No evidence of disease activity in patients receiving fingolimod at private or academic centers in clinical practice: a retrospective analysis of the multiple sclerosis, clinical, and magnetic resonance imaging outcomes in the USA (MS-MRIUS) study

Abstract

Objective: The impact of multiple sclerosis (MS) center type on outcomes has not been investigated. This study aimed to evaluate baseline characteristics and clinical and magnetic resonance imaging (MRI) outcomes in patients with MS receiving fingolimod over 16 months’ follow-up at private or academic centers in the USA.

Methods: Clinical and MRI data collected in clinical practice from patients initiating fingolimod were stratified by center type and retrospectively analyzed. No evidence of disease activity (NEDA-3) was defined as patients with no new/enlarged T2/gadolinium-enhancing lesions, no relapses, and no disability progression (Expanded Disability Status Scale scores).

Results: Data were collected for 398 patients from 25 private centers and 192 patients from eight academic centers. Patients were older (median age = 43 vs 41 years; p = .0047) and had a numerically shorter median disease duration (7.0 vs 8.5 years; p = .0985) at private vs academic centers. Annualized relapse rate (ARR) was higher in patients at private than academic centers in the pre-index (0.40 vs 0.29; p = .0127) and post-index (0.16 vs 0.08; p = .0334) periods. The opposite was true for T2 lesion volume in the pre-index (2.86 vs 5.23 mL; p = .0002) and post-index (2.86 vs 5.11 mL; p = .0016) periods; other MRI outcomes were similar between center types. After initiating fingolimod, ARRs were reduced, disability and most MRI outcomes remained stable, and a similar proportion of patients achieved NEDA-3 at private and academic centers (64.1% vs 56.1%; p = .0659).

Conclusion: Patient characteristics differ between private and academic centers. Over 55% of patients achieved NEDA-3 during fingolimod treatment at both center types.

Keywords:

• Multiple sclerosis
• Private center
• Academic center
• Fingolimod
• No evidence of disease activity

Transparency

Declaration of funding

Oxford PharmaGenesis and IQVIA received funding from Novartis Pharma AG.

Declaration of financial/other relationships

R.Z. has received personal compensation from EMD Serono, Sanofi Genzyme, Novartis, Celgene, and Claret Medical for speaking and consultancy fees. He has received financial support for research activities from Claret Medical, Sanofi Genzyme, IMS Health, and Novartis. N.K. is a paid consultant for IQVIA, Basel, Switzerland. J.R.K. was a paid employee of IQVIA (previously QuintilesIMS), Burlington, MA, USA, at the time of this study. E.L. has received honoraria as a speaker and consultant for Acorda, Biogen, Genzyme, Novartis, Teva Pharmaceuticals, and Genentech. J.S. has no conflicts of interest to report. J.C. has performed advisory, consultancy, and speaker activities for Acorda, Biogen, EMD Serono, Genzyme, Novartis, Roche, and Teva; and received grant/research support from Biogen, Genzyme, Novartis, Roche, and Celgene. J.M. and D.S. are paid employees of Novartis Pharma AG, Basel, Switzerland. S.K. is a paid employee of Novartis Pharmaceuticals, East Hanover, NJ, USA. B.W.-G. has received honoraria as a speaker and consultant for Biogen, EMD Serono, Sanofi Genzyme, Novartis, Teva Pharmaceuticals, and Genentech. She has received research funds from Biogen, EMD Serono, Sanofi Genzyme, Novartis, and Teva Pharmaceuticals. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.

Data availability statement

Novartis is committed to sharing, with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trial, in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Acknowledgments

The authors thank Dr Anne-Marie Couto and Helen Schofield at Oxford PharmaGenesis, Oxford, UK for medical writing support, editorial assistance, and collation and incorporation of comments from all authors.