{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T13:12:41Z","timestamp":1787317961864,"version":"build-2736575974"},"reference-count":28,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2013,10,23]],"date-time":"2013-10-23T00:00:00Z","timestamp":1382486400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2013,12]]},"abstract":"<jats:p>Objective: To describe the clinical evidence supporting the safety, efficacy, and clinical utility of oral dimethyl fumarate for the treatment of multiple sclerosis (MS). Data Sources: A comprehensive PubMed search was conducted in July 2013 using the search terms dimethyl fumarate and Tecfidera. Reference lists of abstracted publications were reviewed to identify relevant works that were not retrieved via the electronic search. Additional information was obtained from the FDA Web site, manufacturer prescribing information, and Clinicaltrials.gov. Study Selection and Data Abstraction: Clinical trials and review articles that included the use of dimethyl fumarate in the treatment of MS and were available in English were abstracted for review. Data Synthesis: The safety and efficacy of dimethyl fumarate for the treatment of relapsing remitting MS was confirmed in 2 phase III trials, DEFINE and CONFIRM. Relative to placebo, twice-daily dimethyl fumarate was found to reduce the proportion of patients with relapses at 2 years by 34% to 49% and the annualized relapse rate by 44% to 53%. Although the incidence of serious adverse effects did not differ from that of placebo, intolerable flushing and gastrointestinal adverse effects prompted discontinuation in 3% and 4% of patients, respectively. Conclusions: In March 2013, dimethyl fumarate was approved as a third oral option for patients with relapsing forms of MS. Although no head-to-head trials have been conducted, a comparison of data from phase III trials suggests that the efficacy of dimethyl fumarate is comparable to that of existing oral agents and may offer a preferable safety profile.<\/jats:p>","DOI":"10.1177\/1060028013509232","type":"journal-article","created":{"date-parts":[[2014,1,6]],"date-time":"2014-01-06T14:16:10Z","timestamp":1389017770000},"page":"1697-1702","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":46,"title":["Dimethyl Fumarate (Tecfidera)"],"prefix":"10.1177","volume":"47","author":[{"given":"Jineane V.","family":"Venci","sequence":"first","affiliation":[{"name":"University of Rochester Medical Center\/Strong Memorial Hospital, Rochester, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mona A.","family":"Gandhi","sequence":"additional","affiliation":[{"name":"St John Fisher College Wegmans School of Pharmacy, Rochester, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2013,10,23]]},"reference":[{"key":"bibr1-1060028013509232","unstructured":"Longo DL. Harrison\u2019s principles of internal medicine. In: Multiple Sclerosis and Other Demyelinating Diseases. 18th ed. New York, NY: McGraw-Hill; 2012:chap 380. http:\/\/www.accessmedicine.com\/content.aspx?aID=9147780. Accessed September 3, 2013."},{"key":"bibr2-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000316802.35974.34"},{"key":"bibr3-1060028013509232","unstructured":"Center for Drug Evaluation and Research. Medical review: dimethyl fumarate. http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2013\/204063Orig1s000MedR.pdf. Accessed August 1, 2013."},{"key":"bibr4-1060028013509232","unstructured":"Tecfidera (dimethyl fumarate) [package insert]. Cambridge MA: Biogen Idec Inc; 2013."},{"key":"bibr5-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.111.190132"},{"key":"bibr6-1060028013509232","first-page":"e00055","volume":"3","author":"Lin SX","year":"2011","journal-title":"ASN Neuro"},{"key":"bibr7-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1114287"},{"key":"bibr8-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1206328"},{"key":"bibr9-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1002\/ana.20703"},{"key":"bibr10-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.33.11.1444"},{"key":"bibr11-1060028013509232","unstructured":"Center for Drug Evaluation and Research. Summary review: dimethyl fumarate. http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2013\/204063Orig1s000SumR.pdf. Accessed August 1, 2013."},{"key":"bibr12-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.2003.05433.x"},{"key":"bibr13-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1300283"},{"key":"bibr14-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3181b9c8f7"},{"key":"bibr15-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa044397"},{"key":"bibr16-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.43.4.655"},{"key":"bibr17-1060028013509232","doi-asserted-by":"crossref","first-page":"1498","DOI":"10.1016\/S0140-6736(98)03334-0","volume":"352","author":"Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing\/remitting multiple sclerosis","year":"1998","journal-title":"Lancet"},{"key":"bibr18-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.45.7.1268"},{"key":"bibr19-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1002\/ana.410390304"},{"key":"bibr20-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0909494"},{"key":"bibr21-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1014656"},{"key":"bibr22-1060028013509232","unstructured":"US Food and Drug Administration. FDA Drug Safety Communication: Safety review of a reported death after the first dose of multiple sclerosis drug Gilenya (fingolimod). http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm284240.htm#data. Accessed August 1, 2013."},{"key":"bibr23-1060028013509232","unstructured":"US Food and Drug Administration. FDA drug safety communication: revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod). http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm303192.htm. Accessed August 8, 2013."},{"key":"bibr24-1060028013509232","unstructured":"Gilenya (fingolimod) [package insert]. East Hanover, NJ: Novartis; 2013."},{"key":"bibr25-1060028013509232","unstructured":"Aubagio (reriflunomide) [package insert]. Cambridge, MA: Genzyme; 2012."},{"key":"bibr26-1060028013509232","doi-asserted-by":"publisher","DOI":"10.1111\/j.0007-0963.2004.05903.x"},{"key":"bibr27-1060028013509232","unstructured":"ClinicalTrials.gov. http:\/\/clinicaltrials.gov\/ct2\/results?term=dimethyl+fumarate&Search=Search. Accessed Aug 1, 2013."},{"key":"bibr28-1060028013509232","unstructured":"RED BOOK Drug References. Truven Health Analytics. http:\/\/thomsonreuters.com\/products_services\/healthcare\/healthcare_products\/clinical_deci_support\/micromedex_clinical_evidence_sols\/med_safety_solutions\/red_book\/. Accessed August 1, 2013."}],"updated-by":[{"DOI":"10.1177\/1060028014529923","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2014,4,14]],"date-time":"2014-04-14T00:00:00Z","timestamp":1397433600000}}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1060028013509232","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1060028013509232","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1060028013509232","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T11:14:33Z","timestamp":1777374873000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1060028013509232"}},"subtitle":["A New Oral Agent for Multiple Sclerosis"],"short-title":[],"issued":{"date-parts":[[2013,10,23]]},"references-count":28,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2013,12]]}},"alternative-id":["10.1177\/1060028013509232"],"URL":"https:\/\/doi.org\/10.1177\/1060028013509232","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,10,23]]}}}