Safety and Efficacy of Juniperus ashei Sublingual-Swallow Ultra-Rush Pollen Immunotherapy in Cypress Rhinoconjunctivitis
A Double-Blind, Placebo-Controlled StudyVervloet D. · Birnbaum J. · Laurent P. · Hugues B. · Fardeau M.F. · Massabie-Bouchat Y.P. · Aferiat-Derome A. · André C.
aUPRES EA 3287, Service de Pneumologie, Hôpital Sainte-Marguerite and b Private practice, Marseille, cPrivate practice, Salon de Provence, dPrivate practice, Aix en Provence, and eScientific and Medical Department, Stallergènes, Antony, France
Background: The safety and efficacy of high-dose sublingual-swallow immunotherapy (SLIT) has been established in pollen rhinoconjunctivitis. This treatment has now been evaluated using an ultra-rush incremental dose regimen with a Juniperus ashei allergen extract in patients allergic to Cupressus sempervirens and Cupressus arizonica. Methods: Patients received either placebo or SLIT. Evaluation of safety was based on the frequency of adverse events during the incremental dose period (half a day) and during maintenance therapy (4 months). Evaluation of efficacy was based on symptom and medication scores at the pollen peak. Results: Seventy of the 76 patients included completed the study. There were no drop-outs during the rush procedure. One patient in the active group dropped out during the maintenance therapy due to adverse events: gastric pain and vomiting. There was also 1 drop-out in the placebo group due to pregnancy. Adverse events were infrequent, local and mild. Symptom scores for rhinitis and conjunctivitis were not statistically different between groups, but there was a marked and significant (p < 0.03) decrease of the medication score (about 50%) and nasal steroid consumption (about 75%) in the active treatment group. An increase from baseline of serum IgE and IgG4 J. ashei-specific antibodies was only observed in actively treated patients (p < 0.04 and p < 0.01, respectively). Conclusions: The tolerability and safety of high-dose ultra-rush SLIT were comparable to those reported in previous SLIT studies. SLIT with J. ashei extract, due to its high Jun a 1 content, significantly reduced nasal steroid consumption in patients allergic to European cypress.