ALK-Abelló (Italy)

Atopic Dermatitis (AD) is a common inflammatory itching skin disease1. This skin disorder affects a large number of children and adults2. Epidemiological studies show that up to 25% of children and up to 3% of adult are affected worldwide3. Several studies in addition suggest an increasing prevalence of AD. The clinical picture of AD is dominated by chronic eczematous skin lesions in typical localizations4. In infants and small children, the rash is often present on the skin around the knees and elbows and the cheeks5. In teenagers and adults, the rash is often present in the creases of the wrists, elbows, knees or ankles, and on the face or neck. Symptoms commonly could vary from person to person. The most common symptoms are dry, itchy skin and rashes on the face, inside the elbows and behind the knees, and on the hands and feet6. Itching is the most relevant and common symptom of atopic dermatitis. Scratching and rubbing in response to itching irritates the skin, increases inflammation, and actually increases itchiness. Itching is a particular problem during sleep when conscious control of scratching is lost. The appearance of the skin that is affected by atopic dermatitis depends on the amount of scratching and the presence of secondary skin infections. The skin may be red and scaly, be thick and leathery, contain small raised bumps, or leak fluid and become crusty and infected. These features can also be found in people who do not have atopic dermatitis or who have other types of skin disorders. Atopic dermatitis may also affect the skin around the eyes, the eyelids, and the eyebrows and lashes. Scratching and rubbing the eye area can cause the skin to redden and swell. Some people with atopic dermatitis develop an extra fold of skin under their eyes. Patchy loss of eyebrows and eyelashes may also result from scratching or rubbing. In addition clinically unaffected skin in AD is not normal. It is frequently dry and has a greater irritant skin response than normal healthy skin7. Microscopic studies reveal a sparse perivascular T-cell infiltrate in unaffected AD skin that is not seen in normal healthy skin8. There is a marked infiltration of CD41 activated memory T cells in acute AD9. Antigenpresenting cells (eg, Langerhans cells inflammatory dendritic epidermal cells and macrophages) in lesional and, to a lesser extent, in nonlesional skin bear IgE molecules10.

Background. Allergen-specific sublingual immunotherapy (SLIT) is considered a causal treatment of respiratory allergies. Compliance to the SLIT is an important aspect for a positive clinical outcome. Study Aim. To evaluate if compliance with grass Allergy Immunotherapy Tablet (AIT) can be increased by providing an electronic compliance device (CED) (Memozax; a tablet-container with a programmable daily acoustic alarm). Patients and Methods. 261 patients with grass allergy were enrolled and randomized (1 : 1) to 1-year treatment with AIT (Grazax) using a CED (group A; n = 122) or without (Group B, n = 139). Compliance was measured through tablet count at each visit. Results. The 12-month compliance, mean (SD), in group A was 83% (21) and 83% (24) in group B. A total of 81% of patients reported a significant clinical improvement of symptoms after treatment in comparison with the previous year. No severe adverse reactions were observed in the study. Conclusion. Compliance to the treatment with AIT administered for 12 consecutive months is in general good. The use of CED is not associated with a greater compliance. AIT treatment was associated with a significant clinical improvement in >80% of patients with a good tolerability and safety profile.

Immunotherapy (IT) is the only causal treatment for allergic subjects recognized to be effective and to offer long-lasting efficacy. The noninjective routes, aimed at improving the safety of the treatment, have been validated as effective in adults, but documentation of their safety in children is still poor. The aim of the present survey study was to assess the safety of sublingual immunotherapy in pediatric patients, by evaluating a large population. A total of 268 children (aged 2-15 years), receiving sublingual IT for respiratory allergy, were followed-up over a period ranging from 3 months to 7 years (mean 34 months). The side-effects possibly due to the treatment were recorded on a proper diary card; self-assessment of the clinical outcome was also evaluated. About 96000 doses of extract were globally administered. Local side-effects were of no clinical relevance. Eight side-effects were reported (3% of patients; 0.083 per 1000 doses). Seven systemic side-effects (abdominal pain, conjunctival itching, and rhinitis) were mild and required no treatment. One case of urticaria was well controlled with oral antihistamines. No life-threatening event occurred. The clinical outcome was judged excellent or good by 80% of the patients. The sublingual IT herein investigated appeared to be well tolerated and safe in pediatric patients. The risk/benefit ratio was therefore favorable.