Has the medication received FDA approval? Yes the FDA approved dimethyl fumarate on March 27, 2013.

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1 Dimethyl Fumarate [formerly called BG-12] (Tecfidera ) CLINICIAN INFORMATION What is the medication? April 2013 Generic: Dimethyl Fumarate [formerly called BG-12] Brand name: Tecfidera The third oral medication approved by the US Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS) Has the medication received FDA approval? Yes the FDA approved dimethyl fumarate on March 27, What are the indications and uses (e.g., in which types of MS)? Dimethyl fumarate is approved for the treatment of relapsing forms of MS. What were the findings in the pivotal trials of this medication? (For whom has it shown benefit? For whom might it prove harmful? For whom do we have no data?) Two Phase III pivotal trials were conducted and published in the New England Journal of Medicine September 20, DEFINE trial (Gold R, et al N Engl J Med. 2012;367: ) - Trial Design: In a two-year randomized, double blind, placebo-controlled trial, two doses of oral BG mg twice daily or 240 mg three times daily were compared with placebo in 1234 patients with relapsing-remitting MS aged and with entry Expanded Disability Status Scale (EDSS) score of 0 5, who had at least one clinically documented relapse in the year prior to entry, or who had at least one gadolinium-enhancing lesion on an MRI within six weeks of randomization. A subgroup of 540 patients evenly assigned to treatment allocation was included in the MRI component of the study and had MRIs at weeks 24, 48, and 96. Their demographics were similar to those of the study population as a whole. - Primary Endpoint: The primary endpoint was the proportion of patients who had a protocol-defined relapse within the two-year study period. Relapses were defined as new or recurrent neurologic symptoms of longer than 24-hour duration that were unassociated with fever or infection and were accompanied by new, objective neurologic findings. An Independent Neurologic Evaluation MS COALITION (800) x of 8

2 Committee assessed the reported relapses and was blinded to treatment assignment. - Secondary Endpoints: Secondary clinical endpoints included annualized relapse rates and the time to progression of disability. Disability progression was defined as a 1-point (or higher) increase on the EDSS score if the entry EDSS score was 1.0 or higher; or as a 1.5-point (or higher) increase on EDSS score if entry EDSS score was 0, with the increased score sustained for 12 weeks. Secondary MRI endpoints included number of new or enlarging T2 lesions and the number of gadolinium-enhancing lesions. - Results: 1237 subjects were randomized. Of those, 1234 received at least one dose and constituted the intention-to-treat cohort that was analyzed. Seventyseven percent of subjects completed the study. About 40% of the cohort had previously been treated with another disease-modifying agent for MS. The proportion of subjects relapsing within two years was 27% in the 240-mg-bid group, 26% in the 240-mg-tid group, and 46% in the placebo group, with relative risk reductions of 49% and 50% for the bid and tid groups, respectively, as compared with placebo; p<0.001 for both comparisons. [primary endpoint] Annualized relapse rate at 2 years was 0.17 for 240 mg bid, 0.19 for 240 mg tid, and 0.36 for placebo with relative reductions of 53% for 240 mg bid and 48% for 240 mg tid as compared with placebo; p value <0.001 for both comparisons. The proportion of patients with EDSS progression sustained for at least 12 weeks during the two-year study was 16% for 240 mg bid, 18% for 240 mg tid, and 27% for placebo, with relative risk reductions of 38% for 240 mg bid and 34% for 240 mg tid as compared with placebo; p=0.005 for bid, p=0.01 for tid. In the MRI subset, new or enlarging T2 lesions were reduced at 2 years by 85% in the 240-mg-bid group and by 74% in the 240 mg-tid group as compared with placebo; p<0.001 for both comparisons. Ninety-three percent of the 240 mg- bid group and 86% of the 240-mg-tid group had no enhancing lesions on MRI at 2 years as compared with 62% of the placebo group. CONFIRM study (Fox RJ et al. N Engl J Med 2012;367: ) - Trial Design: This was a Phase III randomized trial comparing blinded oral BG mg bid or 240 mg tid with placebo over two years. A reference active comparator group received glatiramer acetate and was rater-blinded but not subject-blinded subjects were equally and randomly allocated among the four arms. Entry criteria were identical to those of the DEFINE trial. A subset 2 of 8

3 of 681 subjects received MRI scans at baseline, 24, 48, and 96 weeks. The study was not designed or powered to test the superiority or noninferiority of BG-12 as compared with glatiramer acetate. - Primary Endpoint: The primary endpoint was annualized relapse rate at two years on the basis of protocol-defined relapses by criteria identical to those used in the DEFINE trial. An independent Neurologic Evaluation Committee that was blinded to treatment allocation reviewed relapse events. - Secondary Endpoints: Proportion of subjects relapsing within two years defined as above Time to confirmed disability progression as defined by EDSS score change sustained for at least 12 weeks as specified in the DEFINE trial Number of new or enlarging T2 lesions in the MRI subset at two years Number of new hypointense T1 lesions in the MRI subset at two years - Results: 1430 subjects with relapsing-remitting MS were randomized; 1417 received at least one dose and constituted the intention-to-treat population that was analyzed. Eighty percent completed the study. Approximately 29% had previously received disease-modifying therapy (DMT) for MS. Annualized relapse rates were 0.22 for 240 mg bid and 0.20 for 240 mg tid as compared with 0.40 for placebo, representing relative reductions of 44% and 51% for the bid and tid doses, respectively, as compared with placebo; p<0.001 for both comparisons [primary endpoint]. Annualized relapse rate for glatiramer acetate was 0.29, representing a 29% relative risk reduction as compared with placebo; p=0.01. The proportion relapsing over two years was 29% for 240 mg bid, 24% for 240 mg tid, 32% for glatiramer acetate, and 41% for placebo, representing relative risk reductions for relapse of 34% for bid (p=0.002), 45% for tid (p<0.001), and 29% for glatiramer acetate (p=0.01), respectively, when compared with placebo. Disability progression as measured by change in EDSS score occurred in 13% of each of the BG-12 groups, 16% in the glatiramer acetate group, and 17% in the placebo group. Differences between groups were not statistically significant. The mean number of new or enlarging T2 lesions at two years was reduced by 71% in the 240-mg-bid group, 73% in the 240-mg-tid group, and 54% 3 of 8

4 in the glatiramer acetate group as compared with placebo (p<0.001 for all comparisons). The mean number of new T1 hypointense lesions was reduced by 57% in the 240-mg-bid group (p<0.001), 65% in the 240-mg-tid group (p<0.001), and 41% in the glatiramer acetate group (p=0.002) as compared with placebo. The proportion of subjects without new or enlarging T2 lesions at two years was 27% for 240 mg bid, 31% for 240 mg tid, 24% for glatiramer acetate, and 12% for placebo. The proportion of subjects without new T1 hypointense lesions at two years was 39% for 240 mg bid, 44% for 240 mg tid, 34% for glatiramer acetate, and 21% for placebo. What is the mechanism of action of dimethyl fumarate and the rationale for its use in MS? This oral formulation of dimethyl fumarate (DMF) is rapidly hydrolyzed to its active metabolite, monomethyl fumarate (MMF). Although the mechanism by which the medication exerts its beneficial effect in MS is unknown, DMF and MMF have been shown to activate the nuclear factor (erythroid-derived 2)-like 2 transcriptional antioxidant pathway that protects cells, including neurons, from oxidative stress. DMF may also modulate immune cell responses by shifting dendritic cell differentiation, suppressing proinflammatory cytokine production, or inhibiting proinflammatory pathways. MMF is a nicotinic acid receptor agonist in vitro. What are the delivery route and recommended dosing? Tecfidera comes in a time-release capsule. An initial titration dose of 120 mg bid for one week (7 days) is recommended, followed by escalation to the maintenance dose of 240 mg bid. A first-month dosing kit containing medication in these doses is available. The capsule should be swallowed whole and not crushed, chewed, or opened and sprinkled on food. It may be taken with or without food; however, taking the medication with food appears to reduce the occurrence of flushing. Can this medication be used with other medications? DMTs: - Has this medication been tested in combination with other medications? No published studies have evaluated the use of DMF in combination with other MS DMTs. 4 of 8

5 Other Medications - Are there potential concerns regarding concurrent or prior use of other medications? No specific concerns were identified in the pivotal trials (DEFINE and CONFIRM) regarding concurrent or prior use of other medications. No specific concerns were identified for DMF with prior use of other MS DMTs, but 60% and 70% of the patients in DEFINE and CONFIRM, respectively, were naïve to MS DMTs at study entry. Pharmacokinetic studies have also not identified any potential drug interactions. DMF is not metabolized by the cytochrome P450 system and is primarily excreted through CO2 exhalation with minor renal and fecal contributions. How does the expected treatment effect compare with the treatment effect provided by other available medications? The CONFIRM trial (see details above) included glatiramer acetate as a reference comparator, but the study was not designed or powered to test the superiority or noninferiority of DMF as compared with glatiramer acetate. Available data do not allow firm conclusions about the relative effectiveness of DMF as compared with the other FDA-approved MS DMTs. Head-to-head comparative studies would be needed to determine relative effectiveness. What are the possible short-term adverse effects (AEs)? What is the range of severity of these AEs, and what are the recommended management strategies? AEs were similar in the two pivotal trials (DEFINE and CONFIRM) described above. AEs most commonly associated with DMF more often than placebo included flushing and gastrointestinal (GI) events, including diarrhea, nausea and vomiting, and abdominal pain, with flushing and GI events occurring in approximately 30% 40% of patients. Flushing and GI events were most common in the first month of treatment and decreased thereafter. Administration of DMF with food may reduce the incidence of flushing. Lymphopenia occurred in approximately 30% of patients taking DMF during the first year of treatment and then stabilized. Four weeks after stopping DMF, mean lymphocyte counts increased but did not reach baseline level and 6% remained below 500 x 106/ ml. Other AEs more common with DMF than with placebo were rash, pruritis, erythema, albuminuria, and elevation of aspartate aminotransferase. Most AEs were mild or moderate in severity. In the pivotal trials, gastroenteritis and gastritis were the only serious AEs other than MS relapses that occurred in two or more patients receiving DMF. 5 of 8

6 What are the known and theoretical long-range morbidity and mortality health risks? The following is known about health effects of DMF from the pivotal trials: Mean white cell counts and lymphocyte counts decreased over the first year of therapy and then stabilized. Transient increases in mean eosinophil counts were seen during the first 2 months of therapy. Overall infection incidence and serious infection incidence did not differ between DMF and placebo, and no opportunistic infections occurred. The incidence of malignant neoplasms was low and similar in the DMF and placebo groups in the DEFINE trial. No malignant neoplasms were seen in the CONFIRM trial. Elevated liver transaminase levels occurred more often with DMF (6%) than with placebo (3%), particularly during the first 6 months of therapy, in the DEFINE study, but there was no difference from placebo in the CONFIRM study; no cases of hepatic failure were reported. Proteinuria was reported more frequently with DMF than with placebo (8% in placebo group and 9% and 12% in the two DMF arms of DEFINE). No cases of renal failure were reported in either pivotal trial. The long-term risks of MS treatment with DMF are unknown. Has the FDA included any black box warnings about this medication? No. What training is recommended or required for patients and clinicians before initiating this treatment? There is no specific training required of either patient or clinician before initiating this treatment. What is the pregnancy rating for this medication? DMF has a pregnancy category C rating. Studies in laboratory animals revealed maternal reduction in body weight as well as AEs related to fetal survival, growth, sexual maturation, and neurobehavioral function. It is not known whether DMF is excreted in breast milk, and caution is advised when considering DMF for a woman who is breastfeeding. There is a pregnancy registry for women who were exposed to DMF during pregnancy. Clinicians are encouraged to request that patients enroll by calling Does this medication interact or interfere with oral contraceptives? No potential drug interactions with DMF have been identified. 6 of 8

7 Can Tecfidera be prescribed to pediatric or geriatric patients with MS? The safety and effectiveness in pediatric patients have not been established. Studies of DMF did not include sufficient numbers of patients over 65 years to determine whether they respond differently than younger patients. Has the FDA recommended or required a safety-monitoring program? What kind of safety monitoring is recommended (including prescreening, routine checkups, and laboratory tests)? The FDA has not required a safety-monitoring program, but it has recommended the following safety-monitoring procedures: Before initiating treatment with DMF, a recent complete blood count (CBC) (i.e., within 6 months) should be available. A CBC is recommended annually and as clinically indicated. Withholding treatment should be considered in patients with serious infection(s) until any infection present is resolved. Are there any recommended limits on duration of treatment with this medication? There are no recommended limits to the duration of treatment with DMF. What happens following termination of treatment with this medication? As with discontinuing any DMT, MS activity may return following the discontinuation of DMFe. What treatment options are available for patients after being treated with DMF? Other MS DMTs. What is the washout period? There is no specific washout period recommended for DMF. How can a provider identify a suboptimal treatment response? Clinical assessment, neuroimaging (MRI), and patient self-report indicative of continued MS disease activity in a patient adherent to treatment. Is the manufacturer/distributor offering any financial assistance program for patients? Biogen Idec offers comprehensive insurance and financial assistance programs, including a $10 copay program for eligible patients. Contact information: or Tecfidera.com. Are there any special considerations for this drug? Before starting therapy, a recent (with six months) CBC should be reviewed. Thereafter, the FDA recommends annual CBCs and as clinically indicated. Health care professionals should consider withholding treatment in patients with serious infections until the infections resolve. 7 of 8

8 COMMENTARY BY TEMPLATE AUTHORS Only patients with relapsing-remitting MS were enrolled in the two pivotal trials of DMT. The effect of DMT on patients with secondary progressive MS who do not have relapses is unknown. AUTHORS: Bruce Cohen, MD; June Halper, MSN, APN-C, MSCN, FAAN; Ruth Whitham, MD, FAAN EDITOR: Rosalind Kalb, PhD DISCLOSURES: Bruce A. Cohen, MD, was a member of the independent neurologic evaluation committee which blindly reviewed relapse occurring in the DMT studies. June Halper, MSN, APN-C, MSCN, FAAN, is a consultant and non-cme speaker for Acorda Therapeutics. Ruth Whitham, MD, FAAN, has no disclosures. Rosalind Kalb, PhD, has no disclosures. DISCLAIMER: The Emerging Therapies Collaborative is proud to be a source of information about multiple sclerosis. Our comments are based on published data and expert opinion, but do not represent individual therapeutic recommendations or prescriptions. For specific information and advice, consult your physician. FOR COMPLETE DISCLOSURES AND OTHER INFORMATION: Please visit our website at or us at For additional information, healthcare professionals are invited to the National MS Society s Professional Resource Center at 8 of 8

9 Update on Dimethyl Fumarate (Tecfidera) HEALTHCARE PROFESSIONAL INFORMATION Update Posted on December /2014: The US Food and Drug Administration (FDA) approved a change to the prescription label for dimethyl fumarate (Tecfidera) to include new information: Dosage and Administration, Dosing Information The Dosing and Administration section has been changed to include the following: Section 2.1: Dosing Temporary dose reductions to 120 mg twice a day may be considered by individuals who do not tolerate the maintenance dose. The recommended dose of 240 mg twice a day should be resumed within 4 weeks. Discontinuation of treatment with dimethyl fumarate should be considered for patients unable to tolerate the return to the maintenance dose. The incidence or severity of flushing may be reduced by taking dimethyl fumarate with food or by the administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to taking the medication. Contraindications Section 4 has changed to include the following: Dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of this medication. Reactions have included anaphylaxis and angioedema. Warnings and Precautions The Warnings and Precautions section has been changed to include the following: 5.1 Anaphylaxis and Angioedema Dimethyl fumarate can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria and swelling of the throat and tongue. MS COALITION (800) x of 3

10 5.2 Progressive Multifocal Leukoencephalopathy (PML) A fatal case of PML occurred in a patient who received dimethyl fumarate for four years while enrolled in a clinical trial. The patient experienced prolonged lymphopenia (counts predominantly <0.5x109/L for 3.5 years) while on the medication; however the role of lymphopenia in this case is not known. The patient had no identified systemic medical conditions resulting in a compromised immune system and had no previous treatment with natalizumab (known to have an association with PML) and no concomitant treatment with an immunosuppressive or immunomodulatory medication. 5.3 Lymphopenia Dimethyl fumarate may decrease lymphocyte counts. In the pivotal trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment and then remained stable. Four weeks after stopping the medication, mean lymphocyte counts increased but did not return to baseline. 6% of dimethyl fumarate patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L. The incidence of infections did not differ between patients treated with dimethyl fumarate and those who received placebo. There was no increased incidence of serious infections in patients with lymphocyte counts <0.8x109/L or 5x109/L in controlled trials, although one patient in an extension study developed PML (see Warnings and Precautions, Section 5.2). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5x109/L for at least six months, and the majority of counts in these patients remained <0.5x109/L with continued therapy. A CBC including lymphocyte count should be obtained before initiating treatment with dimethyl fumarate, as well as six months after treatment, and every 6-12 months thereafter and as clinically indicated. Consider interruption of treatment in patients with lymphocyte counts <0.5x109/L that persist for more than six months. MS COALITION (800) x of 3

11 Given the potential for delay in lymphocyte recovery after discontinuation of treatment, consider following lymphocyte counts until lymphopenia is resolved. Consider withholding treatment in patients with serious infections until the infection(s) is resolved. 5.4 Flushing The following information was added to the warning about flushing: Administration of dimethyl fumarate with food may reduce the incidence of flushing. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate may reduce incidence or severity of flushing. The Emerging Therapies Collaborative will continue to post updated information as it becomes available. DISCLAIMER: The Emerging Therapies Collaborative is proud to be a source of information about multiple sclerosis. Our comments are based on published data and expert opinion, but do not represent individual therapeutic recommendations or prescriptions. For specific information and advice, consult your physician. MS COALITION (800) x of 3

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