| 18 May 2012 | |
| – Use of Biomarker has Potential to Advance Personalized Treatment for MS Patients – WESTON, MA, USA & DUBLIN, Ireland I May 17, 2012 I Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced that the New England Journal of Medicine published research from the companies’ global risk management program that updates the risk of TYSABRI® (natalizumab)-associated progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection that usually leads to death or severe disability, in people with multiple sclerosis (MS). The analysis looked at three risk factors associated with a patient’s PML risk: anti-JC virus (JCV) antibody status, use of immunosuppressant (IS) therapy prior to TYSABRI initiation, and longer duration of treatment with TYSABRI. Biogen Idec and Elan developed the quantitative risk stratification algorithm to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI, a highly effective treatment for relapsing forms of MS. “By identifying these risk factors and incorporating them into our risk stratification algorithm, we bring the advantages of personalized medicine to MS,” said Alfred Sandrock, M.D., Ph.D., senior vice president, development science and chief medical officer, Biogen Idec. “This approach to treatment is intended to help patients better understand their individual benefit-risk profiles when considering TYSABRI as a treatment option.” About the Research Researchers used data from clinical studies, post-marketing sources, and an independent Swedish registry to estimate the incidence of PML among TYSABRI-treated patients. Data as of Feb 29, 2012 from 212 confirmed cases of PML among 99,571 TYSABRI-treated patients were used to develop a risk stratification algorithm based on three established risk factors for PML: anti-JCV antibody status, prior use of IS therapy, and duration of treatment with TYSABRI (one to 24 months vs. 25 to 48 months). Based on the presence or absence of these risk factors, patients were divided into distinct subgroups at lower or higher risk for the development of PML. The risk of PML increased with longer duration of TYSABRI treatment, with the greatest increase observed after two years of therapy. Data beyond four years of therapy were limited. Blood samples from 5,896 MS patients who participated in three clinical studies – AFFIRM , STRATIFY-1, and the U.S. arm of the TYSABRI Global Observational Program in Safety [TYGRIS] study – as well as blood samples from patients included in the Swedish Multiple Sclerosis registry, were tested for anti-JCV antibodies.
The risk of PML increased with longer duration of TYSABRI treatment, with the greatest increase observed after two years of therapy. Data beyond four years of therapy were limited.
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The prevalence of anti-JCV antibodies in the general MS population was 54.9 percent (95% confidence interval [CI], 53.7 – 56.2) and differed from the 100 percent anti-JCV antibody positivity observed in the 54 MS patients who developed PML and had known pre-PML anti-JCV antibody status. Because all 54 MS patients with known pre-PML anti-JCV antibody status tested positive, a sensitivity analysis assuming one hypothetical anti-JCV antibody negative PML patient was used to estimate the PML risk in antibody negative patients.
Anti-JCV antibody status, combined with prior IS use and TYSABRI treatment duration were used to stratify patients at lower or higher risk for the development of PML. There was an approximately 120-fold difference between patients in the lowest and highest risk groups. Patients who were anti-JCV antibody negative were at the lowest risk for PML with an estimated risk of 0.09 cases or fewer per 1,000 patients (95% CI, 0 to 0.48).
The highest risk of PML was found in patients who had received 25 to 48 months of TYSABRI treatment, had been treated with an IS therapy before TYSABRI treatment was initiated, and were positive for anti-JCV antibodies. The PML incidence in this group was estimated to be 11.1 cases per 1,000 patients (95% CI, 8.3 to 14.5).
The authors concluded that data from prospective studies are needed to further characterize these risks.
“Although TYSABRI has proven efficacy, the risk of PML has been a cause of concern for patients,” said Ted Yednock, head of global research at Elan. “This analysis illustrates how the risk stratification model we have developed with Biogen Idec can help physicians and MS patients make more informed treatment decisions.”
About the Risk Stratification
The TYSABRI U.S. label and EU Summary of Product Characteristics were updated to add anti-JCV antibody status as a risk factor for PML. In addition to prior IS therapy and duration of TYSABRI therapy, anti-JCV antibody status is the third factor in the risk stratification model developed by Biogen Idec and Elan that helps identify a patient’s risk for developing PML. Physicians can determine their MS patient’s anti-JCV antibody status by using the STRATIFY JCV assay, the first blood test to be market authorized for the qualitative detection of antibodies to the polyomavirus JC virus.
The TYSABRI U.S. label and EU Summary of Product Characteristics were updated to add anti-JCV antibody status as a risk factor for PML. In addition to prior IS therapy and duration of TYSABRI therapy, anti-JCV antibody status is the third factor in the risk stratification model developed by Biogen Idec and Elan that helps identify a patient’s risk for developing PML. Physicians can determine their MS patient’s anti-JCV antibody status by using the STRATIFY JCV assay, the first blood test to be market authorized for the qualitative detection of antibodies to the polyomavirus JC virus.
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