Post-marketing survey on the safety of sublingual immunotherapy in children below the age of 5 years
Article first published online: 17 MAY 2005
Clinical & Experimental Allergy
Volume 35, Issue 5, pages 560–564, May 2005
How to Cite
Rienzo, V. D., Minelli, M., Musarra, A., Sambugaro, R., Pecora, S., Canonica, W. G. and Passalacqua, G. (2005), Post-marketing survey on the safety of sublingual immunotherapy in children below the age of 5 years. Clinical & Experimental Allergy, 35: 560–564. doi: 10.1111/j.1365-2222.2005.02219.x
- Issue published online: 17 MAY 2005
- Article first published online: 17 MAY 2005
- Submitted 21 July 2004; revised 23 November 2004; accepted 8 February 2005
- respiratory allergy;
- sublingual immunotherapy
Background The age below 5 years is considered a prudential limit for immunotherapy in view of the possible severity of side-effects. Sublingual immunotherapy (SLIT) seems to be safe, but no study in very young children is available. We performed a safety post-marketing surveillance study in children below 5 years.
Methods Children aged 3–5 years with respiratory allergy receiving SLIT were followed-up for at least 2 years. A diary card for side-effects was filled by parents at each dose given. Local and systemic side-effects were graded as: mild (no intervention, no dose adjustment), moderate (medical treatment and/or dose reduction), severe (life-threatening/hospitalization/emergency care). The comparative safety of different allergens and regimens was also assessed.
Results One hundred and twenty-six children (mean age 4.2 years, 67 male) were included. Seventy-six (60%) had rhinitis with asthma, 34 (27%) rhinitis only and 16 (13%) only asthma. Immunotherapy was prescribed for mites (62%), grasses (22.2%), Parietaria (11.9%), Alternaria (2.4%) and olive (1.5%). Eighteen children underwent an accelerated build-up. The total number of doses was about 39 000. Nine side-effects were reported in seven children (5.6% patients and 0.2/1000 doses). Two episodes of oral itching and one of abdominal pain were mild. Six gastrointestinal side-effects were controlled by reducing the dose. All side-effects occurred during up-dosing phase. No difference in terms of safety among the allergens used was observed.
Conclusion SLIT is safe also in children under the age of 5 years.