The results of this study were presented in part as poster presentations at the XXIXth Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in London, UK, June 2010.
A randomized placebo-controlled trial of rush preseasonal depigmented polymerized grass pollen immunotherapy*
Article first published online: 23 NOV 2011
© 2011 John Wiley & Sons A/S
Volume 67, Issue 2, pages 272–279, February 2012
How to Cite
Pfaar, O., Urry, Z., Robinson, D. S., Sager, A., Richards, D., Hawrylowicz, C. M., Bräutigam, M. and Klimek, L. (2012), A randomized placebo-controlled trial of rush preseasonal depigmented polymerized grass pollen immunotherapy. Allergy, 67: 272–279. doi: 10.1111/j.1398-9995.2011.02736.x
- Issue published online: 11 JAN 2012
- Article first published online: 23 NOV 2011
- Accepted for publication 23 September 2011 Edited by: Thomas Bieber
- allergic rhinitis;
- depigmented polymerized allergen extract;
- grass pollen;
- specific subcutaneous immunotherapy
To cite this article: Pfaar O, Urry Z, Robinson DS, Sager A, Richards D, Hawrylowicz CM, Bräutigam M, Klimek L. A randomized placebo-controlled trial of rush preseasonal depigmented polymerized grass pollen immunotherapy. Allergy 2012; 67: 272–279.
Background: Specific subcutaneous immunotherapy (SCIT) for seasonal rhinoconjunctivitis with unmodified allergen extracts is effective, but limited by risk of side-effects and involves treatment over 3 years. We examined a depigmented polymerized grass pollen extract for immunogenicity and for clinical efficacy in a rush preseasonal regimen.
Methods: Depigmented polymerized grass pollen extract was tested for proliferation and cytokine production by peripheral blood mononuclear cells. A prospective, double-blind, placebo-controlled trial of 195 grass pollen allergic patients treated with preseasonal rush immunotherapy using depigmented polymerized allergenic extract of mixed grass pollen was performed over 2 years. Primary outcome was combined symptom and medication score (SMS) during the peak of the second grass pollen season. Secondary outcomes included combined score over the whole season, during the first grass pollen season, individual symptom and medication scores, quality of life, well days/hell days and responder analysis. Adverse events were classified using the EAACI scale. Grass pollen-specific IgE and IgG4 were measured before and during treatment.
Results: Depigmented polymerized extract stimulated dose-dependent T-cell proliferation and cytokine production. Patients treated with preseasonal SCIT showed improved combined scores during peak season at year 2 (median 3.93, interquartile range 0.77–6.27 vs median 5.86 for placebo, 3.11–8.36, P < 0.01). Most secondary outcomes were significantly better for active treatment. Side-effects were minimal, with no grade 3 or 4 reactions.
Conclusions: Depigmented polymerized grass pollen extract is immunogenic and clinically effective in rush preseasonal SCIT. This form of immunotherapy may be an attractive option for some patients.