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FDA approves Grastek for grass allergies
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The FDA has approved the second sublingual immunotherapy agent in 2 weeks, according to a press release.
Grastek (Timothy Grass Pollen Allergen Extract, Merck) sublingual immunotherapy (SLIT) tablets are indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis in patients aged 5 to 65 years. Two weeks ago, Greer/Stallergenes received approval for its grass pollen SLIT agent, Oralair.
David I. Bernstein
“Every grass pollen season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication,” David I. Bernstein, MD, professor of medicine and environmental health, division of immunology, allergy and rheumatology, University of Cincinnati College of Medicine, said in a press release. “These patients often have multiple sensitivities. Some of these patients may be candidates for immunotherapy, but decline allergy shots. With the FDA approval of Grastek, allergy specialists now have a new sublingual approach to offer these patients for their grass allergies.”
The first dose would be administered at a doctor’s office. Data indicate that the drug be initiated 12 weeks before the expected onset of each grass pollen season, and continued throughout the season.
In clinical trials, patients treated with the agent exhibited significant reductions in nasal and ocular symptoms, as well as a reduction of symptom-relieving allergy medication use.
The most common adverse reactions reported in clinical studies for patients aged 5 to 17 years and patients aged 18 to 65 years with Timothy grass pollen-induced allergic rhinitis with or without conjunctivitis and treated with Grastek vs. placebo, respectively, were oral pruritus (24.4% vs. 2.1% and 26.7% vs. 3.5%), throat irritation (21.3% vs. 2.5% and 22.6% vs. 2.8%), mouth edema (9.8% vs. 0.2% and 11.1% vs. 0.8%), and ear pruritus (12.5% vs. 1.1%, patients aged to 18-65 years), according to the release.
The drug contains a black boxed warning due to the drug’s potential for anaphylaxis. Grastek is contraindicated in patients with severe, unstable, or uncontrolled asthma, or with a history of severe systemic or local reaction to sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients (ie, gelatin, mannitol and sodium hydroxide) in the product.
For more information:
FDA Briefing Document. Biologic License Application (BLA) for Timothy Grass Pollen Allergen Extract Tablet for Sublingual Use. Accessed April 15, 2014.
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Andy Nish, MD
There are pediatric and adult patients who are wary of subcutaneous immunotherapy due to needle phobia. For those patients, this FDA approval opens up an avenue that is not currently available.
It will be interesting to see whether insurance companies will pay for this form of immunotherapy. We do know that SLIT has been shown to be clinically effective, particularly for patients who are sensitized to the same class of pollens, and in this class grass. However, studies have shown that it is not as successful in patients who are polysensitized.
Even still, this approval offers promise for treating some patients who would otherwise not be administered subcutaneous immunotherapy, but it is limited in the scope as to what allergies it can treat.
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Anju T. Peters , MD
This is the second SLIT approved this month. SLIT is a great option for patients with allergic rhinitis who have failed regular medical therapy (ie, allergen avoidance or taking medications) and are still symptomatic. Until now, the only option we had was subcutaneous immunotherapy, which can be very time consuming; it has a risk for severe allergic reaction, although that risk is very low.
Right now, there are only two SLIT agents and both are for grass pollen allergies, but in the future we hope to have one for dust mites as well as ragweed.
For a patient who cannot spend the time at the doctor’s office, SLIT could be a very convenient way of giving immunotherapy. It’s safer than administering subcutaneous immunotherapy, and it does show efficacy.
There is an issue of concern, in that, most of our patients are allergic to multiple allergens, so we right now don’t have SLIT for them. The other area of concern is adherence to SLIT at home. Its efficacy is very much reliant on a patient’s self-administration.
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David M. Lang, MD
Approximately 1 in 5 Americans suffers from allergic rhinitis, and the prevalence of this condition has been increasing worldwide. When untreated or undertreated, allergic rhinitis can have a significant impact on one’s quality of life, and may adversely affect performance at work or school. For more than a century, allergen immunotherapy, given as “allergy shots,” has been used to treat allergic rhinitis sufferers whose symptoms were not adequately controlled by avoidance measures and use of regular medication. Many studies around the world have shown allergen immunotherapy is effective for reducing symptoms in properly selected patients with allergic rhinitis (and asthma).
The FDA approval of Grastek, an oral immunotherapy tablet, marks our entry into a new era for treatment of grass allergy. This is a more convenient form of immunotherapy that, similar to allergy shots, can modify the immune response to provide protection against the symptoms typically experienced with grass pollen exposure. This is an important advance that has clear potential to benefit a large segment of the US population.
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John R. Cohn, MD
This is interesting technology but it is unclear where it will fit into our clinical armamentarium. The recent FDA decision approved products that are relevant to limited seasons, in this case grass pollen. Grass is an important allergen in our region, but the season still lasts but a matter of weeks.
For patients that have to start treatment 4 months in advance, it is unclear if there is enough incentive for them to do so.
Most of the indications for giving patients allergy immunotherapy are based on a failure of medication to provide satisfactory relief. Satisfactory in this context can have a variety of meanings, including medication side effects or inadequate relief. Another factor is the duration of symptoms. For pollen allergic patients with tree, weed and grass allergies, seasonal symptoms can run from March to October or November. Subcutaneous immunotherapy (SCIT) allows for treatment of multiple allergens spanning several seasons. Seen in that context, Grastek only covers a limited part of that time period, making allergen immunotherapy potentially less useful.
Generally, we do not tend to put patients on a subcutaneous immunotherapy who have a limited season and develop adequate control with prescription and over-the-counter medications. While custom SLIT extracts have been prepared that include multiple allergens, these products are not designed or approved that way.
When I speak to trainees, I tell them they will not use every treatment with every patient. These are more tools for the tool box. The challenge for each allergist and their patients is finding the best regimen in terms of efficacy, adverse events, convenience and cost.
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