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概要
Tolerability of the SQ-Standardised Grass Sublingual Immunotherapy Tablet in Adult Patients during Routine Administration: A Non-Interventional Observational Study
Hans-Georg Vitzthum, Hendrik Wolf, Jörg Schnitker and Eike Wüstenberg
Objective: The SQ-standardised grass sublingual immunotherapy (SLIT) tablet, GRAZAX® (ALK, Denmark) has been shown to be efficacious and well tolerated in a large number of clinical trials performed in Europe and USA. The aim of this study was to investigate the administration of the SQ grass SLIT-tablet in a real life setting.
Methods: This study was non-interventional, open-label, observational including 1,109 patients from 434 clinics in Germany treated between November 2006 and February 2009 with the SQ grass SLIT-tablet. Patients were followed at visits every 3 months for 9-12 months after start of therapy. Assessments included tolerability, compliance, patient satisfaction and treatment effect. Adverse drug reactions (ADRs) reported were coded by using the Medical Dictionary for Regulatory Activities (MedDRA).
Results: A total of 534 (48.2%) patients experienced ADRs that were considered to be related to treatment in 299 (27.0%) patients. Treatment was discontinued in 98 (8.8%) patients due to ADRs. ADRs were experienced by 460 (41.5%) patients after first administration and classified in 440 (39.7%) patients as mild tolerable reactions at the application site needing no further treatment and in 20 (1.8%) patients as intolerable reactions and reactions that needed treatment by medication all of which are specified in the summary of product characteristics for GRAZAX®. Most frequently reported ADRs were paraesthesia oral, oedema mouth, oral pruritus, oral discomfort, swollen tongue and throat irritation. Serious ADRs related to treatment were reported by three patients, all patients fully recovered. Compliance (70.9%) and patient satisfaction with the treatment effect (92.6%) were high. Subjective well-being was improved in 74.7% of patients and symptoms and medication use were reduced versus previous seasons without SQ grass SLIT-tablet.
Conclusions: Our results confirm that the SQ grass SLIT-tablet is well tolerated during routine administration. Compliance, patient satisfaction, and treatment effect were found to be high.