Treatment of seasonal allergic rhinoconjunctivitis with a once-daily SQ-standardized grass allergy immunotherapy tablet

Abstract

Objectives:

Specific immunotherapy with the grass allergy immunotherapy tablet (AIT) has been developed as an effective, well tolerated, and convenient treatment for grass pollen induced seasonal allergic rhinoconjunctivitis (ARC). Six phase II/III randomized, placebo-controlled trials with the duration of a single grass pollen season of treatment using the SQ-standardized grass AIT, Grazax (Phleum pratense, 75,000 SQ-T/2,800 BAU, ALK, Denmark), have been published previously. This review compares results from these trials.

Methods:

As outcome measures and methods of assessing them were similar across the trials, we have summarized the main efficacy findings (Total Combined Score [TCS], average daily rhinoconjunctivitis symptom and medication scores, percentage of well days, quality of life scores) during a single season of treatment with grass AIT in adults and children with seasonal ARC.

Results:

The results of the European and North American trials were similar. Compared with the placebo group, who received symptomatic medications only, treatment with grass AIT resulted in fewer rhinoconjunctivitis symptoms, a lower intake of symptomatic medication, better patient self-rated quality of life and a greater percentage of well days during the entire grass pollen season. The data indicate that grass AIT treatment is equally effective in adults and children; the measured effect varies with pollen exposure, but is comparable across regions and continents, with a consistent difference compared with placebo in TCS that was above 20% for all trials. Local adverse events were experienced by the majority of patients. These reactions were generally mild to moderate in severity and transient in duration. Systemic adverse events were rare.

Conclusions:

This review confirms SQ-standardized grass AIT as a suitable therapeutic option for seasonal use in patients aged 5 years or older with grass pollen induced ARC.

Key words::

• Adult
• Allergic rhinoconjunctivitis
• Children
• Grass pollen
• Grass allergy immunotherapy tablet
• Specific immunotherapy

Transparency

Declaration of funding

ALK-Abello has sponsored the European studies included in this manuscript. Sherring-Plough / Merck has sponsored the North American trials.

Declaration of financial/other relationships

H.N. was a principle investigator on an ALK-Abello grant to National Jewish to assess the potency of a dog dander extract and is a consultant to Merck on their studies of AIT in the USA. L.L. is an employee of ALK. M.S.B. is a speaker and consultant for Merck.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

Editorial assistance in the preparation of this manuscript was provided by Watermeadow Medical, UK and funded by ALK-Abello.