Safety, tolerability and efficacy of sublingual allergoid immunotherapy with three different shortened up-dosing administration schedules.

Sublingual immunotherapy with monomeric allergoid, given according to the standard schedule, was reported to be effective and safe in many clinical trials. However, a long period of time may elapse before achievement of a clinical benefit. This study was thus performed using two different shortened (4-day) induction (= up-dosing) schedules, which allowed a rapid achievement of the maintenance dosage. Overall, 86 patients suffering from rhinitis and oculorhinitis have been recruited, none of whom had received immunotherapy before. The study design was prospective, randomized, with three parallel groups receiving, according to a randomization list, one of the three induction (two up-dosing one no-up-dosing) phase schedules under study. A fourth group of patients served as controls, and did not receive any sublingual immunotherapy but only rescue medications if and when necessary. All patients were evaluated to assess their baseline conditions, and thereafter at 3 and 6 months. The evaluation parameters were: Visual Analogue Scale, symptom-medication scores, nasal provocation test. All three induction schedules under study were well accepted by the patients, with very few adverse reactions. The clinical efficacy, evaluated with Visual Analogue Scale (p < 0.001), symptom-medication scores (p < 0.02) and nasal provocation tests (p < 0.01), was found to be significant in all three sublingual immunotherapy-treated groups of 64 (n86) patients, but was not significant in controls 22 (n86). According to the Authors, with this simplified schedule process, sublingual immunotherapy is a therapeutic option that is becoming increasingly well-accepted not only by allergy specialists but also by patients.

RCT Entities:   Population Interventions Outcomes