11-Year Follow-up of Bayer’s BENEFIT Interferon-beta1b Treatment Reveals Positive Results For MS Patients

Results from the BENEFIT11 trial indicate that early treatment with IFNB-1b leads to improvements in cognition and fatigue in the long-term, as well as sustained employment and favorable magnetic resonance imaging (MRI) outcomes, measured at the 11-year mark. Supported by Bayer HealthCare Pharmaceuticals, the study, titled “Long-term Impact of Early MS Treatment with Interferon Beta-1b (IFNB-1b): Clinical, MRI, Employment, and Patient-Reported Outcomes (PROs) at the 11-Year Follow-up of BENEFIT (BENEFIT 11)” was presented on April 23, 2015 at the American Academy of Neurology Annual Meeting.

The trial provides more data about long-term treatment with IFNB-1b for people with early indicators of multiple sclerosis (MS).

The BENEFIT trial included patients with MS and clinically isolated syndrome. Clinically isolated syndrome consists of an initial attack on myelin in the central nervous system, putting someone at risk for developing MS. Multiple Sclerosis is characterized by the degeneration of myelin, which impairs nerve conduction and causes symptoms such as loss of movement, sensory, problems, pain and loss of vision.

People who participated in the BENEFIT study either received IFNB-1b or a placebo (sugar pill). After the second case of clinically isolated syndrome, or after 2 years, all participants in the study were given IFNB-1b. The researchers measured MRI, performed laboratory tests, and took measurements about other outcomes eleven years after the beginning of the study.

278 MS patients participated in the study.  At year 11, those who had received IFNB-1b still had a lower overall yearly relapse rate and a longer time to their first MS relapse than people who received placebo. They also had a lower incidence of clearly diagnosed MS. The expanded disability status scale (EDSS) score — a measurement of impairment used in people with MS — was the same in both groups. The paced auditory serial addition test (PASAT) scores, a measurement of cognitive ability, were high in both groups. Of the 81% who were employed when their physician first diagnosed their clinically isolated syndrome, 73% were still employed.

A total of 12% had retired early or were receiving long-term disability, as opposed to 2.9% at the beginning of the study. Furthermore, 64% did not take any sick leave for the most recent year. Health-related quality of life did not change. A total of 46% of study subjects experienced no fatigue. Both groups had similar MRIs. A total of 86% had no gadolinium-enhancing lesions, indicators of areas in which myelin is damaged.

In their report, the researchers concluded that “results from BENEFIT11 support a long-term impact of early treatment with IFNB-1b on clinical measures, including cognition and fatigue, and health economic and MRI outcomes.”