EMD Serono, the U.S. biopharmaceutical division of Merck KGaA, Darmstadt, Germany, recently announced that the results of the 15 year follow-up trial PRISMS-15 (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) evaluating Rebif® (interferon beta-1a), a high-dose, high-frequency interferon beta for the treatment of patients with relapsing forms of multiple sclerosis (MS), were published in the Journal of Neurology, Neurosurgery and Psychiatry (JNNP). The study is entitled “Factors influencing long-term outcomes in relapsing–remitting multiple sclerosis: PRISMS-15“.
The study reveals clinical data from a pivotal trial examining the association between cumulative exposure to treatment with subcutaneous (sc) interferon (IFN) beta-1a and other potential predictive factors in patients with a diagnosis of relapsing–remitting multiple sclerosis (RRMS).
“The publication of the PRISMS-15 study in JNNP offers the MS medical community a retrospective single visit assessment in a subset of RRMS patients from the PRISMS trial with varying exposure to Rebif,” said Dr. Rick Munschauer, Vice President, Medical Affairs, Neurology and Immunology, EMD Serono in a press release.
Rebif is used to decrease or delay the manifestation of some of the physical disability and frequency of relapses in MS patients. The study revealed that the cumulative exposure and long-term treatment with IFN beta-1a (sc) seemed to be linked to better clinical outcomes in terms of number of relapses, annualized relapse rate, time to Expanded Disability Status Scale (EDSS) progression, change in EDSS, and conversion to secondary-progressive MS (SPMS).
In addition to Rebif, the company is involved in strategic research partnerships with leading healthcare and academic institutions for the funding and encouragement of research in the field of neurology.
EMD Serono also has ongoing MS research programs with a Phase I clinical trial on ATX-MS-1467, an investigational drug for the treatment of patients with RRMS, and a Phase IIb clinical trial on imilecleucel-T, a drug candidate for the treatment of patients with a diagnosis of secondary progressive MS (SPMS), a condition with a high unmet medical need. The company has an option arrangement with Opexa Therapeutics, Inc. for the development and commercialization of imilecleucel-T.
RRMS is characterized by clearly defined attacks of worsening neurologic function. These attacks — often called relapses, flare-ups or exacerbations — are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely, and there is no apparent progression of disease. RRMS is the most common disease course at the time of diagnosis, with around 85 percent of people being initially diagnosed with RRMS, compared to 10-15 percent with progressive forms of the disease.