Source: DGNews  |  Posted 2 years ago

By Bruce Sylvester

SAN DIEGO -- October 28, 2009 -- Preliminary data from a long-term, prospective
safety study presented here at the American College of Gastroenterology (ACG)
74th Annual Scientific Meeting suggests that first-trimester exposure to
adalimumab does not increase risks for live birth malformations.

“This is an ongoing study and these are preliminary data,” said presenter and
lead investigator Diana Johnson, Department of Pediatrics, University of
California, San Diego, La Jolla, California, on October 25. “But so far we have
seen no pattern in malformations for adalimumab-treated versus other women.”

The study is being conducted by the Organization of Teratology Information
Specialists (OTIS), a North American network of teratogen (an agent that can
cause malformations of an embryo or fetus) counselling services that provides
information to healthcare providers and pregnant women.

The OTIS Autoimmune Diseases in Pregnancy Project started in 1999, uses 1
coordinating centre to recruit and follow patients, and draws on the wider OTIS
network to screen and refer pregnant women who qualify for study participation.

As of October 22 (5.5 years of the study), pregnancy outcomes were available
for 239 women in the cohort. Pregnancy outcomes were obtained by maternal
interview and medical record review. All liveborn infants were examined for
major and minor anomalies by a team of paediatric specialists.

Outcomes in the first-trimester adalimumab-exposed group (n = 94) were compared
with a disease-matched group of women with rheumatoid arthritis or Crohn’s
disease who had not been treated with adalimumab (n = 58) and to a non-diseased
group of women (n = 87).

The researchers reported that 7 (8.8%) of the 94 women in the
adalimumab-exposed group delivered live infants with major birth defects. These
included 1 undescended testicle; 1 microcephaly; 1 ventricular septal defect; 1
congenital hip dysplasia with inguinal hernia; 1 congenital hypothyroidism; 1
bicuspid aortic valve and agenesis of the corpus callosum (a twin, in which the
2nd twin had a patent ductus arteriosus); and 1 congenital hydronephrosis (a
twin, in which the 2nd twin was spontaneously aborted).

There were 2 (3.8%) reported malformations among live births in the diseased
comparison group and 4 (5.1%) in the non-diseased group. The researchers noted
that rates for all 3 groups are consistent with the expected range in the
general population.

The investigators emphasised that firm conclusions await accumulation and
evaluation of data on a larger group of patients.

Funding for the OTIS Autoimmune Diseases in Pregnancy Project is provided by
Abbott Laboratories, Amgen, Apotex, sanofi-aventis, Barr, Bristol-Myers Squibb,
Kali, Par, Sandoz, Sanofi Pasteur, and Teva Pharmaceuticals.

Presentation title: Pregnancy Outcomes in Women Exposed to Adalimumab: An
Update on the Autoimmune Diseases in Pregnancy Project. Abstract 269