TY - JOUR
T1 - Impact of fingolimod on clinical and magnetic resonance imaging outcomes in routine clinical practice
T2 - A retrospective analysis of the multiple sclerosis, clinical and MRI outcomes in the USA (MS-MRIUS) study
AU - MS-MRIUS Study Group
AU - Zivadinov, Robert
AU - Medin, Jennie
AU - Khan, Nasreen
AU - Korn, Jonathan R.
AU - Chitnis, Tanuja
AU - Naismith, Robert T.
AU - Alvarez, Enrique
AU - Dwyer, Michael G.
AU - Bergsland, Niels
AU - Carl, Ellen
AU - Silva, Diego
AU - Weinstock-Guttman, Bianca
N1 - Publisher Copyright:
© 2018
PY - 2019/1
Y1 - 2019/1
N2 - 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.
AB - 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.
KW - Brain atrophy
KW - Clinical outcomes
KW - Fingolimod
KW - MRI outcomes
KW - Real-world evidence
KW - Relapsing multiple sclerosis
UR - http://www.scopus.com/inward/record.url?scp=85055055960&partnerID=8YFLogxK
U2 - 10.1016/j.msard.2018.09.037
DO - 10.1016/j.msard.2018.09.037
M3 - Article
C2 - 30342416
AN - SCOPUS:85055055960
SN - 2211-0348
VL - 27
SP - 65
EP - 73
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
ER -