Pulmonary Therapy (Jun 2018)
Intra-Seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet Routinely Applied by Allergy Specialists and General Practitioners with Experience in Treatment of Allergy: A Non-Interventional Observational Study
Abstract
Abstract Introduction Intra-seasonal start of treatment with the SQ® grass sublingual immunotherapy(SLIT) tablet (GRAZAX®, ALK, Denmark) has been previously demonstrated to be well-tolerated. The objective of our study was to investigate the tolerability of intra-seasonal start of treatment comparing patients treated by allergists and general practitioners experienced in treatment of allergy (GPs). Methods In a non-interventional, open-label, observational study, data on intra-seasonal start with the SQ® grass SLIT tablet were recorded in patients treated by allergists and GPs in Germany. Adverse events (AEs) were recorded by the physicians at first administration and during the 1–3-month observation period. The tablets taken and any AEs were recorded by the patients in diaries for the first 14 days. Results Treatment with the SQ® grass SLIT tablet was started in 198 patients, and in 179 intra-seasonal (allergists: 140, GPs: 39) and 19 post-seasonal; average treatment period was 47 days. AEs related to intra-seasonal start were reported in 43.6% of patients; no relevant differences between allergists and GPs were observed. In the subgroup of GPs, patients were younger (p = 0.0191), had more frequently asthma (p = 0.0043), more patients used symptomatic medication in the previous pollen season (p = 0.0198) and were more frequently treated for other diseases (p = 0.0467). In the allergists subgroup, more diagnostic allergy tests were applied (p < 0.0001) with less anti-allergic premedication at first administration (p = 0.0026). Conclusion The intra-seasonal start of treatment with the SQ® grass SLIT tablet in patients routinely treated by allergists or GPs with experience in treatment of allergy was well-tolerated, although patient characteristics were different with respect to age, frequency of asthma and concomitant allergies, use of symptomatic medication in the previous grass pollen season and concomitant treatment of other diseases. The safety profile from a previous placebo-controlled clinical trial and data from a previous real-life study on intra-seasonal start performed by allergists were confirmed.
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