An intranasal Syk-kinase inhibitor (R112) improves the symptoms of seasonal allergic rhinitis in a park environment - 18/08/11
, Robert B. Berkowitz, MD b, Elliott B. Grossbard, MD c
Reprint requests: Eli O. Meltzer, MD, Allergy and Asthma Medical Group and Research Center, 9610 Granite Ridge Drive, Suite B, San Diego, CA 92123-2661.San Diego and South San Francisco, Calif, and Woodstock, Ga
Abstract |
Background |
R112 inhibits Syk kinase, a transducer of signaling through the Fcε receptor of mast cells, blocking mast cell responses to allergic stimuli.
Objective |
Examine the efficacy and safety of intranasal R112 in volunteers with symptomatic seasonal allergic rhinitis compared with a placebo in a park setting.
Methods |
In this double-blind, placebo-controlled study of 319 volunteers with seasonal allergic rhinitis, 160 were randomized to intranasal R112 and 159 to a vehicle control during 2 days at 2 separate locations in spring 2004. Subjects were evaluated for symptoms of allergic rhinitis (ie, sneezes, runny nose/sniffles, itchy nose, stuffy nose) on the basis of a possible maximum score of 32 for the Global Symptom Complex (GSC) scale. The primary outcome evaluated was the difference in the reduction in GSC (area under the curve over a period of 8 hours) from baseline between R112 and vehicle placebo.
Results |
At baseline, the combined GSC was 
18/32 and equal between treatment groups. After 8 hours (dosing 3 mg/nostril every 4 hours × 2), R112 significantly reduced the GSC compared with placebo (7 vs 5.4 units, respectively; P=.0005). Each individual symptom combined to form the GSC was also significantly improved in the R112 group compared with control (P < .05). As early as 45 minutes after dosing, R112 showed a significant improvement in symptoms over placebo, and the duration of action exceeded 4 hours. Adverse effects were indistinguishable between the groups and clinically insignificant.
Conclusion |
Intranasal R112 was effective in this park study and is a promising new treatment for seasonal allergic rhinitis.
El texto completo de este artículo está disponible en PDF.Key words : Allergic rhinitis, mast cell inhibition, R112, park study, mast cell mediators, Syk-kinase
Abbreviations used : ANCOVA, AUC, GSC, ITT, SAR
Esquema
| Supported by Rigel Inc, San Francisco, Calif. Disclosure of potential conflict of interest: E. O. Meltzer is a consultant to Alcon, Altana, AstraZeneca, Sanofi, Aventis, Corixa, Critical Therapeutics, Dey, Genentech, GSK, Greer, Merck, MedPointe, Pfizer, Rigel, Schering, and Wyeth; has received grants/research support from Alcon, Altana, AstraZeneca, Sanofi, Aventis, Genentech, GSK, Novartis, Pfizer, Schering, Rigel, Wyeth, and Merck; is employed by the Allergy and Asthma Medical Group and Research Center; and is on the speakers' bureau for Sanofi, Aventis, AstraZeneca, Genentech, GSK, Merck, Pfizer, and Schering. R. Berkowitz is a consultant for multiple pharmaceutical companies and has received multiple research grants. E. Grossbard has stock/other equity ownership in Rigel and is employed by Rigel. |
Vol 115 - N° 4
P. 791-796 - avril 2005 Regresar al número
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