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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Future Medicine Ltd
2018
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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 |
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. |
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