Every Tuesday, the girl from Fredericksburg, Virginia goes to her allergist’s office for another needle. “She hates them,” says her mother, Cynthia Staats. “It’s not an easy process. There’s lots of crying.” The immunotherapy shots do give Sabrina some relief, and she now is able to eat some foods that are closely related to pollen.
But the number of visits and the stress of the treatment can take their toll. This makes Staats one of many who are eager to learn more about newer under-the-tongue tablets that could replace those needles and be taken at home – with no doctor’s visits required after the first dose. While the tablets sure seem easier, would they be right for Sabrina?
Following thorough study, the FDA in 2014 approved three such pills that allergists can now prescribe to patients with bothersome pollen allergies. Ragwitek is to treat ragweed allergy (and is for adults only), Grastek is for Timothy and related grass pollens, and Oralair protects people from five different types of grass.
The pollen tablets are a form of treatment called sublingual immunotherapy, or SLIT, in which the pill is held under the tongue and quickly dissolves. Like allergy shots, they work by introducing your immune system to a tiny amount of pollen every day, which eventually makes you less sensitive. After weeks of exposure, the way your immune system reacts to pollen changes.
Studies have found patients who took SLIT had fewer allergy symptoms during pollen season and needed significantly less medication than people who were taking a placebo pill.
We turned to allergists and SLIT researchers Dr. Linda Cox and Dr. Harold Nelson to answer some of our readers’ most common questions about the new pills.
Q. What symptoms do SLIT tablets help to resolve?
The pills are approved for the treatment of runny, itchy, and congested nose, and red, irritated eyes. In Europe, where the pills have been on the market for years, studies are looking at whether the pills can help relieve wheezing and skin problems, too.
Q. How does a doctor determine if you’re a good candidate for SLIT?
The tablets are a good match for people who have grass or ragweed as their main allergy trigger, says Cox, who is based in Florida. If you’re already struggling year-round with other airborne allergens, like house dust mite and molds, the pills aren’t going to help with those, although research continues into other areas where SLIT may be an effective treatment.
Many people who currently get allergy shots specifically for grasses and ragweed might find the pills a more attractive option than repeated doctor’s office visits, says Nelson, an allergist at National Jewish Health in Denver.
For SLIT to work well, Cox says a person must be dedicated to taking the dose consistently as prescribed. Since the tablets are so new in the United States, some allergists are still learning about them. Cox, a past president of the American Academy of Allergy, Asthma and Immunology, is heading a group of doctors that is drawing up guidelines to assist the allergists.
Q. When and for how long do you take the pollen tablets?
The drug makers say you should start taking the pills two-to-four months before pollen season begins in your area. They’re designed to be taken leading up to, and during pollen season –then you can stop until next year. And if grass pollen season is less than two months away? “I would still try it,” Cox says.
Q. Does SLIT work forever, even after you’ve stopped taking it?
Probably not, says Nelson, but the answer is not entirely clear. People who took SLIT for three years, then stopped, still had immunity two seasons later, he says. The more enduring protection has been seen in those who took the tablets for four to five years. And one small study from Italy suggests the longer you take SLIT tablets, the longer you’re immune after you stop the pills.
Nelson recently rounded up 11 small studies that compared immunotherapy and SLIT. He sees immunotherapy as probably more effective on symptoms, but there’s the trade-off, of course – all those shots and years full of trips to the allergist’s office.
Q. Do I still have to take other allergy medications?
Yes. Research shows that people taking the SLIT pills decreased by 1/3 the amount of medication they were taking to relieve symptoms. But it didn’t eliminate the need for medication. Don’t toss out your nasal sprays and antihistamines.
Q. Some people have reactions to immunotherapy shots. Are the pills safer? Are there side effects?
The pills are safer, both experts agree. “Hands down. It’s not even debatable,” Cox says. With traditional allergy shots, there is about one severe reaction for every 30,000 injections, and people have, on rare occasions, died from them.
No deaths have been linked to sublingual tablets. After years of use in Europe and testing in North America, Nelson says there are only a very few known cases of reactions that have been labeled as anaphylaxis, and milder anaphylaxis at that.
The most common side effect is an itchy or swollen mouth in the initial stages of taking the drug. Nelson says these symptoms tend to disappear after one or two weeks, and the episodes usually only last an hour. “In general, the side effects are just not considered that bothersome.”
Q. Who should not use these pills?
Someone who has had a severe allergic reaction to allergy shots should steer clear of SLIT, Nelson says. People with severe and uncontrolled asthma should also avoid the drugs. There are some age limits on the grass pollen therapies: Oralair is approved for ages 10 to 65, and Grastek, for ages 5 to 65. Ragwitek, as mentioned above, is available to patients between 18 and 65 years of age.
People with the form of food allergy called eosinophilic esophagitis (EOE) shouldn’t take SLIT. Since that condition involves severe inflammation of the esophagus, the dissolving tablets might make those symptoms worse.
Anyone who takes heart medication such as beta blockers or diuretics is advised to not use the tablets. If you have a reaction to SLIT that requires epinephrine, it’s a bad combination.
Q. Will insurance cover the pollen tablets?
Most private prescription plans cover the cost of Grastek, Ragwitek, manufactured by Merck and Oralair, distributed by Greer Laboratories. Both manufacturers also offer prescriptions savings plans.
Q. What are patients taking the new pills saying?
Cox has a handful of patients on the pills, and they definitely find the therapy helpful. She’s heard that their symptoms and quality of life have improved, and the stories of relief are similar to those she hears from people receiving allergy shots. One patient who was having frequent outbreaks of eczema said even those stopped after he began the pills.
Q. The pills treat grass and ragweed allergies, but what about tree pollen?
In Europe, where sublingual pills got their start, there is a sublingual immunotherapy for birch pollen. However, it isn’t a pill, it’s a liquid pollen extract.
Q. What about liquid under-the-tongue drops?
Some allergists offer immunotherapy in the form of liquid drops you can also place under the tongue. Often, extracts of several different allergens are mixed together in the drops.
Nelson says the science on those liquid drops is simply not in the same league when compared to the formal “blinded” studies which were conducted in order for the new SLIT tablets to receive regulatory approval. For the under-tongue pills, researchers also narrowed down the most effective dose of allergens.
No such testing has been done on the liquid drops, which are taken from extracts that are only approved for injections. The expert says research has “raised serious questions” about whether this “off-label” approach of including multiple allergens in under-the-tongue drops works. “There’s an awful lot of SLIT being done out there which has no scientific basis,” Nelson says.