A new multiple sclerosis (MS) treatment known as “BG-12″ helps to prevent relapse in MS sufferers, two new studies have revealed.
The new MS treatment, which researchers hope will quickly gain the US Food and Drug Administration’s (FDA) approval, comes in pill form. BG-12 could provide doctors with a new treatment option and ease the pain and discomfort of the 400,000 MS sufferers in the United States.
The most recent trials of BG-12 were phase III; typically, this is the step closest to a drug’s approval as scientists gather more data on its effectiveness and safety.
The first of the two studies to focus on BG-12, known as the DEFINE trial, used a sample of 1,200 patients. Participants were split into three groups: those taking 240 milligrams of BG-12 three times a day, those taking 240 milligrams twice a day, and those taking a placebo. The results were emphatically positive: After two years had passed, those taking BG-12 twice a day saw a 49 percent reduction in relapses while there was a 50 percent drop among those taking the drug three times a day compared with placebo takers.
The same study also discovered that BG-12 triggered notable reductions in the risk of MS leading to disability for the patients; MRI scans confirmed that those using BG-12 had developed fewer new or active MS lesions than those taking a placebo.
The second study focused on 1,400 people and again set out to determine whether BG-12 could lower the average yearly rate of relapse for patients after two years.
Known as the CONFIRM trial, this study looked at relapse rates of participants on a 240 milligram dose of BG-12 twice a day, participants on the same dose three times a day, and a group who were taking placebos. In this study, however, there was a fourth group: individuals receiving the injectable MS drug, glatiramer acetate, which is sold as Copaxone and was approved by the FDA in 1996.
The results after one year showed that patients using BG-12 twice daily had reduced their relapses by 44 percent while those using it three times a day reduced it by 51 percent compared to placebo takers. People taking glatiramer acetate reduced their risk by 29 percent.
Multiple sclerosis is an autoimmune disease that causes the body’s natural defenses to attack the central nervous symptom. This can lead to symptoms that vary from numbness in the limbs to severe symptoms like disability, loss of vision, or paralysis.