Pregnancy & TNF-a Inhibitor Therapy
Posted on: 03/26/07
Two cohort studies were presented at the American Academy of Dermatology 65th annual meeting in February, 2007 that concluded, based on preliminary data, that there appears to be no risk for adverse outcomes for women when having taken Enbrel (etanercept) or Humira (adulimumab) during the first trimester of pregnancy.
Both Enbrel and Humira are biologic medications, TNF-a Inhibitors that are approved by the FDA for use in treating ankylosing spondylitis (AS). Humira and Enbrel are also approved for psoriatic arthritis.
Pincipal investigator Christina Chambers, PhD, MPH, associate professor in the Department of Pediatrics at the University of California at San Diego, presented the studies. The studies' data comes the Organization of Teratology Information Specialists (OTIS), a North American registry of university-based pregnancy risk counseling services.
Said Dr. Chambers, "Obviously, we can't conduct clinical trials to test safety during pregnancy. That's why we have to conduct these post-marketing analyses, to see if there are any red flags, and we haven't seen any."
Both studies to issue a word of caution in their conclusions, stating "Firm conclusions await accumulation of sufficient sample size in the cohort study."
For more information on TNF-a inhibitors and pregnancy, please see our Women's Health Section.
For more information on OTIS, visit their website by clicking here.
References:
AAD 65th Annual Meeting: Posters 38 and 39. Presented February 4, 2007. Click here to read the posters in the Supplement to the American Academy of Dermatology, Poster Abstracts from the AAD 65th Annual Meeting - page 15 of the PDF document.
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