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Octagam(®) for chronic inflammatory demyelinating polyneuropathy: results from three observational studies

AIM: To present data from three studies of a Post-Authorization Safety Surveillance (PASS) program for the subset of patients receiving Octagam(®) 5% or 10% for chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS: Data on patients with CIDP treated with Octagam were analyzed to assess...

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Detalles Bibliográficos
Autor principal: Wietek, Stefan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Medicine Ltd 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6190209/
https://www.ncbi.nlm.nih.gov/pubmed/29517417
http://dx.doi.org/10.2217/nmt-2018-0006
Descripción
Sumario:AIM: To present data from three studies of a Post-Authorization Safety Surveillance (PASS) program for the subset of patients receiving Octagam(®) 5% or 10% for chronic inflammatory demyelinating polyneuropathy (CIDP). METHODS: Data on patients with CIDP treated with Octagam were analyzed to assess its safety and tolerability. RESULTS: Of 2314 patients included in the studies, 58 patients (mean age: 64.6 years) received Octagam for CIDP, mean dose of which was 0.8 g/kg bodyweight/course. 81% of observations for clinical appearance since last observation were assessed as stable and 16.6% showed an improved clinical appearance with treatment. Adverse drug reactions were rare (<0.7% of infusions). CONCLUSION: Octagam was effective and well-tolerated in patients with CIDP.