Sublingual immunotherapy with grass pollen is not effective in symptomatic youngsters in primary care

BackgroundSublingual immunotherapy (SLIT) is considered safer and more convenient than subcutaneous therapy and therefore has been proposed as especially suitable for children and in primary care. Most efficacy studies in children lack power to be conclusive, and all have been performed in referral centers.ObjectiveTo investigate the efficacy of SLIT with grass pollen allergen in children and adolescents with rhinoconjunctivitis in a primary care setting.MethodsYoungsters aged 6-18 years with hay fever were enrolled from general practices and randomly assigned to receive placebo or grass pollen mix for 2 years. The primary outcome was the mean daily total symptom score (scale 0-15) comprising sneezing, itching nose, watery running nose, nasal blockage, and itching eyes during the months May-August of the second treatment year.ResultsOut of 204 youngsters randomized, 168 entered the intention-to-treat analysis (91 verum, 77 placebo). The mean daily total symptom score did not differ between participants allocated to verum and those allocated to placebo (difference for verum minus placebo: −0.08, 95%CI, −0.66-0.50; P = .78). No differences were found for rescue medication–free days, disease-specific quality of life, and overall evaluation of the treatment effect. Local side effects were more frequent in the verum group (39% vs 17% of participants; P = .001).ConclusionSublingual immunotherapy with grass pollen in a primary care setting is not effective in children and adolescents.Clinical implicationsCurrently, SLIT cannot be recommended for general practitioners as a therapeutic modality in youngsters with grass pollen allergy.