Tecfidera sustained clinical efficacy and safety in patients with multiple sclerosis (MS) taking the drug for up to 4 years
- 50% reduction in relapse rate compared with placebo.
- Patients taking BG-12 also had a significantly reduced risk for disability progression and a significant positive effect on MRI outcomes in this patient population.
- 4 year Tecfidera clinical efficacy and safety data in patients with MS released
(18/10/13)
Latest results from the clinical trial program with BG-12 (dimethyl fumarate; Tecfidera, Biogen Idec) suggest sustained clinical efficacy and safety in patients with multiple sclerosis (MS) taking the drug for up to 4 years.
In addition, a separate post hoc analysis of the phase 3 pivotal Determination of the Efficacy and Safety of Oral Fumarate in Relapsing–Remitting MS (DEFINE) and Comparator and an Oral Fumarate in Relapsing–Remitting Multiple Sclerosis (CONFIRM) clinical trials shows that BG-12 reduced relapses and disease activity in treatment-naive patients.
Commenting on these results for Medscape Medical News, Bernd Kieseier, MD, Heinrich Heine University, Düsseldorf, Germany, who did a talk rounding up meeting highlights including these new results, said, "These are reassuringly meaningful clinical results showing that the effects of BG-12 over 2 years are maintained in the third and fourth year, with no additional safety concerns."
Professor Kieseier commented: We can see from these latest results that the benefit has been maintained, and in the patients switched from placebo or glatiramer acetate the annual relapse rate has come down to a similar level as those who were taking BG-12 long-term."
In terms of safety, no new adverse effects were reported in patients continuing to receive BG-12 in ENDORSE. The most common adverse events in patients who were switched to BG-12 from placebo or GA were flushing and gastrointestinal events, the incidences of which were generally similar to those observed in DEFINE and CONFIRM, Biogen reports. The most common adverse event in patients continuing to receive long-term BG-12 is nasopharyngitis (common cold).
He added that BG-12 did not seem to have severe toxicities. "Patients will appreciate that. The driving interest in this drug at the moment is its good efficacy paired with good tolerability, and these results show that this profile continues to be there in the long-term."
Treatment-Naive Patients
In a separate post hoc analysis from the phase 3 DEFINE and CONFIRM studies of 678 new treatment-naive patients with MS, BG-12 was associated with a 50% reduction in relapse rate compared with placebo. Patients taking BG-12 also had a significantly reduced risk for disability progression and a significant positive effect on MRI outcomes in this patient population.
Source: Medscape Multispecialty Copyright © 1994-2013 by WebMD LLC (18/10/13)
