Biologics Are Safe When Used During Pregnancy in IBD Save

This is a reposting of an earlier report on RheumNow that includes additional commentary from Dr. Sunada Kane, a gastroenterologist at the Mayo Clinic who specializes in both inflammatory bowel disease (IBD) and pregnancy. 

This study analyzed Danish (2004–2012) and Swedish (2006–2012) population-based health registers to determined if TNF inhibitor (TNFi) use in patients with chronic inflammatory disease (inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis) resulted in a higher rate of birth defects. (Citation source http://buff.ly/1pEgwXt)

Women were exposed to TNFi treatment during early pregnancy and compared to normal controls (n = 21,549).  Birth defects were slightly more prevalent among infants born to women with chronic inflammatory disease (regardless of TNFi use), when compared to the general population (4.8% vs. 4.2%). Birth defects occurred in 6.3% of women who received anti-TNF treatment and 4.7% in women with chronic inflammatory disease not taking TNFi.

A nonsignificant trend was seen for any defect while on anti-TNF therapy (OR 1.32; 95% CI, 0.93–1.82); the OR for a cardiovascular defect was 1.60 (95% CI, 0.93–2.58), and the OR for a urinary defect was 2.22 (95% CI, 0.86–4.71).

This study is limited by a) mixing disorders (RA, PsA, IBD, AS) with highly variable risks for disease activity during pregnancy and differential rates of pregnancy related complications; and b) no adjustment for disease activity (largely because such administrative registry data does not include measures of disease activity).

In the accompanying video, Dr. Kane comments on the encouraging message from this large population based study. This is one of the largest TNFi exposed pregnancy cohorts and does not show a significantly higher risk of having children with birth defects. Some may view this slight trend for higher numbers as cautionary evidence. But, most of the evidence thus far published concur with the lack of data to indicate a serious risk for major birth defects. Larger studies are needed and would be ideal in the future.