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Journal Article
Research Support, Non-U.S. Gov't
Octagam ® for chronic inflammatory demyelinating polyneuropathy: results from three observational studies.
Neurodegenerative Disease Management 2018 August
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.
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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