Immunosuppressives and biologics during pregnancy and lactation

Abstract

SummaryAn increasing and early-onset use of immunosuppressives and biologics has become more frequently seen among patients with inflammatory bowel diseases (IBD) and rheumatic disorders. Many women in their childbearing years currently receive such medications, and some of them in an interdisciplinary setting. Many questions arise in women already pregnant or wishing to conceive with respect to continuing or discontinuing treatment, the risks borne by the newborns and their mothers and long-term safety. Together with the Austrian Society of Rheumatology and Rehabilitation, the IBD working group of the Austrian Society of Gastroenterology and Hepatology has elaborated consensus statements on the use of immunosuppressives and biologics in pregnancy and lactation. This is the first Austrian interdisciplinary consensus on this topic. It is intended to serve as a basis and support for providing advice to our patients and their treating physicians.

Biologic Drugs for Rheumatoid Arthritis in the Context of Biosimilars, Genetics, Epigenetics and COVID-19 Treatment

“…It has been demonstrated that prenatal exposition on TNFi does not influence development of T or B cells [ 28 , 29 ]. Yet, there are some safety concerns regarding risk of developing serious infections, such as tuberculosis due to detectable anti-TNF antibodies in infants sera [ 30 ]. According to the EULAR experts, some TNFi including certolizumab (CTZ) and ETN have been approved during pregnancy [ 31 , 32 ].…”

“…Available data from two cohort studies, CRIB and CRADLE, led to its registration in EU for the treatment during pregnancy and breast-feeding periods [ 31 , 34 , 35 ]. Similarly, ETN due to its low concentrations in the breast milk and undetectable levels in newborn sera is considered by EULAR safe, although strength of evidence is lower in ETN than in CTZ [ 30 ]. Data on teratogenic effects of TNFi are limited and there is no strong evidence of potentially harmful effects, if used in preconception period [ 32 ].…”

Systemic immunosuppressive therapies for uveitis in developing countries

“…Infliximab can be limited to the first trimester, adalimumab to the second trimester, and certolizumab to the third trimester since it has a low placental transfer. [ 98 99 100 ] Children whose mothers have been exposed to TNF blockers should not be given live-attenuated vaccines until 7 months of age. Other biologicals like rituximab and tocilizumab have limited data so they should be avoided in pregnancy.…”

“…To conclude, it is important to understand that pregnancy in uveitis is a challenging situation for uveitis specialists. [ 98 99 100 ]…”

<p>Fetal Acrania (Exencephaly) in the Context of a Pregnant Female Taking Adalimumab for Psoriasis: A Case Report</p>

“… 1 According to the 1979 FDA pregnancy risk categories, adalimumab is classified as pregnancy category B and appears to be safe to use by pregnant women during the first and second trimesters. 2 , 3 In 2015, the FDA replaced these categories by the Pregnancy and Lactation Labeling Rule (PLLR) which requires drug companies to present more information to providers and patients. 4 Guidelines published by the British Society for Rheumatology and the British Health Professionals in Rheumatology in 2016 recommended discontinuing adalimumab at the end of the second trimester of pregnancy.…”