Isabella Hornick; Jackie Eghrari-Sabet, MD , 2025-04-18 11:51:00
April 18, 2025
6 min read
Key takeaways:
- House dust mite allergy is common in young children because they are often in places where dust mites reside.
- Odactra for patients aged 5 to 11 years does not have to be prescribed by an allergist.
In February, the FDA approved the Odactra tablet, a sublingual immunotherapy, to treat house dust mite-induced allergic rhinitis in patients aged 5 to 11 years, according to a manufacturer-issued press release.
As Healio previously reported, Odactra (ALK) was approved for patients aged 12 to 17 years in 2023, and for patients aged 18 to 65 years in 2017.
In February, the FDA approved the Odactra tablet, a sublingual immunotherapy, to treat house dust mite-induced allergic rhinitis in patients aged 5 to 11 years. Image: Adobe Stock
The recent approval is based on findings from the multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 3 House Dust Mite Allergy Trial In Children (MATIC or MT-12).
In this trial of 1,460 children aged 5 to 11 years, researchers reported that Odactra significantly lowered average daily total combined rhinitis scores by 22% compared with placebo during the last 8 weeks of the 1-year treatment period (absolute treatment difference, 1; 95% CI, 0.5-1.4).
According to the study, children receiving Odactra also experienced fewer symptoms based on rhinitis daily symptom score, used less medication based on rhinitis daily medication score and had better disease-related quality of life based on rhinoconjunctivitis total combined score and Pediatric Rhinoconjunctivitis Quality of Life Questionnaire score.
In terms of safety, researchers observed a greater proportion of children reporting a treatment-related adverse event in the Odactra vs. placebo group (75.4% vs. 53.5%). Among the children receiving Odactra, 74.6% had a mild adverse event, 13.2% had a moderate event, less than 1% had a severe event and less than 2% discontinued the treatment.
Healio spoke with Jackie Eghrari-Sabet, MD, allergist/immunologist and clinical associate professor at the George Washington University School of Medicine, to learn more about house dust mite allergy, how Odactra’s expansion will change care in younger children and how it will impact clinicians other than allergists.
Healio: What are dust mites and how common is house dust mite allergy?
Eghrari-Sabet: Dust mites are microscopic insect-like creatures. You cannot see them with your naked eye. They go along and eat dead skin cells, and what comes out the other end are the feces of the dust mites, which are even more microscopic than the dust mites themselves. Those get airborne, you breathe them in, and it causes the allergy.
Dust mites are going to be anywhere where there are dead human skin cells. The all-you-can-eat dust mite buffet would probably be your bed and pillow because you are in there rolling around shedding skin cells. Another great place for dust mites would be carpeting because you’re walking around shedding your skin cells.
When we break that down to look at elementary school age kids, they spend a lot of time in these dust mite environments, notably in bed with pillows and stuffed animals, which are another huge reservoir, especially if you’re snuggling with a stuffed animal.
The impact of dust mites, because of where the kids are, is very significant. Allergy is the No. 1 chronic disease in school age children, and it becomes the No. 1 reason why they miss school because of managing and dealing with their allergies.
In the allergy world, dust mites are really one of the more significant allergens because they’re available everywhere that a human and its skin cells are, and they are not tied to a certain time of year. They’re there all year round, so that’s a big deal.
Additionally, dust mite allergy is very common because it’s geographically independent. There are dust mites all over the world, whereas with oak tree pollen, you’re not getting a lot of oak tree pollen in Miami or Tucson.
Healio: What are the negative impacts of this allergy in children aged 5 to 11 years?
Eghrari-Sabet: In terms of medical downsides, if your nose and sinuses are all affected, you are much more prone to get other related health conditions as a result. Kids with allergies are also much more likely to go on and get allergic asthma.
In terms of daily living downsides, kids can certainly miss school, but when they’re in school, there’s also a problem. Imagine you’re trying to learn long division, and you have to keep blowing your nose, wiping your eyes and coughing. You’re very distracting to the other student next to you, but it’s also difficult for you to concentrate when you’re going through all that. Maybe you’re the goalie in soccer, and you’re out there trying to focus on the ball, but you’ve got these horrible allergies and snot running down your face. It’s going to impact you in a lot of ways.
Lastly, allergies can just make you tired, and the effect of managing the allergies and the medication themselves, especially those sedating antihistamines, can make you exhausted.
Healio: How will the expansion of Odactra change care in children aged 5 to 11 years?
Eghrari-Sabet: It’s a total game changer. As somebody who is a board-certified allergist, I’m the one that says, “I diagnosed you with your allergies. Now let’s talk about what are our options for treatment.” Up until now, our only option for treatment in that age group was immunotherapy done as an allergy shot. Now with Odactra, we can deliver this same immunotherapy for dust mites as an allergy tablet.
It is important to point out that Odactra is not a symptomatic treatment. It’s not a “oh, your allergies have exploded, let’s bring out the cleanup committee,” which includes antihistamine, nasal sprays and eye drops. That’s all for managing the symptoms that have already happened.
Immunotherapy is, “let me introduce your immune system to Odactra, the allergen of dust mite, and your immune system is going to build up a tolerance, so you’re not going to manifest those symptoms.”
We could do 3 years of an antihistamine, and at the end of the 3 years, you are still immunologically the exact same person as when we started. However, if we do 3 years of Odactra, at the end of that period of therapy, your immune system has become tolerant to the dust bites. That’s huge.
The other thing that’s great about it is that because it is a tablet and not an injection, it suddenly allows many more clinicians to be able to prescribe it. If somebody is going to go on allergy shots, they really have to come to an allergist, and I’ve got to mix up your allergy shots for you. There’s a limitation about how many people can get on allergy shots because you’ve got to come to an allergist.
But Odactra can be prescribed by a pediatrician, a family practice physician and an allergist because it’s a prescription that gets filled in a pharmacy. There’s a much broader, wider access of the therapy.
Healio: Are there any findings from the phase 3 study you would like to highlight?
Eghrari-Sabet: The first thing you want to look at is, who did they study? When I’m talking to other clinicians, I ask, “Did they study your patients?” When I’m talking to parents, I ask, “Did they study your kid?” The answer is yes because they studied this age group.
Then you need to focus on what the researchers were looking for and the outcome of the study. They wanted to find out if there was a decrease in allergic manifestation from dust mites if you go on this immunotherapy, and that’s what the study showed.
Now, when I’m talking to parents, I can say there was a large study that was done where they gave people just like your child Odactra, and they compared them with a placebo group. What they found is, after taking the Odactra for the set period of time of the study, patients on Odactra manifested far fewer allergic symptoms, and it stayed past being on the medication. That’s how it got approved, so we should really be using this to be able to tell people that I can already predict the outcome.
If your child is like the children in the study, I would assume that your child would have a similar outcome to those that were in the study. That’s the benefit of real-world studies and making sure that you have a wide variety of people that you’re studying and being very specific about what am I looking for in terms of the outcome.
Healio: Would you briefly characterize what the impact of this news is for the everyday clinician?
Eghrari-Sabet: The everyday clinician now has the availability of prescribing immunotherapy that previously they did not. They had to have a whole setup to be able to make this immunotherapy. Now, it’s writing a prescription and sending the patient to a pharmacy.
It’s a totally new way of thinking about how we’re going to manage this disease. It’s not by symptom control, but by immunotherapy, which harnesses the patient’s own immune system. That means you’ll need to brush up on how you are going to educate your parents and patients and think about the outcomes you are looking for. What you’re looking for is a much longer-term effect than just a 24-hour symptom control medication.
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For more information:
Jackie Eghrari-Sabet, MD, can be reached at allergy@healio.com.
Perspective
Treatment options for children aged 5 to 11 years with house dust mite allergy include symptom-relief medications (antihistamines, nasal steroids), environmental control measures (dust-mite-proof bed covers) and disease-modifying immunotherapies such as allergy shots or allergy drops. Most medications are over the counter now and do not require prescription to access, although this also means they are not covered by insurance benefits.
Allergy shots (subcutaneous immunotherapy) are a widely available immunotherapy option but involve frequent injections and in-office visits and carry a risk for anaphylaxis. Insurance benefits may or may not cover the cost of the treatment, though there are other costs to consider including missed work/school, travel and time lost to appointments.
Allergy drops (sublingual immunotherapy [SLIT]) are a personalized, noninvasive treatment that avoids injections and minimizes anaphylaxis risk. They usually are not covered by insurance, and they require self-responsibility for home-based dosing adherence, with a tradeoff of having much fewer required appointments and therefore less missed work/school and less lost time.
As a standardized SLIT tablet, Odactra’s FDA approval for children aged 5 to 11 years expands access to a noninvasive, disease-modifying treatment that may be covered by insurance. While Odactra lacks the dosing flexibility and multi-allergen customization of SLIT drops (and allergy shots), it provides a standardized, convenient option for children with house dust mite as a primary trigger. For families needing insurance-supported care, or for clinics without expertise in or access to customized SLIT, this offers a meaningful step forward to optimizing dust mite treatment options for children.
Our clinic has long specialized in the provision of liquid SLIT, offering personalized, noninvasive, multi-allergen immunotherapy procedures for patients of all ages, so Odactra may not significantly change our unique practice. However, it is a welcome addition to the broader allergy treatment landscape, should be simple for traditional allergy practices to offer as a prescription option and could benefit families seeking a potentially covered, tablet-based option for their child. More importantly, it expands access to and further reinforces the value of early, noninvasive immunotherapy in modifying the allergic march and improving long-term outcomes for children.
Nikhila D. Schroeder, MD, MEng
Disclosures: Schroeder reports no relevant financial disclosures.