Background Fingolimod, an oral sphingosine 1-phosphate receptor modulator, is approved by EMA for relapsing-remitting multiple sclerosis (RRMS). Objectives To assess the effectiveness and safety of fingolimod in patients with RRMS in real-world clinical practice in Portugal. Methods Retrospective, multicentre, non-interventional study, reporting 3 years follow-up of data collected from October 2015 to July 2016. Sociodemographic data and previous treatments at baseline and data regarding disease evolution, including number of relapses, annualised relapse rates (ARR) and Expanded Disability Status Scale (EDSS), were collected. Results Two-hundred and seventy-five participants were enrolled in the REALMS study. Results showed that the main reason to switch to fingolimod was failure of previous treatment (56.7%) and only 3.6% were naïve patients. In the total population, there was a significant decrease in ARR of 64.6% in the first year of treatment, 79.7% in the second year and 82.3% in the third year, compared with baseline. More than 67.0% of patients had no relapses during the 3 years after switching to fingolimod. EDSS remained stable throughout the study. Conclusions Therapy with fingolimod showed a sustained effectiveness and safety over the 3 years, particularly on patients switched from first-line drugs (BRACE). No new safety issues were reported.
ObjectivesThe diagnostic criteria for inflammatory demyelinating diseases of the central nervous system have evolved over the past years. Close follow up and accurate multiple sclerosis (MS) diagnosis are key to optimal treatment. We retrospectively reviewed the patients who had a diagnostic revision.MethodsThe medical records of patients referred to our MS clinic (Centro Hospitalar Universitário de São João, Porto, Portugal) (n = 635) between 2009 and 2016 were reviewed. A total of 62 patients were identified, 44 were misdiagnosed with MS; 18 had another diagnosis, later redefined as MS. A total of 44 controls (with MS diagnosis) were matched to the 44 misdiagnosed cases, and a statistical analysis was carried out to determine the predictors of misdiagnosis.ResultsThe mean age of our population (n = 44) was 51 ± 11 years; 77% were women. The mean duration of misdiagnosis was 13 years. Optic neuritis was the most frequent presenting symptom (25%), followed by spinal cord syndrome and non‐specific neurological symptoms (20% each). The most frequent MS misdiagnoses were non‐specific white matter hyperintensities, optic neuritis and cerebrovascular disease. The mean Extended Disability Status Scale and Multiple Sclerosis Severity Score was 0 (SD 2) and 0.6 (SD 2), respectively, in the misdiagnosed group, and 3.5 (SD 5.4) and 3.2 (SD 5.6), respectively, in the control group. From all the variables analyzed, we found that the presence of black holes and spinal cord lesions were predictors of a correct MS diagnosis (P < 0,05).ConclusionsOur series underlines the need to continuously rethink an MS diagnosis and to thoughtfully use paraclinical tests (oligoclonal bands and magnetic resonance imaging) avoiding an unfounded diagnosis. The first event might not be atypical, as has been reported in other series.
Objectives:To study the association between multiple sclerosis (MS) and other autoimmune diseases (AID).Methods: From a cohort of 635 patients with MS, 66 patients with an history of AID were selected. Controls, matched 1:1, were chosen from the population of patients with MS without autoimmune comorbidities. Further analysis aimed to compare these groups. Results:The prevalence of comorbid AID in our population was 10.4%. The mean age was 43 ± 13 years; 77% were women. A total of 15 different types of AID were identified, the predominant one was autoimmune thyroiditis (18/66; 27%). In 46% of patients, the AID was diagnosed before, and in 49%, it was diagnosed after the diagnosis of MS. The presence of family history of AID was not associated with the risk of developing AID. Our analysis found no association between the presence of AID and disease activity (new lesions, gadolinium enhancement, mean of annual relapse rate, initiation of a second-line treatment), either when considering each variable individually or within a composite score. The median Extended Disability Status Scale and Multiple Sclerosis Severity Score was 1.5 (interquartile range [IQR] 3.0) and 1.0 (IQR 3.0), respectively, in the AID group, and 1.5 (IQR 3.0) and 2.0 (IQR 3.0), respectively, in the control group, and the difference was not statistically significant. The presence of a concomitant AID influenced therapeutic choice in nine patients. Conclusions:The present study underlines the varied range of AID that might coexist with MS. This common ground does not seem to have a negative effect on the disease course. K E Y W O R D Sautoimmune diseases, demyelinating diseases, immune system diseases, immunomodulation, multiple sclerosis
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