A One-Strength Dose Escalation Regimen for Birch Pollen Subcutaneous Immunotherapy Is Safe and Tolerable in Children, Adolescents, and Adults.

Abstract

Allergen immunotherapy is the only disease-modifying treatment for IgE-mediated diseases for patients 5 years and over. The question is often asked why children receive the same doses as adults. There is not a single dose-finding study including children and/or adolescents. Moreover, randomized controlled trials that include all age groups but report effects separately are rare. This randomized trial investigated the safety and tolerability of an accelerated dose escalation schedule (One-Strength group) compared to the standard regimen (Standard group) when using a birch pollen SCIT allergoid in patients aged 5-65 years. Overall, 201 patients were randomized to the two regimens: 87 adults, 52 adolescents, 62 children. Three hundred eighty-two treatment-related adverse drug reactions (ADRs) occurred in 81 patients (40.5%). A higher proportion of patients in the One-Strength group (48.5%) experienced at least one ADR compared to those in the Standard group (32.0%). The majority of ADRs were local (93.3%), and the majority were of mild intensity (95.8%). 3 patients in the One-Strength and 1 patient in the Standard group developed a total of 9 systemic ADRs, which all were classified as WAO grade 1 or 2 and most of mild intensity. No event of WAO grade 3 or higher was reported. No serious ADR occurred. Overall, tolerability was assessed as "very good" or "good" by more than 96% of investigators and patients. Safety and tolerability were comparable in the three age groups. Birch pollen SCIT was safe and well-tolerated when administered using a One-Strength dose-escalation regimen in patients aged 5-65 years.