Safety of sublingual immunotherapy with monomeric allergoid in adults: multicenter post-marketing surveillance study.
BACKGROUND
Sublingual immunotherapy (SLIT) appears to be acceptably safe in clinical trials, but post-marketing data are needed to provide essential information. This study specifically 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 allergy were followed up for 3 years by a specific questionnaire for side-effects. SLIT (LAIS, Lofarma SpA, Milan, Italy), a monomeric allergoid in tablets, was administered, in association with drug therapy, pre- or pre-coseasonally 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.
Lombardi
C
C
Allergy and Respiratory Unit, S. Orsola Hospital, Brescia, Italy.
Gargioni
S
S
Melchiorre
A
A
Tiri
A
A
Falagiani
P
P
Canonica
G W
GW
Passalacqua
G
G
D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000008:administration & dosage / Q000009:adverse effects*; D000080384:Allergoids; D003888:Desensitization, Immunologic / Q000009:adverse effects* / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D012130:Respiratory Hypersensitivity / Q000188:drug therapy*; D013607:Tablets; D016896:Treatment Outcome
D000485:Allergens; D000080384:Allergoids; D010936:Plant Extracts; D013607:Tablets