Background/Aims: Researchers increasingly recognize the high frequency of comorbidity in multiple sclerosis (MS) and the negative impact on quality of life and disability, but little work has evaluated methods of comorbidity measurement in MS. We aimed to validate a self-report questionnaire for assessing comorbidity in MS. Methods: Patients with MS were recruited from the MS Clinic in Winnipeg, Canada and the Mellen Center (Cleveland Clinic, Cleveland, Ohio, USA) from October 2008 to 2009. Using a questionnaire, participants reported the presence or absence of 36 comorbidities, sociodemographic characteristics, and disability status. Abstractors blinded to questionnaire results collected data regarding the comorbidities of interest and their treatments. Using the medical record as the gold standard, we determined the sensitivity, specificity, positive and negative predictive values of the questionnaire data. To measure agreement we calculated kappa (ĸ) statistics. Results: We enrolled 404 participants. Agreement between self-report and medical records was high (ĸ >0.82) for diabetes and hypertension; substantial (ĸ = 0.62–0.80) for hyperlipidemia, thyroid disease, glaucoma, and lung disease; moderate (ĸ = 0.43–0.56) for osteoporosis, irritable bowel syndrome, migraine, depression, heart disease, and anxiety disorders. Agreement was slight to fair for the remaining comorbidities. Conclusions: Self-report is a valid way to capture comorbidities affecting MS patients.

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BackgroundDimethyl fumarate and fingolimod are oral disease-modifying therapies approved to treat relapsing multiple sclerosis. Prior observational studies and our previous 12-month investigation showed comparable clinical efficacy.ObjectiveThe purpose of this study was to assess real-world efficacy and discontinuation of dimethyl fumarate and fingolimod over 24 months in patients with multiple sclerosis.MethodsPatients treated with dimethyl fumarate (n = 395) or fingolimod (n = 264) completed 24-month follow-up in a large academic multiple sclerosis center. Discontinuation rates and measures of disease activity were compared after propensity score weighting. The primary outcome was on-treatment annualized relapse rate ratio. Other measures included rate of drug discontinuation and brain magnetic resonance imaging activity defined as new T2 and/or gadolinium-enhancing lesions.ResultsPropensity score weighting showed excellent covariate balance. At 24 months, dimethyl fumarate demonstrated comparable annualized relapse rate (rate ratio = 1.45, 95% confidence interval 0.53–3.99) and brain magnetic resonance imaging activity (odds ratio = 1.38, 95% confidence interval 0.83–2.32). Dimethyl fumarate patients discontinued therapy earlier compared to fingolimod (hazard ratio = 1.40, 95% confidence interval 1.11–1.77) and were more likely to discontinue therapy due to intolerability (odds ratio = 1.98, 95% confidence interval 1.18–3.23).ConclusionDimethyl fumarate and fingolimod had similar reductions in annualized relapse rate in clinical trials, and our real-world experience supports this observation. Dimethyl fumarate-treated patients had higher likelihood of early discontinuation, and this was mostly due to intolerability.

Background: Dimethyl fumarate and fingolimod are oral disease-modifying therapies approved to treat relapsing multiple sclerosis. Prior observational studies and our previous 12-month investigation showed comparable clinical efficacy. Objective: The purpose of this study was to assess real-world efficacy and discontinuation of dimethyl fumarate and fingolimod over 24 months in patients with multiple sclerosis. Methods: Patients treated with dimethyl fumarate (n ¼ 395) or fingolimod (n ¼ 264) completed 24-month follow-up in a large academic multiple sclerosis center. Discontinuation rates and measures of disease activity were compared after propensity score weighting. The primary outcome was on-treatment annualized relapse rate ratio. Other measures included rate of drug discontinuation and brain magnetic resonance imaging activity defined as new T2 and/or gadolinium-enhancing lesions. Results: Propensity score weighting showed excellent covariate balance. At 24 months, dimethyl fumarate demonstrated comparable annualized relapse rate (rate ratio ¼ 1.45, 95% confidence interval 0.53 3.99) and brain magnetic resonance imaging activity (odds ratio ¼ 1.38, 95% confidence interval 0.83 2.32). Dimethyl fumarate patients discontinued therapy earlier compared to fingolimod (hazard ratio ¼ 1.40, 95% confidence interval 1.11 1.77) and were more likely to discontinue therapy due to intolerability (odds ratio ¼ 1.98, 95% confidence interval 1.18 3.23). Conclusion: Dimethyl fumarate and fingolimod had similar reductions in annualized relapse rate in clinical trials, and our real-world experience supports this observation. Dimethyl fumarate-treated patients had higher likelihood of early discontinuation, and this was mostly due to intolerability.

Background Fingolimod is approved by the U.S. Food and Drug Administration to reduce relapses and disability progression in relapsing forms of MS. Several screening studies and a first-dose observation (FDO) period are recommended due to adverse effects observed in clinical trials. Objective To describe the early experience with fingolimod, including startup, tolerability and safety in a large academic multiple sclerosis (MS) center. Methods Patients prescribed fingolimod from September 2010 to July 2011 were identified through electronic medical records. Demographics, MS disease history, pre-treatment screening studies, FDO experience during shared medical visits and three month follow-up data were analyzed. Results Three hundred ninety-one patients were prescribed fingolimod of whom 317 started the medication and were included in the analysis. Fingolimod was most frequently used in relapsing remitting MS (n = 256, 80.8%) and was prescribed as a first-line agent in 11 cases (3.5%). FDO was uneventful in 308 patients (96.8%). Adverse events during FDO were self limited and included symptomatic bradycardia (n = 3), chest tightness (n = 2) and hypertension (n = 1). Fingolimod was discontinued in 30 patients (9.5%) at three months. Adverse effects leading to discontinuation by more than one patient included headache (n = 4), macular edema (n = 3), nausea (n = 3) and hypertension (n = 2). Conclusions Fingolimod was well tolerated during FDO and adverse events were self limited. The shared medical visit is an appropriate setting for FDO. Adverse effects were similar to those described in clinical trials but discontinuation rate was higher.