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Biologika in Schwangerschaft und Stillzeit

Biologics during pregnancy and breast-feeding

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Zusammenfassung

Der Einsatz von Biologika-Therapien, insbesondere von TNF-α-Inhibitoren als therapeutisches Konzept bei Patienten mit unzureichendem Ansprechen auf traditionelle Basistherapien, nimmt zu. Frauen mit entzündlich-rheumatischen Erkrankungen benötigen nicht selten eine medikamentöse Therapie in der Schwangerschaft und Stillzeit, hier stellt sich die Frage nach deren Sicherheit. TNF-α-Inhibitoren werden von der FDA in die Kategorie B eingestuft, da keine ausreichenden Daten zur Schwangerschaft beim Menschen vorliegen. Im letzten Jahrzehnt gab es eine wachsende Anzahl von Publikationen mit exponierten Schwangerschaften, insbesondere Fallserien und Registerdaten. Legt man diese zugrunde, haben die bisher vorliegenden Daten keine belastbaren Hinweise auf ein erhöhtes Risiko von Fehlbildungen ergeben. Da nur wenige Fallberichte über eine Exposition während der gesamten Schwangerschaft vorliegen, sollte sicherheitshalber nach der Konzeption abgesetzt werden.

Allerdings kann es in Einzelfällen nach sorgfältiger Abwägung der klinischen Situation begründet sein, die Therapie auch in der Schwangerschaft fortzusetzen. Stillen unter TNF-α-Inhibitoren ist wahrscheinlich sicher. Das fetale Risiko zur Exposition mit anderen Biologika-Therapien wie z. B. Rituximab ist nicht geklärt.

Abstract

Over the past years, biological therapies, especially anti-TNF-α antibody therapy has emerged as a treatment approach in patients who have failed to achieve or maintain remission with tradional DMARDs. Women suffering from inflammatory arthritis may need to continue therapy throughout pregnancy and/or in the lactation period, hence the increased concern over the safety of antirheumatic drugs during pregnancy. Anti-TNF agents fall within the US FDA category B concerning fetal risk, indicating that no adequate and well-controlled studies have been conducted in pregnant or lactating women. However, in the last decade, numerous case series and registry data of pregnancies exposed to anti-TNF therapy have accumulated in the literature. According to these data, TNF inhibitor therapies appear to be safe in pregnancy, since no increased risk of malformations has been demonstrated. Ceasing therapy after conception should be considered, but treatment may be continued during pregnancy when indicated.

The use of these agents is likely compatible with breast-feeding. The extent of fetal risk is not clarified for exposure to other biologics, such as Rituximab.

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Die korrespondierende Autorin weist auf folgende Beziehungen hin: Vorträge und Beratungstätigkeit für Abbott, Wyeth, Essex, Roche, Chugai.

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  1. Klinik für Endokrinolologie, Diabetologie und Rheumatologie, Rheumazentrum Rhein-Ruhr, Moorenstr. 5, 40225, Düsseldorf, Deutschland

    R.E. Fischer-Betz MD & M. Schneider

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  1. R.E. Fischer-Betz MD
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  2. M. Schneider
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Correspondence to R.E. Fischer-Betz MD.

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Fischer-Betz, R., Schneider, M. Biologika in Schwangerschaft und Stillzeit. Z. Rheumatol. 69, 780–787 (2010). https://doi.org/10.1007/s00393-010-0640-2

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