Results from the 16-year follow-up to the pivotal Betaferon (interferon-beta-1b) trial, published today in the journal Neurology, provide the longest and most complete patient follow-up data and support the long-term safety profile of Betaferon in multiple sclerosis (MS).
Results demonstrated that no new or unexpected adverse events (AEs) emerged with long-term therapy, and the observed treatment-related AEs decreased over time.
“These data confirm that Betaferon has a favorable safety and tolerability profile,” said Anthony T. Reder, Professor of Neurology at the University of Chicago and lead study author. “Over the years, healthcare professionals have been able to greatly reduce treatment-related adverse events and increase patients adherence to Betaferon therapy with dose escalation at initiation of therapy and the routine use of an autoinjector and co-medication with non-steroidal anti-inflammatory drugs (or NSAIDs).”
Interestingly, preliminary findings suggest that there was improved survival for patients assigned to Betaferon in the pivotal trials (94.6 percent in those who received 250µg and 91.7 percent in patients treated with Betaferon 50µg) compared with placebo (81.7 percent).
“MS is a chronic condition that requires treatment with a medication that combines efficacy with a safety profile that is manageable and predictable even over the long term,” said Leslie Donato, Vice President, Neurology, Bayer. “The results of the 16-year long-term study add to the wealth of data supporting Betaferons benefit-to-risk profile. We look forward to seeing additional outcomes from the 20-year follow-up study.”
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