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Sublingual pollen pill provides durable relief.

ORLANDO - Patients who underwent 3 consecutive years of desensitization to grass pollen with seasonal use of a daily, sublingual pill maintained their reduced level of allergy during the following fourth season despite stopping pill treatment, according to results from a study of 432 patients.

The findings provide the first evidence that sublingual desensitization produces allergy disease modification similar to that of subcutaneous desensitization, Dr. Hans-Jorgen Mailing said during a poster presentation at the meeting.

"The data show sustained clinical efficacy when you stop treatment," said Dr. Mailing, professor of medicine at the University of Copenhagen and chief of the allergy clinic at Gentofte Hospital in nearby Hellerup. "That is disease modifying. If there is no efficacy after you stop treatment, then this treatment will not be viable."

Although long-term efficacy is crucial, "up to now, it seems like sublingual is equivalent to subcutaneous," he said in an interview. But Dr. Mailing cautioned that a major test will be the ability of sublingual desensitization to maintain allergy desensitization during a second year off treatment--results that will come during the fifth and final year of the study and will be available a year from now.

Prior reports from the current study documented the ability of the sublingual grass pollen pill to produce desensitization in adult patients during each of the 3 years of active treatment (J. Allergy Clin. Immunol. 2011;128:559-66).

During the first 3 years, the oral desensitization regimen led to progressively higher levels of symptom reduction each year, compared with placebo, a pattern that mimicked what typically occurs with subcutaneous desensitization.

The new results showed that during patients' first year off active treatment, symptom relief showed a trend toward a small dip in efficacy (see box), compared with placebo, although patients also self-reported a maintained, positive effect on their total quality of life scores.

During the first year off treatment, the average adjusted symptom score (the study's primary end point) was 29% below the placebo level among 136 patients who both took the pill starting 2 months before the start of their allergy season and remained in the study. The symptom score was 23% below placebo among the 142 patients who took the pill starting 4 months before the start of their allergy season and remained in the study.

The study initially randomized 633 adult patients with grass pollen allergy at several European centers. Patients began receiving either the active desensitization tablet or placebo at 2 months or 4 months before the onset of their local grass pollen season, and continued daily treatment through the end of the local pollen season. They then resumed the same treatment schedule during the subsequent 2 years. By the end of the fourth year of the study, roughly two-thirds of the initially enrolled patients remained in the study.

The most common adverse effect was mouth pruritus, followed by throat irritation. All the adverse effects were mild or moderate, and their incidence and severity steadily declined during the 3 years of active treatment. No patients had an anaphylactic reaction. The worldwide experience with the sublingual grass pollen tablet has so far resulted in six episodes of "doubtful" anaphylaxis. Dr. Mailing said, adding that the sublingual tablet "is safer" than subcutaneous injections.

The study was sponsored by Stallergenes, which markets the tablet as Oralair in Europe. Dr. Mailing disclosed ties with Stallergenes and several other drug companies.
Symptoms Improved With Sublingual Pill
Percent decline in average adjusted symptom scores relative to
patients on placebo

 Treatment began 2 months Treatment began 4 months
 before start of season before start of season
First season w/o -21% -18%
Second season -35% -32%
w/o active
Third season of -38% -35%
First season w/o -29% -23%

Note: All changes were statistically significant relative to the
placebo patients. Source: Dr. Mailing

Note: Table made from bar graph.


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Author:Zoler, Mitchel L.
Publication:Internal Medicine News
Article Type:Clinical report
Date:Mar 15, 2012
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