https://orcid.org/0000-0002-5488-5700
Figures & data
Table 1. Batch release specifications for GRAZAX®
Figure 1. Scheme of the immunological response to allergen-specific immunotherapy (AIT). AIT during the early phase of the treatment (1–4 months), induces both mast cell desensitization and upregulation of Th2 response, mediated by high levels of IgE and IL4. During the active phase (1–3 y), a switch of isotype occurs. The levels of IgG4 increase while IgE significantly decrease. In this period is the maximum effect of IgG4 interference. Later, after 3 y of AIT treatment, in the post-therapy period, the regulatory response is established, and levels of IgE and IL4 are significantly decreased
Figure 2. Example of a 5-y prospective clinical trial design
GRAZAX® has three prospective 5-y studies on allergic rhinitis, asthma prevention, and immunological mechanisms.
Figure 3. Clinical outcome of pivotal 5-y study
Magnitude of the effect is similar during active treatment period, as well as during 2-y follow-up. However, underlying immunological mechanisms () greatly vary over the years. Grey bars represent placebo and blue bars represent active treatment.
Figure 4. Summary of clinical trials performed in Europe
GRAZAX® possesses the most complete and comprehensive clinical development programme ever performed in AIT.
Table 2. Summary of main Clinical trials performed with GRAZAX®
