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Title: | A Retrospective Analysis of Real-World Discontinuation Rates with Delayed-Release Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis. | Authors: | Grant L.;Allan M. | Institution: | (Allan) Monash Health, Clayton, VIC 3168, Australia (Grant) Biogen, North Ryde, NSW 2066, Australia | Issue Date: | 25-May-2020 | Copyright year: | 2020 | Publisher: | Adis | Place of publication: | United Kingdom | Publication information: | Neurology and Therapy. 9 (1) (pp 85-92), 2020. Date of Publication: 01 Jun 2020. | Journal: | Neurology and Therapy | Abstract: | Introduction: The main objective of this study was to examine discontinuation rates associated with delayed-release dimethyl fumarate (DMF) when used for the treatment of relapsing multiple sclerosis (MS) in a real-world, clinical practice setting. Method(s): Data were collected retrospectively from charts of adult patients with relapsing-remitting MS treated at a single large institution in Australia, who completed at least 6 months of continuous therapy, either with DMF or another MS medication administered following DMF discontinuation. The primary endpoint was overall discontinuation rate. Secondary endpoints included discontinuation rate 6 months after initiation of DMF therapy; incidence of adverse events, particularly gastrointestinal events; discontinuation rate because of adverse events; and use of concomitant medications by patients during administration of DMF. Result(s): A total of 100 patients initially prescribed DMF between October 1, 2013 and June 30, 2014 were included in the analysis. The mean age of the patients was 43 years and 80% were female. The overall discontinuation rate was 13%, with 9% discontinuing because of gastrointestinal tolerability issues, within the first 6 months. Dose changes as a result of adverse events occurred in 15% of patients, and none of the adverse events reported were serious. Only one patient discontinued owing to lack of efficacy. Conclusion(s): This study, conducted shortly after the approval of DMF in Australia when first-hand clinical experience was still limited, demonstrated that DMF has an acceptable tolerability profile in the real-world setting that is similar to that demonstrated in clinical trials.Copyright © 2019, The Author(s). | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1007/s40120-019-00174-3 | ISSN: | 2193-8253 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/35363 | Type: | Article | Subjects: | *multiple sclerosis/pc [Prevention] priority journal retrospective study unspecified side effect/si [Side Effect] acetylsalicylic acid/dt [Drug Therapy] alemtuzumab/dt [Drug Therapy] antacid agent antidiarrheal agent antihistaminic agent beta1a interferon/dt [Drug Therapy] fingolimod/dt [Drug Therapy] *fumaric acid dimethyl ester/ae [Adverse Drug Reaction] *fumaric acid dimethyl ester/dt [Drug Therapy] glatiramer/dt [Drug Therapy] interferon beta serine/dt [Drug Therapy] natalizumab/dt [Drug Therapy] proton pump inhibitor serotonin 3 antagonist teriflunomide/dt [Drug Therapy] female abdominal pain/dt [Drug Therapy] adult article disease duration disease severity drug efficacy drug safety drug withdrawal flushing gastrointestinal disease human major clinical study male *multiple sclerosis/dt [Drug Therapy] multiple sclerosis unspecified acetylsalicylic acid alemtuzumab antacid agent antidiarrheal agent antihistaminic agent beta1a interferon fingolimod fumaric acid dimethyl ester [Adverse Drug Reaction] fumaric acid dimethyl ester glatiramer interferon beta serine natalizumab proton pump inhibitor serotonin 3 antagonist teriflunomide abdominal pain disease duration drug efficacy drug safety drug withdrawal flushing gastrointestinal disease multiple sclerosis human major clinical study male *multiple sclerosis / *drug therapy / *prevention priority journal retrospective study unspecified side effect / side effect Article female drug withdrawal adult abdominal pain / drug therapy drug safety drug efficacy disease duration gastrointestinal disease disease severity flushing |
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