair® (omalizumab) for allergic asthma and chronic
idiopathic urticaria (CIU); Pulmozyme® (dornase alfa)
for cystic fibrosis; and Esbriet® (pirfenidone) for
idiopathic pulmonary fibrosis (IPF). Roche has more than 15
investigational medicines in clinical development for immunological
diseases that include asthma, autoimmune diseases, rheumatoid
arthritis, ulcerative colitis and Crohn's disease.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] Gupta RS, Warren CM, Smith BM, et al. Prevalence and Severity
of Food Allergies Among US Adults. JAMA Netw Open.
2019;2(1):e185630. doi:10.1001/jamanetworkopen.2018.5630.
[2] Gupta RS, Warren CM, Smith BM, et al. The Public Health Impact
of Parent-Reported Childhood Food Allergies in the United States.
Pediatrics. 2018;142(6):e20181235. doi:10.1542/peds.2018-1235.
[3] USDA Food Safety and Inspection Service. Food Allergies.
https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/food-allergies.
Accessed November 2023.
[4] Xolair (omalizumab) Prescribing Information. Genentech, Inc.
and Novartis Pharmaceuticals Corporation 2024.
[5] Groetch M, Mudd K, Woch M, et al. Retail Food Equivalents for
Post-Oral Immunotherapy Dosing in the Omalizumab as Monotherapy and
as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in
Food-Allergic Children and Adults (OUtMATCH) Clinical Trial. J
Allergy Clin Immunol Pract. 2023;11(2):572-580.e2.
doi:10.1016/j.jaip.2022.10.022.
[6] Benedé S, Blázquez AB, Chiang D, Tordesillas L, Berin MC. The
Rise of Food Allergy: Environmental Factors and Emerging
Treatments. EBioMedicine. 2016;7:27-34.
[7] US FDA. Food Allergies.
https://www.fda.gov/food/food-labeling-nutrition/food-allergies.
Accessed February 2024.
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