title: Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents.
abstract: The efficacy and safety of five-grass pollen 300IR sublingual immunotherapy (SLIT) tablets (Stallergènes SA, France) have previously been demonstrated in paediatric patients. This report presents additional data concerning efficacy at pollen peak, efficacy and safety according to age, nasal and ocular symptoms, use of rescue medication, satisfaction with treatment and compliance. Children (5-11 yr) and adolescents (12-17 yr) with grass pollen-allergic rhinoconjunctivitis were included in a multinational, randomized, double-blind, placebo-controlled study and received either a 300IR five-grass pollen tablet or placebo daily in a pre- (4 months) and co-seasonal protocol. The severity of six symptoms (sneezing, rhinorrhoea, nasal congestion, nasal and ocular pruritis, and tearing) was scored, and rescue medication use was recorded daily during the pollen season. Patient satisfaction was recorded at the season end. A total of 161 children and 117 adolescents were evaluated (n = 267). 300IR SLIT was effective over the whole season (p = 0.0010) and at the pollen peak (p = 0.0009). The adjusted mean difference between 300IR and placebo groups was significant for both nasal (p = 0.0183) and ocular (p < 0.0001) symptoms. Rescue medication use was statistically lower in the SLIT group during the pollen season and at the pollen peak (both p < 0.05). More patients in the SLIT group were satisfied with their treatment compared to placebo (83.2% vs. 68.1%, p = 0.0030), and compliance was high (SLIT 93.9% of patients were compliant, placebo 94.8% of patients were compliant). SLIT was well tolerated by children and adolescents. 300IR five-grass pollen tablets are effective and safe during the pollen season and at the pollen peak in children and adolescents with grass pollen rhinoconjunctivitis.
authors: Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, Denmark.
authors: Susanne
authors: S
authors: Halken
authors: Lone
authors: L
authors: Agertoft
authors: Jürgen
authors: J
authors: Seidenberg
authors: Carl-Peter
authors: CP
authors: Bauer
authors: François
authors: F
authors: Payot
authors: Maria Flora
authors: MF
authors: Martin-Muñoz
authors: Małgorzata
authors: M
authors: Bartkowiak-Emeryk
authors: Andrea
authors: A
authors: Vereda
authors: Stephanie
authors: S
authors: Jean-Alphonse
authors: Michel
authors: M
authors: Melac
authors: Martine
authors: M
authors: Le Gall
authors: Ulrich
authors: U
authors: Wahn
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000367:Age Factors; D000485:Allergens / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D010349:Patient Compliance; D017060:Patient Satisfaction; D006109:Poaceae / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000453:epidemiology / Q000276:immunology / Q000628:therapy*; D012621:Seasons; D013607:Tablets / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000485:Allergens; D013607:Tablets