This article discusses the work of Robert Wood, MD, deputy director of Pediatric Research and associate program director of the ICTR Clinical Research Units (CRUs)

Results suggest omalizumab has the potential to be a ‘life-changing’ medication for patients with food allergy, including those with multiple food allergies.

A study led by Johns Hopkins Children’s Center shows omalizumab — an injectable, Food and Drug Administration (FDA)-approved medication for treating asthma and other allergic conditions — substantially reduced potentially life-threatening reactions in patients with an allergy to peanut and other common food allergies.

A report on the first stage of a three-stage study, which was funded by the National Institutes of Health (NIH), was published Feb. 25 in The New England Journal of Medicine and presented during a late breaking symposium at the American Academy of Allergy, Asthma & Immunology annual meeting in Washington, D.C. The FDA recently approved omalizumab for treatment of multiple food allergies following an interim analysis based on this study.

In the study, investigators compared the effects of 16–20 weeks of omalizumab injections with placebo injections in 180 participants ranging from age 1 to 55 with a history of peanut allergy and at least two other food allergies. The subjects were randomly assigned to receive omalizumab or placebo. All but three of the participants were age 17 or younger.

Researchers found after 16 weeks, 66.9% of patients treated with omalizumab were able to tolerate 600 milligrams (mg) or more of peanut protein — equal to about 2.5 peanuts, compared with 6.8% of participants who received placebo injections. The researchers also found that omalizumab injections increased participants’ threshold reactivity not just to peanuts but to other common food allergens — milk, eggs, wheat, cashews, walnuts and hazelnuts — to levels that would protect most patients from reactions after accidental exposure.

“The day-to-day life of patients with food allergy is consumed by fear of accidental exposure to food allergens,” says Robert Wood, M.D., director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center, and the study’s principal investigator. “Our findings have the potential to be very meaningful, and potentially even life changing, for people with food allergies.”

According to researchers, up to 8% of children and 10% of adults have at least one food allergy, and up to 86% are allergic to more than one food. This condition requires constant vigilance and has significant, detrimental effects on quality of life, including nutrition, mental health and even personal finances.

Management of food allergies mostly relies on avoidance and emergency treatment with epinephrine when an accidental exposure occurs. Currently, there is only one additional FDA-approved treatment for food allergy — an oral immunotherapy product that is approved for peanut allergy in children 4 to 17 years old.

The study, Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants (OUtMATCH), was designed as a collaborative effort among Wood, investigators from other study sites, National Institute of Allergy and Infectious Diseases (NIAID) scientists and Genentech/Novartis. The NIAID-funded Consortium for Food Allergy Research, which Wood leads, conducted the trial at 10 medical centers across the U.S.

“A majority of people not only reached the primary endpoint of 600 mg or more of peanut, an amount that exceeds most accidental exposures, but also the majority of participants tolerated 4,000 mg of peanut protein, which is equivalent to about 15 peanuts,” says Wood. In addition, almost 50% of participants who received omalizumab were able to successfully eat a cumulative dose of 6,044 mg of peanut protein — which is equal to about 25 peanuts.

During the study, omalizumab also significantly increased the reaction threshold for tree nuts, milk, eggs and wheat. About 69% of participants could tolerate a cumulative dose of 1,044 mg of two foods, and 47% were able to tolerate a cumulative dose of 1,044 mg of three foods. “This is unique, because we found omalizumab is effective for seven different food allergens,” explains Wood.

The research team also assessed the effects of longer periods of omalizumab treatment. The first 60 participants entered a 24-week extension phase of the study. Researchers found most participants’ reaction threshold remained the same or increased when they continued receiving omalizumab during this period. Researchers also studied the safety of omalizumab with, they say, reassuring results that are similar to what is known for the medication’s use for other conditions. They say this is important since the medication had never been studied in children as young as 1 year of age.

The investigators caution that while the overall study indicates the benefits and safety of omalizumab to treat food allergies, there was substantial variability in response among individual participants. For example, 14% of subjects did not tolerate even 30 mg of peanut. Therefore, patients will still need to avoid the foods to which they are allergic even when treated, and continue to carry self-injectable epinephrine. The researchers also note that the study was limited in that participants were mostly non-Hispanic and Caucasian, and that future studies would be needed to assess the drug’s effectiveness in more diverse populations.

Along with Wood, study authors from Johns Hopkins are Jennifer Dantzer and Kim Mudd. Other authors are Alkis Togias, Lisa Wheatley, Amanda Rudman Spergel, Maria Veri, Sanaz Hamrah, Erica Brittain and Julian Poyser from NIAID, which is part of the NIH; Scott Sicherer, Julie Wang and Marion Groetch from the Icahn School of Medicine at Mount Sinai; Wayne Shreffler and David Pyle from Massachusetts General Hospital; Edwin Kim, Corinne Keet and Michael Kulis from the University of North Carolina School of Medicine; Stacie Jones and Amy Scurlock from the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital; Donald Leung and Bruce Lanser from National Jewish Health; Brian Vickery and Tricia Lee from Children’s Healthcare of Atlanta; J. Andrew Bird and Christopher Parrish from the University of Texas Southwestern Medical Center; Jonathan Spergel and Terri Brown-Whitehorn from the Perelman School of Medicine at the University of Pennsylvania; Ahmar Iqbal and Julie Olsson from Genentech/Roche; Monica Ligueros-Saylan and Alkaz Uddin from Novartis; Agustin Calatroni, Charmaine Marquis Huckabee, Nicole Rogers and Nancy Yovetich from Rho Inc.; and Sayantani Sindher, Andrew Long and R. Sharon Chinthrajah from the Stanford Medicine Sean N. Parker Center for Allergy and Asthma Research.

The study was funded by grants from the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health, under award numbers UM2AI130836, UM1AI130838, UL1TR003098, UM1TR004408, UM1AI130570, UM1AI130839, UM1AI130936 UM1TR004406, UL1TR002535, UM1TR004399, UL1TR001878, UM1AI130781, UM1AI130839, UM2AI13083605, and UL1TR002378, UL1 TR003107, and the Claudia and Steve Stange Family Fund. Genentech/Novartis provided omalizumab for the study as well as monetary support to The Johns Hopkins University for conduct of the study.

Funding and a product for the study described in this press release was provided by Genentech. Robert Wood is a paid consultant to Genentech. This arrangement has been reviewed and approved by The Johns Hopkins University in accordance with its conflict-of-interest policies.

View this video to hear Robert Wood, M.D., director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children’s Center, discuss the OUtMATCH study.

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