SLIT Study in U.S. Boosts Chances for FDA Approval
A study published in the Journal of Allergy and Clinical Immunology by an allergic disease specialist at Allegheny General Hospital states that oral allergy treatment, or sublingual immunotherapy (SLIT), is a "safe and effective alternative to injections for adults who are allergic to ragweed pollen," reports Medical News Today.
As covered in our recent Allergy Consumer Report feature article, Sublingual Immunotherapy Offers Hope of a Cure for Allergies, SLIT is widely used in Europe, but is not yet approved by the United States Food and Drug Administration (FDA). The study might help change this.
As David Skoner, MD, director of AGH's Division of Allergy, Asthma and Immunology and a co-lead investigator in the study puts it, "The study's findings mark a step forward in gaining approval for sublingual administration of allergy medication. We believe a large number of patients would greatly benefit from having access to this new oral treatment to ease their symptoms."
The study involved 115 patients who were randomly assigned to a medium or high dose of standardized glycerinated short ragweed pollen extract or to a placebo. The patients kept journals of their symptoms over the course of 17 weeks during ragweed pollen season. Results showed that frequency of daily symptoms and the need for additional medication were significantly lower in the group taking the high-dose medication versus those on the placebo. The frequency of adverse events was similar in both groups, indicating little risk in undergoing SLIT.
Co-investigator Deborah Gentile, MD, Director of Research in AGH's Division of Allergy, Asthma and Immunology says, "The sublingual method so far has been safe, and the adherence rate should be better because no injections are involved and the medication is administered at home."
Overall, the researchers concluded that SLIT was safe and effective in reducing symptoms in ragweed-allergic individuals; however, they also suggested that additional trials are needed to definitively establish efficacy. Additionally, questions remain regarding treatment schedules, optimal doses, and cost-effectiveness.
This latter issue – cost-effectiveness – could be greatly alleviated once FDA approval is gained and insurance can begin covering SLIT. We look forward to more such studies that will hopefully push SLIT further toward FDA approval and put a promising allergy treatment option within reach for so many allergy sufferers.
As covered in our recent Allergy Consumer Report feature article, Sublingual Immunotherapy Offers Hope of a Cure for Allergies, SLIT is widely used in Europe, but is not yet approved by the United States Food and Drug Administration (FDA). The study might help change this.
As David Skoner, MD, director of AGH's Division of Allergy, Asthma and Immunology and a co-lead investigator in the study puts it, "The study's findings mark a step forward in gaining approval for sublingual administration of allergy medication. We believe a large number of patients would greatly benefit from having access to this new oral treatment to ease their symptoms."
The study involved 115 patients who were randomly assigned to a medium or high dose of standardized glycerinated short ragweed pollen extract or to a placebo. The patients kept journals of their symptoms over the course of 17 weeks during ragweed pollen season. Results showed that frequency of daily symptoms and the need for additional medication were significantly lower in the group taking the high-dose medication versus those on the placebo. The frequency of adverse events was similar in both groups, indicating little risk in undergoing SLIT.
Co-investigator Deborah Gentile, MD, Director of Research in AGH's Division of Allergy, Asthma and Immunology says, "The sublingual method so far has been safe, and the adherence rate should be better because no injections are involved and the medication is administered at home."
Overall, the researchers concluded that SLIT was safe and effective in reducing symptoms in ragweed-allergic individuals; however, they also suggested that additional trials are needed to definitively establish efficacy. Additionally, questions remain regarding treatment schedules, optimal doses, and cost-effectiveness.
This latter issue – cost-effectiveness – could be greatly alleviated once FDA approval is gained and insurance can begin covering SLIT. We look forward to more such studies that will hopefully push SLIT further toward FDA approval and put a promising allergy treatment option within reach for so many allergy sufferers.
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