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Abstrait
Intra-Seasonal Short-Time Up-Dosing with SQ-Standardised Subcutaneous Immunotherapy in Patients with Intermittent Allergic Rhinoconjunctivitis is Well Tolerated during Routine Application: A Non-Interventional, Observational Study
Rainer Reiber, Hendrik Wolf, Jörg Schnitker and Eike Wüstenberg
Background: For patients with pollen induced allergic rhinoconjunctivitis, a pre-seasonal start of subcutaneous specific immunotherapy is generally recommended in international guidelines. In a placebo-controlled trial intraseasonal up-dosing of subcutaneous immunotherapy to 10,000 SQ-U (Alutard SQ®) was shown to be well tolerated and to induce significant immunologic effects. The aim of our study was to investigate the feasibility of intra-seasonal up-dosing during routine application.
Methods: In an open, non-interventional observational study, data on tolerability of subcutaneous immunotherapy (Alutard SQ®) in patients with grass pollen induced allergic rhinoconjunctivitis were recorded by 110 physicians between May and November 2009 in Germany. Therapy was initiated within grass pollen season according to a 6-injection up-dosing schedule from 100 to 10,000 SQ-U with 1-3 days intervals, repeating this dose after 2 and 4 weeks during and up-dosing to the final maintenance dose of 100,000 SQ-U after the end of grass pollen season.
Results: Data for 250 patients could be evaluated, 198 patients had been up-dosed up to the peak grass pollen season and 52 after the peak. Adverse drug reactions were observed in 61.6% of patients with up-dosing up to the peak grass pollen season and in 48.1% with up-dosing after the peak with swelling at the injection site as most common reaction. The overall rate of systemic allergic reactions was low in both groups. Mild to moderate respiratory symptoms were more frequently reported in patients up-dosed up to the peak grass pollen season. Overall tolerability was assessed as “very good” or “good” by >90% of patients and physicians.
Conclusions: Intra-seasonal short-time up-dosing with Alutard SQ® grasses and rye by 6 injections from 100 to 10,000 SQ-U with 1-3 days interval was observed to be well-tolerated during routine application and thus confirms data obtained from the placebo-controlled clinical trial.