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Offline agate

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(AAN) Tecfidera & pregnancy...
« on: May 09, 2014, 11:45:36 am »
Presented at the annual AAN conference in Philadelphia, April 30, 2014:

Quote
[S24.006] Delayed−Release Dimethyl Fumarate and Pregnancy: Preclinical Studies and Pregnancy Outcomes Reported During the Clinical Development Program


Ralf Gold,1J. Theodore Phillips,2Eva Havrdova,3Amit Bar-Or,4Ludwig Kappos,5Janet Clarke,6Huixing Yuan,6Mark Novas,7Jie Li,6Marianne Sweetser,7Nuwan C. Kurukulasuriya,6Vissia Viglietta,7Robert J. Fox8

1Bochum, Germany, 2Dallas, TX, USA, 3Praha 2, Czech Republic, 4Montreal, QC, Canada, 5Basel, Switzerland, 6Weston, MA, USA, 7Cambridge, MA, USA, 8Cleveland, OH, USA

OBJECTIVE:

Present preclinical data from animal reproductive toxicology studies and the outcomes of pregnancies occuring during the delayed-release dimethyl fumarate (DMF)[Tecfidera] clinical development program.

BACKGROUND:

No formal studies of delayed-release DMF were conducted in pregnant women, but pregnancies have occurred during the clinical development program.

DESIGN/METHODS:

Reproductive and developmental toxicology was evaluated in rats and rabbits. Delayed-release DMF clinical studies included 2,665 MS patients, 320 psoriasis patients, 101 rheumatoid arthritis patients, and 338 healthy volunteers. Subjects were required to use reliable contraception and immediately discontinue drug in the event of pregnancy. Pregnancy outcomes as of January 2, 2013 (data cutoff) are reported in this abstract; outcomes as of January, 2014 will be presented.

RESULTS:

There was no evidence of impaired fertility in rats or teratogenicity in rats and rabbits given dimethyl fumarate at doses that caused reductions in maternal weight gain. As of January 2, 2013, 38 pregnancies in delayed-release DMF recipients (37 MS patients, 1 healthy volunteer) and 14 pregnancies in placebo recipients were reported in clinical studies. Information is pending for three delayed-release DMF recipients and one was lost to follow-up; hence, results for delayed-release DMF are reported for the 34 pregnancies with known outcomes. In patients exposed to delayed-release DMF, 22 live births (64.7%), 3 spontaneous abortions (8.8%), and 9 elective terminations (26.5%) were reported.

In placebo recipients, 9 live births (64.3%), 3 spontaneous abortions (21.4%), and 2 elective terminations (14.3%) were reported. No fetal abnormalities were reported. The incidence of spontaneous abortion was consistent with the expected rate of early pregnancy loss in the general population (12-22%).

CONCLUSIONS:

Based on the available data, no increased risk of fetal abnormalities or adverse pregnancy outcomes associated with gestational exposure to delayed-release DMF during the first trimester has been observed. Further data will be collected through a pregnancy registry.

_________________

Study supported by:

Biogen Idec, Inc.

Category - MS and CNS Inflammatory Disease: Clinical Science


S24: Platform Session: Diet and Hormonal Influences in Multiple Sclerosis
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.