Fall in Tennessee means ragweed pollen season is upon us. Next to tree pollen in the springtime, ragweed is the outdoor allergen that causes the most acute misery in our area. Treatment options for ragweed allergy, just like other allergies, include avoidance, medications and immunotherapy — either sublingually (under the tongue) or via injection. Until recently there have been no FDA-approved products for sublingual use. Now, as we have blogged about before, there are a couple of new options that have been approved by the FDA. I’ve written about the grass tablets specifically, so in this post I’ll tackle the ragweed tablet, Ragwitek, and try to lay out the pros and cons as I see them.
When evaluating a new treatment, the two questions you must answer are 1) Is it safe? and 2) Does it work? In the case of the new ragweed tablet, the answers to those questions are 1) Yes. and 2) Yes, but…. First off, all forms of sublingual immunotherapy (SLIT) are generally safer than shots. Though SLIT reactions are rare, they are not unheard of and the package insert for Ragwitek clearly states that it has the potential to cause severe reactions. Because of this, the first dose of Ragwitek must be given in a physician’s office and the patient must be observed for 30 minutes afterward. Though the risk for severe systemic reactions is low, studies reported significant local side effects, including itching of the ears, tongue, mouth and throat, in 5-20% of patients. One study reported tongue swelling in 19% of patients, swelling of the upper airway in 5%, and irritation of the throat in almost 30%. Most of these side effects get better over time, and while the majority of patients were able to complete the studies, a significant minority of patients (25-30%) did not complete the trials for various reasons, including side effects and adverse events.
The effectiveness question is a bit more complicated. Study patients using Ragwitek generally showed around a 25% reduction in symptoms when compared with placebo. That’s a great number, but it is not clear whether the response seen in the study patients is applicable to the average ragweed allergic patient. The problem is, these studies excluded patients who had non-ragweed allergies that required treatment during the ragweed allergy season. Since patients requiring ongoing treatment for cat or dog allergy, allergies to dust mites or molds, or allergies to other weeds were excluded from the study, it is unclear whether such patients would derive any benefit from Ragwitek. Because it is so rare to find a patient who has ragweed as his or her only significant allergen during ragweed season, it is difficult to draw conclusions from these studies that apply to the general allergy population. In selected patients, however, Ragwitek does appear to have benefits in both reducing symptoms and medication usage.
Another hurdle for Ragwitek is the timing of administration. The effectiveness of Ragwitek when started during ragweed season has not been established. Instead, it has to be started 12 weeks prior to ragweed season and continued during the season. In Tennessee that means starting some time in May and continuing daily treatment until the first frost, which is usually in late October or early November. This adds up to around 6 months of daily therapy. So if you’re looking for relief this season, you’re out of luck.
Finally, a word about cost. Ragwitek is an expensive product. Each pill wholesales for $8.25, so for 180 days of therapy the cost comes out to $1,485.00. And that’s just for a single season of allergies related to just ragweed. This, of course, represents the cost to the insurance company, not the patient who will, however, have to bear the top-tier pharmacy co-payment for each monthly prescription. Since allergy shots are covered by insurance without a co-paymant, treat all of a patient’s allergies, and give long-term desensitization, they are a comparative bargain.
In summary, Ragwitek has been shown to be safe enough for home administration and has been shown to be effective at reducing allergies due to ragweed in a very select patient population. It does have frequent, significant side effects and the cost is not inconsequential. Because of the numerous complexities surrounding Ragwitek, I would strongly recommend consulting with a board-certified allergist if you are considering this potential therapy.