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   DIR Return to: TECFIDERA (dimethyl fumarate, BG-12, Fumaderm)
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       #Post#: 304--------------------------------------------------
       (AAN) Tecfidera & pregnancy...
   DIR By: agate
       Date: May 9, 2014, 3:45 pm
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       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
       --- End Quote ---
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