Novel and Emerging Treatments in Relapsing-Remitting MS

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Novel and Emerging Treatments in Relapsing-Remitting MS

PEG-IFN: Safety


The incidence of all reported adverse events was higher in the PEG-IFN arms versus placebo (94 vs. 83%), with the majority of reported adverse events mild or moderate in severity. The most common adverse events in the PEG-IFN groups were flu-like reaction, injection site erythema, pyrexia, and headache, which is similar to the existing safety and tolerability profile of IFNβ-1a. The incidence of SAEs (11, 14, and 15% in PEG-IFN every 2 weeks, every 4 weeks, placebo, respectively) and serious infections (<1, 1, and 1%) was similar across all study arms. The most common SAE across all treatment groups was MS relapse. There were a total of four deaths: two in the placebo arm (subarachnoid hemorrhage and unknown cause), and one in each PEG-IFN arm (septic shock and unknown cause).

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