April 28, 2004
Source: Serono Inc.
New long-term data supports the importance of early treatment with high dose, high frequency Rebif® (interferon beta-1a) 44 mcg in reducing the long-term accumulation of brain lesion volume in patients with relapsing remitting multiple sclerosis (MS). These findings, presented at the 56th Annual Meeting of the American Academy of Neurology, provide a comprehensive long-term evaluation of MS brain lesion volume as measured by magnetic resonance imaging (MRI) and show the sustained effects of Rebif 44 mcg (three times weekly, subcutaneously).
"This is good news for people with relapsing remitting multiple sclerosis as it shows that earlier initiation of high dose, high frequency interferon beta-1a therapy with Rebif, compared to a two-year delay, is associated with a greater likelihood of reduction in total lesion accumulation over time," said Dr. David Li of the University of British Columbia in Vancouver, British Columbia, Canada.
The findings show that Rebif 44 mcg continued to have an impact in reducing the accumulation of MS lesion volume, as measured on MRI, in patients with relapsing remitting MS (RRMS) after 7-8 years of follow up. MRI lesions provide one of the most sensitive measures of MS disease activity for many patients. The poster reports the results of long-term changes in the accumulation of MRI T2 lesion volume among RRMS patients, who were initially randomized to receive Rebif 44 mcg, Rebif 22 mcg (three times weekly subcutaneously) or placebo, in the PRISMS(1) long term follow up (LTFU) study. After the initial two-year time frame, placebo patients commenced therapy with Rebif for subsequent years.
The PRISMS LTFU MRI evaluation compared lesion volume change from baseline to the LTFU visit (an average of 7.4 years later). In the PRISMS LTFU study, patients initially randomized to Rebif 44 mcg were less likely to have increased lesion area than those initially given Rebif 22 mcg or placebo for two years followed by Rebif for up to 5.5 years. The proportion of patients showing an increase in total lesion burden over an average of 7.4 years was lowest for Rebif 44 mcg (54%), followed by Rebif 22 mcg (66%) compared to the placebo/Rebif patients (73%). This represents a 26% relative reduction in the risk of lesion accumulation for Rebif 44 mcg (three times weekly) initiated early compared to delayed initiation of treatment. The exact relationship between MRI findings and the clinical status of patients is unknown.
About the PRISMS and the PRISMS Long-Term Follow Up (LTFU) Studies The long-term MRI lesion area data come from an observational follow-up of the patients originally enrolled in 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 three times weekly (184 patients), Rebif 22 mcg three times weekly (189 patients) or placebo (187 patients). After the first two years, placebo patients were re-randomized to receive one of the two active doses of Rebif, while patients already on active treatment continued with the same dose. Overall, 68% of the original randomized cohort returned for the Long Term Follow Up.
The two-year results from the PRISMS study showed that both doses of interferon beta-1a significantly reduced MRI activity and area, relapse rates, as well as reduced progression of Expanded Disability Status Scale (EDSS) scores. Dose-blinded extension data to four years demonstrated sustained treatment benefit over time, with increasing evidence of a dose-effect that favored Rebif 44 mcg. The Long-Term Follow Up assessment was then performed on the seventh or eighth anniversary of patients' enrollment in the original PRISMS study, and these data provided a comprehensive long-term clinical and MRI assessment of cohort of MS patients on therapy with interferon. The LTFU results support the long-term effectiveness of Rebif 44 mcg in the treatment of RRMS.
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-marketed by Serono, Inc. and Pfizer Inc. Rebif has been proven to reduce MRI lesion activity and area, reduce the frequency of relapses, and delay the progression of disability. Rebif is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and can be stored at room temperature for up to 30 days if a refrigerator is not available.
People in the US with relapsing forms of MS can find more information about Rebif in the full prescribing information, online at http://www.Rebif.com or by calling MS LifeLines(TM) toll-free at 1-877-44REBIF (1-877-447-3243). 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 treatment with Rebif with their doctors.
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.
(1) PRISMS: Prevention of Relapses and disability by Interferon beta-1a
Subcutaneously in Multiple Sclerosis.
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