VIENNA, Austria - As the use of tumor necrosis factor-alpha (TNF-α) inhibitors and other biologic drugs continues to increase-particularly among women, who bear the brunt of autoimmune disease-there is some concern about the potential effects of these agents on pregnancy.
Ricard Cervera, MD, PhD, FRCP, founding member of the department of autoimmune diseases at the Hospital Clinic in Barcelona, Spain, spoke to the topic at the Annual European Congress of Rheumatology of the European League Against Rheumatism (EULAR) on Wednesday afternoon. He reported the results of a consensus meeting held in conjunction with the 4th International Conference on Sex Hormones, Pregnancy, and Rheumatic Diseases, September 20-22, 2004, in Stresa, Italy. The consensus meeting was convened to establish guidelines for the use during pregnancy of drugs commonly employed for the treatment of autoimmune disease.
Among these drugs are the biologics, for which very few pregnancies have been reported. It is this lack of information that affects all new drugs, and which leads to the uniform recommendation to avoid biologic therapy if a patient is pregnant or considering pregnancy. CIAOMed had the opportunity to discuss the issue Dr. Cervera following his address.
CIAOMed: Obviously there isn't very much data concerning pregnancy and biologics, but is there a concerted effort to increase the amount of available information? Have registries been established, or are pregnancy trials underway?
Dr. Cervera: The problem now is that most of these therapies are [being evaluated in clinical] trials, and of course, one of the exclusion criteria for all of these trials is pregnancy. All we have is registries of those patients who were already in trials and became pregnant. So far, we have only 30 or 40 pregnancies with infliximab, and 30 or 40 on etanercept. Apparently, none of these pregnancies resulted in malformation
CIAOMed: Your recommendations are clear that a woman who is pregnant should not start using biologics and that a woman planning pregnancy should not initiate their use. What do you tell a patient who becomes pregnant after she's already begun therapy?
Dr. Cervera: If possible, stop the therapy. If it is not possible, we do not recommend stopping the pregnancy, because there are no cases of malformations.
CIAOMed: Do you foresee a time in the near future when, for instance, TNF-α inhibitors will be the recommended therapy for use by women with RA who are pregnant?
Dr. Cervera: It is really difficult to give that sort of recommendation, because we require a proper trial in pregnant women, but, of course, nobody will do it. So, the recommendations will always be to use the lowest effective dosages of drugs during pregnancy and, especially in the case of a new drug, to try to avoid it entirely. But as more women become pregnant on these drugs, probably we will see that, at least for TNF inhibitors, there are no side effects
CIAOMed: This is the only way any data will be generated?
Dr. Cervera: I think so, because for most new drugs this is the way we obtain information during pregnancy.
The five US Food and Drug Administration categories for drug use during pregnancy are:
| Category A | Drugs for which controlled studies in pregnant women fail to demonstrate risk |
| Category B | Drugs for which animal studies demonstrate no risk, but for which there are no studies in humans |
| Category C | Drugs for which animal studies demonstrate risk, but for which there are no studies in humans |
| Category D | Drugs for which there is evidence of human fetal risk, but use of the drug during pregnancy is permitted with proper monitoring |
| Category X | Drugs for which studies have demonstrated the occurrence of fetal abnormalities; not to be used during pregnancy |
Reference:
Cervera R. The risks of biological and immunosuppressant therapies in pregnant patients with rheumatic diseases. Presented at: Annual European Congress of Rheumatology of EULAR; June 8-11, 2005; Vienna, Austria. Abstract SP0012.
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