Biogen (BIIB), Elan (ELN) Update on Long-Term Safety, Efficacy Profile of TYSABRI in MS Patients
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Biogen Idec (Nasdaq: BIIB) and Elan Corporation, plc (NYSE: ELN) announced findings from several studies of TYSABRI (natalizumab) evaluating its long-term safety and efficacy in the treatment of multiple sclerosis (MS) across the course of disease and impact on MS-related symptoms such as fatigue. These data, as well as data relating to the companies’ risk stratification algorithm as a way to help enable individual benefit risk assessment for patients with MS, were accepted for presentation at the 64th Annual Meeting of the American Academy of Neurology (AAN).
“We continue to build on the extensive data we have for TYSABRI and are committed to studying its long-term use and potential effect on symptoms like fatigue, which MS patients struggle with every day,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen Idec. “Our research is aimed at discovering additional ways TYSABRI can help physicians and patients best manage the symptoms of MS and make informed and personalized treatment choices.”
Long-Term Observational Study of TYSABRI
Initial results from the TYSABRI Observational Program (TOP) indicate that post-baseline annualized relapse rates (ARR) after four years for patients receiving TYSABRI therapy decreased from 1.99 at baseline to 0.28 (p<0.0001); disability, as measured by the Expanded Disability Status Scale (EDSS), remained stable over time. TOP is an ongoing open-label, multicenter, observational study designed to assess long-term outcomes in patients with relapsing-remitting MS (RRMS) in Europe, Australia, and Canada. TOP is expected to enroll more than 4,500 patients who will be followed for 10 years.
Neither reduction in ARR nor stabilization of a patient’s EDSS was affected by the type of treatment they were using before initiating TYSABRI therapy. However, ARR were lowest in immunosuppressant (IS) therapy-naïve patients and highest in patients who had used IS therapy (p<0.0001).
The incidence and type of serious adverse events (SAEs) seen in these patients after long-term use was consistent with TYSABRI’s known safety profile. There were no significant differences by baseline treatment history in the incidence of SAEs, infection-related SAEs, or progressive multifocal leukoencephalopathy (PML) during TYSABRI therapy, although there was a trend of higher incidence of PML in patients with prior IS use.
“TOP may help provide insight into the potential impact current treatment may have on long term efficacy and safety outcomes with TYSABRI,” said Professor Ludwig Kappos, MD, chair of Neurology, Research Group Leader Clinical Neuroimmunology and Neurobiology, Department of Biomedicine, University Hospital, Basel, Switzerland. “The reduction of MS relapse and stable disability progression that we observed with TYSABRI in the TOP study across naive and previously treated patients was sustained after four years of treatment.”
Risk-Stratification Initiatives
Biogen Idec and Elan developed a quantitative risk stratification algorithm to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI. The algorithm provides guidance for physicians and patients about the varying degrees of PML risk associated with TYSABRI treatment. The variables impacting PML risk are: anti-JCV antibody status, prior IS use, and TYSABRI treatment duration.
“We are pleased to be able to offer MS patients and their physicians an approach for assessing the potential benefit-risk with TYSABRI,” said Ted Yednock, executive vice president and head of Global Research, Elan. “A significant advancement in this area is the inclusion of anti-JCV antibody status in the TYSABRI label as a risk factor for developing PML, as well as the commercial availability of the STRATIFY JCV™ blood test. Use of this approach for risk stratification is supported by data presented at AAN.”
PML risk was quantified by assessing more than 92,000 MS patients from TYSABRI post-marketing sources and clinical studies; through September 2011 there were 159 cases of PML among this patient population and data show PML risk was lowest in anti-JCV antibody negative patients (no PML cases occurred in anti-JCV antibody negative patients; with the inclusion of one hypothetical anti-JCV antibody negative case, the risk is ≤0.10 cases per 1,000 patients treated). PML risk was highest in patients with all three risk factors: anti-JCV antibody positive status; prior immunosuppressant use; and 25-48 months of TYSABRI treatment (10.6 cases per 1,000 patients treated). The use of anti-JCV antibody status in this algorithm marks the first time a safety biomarker for risk stratification has been used to inform treatment decisions in MS and these data will be updated during the AAN presentation.
A separate study, STRATIFY-2, an ongoing, longitudinal, observational U.S. study, is the largest data set to date to analyze anti-JCV antibody seroprevalence among MS patients. Baseline anti-JCV antibody testing results from more than 35,000 MS patients who were either receiving or considering treatment with TYSABRI showed that the overall prevalence of anti-JCV antibodies was 53.5 percent (95% confidence interval [CI]: 53.0%–54.0%), which is consistent with the prevalence of anti-JCV antibodies observed in MS patients in other clinical research. Interim results from STRATIFY-2 demonstrated prospectively that the PML incidence in TYSABRI-treated anti-JCV antibody negative patients was significantly lower than that in anti-JCV antibody positive patients (anti-JCV negative = 0, CI: 0–0.34; anti-JCV positive=1.02, CI: 0.53–1.78 [p=0.0004]). Final data from STRATIFY-2 will further characterize PML risk in anti-JCV antibody negative and positive patients.
“We continue to build on the extensive data we have for TYSABRI and are committed to studying its long-term use and potential effect on symptoms like fatigue, which MS patients struggle with every day,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen Idec. “Our research is aimed at discovering additional ways TYSABRI can help physicians and patients best manage the symptoms of MS and make informed and personalized treatment choices.”
Long-Term Observational Study of TYSABRI
Initial results from the TYSABRI Observational Program (TOP) indicate that post-baseline annualized relapse rates (ARR) after four years for patients receiving TYSABRI therapy decreased from 1.99 at baseline to 0.28 (p<0.0001); disability, as measured by the Expanded Disability Status Scale (EDSS), remained stable over time. TOP is an ongoing open-label, multicenter, observational study designed to assess long-term outcomes in patients with relapsing-remitting MS (RRMS) in Europe, Australia, and Canada. TOP is expected to enroll more than 4,500 patients who will be followed for 10 years.
Neither reduction in ARR nor stabilization of a patient’s EDSS was affected by the type of treatment they were using before initiating TYSABRI therapy. However, ARR were lowest in immunosuppressant (IS) therapy-naïve patients and highest in patients who had used IS therapy (p<0.0001).
The incidence and type of serious adverse events (SAEs) seen in these patients after long-term use was consistent with TYSABRI’s known safety profile. There were no significant differences by baseline treatment history in the incidence of SAEs, infection-related SAEs, or progressive multifocal leukoencephalopathy (PML) during TYSABRI therapy, although there was a trend of higher incidence of PML in patients with prior IS use.
“TOP may help provide insight into the potential impact current treatment may have on long term efficacy and safety outcomes with TYSABRI,” said Professor Ludwig Kappos, MD, chair of Neurology, Research Group Leader Clinical Neuroimmunology and Neurobiology, Department of Biomedicine, University Hospital, Basel, Switzerland. “The reduction of MS relapse and stable disability progression that we observed with TYSABRI in the TOP study across naive and previously treated patients was sustained after four years of treatment.”
Risk-Stratification Initiatives
Biogen Idec and Elan developed a quantitative risk stratification algorithm to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI. The algorithm provides guidance for physicians and patients about the varying degrees of PML risk associated with TYSABRI treatment. The variables impacting PML risk are: anti-JCV antibody status, prior IS use, and TYSABRI treatment duration.
“We are pleased to be able to offer MS patients and their physicians an approach for assessing the potential benefit-risk with TYSABRI,” said Ted Yednock, executive vice president and head of Global Research, Elan. “A significant advancement in this area is the inclusion of anti-JCV antibody status in the TYSABRI label as a risk factor for developing PML, as well as the commercial availability of the STRATIFY JCV™ blood test. Use of this approach for risk stratification is supported by data presented at AAN.”
PML risk was quantified by assessing more than 92,000 MS patients from TYSABRI post-marketing sources and clinical studies; through September 2011 there were 159 cases of PML among this patient population and data show PML risk was lowest in anti-JCV antibody negative patients (no PML cases occurred in anti-JCV antibody negative patients; with the inclusion of one hypothetical anti-JCV antibody negative case, the risk is ≤0.10 cases per 1,000 patients treated). PML risk was highest in patients with all three risk factors: anti-JCV antibody positive status; prior immunosuppressant use; and 25-48 months of TYSABRI treatment (10.6 cases per 1,000 patients treated). The use of anti-JCV antibody status in this algorithm marks the first time a safety biomarker for risk stratification has been used to inform treatment decisions in MS and these data will be updated during the AAN presentation.
A separate study, STRATIFY-2, an ongoing, longitudinal, observational U.S. study, is the largest data set to date to analyze anti-JCV antibody seroprevalence among MS patients. Baseline anti-JCV antibody testing results from more than 35,000 MS patients who were either receiving or considering treatment with TYSABRI showed that the overall prevalence of anti-JCV antibodies was 53.5 percent (95% confidence interval [CI]: 53.0%–54.0%), which is consistent with the prevalence of anti-JCV antibodies observed in MS patients in other clinical research. Interim results from STRATIFY-2 demonstrated prospectively that the PML incidence in TYSABRI-treated anti-JCV antibody negative patients was significantly lower than that in anti-JCV antibody positive patients (anti-JCV negative = 0, CI: 0–0.34; anti-JCV positive=1.02, CI: 0.53–1.78 [p=0.0004]). Final data from STRATIFY-2 will further characterize PML risk in anti-JCV antibody negative and positive patients.
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