Three New Allergy Products Hit the Market
Over 20 million people in America suffer from allergic rhinitis (hay fever), skyrocketing healthcare expenditures to billions of dollars when you add in the expenses of medications, treatments and missed days of work or school. Of course, avoiding outdoor allergens is next to impossible, but many steps may be taken to eliminate or reduce exposure to indoor triggers (dust mites, cats, dogs, mold spores etc.). Allergy shots are reserved for school-age children and adults who fail to respond to avoidance measures and medications, especially in situations where the allergen is unavoidable.
Despite the plethora of brochures and handouts detailing environmental controls, many allergy sufferers continue to have year-round runny nose, nasal congestion, sneezing and eye allergy symptoms. Six years ago, I posted an article about sublingual immunotherapy (SLIT) and highlighted why it wasn’t ready for prime time.
In the article, I first noted the benefits in comparison to allergy shots. Here is a recap:
- SLIT was safer (fewer episodes of severe allergic reactions)
- No needle injection required, just drops or a tablet under the tongue (a huge plus to many!)
- Weekly doctor visits not required (may be administered at home)
- Younger children could be considered more often for treatment (fewer concerns about safety)
- SLIT is a disease-modifying drug, meaning a period of remission may follow treatment after a few years, allowing shots to be stopped, but continuing to benefit from them
The reasons SLIT was not being widely supported six years ago were as follows:
- SLIT extracts were limited to one allergen for treatment at a time. So, if you were allergic to grass, trees and ragweed, you would only get one of the allergens for treatment.
- There were no established guidelines for administration, such as starting dose, how to progress, or frequency of doses and length of treatment
- There was no FDA-approved formulation
- There weren’t many well-controlled studies in the US showing the effectiveness of SLIT
Earlier this year, however, the FDA approved three sublingual preparations for SLIT, which are now available for treating seasonal allergic rhinitis.
What changed over the last six years?
Pharmaceutical companies, Merck and Stallergenes, presented results of studies on sublingual tablets for treatment of allergic rhinitis to the FDA and subsequently received approval. Almost all of the reasons for lack of support, noted above, were overcome in the last six years.
Currently, there are well-established guidelines on how to administer sublingual Oralair, Grastek and Ragwitek. The dose levels, frequency of dosing, onset of treatment and duration of treatment have been worked out for the above formulations. There are well-controlled studies from clinical trials done in America that report decreased allergy symptoms compared to placebo (fake sublingual tablets) and good safety data.
It will take more time to determine whether currently approved SLIT will be disease-modifying, but I expect it will since similar therapies in Europe have reported this outcome.
A remaining major hurdle is the fact that many allergy sufferers in this country are allergic to multiple allergy triggers and SLIT, as it currently exists, only offers treatment for grass or ragweed allergy. People allergic to tree pollen, dust mites, pets or mold spores won’t be covered by currently available SLIT.
Over time, more sublingual tablets will become available and expand the coverage to other allergy triggers, but the cost, inconvenience and possible side effects, as well as safety factors, may present a challenge.
I’m always excited when new products for treating allergic disorders become available. Every patient is unique in their array of allergy symptoms, allergy triggers and response to treatment. Allergists see a small niche of patients who have problems with only one or two pollen types, but they do exist. Up until this year we (allergists) would attempt to treat many of these patients with more intensive medication regimens (nasal sprays, antihistamines and other oral agents) before considering allergy shots, which meant year-round injections. Now, some of these patients may be started on grass or ragweed tablets several weeks before and through the season, but not necessarily for the entire year. Furthermore, they can take the sublingual tabs at home after the initial dose in the doctor’s office. I’m certain some of my patients will be quite pleased to have new options in allergy treatment.
In a future article, I will go into more detail about some of the differences in administration of SLIT versus allergy shots, as well as some unique, but minor, concerns about SLIT based on experience with it in my office.
Efficacy and safety of grass SLIT, Maloney et al, Annals of Allergy, Asthma and Immunology 2014; 112 : 146-153
Safety and tolerability of a short ragweed SLIT, Nolte et al, Annals of Allergy, Asthma and Immunology 2014; 113: 93-100