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


ABSTRACT: 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.

SUBMITTER: Wietek S 

PROVIDER: S-EPMC6190209 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Octagam<sup>®</sup> for chronic inflammatory demyelinating polyneuropathy: results from three observational studies.

Wietek Stefan S  

Neurodegenerative disease management 20180308 4


<h4>Aim</h4>To present data from three studies of a Post-Authorization Safety Surveillance (PASS) program for the subset of patients receiving Octagam<sup>®</sup> 5% or 10% for chronic inflammatory demyelinating polyneuropathy (CIDP).<h4>Methods</h4>Data on patients with CIDP treated with Octagam were analyzed to assess its safety and tolerability.<h4>Results</h4>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/k  ...[more]

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