Betaseron (interferon beta 1b) is an anti-inflammatory therapy for multiple sclerosis currently produced by Bayer HealthCare. It is a formulation of interferon beta 1b indicated for patients with relapsing-remitting multiple sclerosis (RRMS). In clinical trials, Betaseron was shown to reduce the number of flare-ups in patients who have had their first symptoms of MS and have signs of MS according to magnetic resonance imaging (MRI).
History of Betaseron
Multiple clinical trials have been conducted to demonstrate the safety and efficacy of Betaseron in MS patients, and studies continue to be conducted. These studies led to the original approval for Betaseron by the U.S. Food and Drug Administration in 1993.
One major study used to submit Betaseron to the FDA for approval was a two-year study in which Betaseron delayed the time to a second flare-up in patients with clinically isolated symptoms. In that study, patients started treatment soon after experiencing their first MS flare — 292 patients were treated with Betaseron and 176 patients were treated with placebo. Results showed a significantly reduced risk for a second flare with Betaseron treatment. The likelihood for Betaseron-treated patients to experience a flare was 28 percent, compared to 45 percent for placebo-treated patients.
In this same study, Betaseron also reduced the number of newly active brain lesions detectable by MRI. Among 292 Betaseron-treated patients, an average of 3.7 newly active brain lesions were detected, compared to 8.5 newly active brain lesions in placebo-treated patients. Although Betaseron reduces the time to a second flare-up and the number of newly active brain lesions, there is no current evidence to suggest that Betaseron reduces disability.
How Betaseron Works
Similar to other interferon beta 1b formulations, such as Extavia from Novartis, Betaseron reduces inflammation in the nervous system. As a cytokine (a protein produced by the body that can influence the immune response), it influences cells in the nervous system to produce fewer pro-inflammatory agents and more anti-inflammatory agents, thus protecting neurons from damage. It may also prevent immune cells from crossing the blood-brain barrier (BBB), stopping them from reaching the neurons in the central nervous system (CNS).
Betaseron is delivered via the BetaConnect autoinjector. BetaConnect delivers 0.3 mg of Betaseron by subcutaneous injection.
On May 30, 2017, Bayer received FDA approval for a license to link their BetaConnect autoinjector to a smartphone app, myBETAapp, supporting patients by tracking their injection history and giving the option to share the information with healthcare professionals.