Robert Zivadinov1, Jennie Medin2, Nasreen Khan3, Jonathan R Korn4, Tanuja Chitnis5, Robert T Naismith6, Enrique Alvarez7, Michael G Dwyer8, Niels Bergsland9, Ellen Carl10, Diego Silva11, Bianca Weinstock-Guttman12. 1. Buffalo Neuroimaging Analysis Center, Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, NY, USA; Center for Biomedical Imaging at Clinical Translational Science Institute, University at Buffalo, State University of New York, Buffalo, NY, USA. Electronic address: rzivadinov@bnac.net. 2. Novartis Pharma AG, Basel, Switzerland. Electronic address: jenniemedin@gmail.com. 3. IQVIA, Basel, Switzerland. Electronic address: nasreen.khan@iqvia.com. 4. IQVIA, Burlington, MA, USA. Electronic address: jonkorn@gmail.com. 5. Partners Multiple Sclerosis Center, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: tchitnis@rics.bwh.harvard.edu. 6. Department of Neurology, Washington University, St. Louis, MO, USA. Electronic address: naismithr@wustl.edu. 7. Department of Neurology, University of Colorado School of Medicine, Aurora, CO, USA. Electronic address: enrique.alvarez@ucdenver.edu. 8. Center for Biomedical Imaging at Clinical Translational Science Institute, University at Buffalo, State University of New York, Buffalo, NY, USA. Electronic address: mgdwyer@bnac.net. 9. Center for Biomedical Imaging at Clinical Translational Science Institute, University at Buffalo, State University of New York, Buffalo, NY, USA. Electronic address: npbergsland@bnac.net. 10. Center for Biomedical Imaging at Clinical Translational Science Institute, University at Buffalo, State University of New York, Buffalo, NY, USA. Electronic address: ecarl@bnac.net. 11. Novartis Pharma AG, Basel, Switzerland. Electronic address: diego-1.silva@novartis.com. 12. Jacobs Multiple Sclerosis Center, Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, NY, USA. Electronic address: bw8@buffalo.edu.
Abstract
BACKGROUND: The effectiveness of fingolimod on clinical and magnetic resonance imaging (MRI) outcomes in patients with multiple sclerosis (MS) has been well established in trials and, to a lesser extent, in the real world. OBJECTIVE: To evaluate clinical and MRI outcomes in patients with relapsing MS receiving fingolimod in US clinical practice. METHODS: Clinical and MRI data from 590 patients initiating fingolimod treatment at 33 MS centers in the USA were retrospectively analyzed. Clinical data were obtained from medical records. MRI data were systematically quantified at a centralized imaging facility. Patients had an index (within 6 months before and 1 month after starting fingolimod) and post-index (9-24 months after starting fingolimod) MRI scan; 184 individuals had a pre-index scan (9-24 months before starting fingolimod). RESULTS: In the index to post-index period, mean annualized relapse rates decreased from 0.36 to 0.13 and disability progression occurred in 18.5% of patients. Median T2, T1 and gadolinium-enhancing lesion volume changed by 1.15%, 2.36%, and -100% between the index and post-index scans, respectively, and median annualized percentage changes in brain volume and lateral ventricular volume were -0.32% and +0.66%, respectively. For patients with pre-index scans, MRI outcomes were unchanged or improved during treatment. Outcomes were generally comparable with those in fingolimod phase 3 trials. CONCLUSION: This real-world study highlights the effectiveness of fingolimod and the feasibility of quantifying clinical and MRI data collected from multiple centers during routine clinical practice on a group level using a systematic, quantitative methodology.
BACKGROUND: The effectiveness of fingolimod on clinical and magnetic resonance imaging (MRI) outcomes in patients with multiple sclerosis (MS) has been well established in trials and, to a lesser extent, in the real world. OBJECTIVE: To evaluate clinical and MRI outcomes in patients with relapsing MS receiving fingolimod in US clinical practice. METHODS: Clinical and MRI data from 590 patients initiating fingolimod treatment at 33 MS centers in the USA were retrospectively analyzed. Clinical data were obtained from medical records. MRI data were systematically quantified at a centralized imaging facility. Patients had an index (within 6 months before and 1 month after starting fingolimod) and post-index (9-24 months after starting fingolimod) MRI scan; 184 individuals had a pre-index scan (9-24 months before starting fingolimod). RESULTS: In the index to post-index period, mean annualized relapse rates decreased from 0.36 to 0.13 and disability progression occurred in 18.5% of patients. Median T2, T1 and gadolinium-enhancing lesion volume changed by 1.15%, 2.36%, and -100% between the index and post-index scans, respectively, and median annualized percentage changes in brain volume and lateral ventricular volume were -0.32% and +0.66%, respectively. For patients with pre-index scans, MRI outcomes were unchanged or improved during treatment. Outcomes were generally comparable with those in fingolimod phase 3 trials. CONCLUSION: This real-world study highlights the effectiveness of fingolimod and the feasibility of quantifying clinical and MRI data collected from multiple centers during routine clinical practice on a group level using a systematic, quantitative methodology.
Authors: K Daniels; P B van der Nat; S T F M Frequin; P J van der Wees; D H Biesma; E L J Hoogervorst; E M W van de Garde Journal: Mult Scler Int Date: 2020-06-15