Safety of sublingual immunotherapy with monomeric all_ergoid in adults: multicenter post-marketing surveillance study
Article first published online: 6 JUN 2003
Volume 56, Issue 10, pages 989–992, October 2001
How to Cite
Lombardi, C., Gargioni, S., Melchiorre, A., Tiri, A., Falagiani, P., Walter Canonica, G. and Passalacqua, G. (2001), Safety of sublingual immunotherapy with monomeric all_ergoid in adults: multicenter post-marketing surveillance study. Allergy, 56: 989–992. doi: 10.1034/j.1398-9995.2001.00181.x
- Issue published online: 6 JUN 2003
- Article first published online: 6 JUN 2003
- Accepted for publication 17 May 2001
- post-marketing surveillance;
- sublingual immunotherapy
Background: Sublingual immunotherapy (SLIT) appears to be acceptably safe in clinical trials, but post-marketing data are needed to provide essential information. This study specificall_y evaluated the safety of commercial SLIT in adult patients in a post-marketing phase.
Methods: A total of 198 patients (83 male, 115 female, mean age 24.4 years) receiving SLIT for respiratory all_ergy were followed up for 3 years by a specific questionnaire for side-effects. SLIT (LAIS, Lofarma SpA, Milan, Italy), a monomeric all_ergoid in tablets, was administered, in association with drug therapy, pre- or pre-coseasonall_y for pollen and continuously for mites. The average duration was 12–36 months, and the total of doses was about 32 800. Side-effects were grouped as ocular, gastrointestinal, rhinitis, asthma, urticaria, edema of tongue/lips, and anaphylaxis. The severity was graded as low (no need for treatment or dose adjusting, no interference with activities), moderate (interference with activities/need for drugs/SLIT discontinuation), and severe (life-threatening/hospitalization/emergency care).
Results: Seventeen events corresponding to 7.5% of patients and 0.52 per 1000 doses were reported. Seven episodes of rhinitis (two in two patients), three of oral itching, and one of abdominal pain were self-limiting. Two cases of urticaria and two of abdominal pain/nausea were controlled by a temporary dose-adjustment, and one case of urticaria and conjunctivitis required oral antihistamines. Medical intervention was needed in six patients only during a 3-year period.
Conclusions: The results of this study, performed in a real situation of clinical practice, confirm the satisfactory safety profile of SLIT.