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Six-year natalizumab safety and efficacy data from the STRATA study
ECTRIMS Online Library. Rudick R. Oct 3, 2013; 34073
Disclosure(s): Supported by Biogen Idec Inc. Dr. Rudick has received honoraria or consulting fees from Biogen Idec, Genzyme, Novartis, and Pfizer and research funding from the National Institutes of Health, National Multiple Sclerosis Society, Biogen Idec, Genzyme, and Novartis. Dr. Goodman has received personal compensation from Acorda, Biogen Idec, Genzyme/sanofi-aventis, Novartis, and Teva, for consulting service and has received financial support for research activities from Acorda, Avanir, Biogen Idec, EMD Serono, Genzyme/sanofi-aventis, Novartis, Ono, Roche, Sun Pharma, Takeda, and Teva. Dr. Kappos has received research support from Acorda, Actelion, Allozyne, BaroFold, Bayer HealthCare, Bayer Schering, Bayhill, Biogen Idec, Boehringer Ingelheim, Elan, Genmab, Glenmark, GlaxoSmithKline, Merck Serono, MediciNova, Novartis, sanofi-aventis, Santhera, Shire, Roche, Teva, UCB, Wyeth, Swiss MS Society, Swiss National Research Foundation, European Union, Gianni Rubatto Foundation, and the Novartis and Roche Research Foundations. Dr. Lublin has received research support from Acorda, Biogen Idec, Celgene, Genzyme, Sanofi, NIH, NMSS, Novartis, and Teva, has received fees as a consultant and for advisory boards from Acorda, Actelion, Bayer HealthCare, Biogen Idec, Bristol-Myers Squibb, Celgene, Coronado Bioscience, EMD Serono, Genentech, Genzyme, Johnson & Johnson, MedImmune, Novartis, Pfizer, Questcor, Revalesio, Roche, sanofi-aventis, and Teva, has current financial interests in Cognition Pharmaceuticals, and is co-chief editor for Multiple Sclerosis and Related Diseases. Dr. Polman has received consulting fees and honoraria from Actelion, Bayer Schering, Biogen Idec, GlaxoSmithKline, Merck Serono, Novartis, Roche, Teva, and UCB. Drs. Chirieac and Duda, as well as Fiona Forrestal, MSc, are employees of Biogen Idec.
Dr. Richard Rudick
Dr. Richard Rudick
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Abstract
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Background: The Safety of TYSABRI® Re-dosing and Treatment (STRATA) study is an ongoing, open-label, multinational study evaluating the safety and efficacy of natalizumab in multiple sclerosis patients who completed the AFFIRM, SENTINEL, and GLANCE trials and their open-label extensions.
Objectives: Report natalizumab’s safety and efficacy of through 6 years in STRATA.
Methods: In the initial phase of STRATA, patients (N=1094) received natalizumab 300 mg intravenously every 4 weeks for 24-48 weeks. A total of 647 of 738 non-US patients (88%) and 154 of 356 US patients (43%) participated in the long-term phase of STRATA. Safety and efficacy (Expanded Disability Status Scale [EDSS] and relapse) data were recorded.
Results: As of 20 March 2013, STRATA patients had 4135 patient-years of natalizumab exposure and received a median of 64 (range 1-85) natalizumab infusions; those randomised to natalizumab in feeder studies (n=709) received a median of 67 (range 1-85) infusions. Mean EDSS scores for patients who originally received natalizumab or placebo, respectively, were 2.9 and 3.1 at STRATA baseline; 2.7 and 3.1 at week 48; 2.7 and 3.2 at week 96; 2.8 and 3.2 at week 144; 2.9 and 3.2 at week 192; 2.8 and 3.2 at week 240; and 2.9 and 3.2 at week 288. Overall annualised relapse rate (ARR) has remained low at 0.15. As of 20 March 2013, 11 cases of progressive multifocal leukoencephalopathy (PML) have occurred in STRATA patients. These patients received 33-76 natalizumab doses in STRATA; all were anti-JC virus (JCV) antibody positive prior to PML diagnosis (100% vs 66% of all STRATA patients with available anti-JCV antibody results), and 4 of the 11 patients had prior immunosuppressant use (36% vs 7% of all STRATA patients). In the overall STRATA population, serious adverse events (% of patients) included infections and infestations (4%), neoplasms (3%), and gastrointestinal disorders (2%).
Conclusions: Natalizumab-treated patients generally experienced stable EDSS scores and low ARR over time. Patients initially randomised to 2 years of natalizumab therapy in phase 3 trials retained their lower EDSS scores at inclusion in STRATA in long-term follow-up compared with those initially randomised to placebo, suggesting that early treatment may be preferable to delayed treatment. STRATA data support the role of identified risk factors in development of PML. The ongoing STRATA study will provide further longitudinal information on the natalizumab’s efficacy and safety.
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