Modified Rio Score with Platform Therapy Predicts Treatment Success with Fingolimod and Natalizumab in Relapsing-Remitting Multiple Sclerosis Patients.

Anna Jamróz-Wiśniewska ,Dorota Koziarska,Marcin Wnuk,Radosław Zajdel,Przemysław Puz,Monika Adamczyk-Sowa,Monika Marona,Waldemar Fryze,Anna Karbicka,Arkadiusz Stęposz,Sławomir Wawrzyniak,Bożena Adamczyk,Konrad Rejdak,Ewa Krzystanek,Sławomir Budrewićz ,Agnieszka Słowik ,Anetta Lasek–Bal ,Maja Patalong‐Ogiewa ,Marzena Furtak–Niczyporuk ,Anna Pokryszko−Dragan

doi:10.3390/jcm10091830

Abstract

Background: Reliable markers of disease outcomes in multiple sclerosis (MS) would help to predict the response to treatment in patients treated with high efficacy drugs. No evidence of disease activity (NEDA) has become a treatment goal whereas the modified Rio score (MRS) predicts future suboptimal responders to treatment. The aim of our study was to identify factors that would predict poor response to treatment with natalizumab and fingolimod. Methods: In the multicenter prospective trial, 336 subjects were enrolled, initiating therapy with natalizumab (n = 135) or fingolimod (n = 201). Data on relapse rate, the expanded disability status scale, and MRI results were collected, and MRS was estimated. Results: NEDA-3 after the first year of therapy was 73.9% for natalizumab and 54.8% for fingolimod (p < 0.0001). Patients with MRS = 0 in the last year on platform therapy had the best NEDA-3 (71%) and patients with MRS = 3 had the worst NEDA-3 (41%) in the first year of treatment with the second-line therapy. Conclusion: We conclude that switching to the second-line therapy should occur earlier to enable better results for patients treated with natalizumab or fingolimod. The outcome on both drugs is better with better neurological conditions and lower MRS of the patient on the platform therapy.

Highlights

Multiple sclerosis (MS) is an autoimmune neurological disease that is a chronic, progressive disability and perceived as incurable
We found an association between modified Rio score (MRS) in the year preceding the switch to the secondline drugs and No evidence of disease activity (NEDA)-3 in the first year of therapy with these drugs
(71%) and patients with MRS = 3 had the worst NEDA (41%) in the first year of treatment with the second-line therapy, we conclude that switching to the second-line therapy should occur earlier to enable better results for the patients treated with natalizumab or fingolimod

Summary

Introduction

Multiple sclerosis (MS) is an autoimmune neurological disease that is a chronic, progressive disability and perceived as incurable. Fingolimod (a sphingosine-receptor agonist) and natalizumab (a humanized monoclonal antibody against the cell adhesion molecule α4-integrin) are used when MS becomes highly active because the possible side effects associated with their use are more serious (including progressive multifocal leukoencephalopathy associated mainly with natalizumab use) [1]. This is the so-called escalation therapy approach in contrast to induction therapy, used from the beginning of disease onset (i.e., treatment with immunosuppressive drugs like alemtuzumab, cladribine, mitoxantrone, or autologous-hematopoietic stem cell transplantation, followed by the long-term use of maintenance therapy with diseasemodifying treatment, DMT) used especially in case of rapidly evolving or severe MS (RES) [2]

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