Sublingual Tablets Provide Effective and Safe Immunotherapy for Grass Pollen Allergy: Presented at EAACI

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Title: Sublingual Tablets Provide Effective and Safe Immunotherapy for Grass Pollen Allergy: Presented at EAACI
URL: http://www.pslgroup.com/dg/2235E2.htm
Doctor's Guide
June 11, 2008

By Chris Berrie

BARCELONA, Spain -- June 11, 2008 -- Sublingual immunotherapy (SLIT) with grass pollen tablets is efficacious and shows a good safety profile for children with grass pollen rhinoconjunctivitis, according to a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.

Previously, a meta-analysis indicated little evidence for final conclusions about the benefits of SLIT in children said Ulrich Wahn, MD, Allergy Centre Charité, Campus VirchowKlinikum, Berlin, Germany.

But the new study presented here at the 27th Congress of the European Academy of Allergology and Clinical Immunology (EAACI) provides evidence in favour of SLIT in this population, Dr. Wahn said. "I think this time is changing now, and we should all be open to change our minds, if necessary," he noted in an oral presentation on June 9.

To evaluate the efficacy and safety of 5-grass-pollen SLIT tablets in children with grass pollen rhinoconjunctivitis, Dr. Wahn and colleagues enrolled 278 children aged 5 to 17 years who had seasonal grass-pollen related rhinoconjunctivitis for 2 years or more, a positive skin test, and serum specific immunoglobulin E class 2 or greater.

No previous similar immunotherapy was allowed, and patients had to be asymptomatic to other allergens during the grass pollen season.

Patients underwent an initial 4-week screening period, after which 139 patients were randomised to placebo and 139 to active SLIT pretreatment. The treatment groups were well matched for asthma (21.5% vs 21.4%, respectively) and monosensitisation (40.7% vs 41.2%, respectively).

The treatments were started 4 months prior to the estimated start of the pollen season. The 3-day titration schedule started at 100 IR, and the final dose of 300 IR lasted for a maximum of 5 months.

The primary efficacy outcome was evaluated using the Rhinoconjunctivitis Total Symptom Score (RTSS) for sneezing, rhinorrhoea, nasal pruritis, nasal congestion, watery eyes, and ocular pruritis. The secondary efficacy outcomes were use of rescue medications and safety.

Overall compliance rates for placebo and active treatment were 95% and 94%, respectively, and the primary RTSS outcome was expressed as differences in adjusted means for active treatment versus placebo.

Over the full pollen season, the RTSS saw significant benefit of active treatment (-1.13; P = .001), which was also significant through the worst pollen period of the season (-1.27; P = .0009). The median improvement of RTSS over placebo for the intention-to-treat (ITT) populations over the season and at peak pollen levels were 39.3% and 42.9%, respectively. As individual symptom scores, only nasal pruritis and sneezing did not show significance for the benefits seen.

The use of rescue medication for the active treatment ITT population also showed significant seasonal (48.7%) and peak (51.7%) improvements, with the proportion of symptom-free days significantly improved (placebo, 2.44 days; active, 14.29 days). However, the age subgroups of 5 to 11 years versus 12 to 17 years showed no significant differences in treatment efficacy (39.4% vs 35.0%).

For safety, expected local effects were seen, mainly when beginning treatment; the majority were mild or moderate (>=5% incidence: mouth oedema, oral pruritis, throat irritation).

While noting that for the immunological markers, IgG₄ increased under active treatment, Dr. Wahn concluded that the safety and efficacy of 300 IR sublingual tablets was here confirmed in a paediatric population aged from 5 to 17 years.

Funding for this study was provided by Stallergenes.

[Presentation title: Efficacy and Safety of Five Grass Pollen Sublingual Tablets in Children and Adolescents With Grass Pollen Rhinoconjunctivitis. Abstract O94]

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