The safety of a novel sublingual rush induction phase for latex desensitization

Abstract

Objectives:

In latex allergic individuals the avoidance of all exposure to natural rubber latex products is recommended. Sublingual immunotherapy against latex has recently been proposed. The aim of the study is to evaluate the tolerability of sublingual immunotherapy with latex extract, by a double-blind, placebo-controlled study, according to a three-day build-up phase rush protocol in a population of patients with latex-induced contact urticaria without a professional exposure to latex.

Methods:

Twenty-one patients with latex-induced urticaria were randomized to receive sublingual immunotherapy (SLIT) with latex extract or placebo. Rush (3-day) induction protocol of latex sublingual immunotherapy was performed with increasing doses of ALK-Abelló latex extract at three concentrations of latex proteins (5, 50 and 500 μgmL⁻¹). Any side-effects that might be related to immunotherapy, the corresponding dose and treatment were registered.

Results:

Among the 21 patients, 12 were treated with latex sublingual immunotherapy (9 women and 3 men) and 9 with placebo (8 women and one man). All patients ended the rush protocol. Four patients (19.0%) [one in the SLIT group (8.3%) and three in the placebo group (33.3%)] developed adverse reactions. One SLIT patient reported mouth itching and burning of the tongue. In the placebo group, one patient presented gastrointestinal complaints while two patients reported unspecific symptoms. All these side-effects regressed spontaneously. No statistically significant differences were found between the proportions of adverse events in the two examined groups.

Conclusion:

This study supports the safety of SLIT against latex conducted in adult patients with latex-induced contact urticaria according to a 3-day build-up phase rush protocol. The proposed 3-day induction phase for latex sublingual immunotherapy should be conducted under medical supervision, although in patients with only latex-induced contact urticaria the registered adverse reactions were so slight that it could be argued that patients could start safely our tested rush protocol at home.

Key words:

• Natural rubber latex
• Rush protocol
• Safety
• Sublingual immunotherapy
• Tolerability

Transparency

Declaration of funding

ALK-ABELLÓ S.p.a., Milan, Italy provided the placebo vials, but provided no financial support.

Declaration of financial/other relationships

E.N. has declared that he has consultancy arrangements with Phadia, Allergy Therapeutics, Anallergo, Stallergenes and served on the speakers bureau for Schering-Plough, Almirall, GSK, Astellas, MSD. E.L., G.C., P.D.D. and A.F. have declared no relevant financial relationships. M.M. has declared that he is a member of the Medical Department of ALK. A.V. has declared that he has received grants/research support from Almirall, Schering-Plough and served on the speakers bureau for Phadia, Novartis, GSK, MSD.

Peer reviewers may receive honoraria from CMRO for their review work. Peer Reviewer 1 has declared that he/she has no relevant financial relationships. Peer Reviewer 2 has declared that he/she has received grant/research support from Glaxo SmithKline and Medpointe Pharmaceuticals.