Safety and tolerability of a One-Strength dose-escalation regimen with house dust mite subcutaneous immunotherapy in routine medical care

Accelerated dose escalation for subcutaneous immunotherapy (SCIT) is an important step toward enhancing the convenience and acceptance of SCIT. For a native house dust mite (HDM) SCIT product, the safety and tolerability of an accelerated dose-escalation scheme (One-Strength) was previously shown in a randomized phase II trial [ 1 ]. This prospective, multicenter, non-interventional study aimed to investigate the safety and tolerability of dose escalation with the One-Strength scheme of HDM SCIT under routine medical care conditions in patients aged 12 years and older with HDM-allergic rhinitis/rhinoconjunctivitis with or without asthma. Overall, 337 patients received at least one injection of HDM SCIT, of whom 105 patients experienced at least one adverse drug reaction (ADR), most of which were local reactions at the injection site (92.5%). Overall, 11 patients developed 26 systemic ADRs with symptomatology typical of AIT. Serious ADRs were observed in four patients. All reported ADRs were expected for the HDM SCIT product. A higher frequency of ADRs was observed in patients with asthma versus those without asthma, and in adults versus adolescents. However, the small number of patients with asthma and adolescents precludes firm conclusions. More than 90% of patients and physicians assessed the overall tolerability of the therapy as “very good” or “good.” Overall, 98.0% of patients planned to continue the SCIT with the HDM product. This non-interventional study showed that the One-Strength dose-escalation schedule with the HDM SCIT product is safe and well-tolerated in routine medical care of adults and adolescents. The results confirm those of the previous phase II clinical trial [ 1 ].