Phase ii/iii clinical trial to assess the tolerability and immunological effect of a new updosing phase of dermatophagoides mix–based immunotherapy

Background: immunologically enhanced subcutaneous specific immunotherapy (scit) has been developed with a fast and simplified updosing phase containing equal parts of the house dust mites (hdm) dermatophagoides pteronyssinus and dermatophagoides farinae (dermatophagoides mix) adsorbed on aluminum hydroxide. objective: to evaluate the tolerability and immunological impact of the updosing phase of this new allergen extract formulation. material and methods: we performed a multicenter,open-label,single-arm,phase ii/iii clinical trial. the inclusion criteria were a clinical history of rhinitis/conjunctivitis due to hdm (with/without asthma) and sensitization to hdm (positive specific ige and skin prick test). five updosing injections of dermatophagoides mix (300,600,3000,6000,and 15 000 sq+) were administered at weekly intervals with 1 maintenance injection (15 000 sq+) 2 weeks after the last updosing injection. two days after each visit,patients were contacted by telephone to follow up on any adverse events. ige-blocking factor,igg4,and immediate skin reactivity were evaluated. results: the sample comprised 102 patients (mean [sd] age,29.3 [7.7] years; male,52.9%). there were 117 adverse drug reactions (adr): 101 were local,regardless of reaction size,in 48 (47.1%) patients and 7 were systemic (all grade i) in 5 (4.9%) patients. all adrs were mild,except for 1,which was moderate. six weeks of treatment led to statistically significant increases in ige-blocking factor and igg4,as well as a significant reduction in immediate skin reactivity. conclusion: this new updosing phase of dermatophagoides mix–based immunotherapy had a good tolerability profile and induced a significant immunological effect. © 2015 esmon publicidad.