2/1/2015

An Overview of the Pivotal DEFINE and CONFIRM Clinical Trials

Industry News
An Oral Therapy - Dosage for Relapsing
Forms of Multiple Sclerosis
An Overview of the Pivotal DEFINE and CONFIRM
Clinical Trials

Indication and Important Safety Information

Indication
Tecfidera (dimethyl fumarate) is indicated for the treatment of patients with relapsing forms of
multiple sclerosis.
Important Safety Information
Tecfidera is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the
excipients of Tecfidera. Tecfidera may decrease lymphocyte counts; in clinical trials there was a
mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four
weeks after stopping Tecfidera, mean lymphocyte counts increased but not to baseline. Six percent
of Tecfidera patients and <1% of placebo patients had lymphocyte counts <0.5x109/L. Tecfidera has
not been studied in patients with pre-existing low lymphocyte counts.
The incidence of infections and serious infections was similar in patients treated with Tecfidera or
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2/1/2015

An Overview of the Pivotal DEFINE and CONFIRM Clinical Trials

The incidence of infections and serious infections was similar in patients treated with Tecfidera or
placebo. Consider withholding treatment in patients with serious infections until resolved. A complete
blood count is recommended within 6 months before initiating treatment, annually, and as clinically
indicated.
Tecfidera may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% of
patients taking Tecfidera reported flushing which was mostly mild to moderate in severity. Three
percent of patients discontinued Tecfidera for flushing and <1% had serious flushing events that led
to hospitalization. Taking Tecfidera with food may reduce flushing.
Tecfidera may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain,
and dyspepsia). Four percent of Tecfidera patients and <1% placebo patients discontinued due to
GI events. The incidence of serious GI events was 1%. The most common adverse reactions
associated with Tecfidera versus placebo are flushing (40% vs 6%) and GI events: abdominal pain
(18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%).
Elevations in hepatic transaminases have been reported. A transient increase in mean eosinophil
counts was seen during the first two months. Tecfidera should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant
while taking Tecfidera to enroll in the Tecfidera pregnancy registry by calling 1-866-810-1462 or
visiting www.tecfiderapregnancyregistry.com.
Please see full Prescribing Information and Patient Information for additional important safety
information.

1. Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS; Gold R,
Kappos L, Arnold DL, et al. N Eng J Med 2012;367:1098-1107.
2. Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis; Fox RJ, Miller DH,
Phillips JT, et al. N Engl J Med. 2012;367:2362

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