Investigation of a sublingual immunotherapy with TOL SL® for the treatment of allergic rhinitis, allergic rhinoconjunctivitis and allergic asthma under practice conditions

Background: In recent years specific sublingual immunotherapy (SLIT) has received growing acceptance as an alternative to subcutaneous immunotherapy. Methods: A prospective post-marketing multicenter observational study with TOL SL (R) (Leti Laboratorios LETI, Spain) was conducted in 735 patients in Germany. The majority (66.9%) of the patients were suffering from allergic rhinoconjunctivitis. Assessments should take place at baseline, after 2 - 3 and 12 months of SLIT. The build-up phase lasted for 12 days followed by a maintenance phase of at least 12 months. Results: Oral swelling was reported by 14.6% and oral burning by 21.2% of the patients. In 2 patients (0.3%) the therapy was discontinued due to local reactions. Overall tolerability was assessed as "very good to good" by the physicians in 93.6 and by 91.2% of the patients. Similar ratings for efficacy of the therapy were given by the physicians in 85.9 and by 82.6% of the patients and 95% each appreciated the practicability of the substance administration and the therapy regimen. Conclusion: In the present study TOL SL (R) was safe and well-tolerated in the control of allergic diseases in everyday practice.