Saturday, November 22, 2008

Sublingual Immunotherapy (SLIT): What is it and when will it be available?

Sublingual Immunotherapy (SLIT) is a type of desensitization for allergies where the substances causing allergies (allergens) are placed under the tongue and then swallowed. Some people think of this as placing allergy drops under the tongue. SLIT is currently licensed for use in several European countries, but it is not licensed for use in the U.S. Drug trials have been completed in the U.S. but they did not show a statistically significant benefit over placebo. My office was and is fortunate to be a participant in these studies, through our research department ADAC Research. The manufacturing companies have not given up and have scheduled more trials in the U.S. Stay tuned for details about our next study or check.

Several important questions regarding its use have yet to be answered, to the satisfaction of the F.D.A. and from me. What is the optimal maintenace dose of the allergy extracts? How long should SLIT be given to get the maximum benefit? What is SLIT's long term safety and efficacy? Studies have been completed but they show mixed results. For example, an European study of grass pollen extracts given using SLIT after two years followup showed no benefit (Roder et al 2007). Which allergens can be mixed together safely and with benefit? No combination studies have been done. Benefit has been shown for inidividual allergens: trees, grasses, and dust mites.

I attended the American College of Allergy, Asthma and Immunology's international meeting in Seattle 11/7-12/08. (I was one of perhaps three allergists from South Carolina and the only allergist from the entire Upstate region.) I had an opportunity to listen to and interact with some of the leading researchers in the U.S. during the plenary sessions. This was very stimulating intellectually. I also got to speak with the manufacturers. My impression is that eventually SLIT will be approved in the U.S. Given the current data, I predict SLIT will not be available in the U.S. for at least 3 more years.

2 comments:

Princess Runny said...

Only about 5% of patients with allergies start immunotherapy, yet immunotherapy is recognized as the only disease modifying treatment for allergies and asthma.

There are important advantages of sublingual. Recent studies by Novembre et al showed a four-fold decrease in likelihood of asthma in the group treated with sublingual immunotherapy. No medication can do this.

There is no magic pill for allergies like a ragweed tablet. An FDA approved product which treats only one allergy such as ragweed is at odds with the way most Allergists practice injection therapy which is with a mixture. Immunotherapy mix and dosing should reflect that patients allergies. Individual extracts are already FDA approved. Sublingual application is off-label in the same way that mixing extracts for injection is off-label.

Both injection and sublingual methods work, SLIT is just safer, easier and less expensive so a broader range of allergic patients can be treated. With 5% of allergy sufferers on injection therapy, sublingual immunotherapy could be offered to the other 95% of us.

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