Background. Although the safety and efficacy of sublingual immunotherapy (SLIT) with a five-grass pollen tablet have been demonstrated in randomized clinical trials (RCTs), these outcomes must always be evaluated in real-life medical practice. Methods. In a prospective, open-label, noninterventional, “real-life” study in Germany, we evaluated the safety, tolerability, and effectiveness of SLIT with a five-grass pollen tablet in adults with grass-pollen-induced allergic rhinoconjunctivitis. Results. 808 adults were enrolled between September 2008 and December 2009. 35.3% of the participants experienced at least one adverse drug reaction (ADR), the most common of which were mild-to-moderate gastrointestinal and respiratory disorders. Serious ADRs considered causally related to SLIT treatment occurred in four patients. Overall, the five-grass pollen tablet was considered to have good or very good tolerability by most investigators and patients. Treatment was associated with the relief of nasal, ocular, and bronchial symptoms and decreased symptomatic medication use. However, interpretation of clinical improvements was limited by lower atmospheric grass pollen levels during the study season (relative to the preceding season). Conclusions. In a large population of patients treated in real-life medical practice, SLIT with a five-grass pollen tablet was safe and well tolerated. The patient-reported symptom relief suggests that SLIT was associated with clinical benefits.
Zusammenfassung: Glatiramerazetat (Copolymer-1, Copaxone ), ein immunmodulatorisch wirksames Polypeptid, wird bei der Behandlung der primär schubförmigen multiplen Sklerose (MS) mit Erfolg eingesetzt. Wir berichten über einen 52-jährigen Patienten, der aufgrund einer primär schubförmig verlaufenden MS auf 20 mg Glatiramerazetat täglich subkutan eingestellt wurde und vier Wochen später eine histologisch gesicherte akute Polymyositis mit entsprechenden elektromyographischen Veränderungen und einem massiven Anstieg der Muskelenzyme entwickelte. Nach Absetzen des Präparates normalisierten sich die Beschwerden und Laborparameter innerhalb von drei Wochen vollständig. Eine Myositis unter Glatiramerazetat wurde bisher nicht in der Literatur beschrieben, allerdings bei anderen immunsuppressiv und/oder immunmodulatorisch wirksamen Präparaten wie Cyclosporin, Kortison und den a-, b-, g-Interferonen beobachtet. Es ist zu vermuten, dass Glatiramerazetat, bedingt durch seine immunmodulatorischen Eigenschaften auf das T-Zellsystem, eine akute Myositis verursachen kann.
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