Dr. McDonough:
Welcome to On the Frontlines of Food Allergies on ReachMD. I’m Dr. Brian McDonough, and joining me to discuss the use of omalizumab for reduction of food-allergic reactions is Dr. Robert Wood. Dr. Wood is a Professor of Pediatrics at Johns Hopkins University School of Medicine, and also serves as Chief of the Eudowood Division of Allergy and Immunology in the Johns Hopkins Children’s Center.
Dr. Wood, welcome to the program.
Dr. Wood:
Thank you, Brian. It’s a pleasure to be here.
Dr. McDonough:
Now for some background, you conducted a study that found that omalizumab significantly reduced the risk of food-allergic reactions. What was the process behind choosing omalizumab as the treatment option for this trial?
Dr. Wood:
That’s a great question, and the history of this actually goes back over 15 years, and omalizumab is not a new drug. It’s a drug that was approved in 2003 to treat asthma and subsequently has been approved to treat other allergic conditions, like chronic urticaria. And we and others had done numerous small studies over the last 15 years that all suggested that this drug could significantly impact reactions that people might have to food exposures. And this study was a culmination of lots of time and effort to try to bring the small studies that have been done to a larger study that would then, hopefully, lead to an FDA approval for this repurposing of an old medicine to treat food allergy.
Dr. McDonough:
To dive a little deeper, the study showed that 67 percent of participants could safely consume 600 milligrams of peanuts after treatment with omalizumab. How does this compare to current treatments?
Dr. Wood:
Current treatments are very, very limited. There’s only one other FDA-approved treatment. That’s a product used in oral immunotherapy, which literally means eating small amounts of peanut in a gradually increasing way to build tolerance, and otherwise, we rely on the age-old treatment for food allergy of telling patients to avoid what they’re allergic to and carrying their medications, including epinephrine, at all times in the event of an accidental exposure. So we’re really dealing with a pretty open playing field where there’s very little we had to offer our patients aside from strict avoidance of what they’re allergic to.
Dr. McDonough:
Were there any notable safety concerns or side effects reported during the study?
Dr. Wood:
There were not, and part of this was pretty much expected. Since it is an old drug, there was lots of data regarding short-term and long-term safety. The unique thing about this study is that it was the first one to include participants below age six. So the drug is approved to treat asthma down to age six, urticaria down to age 12, but it had really never been studied in the younger age group, so there was a particularly hard look taken at side effects, adverse events, in that younger population, and we, fortunately, did not see any signal for any adverse event that was more common in the actively treated group than in the placebo group.
Dr. McDonough:
For those just tuning in, you’re listening to On the Frontlines of Food Allergies on ReachMD. I’m Dr. Brian McDonough, and I’m speaking with Dr. Robert Wood about the use of omalizumab for reduction of food-allergic reactions.
We spoke a bit earlier about your study on omalizumab as food allergy treatment, but now let’s shift over to its efficacy in comparison to other remedies. How does omalizumab compare to traditional treatments, like oral immunotherapy, in terms of effectiveness?
Dr. Wood:
In terms of effectiveness, it is at least as effective—in most participants, actually, quite a bit more effective—and we talked about that 600 milligrams, equivalent of two to three peanuts, as the endpoint that we used, but it turned out the majority of participants could tolerate a lot more than that, 16 to 18 peanuts. So there was really quite a large level of protection. And the biggest difference as we compare this to oral immunotherapy is really the safety aspect. So with oral immunotherapy, while it can be a very effective treatment, it comes with a significant level of risk, and the risk includes both acute reactions, which occur in somewhere around 10 percent of people per year of taking a daily dose of oral immunotherapy, and then some more chronic kind of symptoms, particularly abdominal symptoms, that lead to people discontinuing oral immunotherapy in 15 to 20 percent of cases.
Dr. McDonough:
To that point, how might the findings of your study influence the future treatment strategies for food allergies?
Dr. Wood:
The influence is already showing up in our clinic, and I think there’s a couple of key aspects here. The most important may be that oral immunotherapy is a treatment that is very food specific, so if you have allergy to five different foods—and that would be a very typical patient in the regular food allergy clinic—oral immunotherapy can only be directed at one of those. And one of the advantages of omalizumab is that it is not food-specific. It’s not even allergen-specific, so it does an equal job blocking your allergy to your tree pollen or your cat allergy or peanut, cashew, egg, wheat, whatever foods you might be allergic to.
Dr. McDonough:
These are such important studies. It’s such important work because there’s so many people out there dealing with these things. And before we close, Dr. Wood, is there anything else you’d like to share with our audience today?
Dr. Wood:
I think the most common question we get is, “Should I pursue this treatment for myself? For my child?” And we do see a couple of things that have emerged sitting in the clinic everyday talking to patients. The first of those is, “How many foods are you allergic to?” And the more foods you’re allergic to, the more appealing this treatment might be. The second is, “Which foods are you allergic to?” And we focus a lot in our world of food allergy studies on peanut allergy, but the reality is that being severely allergic to things like milk or egg or wheat are much more life-limiting, much more difficult to avoid on a day-to-day basis, so the uptake for those kind of food allergies has really been strong. And then a third aspect has to do with age, and the age piece is different for every family. Some family might think that their greatest risk period is in their preschool-age child because they can’t look out for themselves so well. Another might think it’s really making the transition from preschool to regular school. But the biggest one that stood out clinically has been the individuals who have a severe food allergy, especially multiple food allergies, as a high school age or going off to college age. And the uptake there has been exceptionally brisk with families really thinking that, “Now my child’s food is much less under my control, and once they’re off to college, it will be virtually not under my control any longer.” So we’ve had a really, really strong interest from our patients who are in that teenage through college and young adult age group.
Dr. McDonough:
With those key takeaways in mind, I want to thank my guest, Dr. Robert Wood, for joining me to discuss omalizumab as a treatment for food allergies.
Dr. Wood, it was great having you on the program.
Dr. Wood:
Thanks, Brian. It’s always a pleasure to be here.
Dr. McDonough:
For ReachMD, I’m Dr. Brian McDonough. To access this and other episodes in our series, visit On The Frontlines of Food Allergies on ReachMD.com, where you can Be Part of the Knowledge. Thanks for listening.
