Eight-year Data in Relapsing Remitting MS Support Use of Rebif®
September 19, 2003
Source: Serono, S.A.
New data from a long-term assessment of a cohort of patients with relapsing-remitting multiple sclerosis (RRMS) on Rebif® (interferon beta-1a) therapy will be presented today at the 19th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS) in Milan, Italy. The data will be included in a poster session presented by Professor Ludwig Kappos of the Neurologische Universitatsklinik und Poliklinik in Basel, Switzerland.
The results support the long-term benefit of Rebif® 44 mcg subcutaneously (sc) three times weekly (tiw), in the treatment of RRMS on relapses, disability and magnetic resonance imaging (MRI) outcomes measured, with a favorable risk benefit profile through eight years. The exact relationship between MRI findings and clinical outcomes for patients is unknown.
"These are very important data and good news for the multiple sclerosis (MS) community, said Dr. Donald W. Paty of the University of British Columbia, Vancouver, Canada, an investigator in the PRISMS(1) trial. "These findings support Rebif®'s effectiveness and show that it is generally well-tolerated for eight years duration of treatment and that it appears to modify the natural course of the disease. These data provide additional support to the concept of treating MS patients with high dose high frequency interferon beta in order to gain maximum benefit and prevent disease progression."
In those patients returning for long-term follow-up (LTFU) assessment, approximately 1 in 5 progressed to secondary progressive multiple sclerosis (SPMS). Natural history data from two population-based studies in Canada and Sweden suggest that approximately 1 in 2 patients would have been expected to have progressed to SPMS without treatment.(2) However, differences between study patients and natural history cohorts may exist.
The eight-year extension data come from an open-label follow-up of the PRISMS study, a double-blind, placebo-controlled study, which began in 1994, and involved 560 patients at 22 centers in 9 countries. Patients were originally randomized to receive Rebif® 44 mcg sc tiw (184 patients), Rebif® 22 mcg sc tiw (189 patients) or placebo (187 patients). After the first two years, placebo patients were re-randomized to receive one of the two active doses, while patients already on active treatment continued with the same dose.
A LTFU assessment was performed to coincide with the seventh or eighth anniversary of the first patient visit after enrollment in the original study. Safety, efficacy and antigenicity evaluations were performed as well as retrospective collection of efficacy outcomes since the last evaluative visit in PRISMS. Patients originally randomized to placebo have received active therapy for the intervening time until the LTFU assessment.
A total of 68% (382/560) of the patients in the original randomized cohort returned for the LTFU visit including 74% (136/184) of the patients originally randomized to Rebif® 44 mcg sc tiw. Of these, almost three-quarters were being treated with Rebif® tiw at the time of the LTFU visit, reflecting long-term compliance to high dose, high frequency interferon beta treatment.
Rebif® was generally well tolerated in those seen at the LTFU visit. The most frequently reported adverse events at the time of the LTFU visit were flu-like symptoms and injection-site reactions, the majority of which were mild. Other adverse events generally associated with interferon beta therapy occurred infrequently.
Neutralizing antibody (NAb) rate was 12% (22/184) at the last available assessment in patients randomized to Rebif® 44 mcg sc tiw. The clinical implications of NAb development in patients with relapsing forms of MS have not been fully studied and remain unknown.
Benefit for patients initially randomized to Rebif® 44 mcg sc tiw, compared with those patients initially randomized to placebo and who had been on IFN therapy for up to 5-6 years, was seen on time to progression on a disability scale, time to SPMS, annualized relapse rate, and change in lesion area as measured in MRI. Given that patients initially randomized to placebo have been treated for up to 75% of the observation period with active drug, and that patients could have changed doses or medications, the power of the study to detect differences between original randomization groups is limited.
Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of MS and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system, fight disease and reduce inflammation.
Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. In the United States, Rebif® is co-promoted by Serono and Pfizer Inc.
People in the US with relapsing forms of MS can find more information about Rebif® in the full prescribing information, online at http://www.mslifelines. com or by calling MS LifeLines(TM) toll-free at 1-877-44REBIF. Patients should be instructed to read the Medication Guide accompanying the product. Most commonly reported side effects are injection site disorders, flu-like symptoms, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss with their doctors whether Rebif® is right for them.
MS is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. MS may affect approximately two million people worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
Some of the statements in this press release are forward-looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 17, 2003. These factors include any failure or delay in Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, and government regulations limiting our ability to sell our products. Serono has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
Serono is a global biotechnology leader. The Company has six recombinant products on the market, Gonal-F®, Luveris®, Ovidrel®/Ovitrelle®, Rebif®, Serostim® and Saizen® (Luveris® is not approved in the USA). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are over 30 projects in development.
Serono was awarded the International James D. Watson Helix 2003 Award from the Biotechnology Industry Organization (BIO) in recognition of the Company's outstanding leadership and highest standards of scientific and product achievement.
In 2002, Serono achieved worldwide revenues of US$1.546 billion, and a net income of US$321 million, making it the third largest biotech company in the world. The Company operates in 45 countries, and its products are sold in over 100 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
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