A Q&A on the Efficacy of Ragweed SLIT Tablets in Children

The American Journal of Managed Care^® (AJMC^®) dicussed the efficacy of ragweed sublingual immunotherapy (SLIT) tablets with Anne Ellis, MD, professor of medicine and chair of the Division of Allergy & Immunology at Queen's University in Kingston, Ontario, Canada. Ellis' study entitled, "Efficacy and Safety of Ragweed SLIT-Tablets Across Peak and Entire Season in Children with Allergic Rhinoconjunctivitis" found ragweed SLIT-tablets were efficacious in children with allergic rhinitis with or without conjunctivitis. The abstract was released through the American Academy of Allergy, Asthma & Immunology (AAAAI), which canceled its 2020 Annual Meeting due to COVID-19.

AJMC^®: During peak season, daily symptom score and daily medication score were improved with ragweed SLIT tablets versus placebo in children. Did your study find any differences in efficacy of the treatment in children when compared to adults?

Ellis: Yes, actually, the treatment ended up being more effective in children than it was in the adult population when you compared the results of this trial back to the original Ragwitek trials that led to the Ragwitek tablet being approved for use in North America.

AJMC^®: Why did you select ragweed as the allergen to test in this study?

Ellis: The Ragwitek tablet has already been approved for use in adults, and there was a desire to determine whether or not it would be efficacious in children as well. There's definitely desire both from the manufacturers of new products as well as the FDA to ensure that any new product that is approved in adults also has follow-on studies in the pediatric population to provide actual data in the pediatric population rather than just extrapolating from adult data before allowing it to be used in children.

AJMC^®: Did you find in your study that the tablets had a greater effect on children with asthma?

Ellis: It's important to note a few distinctions there. The efficacy for reducing ragweed induced allergic rhinitis symptoms wasn't necessarily better just because you have asthma. But what was an unexpected and very pleasant and helpful finding was how much the tablet worked to improve asthma symptoms in children with ragweed allergy and allergic asthma. It's not that you do better from a rhinitis perspective because you have asthma, but your asthma actually improves.

AJMC^®: Do you hope that reducing allergy symptoms in children with asthma via the tablets could reduce usage of asthma controller medications?

Ellis: Certainly reduction of asthma medications in general, that's what was shown in our study was that there was a much greater reduction in the use of rescue short-acting beta agonists in the patients treated with the tablet compared to those treated with placebo.

AJMC^®: What are the real world implications of this study?

Ellis: The real world implications of this trial is that this tablet is highly efficacious in reducing symptoms of hay fever, or allergic rhinitis, in children with ragweed induced allergies, but also in reducing symptoms and rescue medication use for those children who also have asthma in addition to ragweed allergy.

AJMC^®: Is there a timeline for these tablets coming to market or being approved?

Ellis: Personally, I'm in Canada, so our regulatory timelines are different from what is possibly anticipated in the United States. But I can tell you that this data has been submitted to both the FDA and Health Canada and approval is anticipated, but I can't give you an exact projection on the timeline at this point.

AJMC^®: Is there anything that stood out about your research or do you have any points you'd like to highlight?

Ellis: I think it's important for anyone reading about the study to recognize just how very highly effective the treatment was in the pediatric population. It indicates that perhaps we should be thinking sooner about intervening with immunotherapies for children, rather than waiting until adulthood when the disease is more established and possibly harder to change the course. One of the advantages of these types of tablets is they can be given safer than traditional subcutaneous immunotherapy injections and therefore are more palatable and likely to be thought of in the pediatric population.