Tocilizumab in Pregnancy Save
Tocilizumab is currently listed as a Category "C" pregnancy risk based on limited pre-clinical (animal) data that was negative. The product label states that "adequate and well-controlled studies with ACTEMRA have not been conducted in pregnant women....and that ACTEMRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus."
An analysis of the cumulative pregnancy outcomes after maternal exposure to tocilizumab was done using Roche Global Safety Database (up till 12/3/114). They found 399 women who have been exposed to tocilizumab (TCZ) shortly before or during pregnancy.
Documented outcomes are available in 288 pregnancies (72.2%). Of these 288 pregnancies, 180 were prospectively reported resulting in 109 live births (60.6%), 39 spontaneous abortions (21.7%), 31 elective terminations of pregnancy (17.2%), and 1 stillbirth.
The rate of malformations was 4.5%. There appears to be an increased rate of preterm birth (31.2%), but it is not known if this was drug or disease activity related.
These preliminary data find no substantial increased malformation risk in women treated with TCZ. Further study is warranted.
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The author has received research/grant financial support on this subject
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