Is abatacept (Orencia) safe for pregnant women with rheumatoid arthritis (RA)?

Updated: May 11, 2018
  • Author: Katherine K Temprano, MD; Chief Editor: Christine Isaacs, MD  more...
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Abatacept (Orencia) is a selective co-stimulation modulator that binds to CD80 and CD86, thereby inhibiting activation of T lymphocytes and interactions with CD28. This drug is indicated for the treatment of moderate to severe RA. Abatacept is considered a pregnancy risk factor C and should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Attempts to conceive should occur 14 weeks after the last abatacept dose, which would correlate with five half-lives of abatacept. [3]

The largest series of maternal exposure to abatacept is 151 pregnancies with 86 live births. [51]  Spontaneous abortion was reported in 40 pregnancies (over half of patients were also receiving MTX) and 19 women chose elective abortion. Two of the mothers were also receiving LEF and mycophenolate. Seven (8.1%) congenital anomalies were identified:

  • Cleft lip/palate
  • Congenital aortic anomaly
  • Meningocele
  • Pyloric stenosis
  • Skull malformation
  • Trisomy 21 with premature rupture of membranes at 17 weeks and subsequent infant death
  • Ventricular septal defect and congenital arterial malformation

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