Assessing treatment response to oral drugs for multiple sclerosis in real-world setting: a MAGNIMS Study

Author:

Ruggieri SerenaORCID,Prosperini LucaORCID,Al-Araji Sarmad,Annovazzi Pietro Osvaldo,Bisecco AlvinoORCID,Ciccarelli Olga,De Stefano Nicola,Filippi MassimoORCID,Fleischer VinzenzORCID,Evangelou Nikos,Enzinger Christian,Gallo Antonio,Garjani AfaghORCID,Groppa Sergiu,Haggiag Shalom,Khalil MichaelORCID,Lucchini MatteoORCID,Mirabella Massimiliano,Montalban Xavier,Pozzilli Carlo,Preziosa PaoloORCID,Río Jordi,Rocca Maria AORCID,Rovira AlexORCID,Stromillo Maria L,Zaffaroni Mauro,Tortorella CarlaORCID,Gasperini ClaudioORCID

Abstract

BackgroundThe assessment of treatment response is a crucial step for patients with relapsing-remitting multiple sclerosis on disease-modifying therapies (DMTs). We explored whether a scoring system developed within the MAGNIMS (MRI in Multiple Sclerosis) network to evaluate treatment response to injectable drugs can be adopted also to oral DMTs.MethodsA multicentre dataset of 1200 patients who started three oral DMTs (fingolimod, teriflunomide and dimethyl fumarate) was collected within the MAGNIMS network. Disease activity after the first year was classified by the ‘MAGNIMS’ score based on the combination of relapses (0–≥2) and/or new T2 lesions (<3 or ≥3) on brain MRI. We explored the association of this score with the following 3-year outcomes: (1) confirmed disability worsening (CDW); (2) treatment failure (TFL); (3) relapse count between years 1 and 3. The additional value of contrast-enhancing lesions (CELs) and lesion location was explored.ResultsAt 3 years, 160 patients experienced CDW: 12% of them scored ‘0’ (reference), 18% scored ‘1’ (HR=1.82, 95% CI 1.20 to 2.76, p=0.005) and 37% scored ‘2’ (HR=2.74, 95% CI 1.41 to 5.36, p=0.003) at 1 year. The analysis of other outcomes provided similar findings. Considering the location of new T2 lesions (supratentorial vs infratentorial/spinal cord) and the presence of CELs improved the prediction of CDW and TFL, respectively, in patients with minimal MRI activity alone (one or two new T2 lesions).ConclusionsEarly relapses and substantial MRI activity in the first year of treatment are associated with worse short-term outcomes in patients treated with some of the oral DMTs.

Publisher

BMJ

Subject

Psychiatry and Mental health,Neurology (clinical),Surgery

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