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Federica Fumagalli

Publications and source records attributed to Federica Fumagalli.

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New insights in sublingual immunotherapy.

Sublingual immunotherapy (SLIT) is accepted in the official documents and is currently used in many European countries. In recent years, new clinical data on efficacy and safety have been published, including meta-analyses in adults and children and surveys of safety in children younger than age 5 years. Moreover, it has been shown that, similar to the injection route, SLIT can prevent the onset of new sensitizations and the onset of asthma. Additionally, the mechanisms of action are beginning to be systematically studied. Some points need further investigation, such as the effect in asthma, the mechanisms of action, and the optimal dose to be administered.

Administration, Sublingual↗

Safety profile of sublingual immunotherapy.

Sublingual immunotherapy (SLIT) was proposed for clinical practice about 20 years ago with the main aim of improving the safety and avoiding the adverse effects of traditional treatment for allergic airways disease. To date, 32 randomized controlled trials and 6 postmarketing surveys have been published that provide a robust documentation of the safety profile of the treatment.Looking at the randomized trials it emerges that the more frequent adverse event of SLIT is oral itching or swelling, followed by gastrointestinal complaints. These adverse events are invariably described as mild and easily managed by adjusting the dose. Relevant systemic adverse events (asthma, urticaria, angioedema) occur sporadically and, with the exception of oral/gastrointestinal adverse events, the incidence of adverse events seems not to differ between the placebo and active groups. The safety profile of SLIT does not differ between adults and children.The postmarketing surveys consistently show that the incidence of adverse events associated with SLIT is less than 10%, corresponding to less than 1 adverse event per 1000 doses, and is thus quite superior to the safety profile of subcutaneous immunotherapy. Of note, the most recent data show that the rate of adverse events with SLIT is not increased in children below the age of 5 years.

Administration, Sublingual↗

Sublingual and oral immunotherapy.

Sublingual immunotherapy (SLIT) is a viable alternative to the subcutaneous route for the treatment of respiratory allergy, whereas the pure oral route has been abandoned because of its lack of efficacy. The main distinctive feature of SLIT is its optimal safety profile, which has been demonstrated in adults and children. The indications for SLIT are similar to those for the subcutaneous route. A long-lasting effect has been demonstrated for the sublingual route, but data are needed to determine the optimal dose and the preventive effect in asthma.

Administration, Oral↗

Safety of allergen-specific sublingual immunotherapy and nasal immunotherapy.

Allergen-specific immunotherapy is a well-established treatment for respiratory allergy. It is usually administered subcutaneously, and with this route several severe adverse events and fatalities have been described. Therefore, in the last 15 years, novel routes of administration (local routes) were developed. Sublingual and local nasal immunotherapy are now considered as viable alternatives to the injection route, mainly due to their optimal safety. The use of nasal immunotherapy is at present declining. On the other hand, sublingual immunotherapy was investigated in twenty-two randomized controlled trials and two postmarketing surveys: its safety profile turned out to be satisfactory in both adults and children, gastrointestinal complaints being the most frequently reported side effects. These side effects were always mild and could be treated with proper dose adjusting. At variance with injection immunotherapy, no severe systemic adverse event has ever been described. Its safety is also supported by pharmacokinetics and immunological data. Experimental data on the safety of sublingual and nasal immunotherapy will be reviewed.

Administration, Intranasal↗

Sublingual immunotherapy.

Allergen-specific immunotherapy, together with drug therapy and allergen avoidance, is a cornerstone in the management of respiratory allergy in both adults and children. Since the introduction of sublingual administration of immunotherapy (SLIT), it was regarded as the most promising approach, especially because of its optimal safety profile. After 15 years of clinical trials, the WHO officially accepted SLIT as a routine clinical option in both adults and children. This paper reviews the up-to-date aspects about clinical efficacy, safety and pharmacokinetics of sublingual immunotherapy.

Administration, Sublingual↗