Document Detail

Safety of sublingual immunotherapy with monomeric allergoid in adults: multicenter post-marketing surveillance study.
MedLine Citation:
PMID:  11576079     Owner:  NLM     Status:  MEDLINE    
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. CONCLUSION: The results of this study, performed in a real situation of clinical practice, confirm the satisfactory safety profile of SLIT.
C Lombardi; S Gargioni; A Melchiorre; A Tiri; P Falagiani; G W Canonica; G Passalacqua
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Allergy     Volume:  56     ISSN:  0105-4538     ISO Abbreviation:  Allergy     Publication Date:  2001 Oct 
Date Detail:
Created Date:  2001-09-28     Completed Date:  2001-11-01     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7804028     Medline TA:  Allergy     Country:  Denmark    
Other Details:
Languages:  eng     Pagination:  989-92     Citation Subset:  IM    
Allergy and Respiratory Unit, S. Orsola Hospital, Brescia, Italy.
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MeSH Terms
Administration, Sublingual
Allergens / administration & dosage,  adverse effects*
Desensitization, Immunologic / adverse effects*,  methods
Middle Aged
Plant Extracts / administration & dosage,  adverse effects*
Product Surveillance, Postmarketing
Respiratory Hypersensitivity / drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Allergens; 0/Allergoid; 0/Plant Extracts; 0/Tablets

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