Early evidence of disease activity during fingolimod predicts medium-term inefficacy in relapsing-remitting multiple sclerosis
| Autor: | Francesca Sangalli, Laura Ferrè, Ferdinando Clarelli, Andrea Mogavero, Vittorio Martinelli, Federica Esposito, Lucia Moiola, Bruno Colombo, Giancarlo Comi, Massimo Filippi |
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| Přispěvatelé: | Ferre, L., Mogavero, A., Clarelli, F., Moiola, L., Sangalli, F., Colombo, B., Martinelli, V., Comi, G., Filippi, M., Esposito, F. |
| Rok vydání: | 2020 |
| Předmět: |
Drug
medicine.medical_specialty Multiple Sclerosis media_common.quotation_subject Disease activity Lesion Multiple sclerosis Cohort Studies 03 medical and health sciences 0302 clinical medicine Multiple Sclerosis Relapsing-Remitting Internal medicine medicine Humans 030212 general & internal medicine fingolimod media_common early prediction medicine.diagnostic_test Proportional hazards model business.industry Fingolimod Hydrochloride Natalizumab real world Magnetic resonance imaging medicine.disease Fingolimod Neurology Female Neurology (clinical) medicine.symptom business disease activity 030217 neurology & neurosurgery Immunosuppressive Agents Cohort study medicine.drug |
| Zdroj: | Multiple sclerosis (Houndmills, Basingstoke, England). 27(9) |
| ISSN: | 1477-0970 |
| Popis: | Background: Fingolimod (FTY) is an effective second-line drug for relapsing-remitting multiple sclerosis, with ~50% patients showing no evidence of disease activity (NEDA) after 2 years. Nonetheless, the early identification of non-responders is extremely important, to promptly address them to more aggressive drugs. Objectives: This cohort study evaluates FTY medium-term effectiveness, searching for early markers of treatment failure. Patients and methods: Three hundred eighty patients starting FTY were enrolled and classified according to NEDA and time to first relapse criteria at 4-year follow-up. Logistic and Cox regression analyses were applied to identify early predictors of non-response. Results: At 4 years, 65.6% of patients were free from relapses and 35.4% had NEDA. Female gender was associated with a higher risk of non-response. Moreover, evidence of clinical and/or magnetic resonance imaging (MRI) activity during the first year of treatment was highly predictive of disease activity in the follow-up: the positive predictive value for non-response was 0.74 for the presence of ⩾1 relapse, 0.73 for the presence of ⩾1 active MRI lesion, and 0.83 for the presence of both clinical and MRI activity. Conclusions: FTY effectiveness persists at medium-term follow-up; a close monitoring during the first year of treatment is warranted to early identify non-responders requiring treatment optimization. |
| Databáze: | OpenAIRE |
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