• DMARDs
• biologics
• breastfeeding
• breastmilk
• corticosteroids
• hydroxychloroquine
• pregnancy
• prescribing
• rheumatic disease

Inflammatory rheumatic diseases frequently affect women of childbearing age. Biologic therapy during pregnancy is an important topic that is yet unresolved. The majority of documented experiences are in case series, case reports, or registries. Tumor necrosis factor (TNF) inhibitors are now better known. Some evidence suggests that it is possible that differences between drugs regarding safety are associated with the structure and capacity to cross the placenta, but we are not aware of any study that supports unequivocally this statement. Most of the monoclonal antibodies are actively transferred to fetal circulation using the neonatal Fc receptor. Although this transfer does not appear to be associated with the risk of miscarriage, stillbirth, or congenital abnormality, the rate of premature births and lower birth weight may be increased. During fetal development, the neonatal period, and childhood, the immune system is constantly maturing. The ability to produce cytokines in response to infectious stimulus remains low for years, but is similar to that of an adult around the age of 3 years owing to the adaptive nature of the newborn’s immune system as a result of exposure to microbes. Therefore, exposure to TNF inhibitors may have serious consequences on the newborn, such as severe infections or allergic reactions. Regarding the former, an anecdotal case report described a fatal case of disseminated bacillus Calmette-Guérin (BCG) infection in an infant born to a mother taking infliximab for Crohn’s disease. Although the baby was born and progressed well initially, he died at 4.5 mo after he was vaccinated with BCG. Fortunately, serious infections do not appear to be frequent in newborns exposed to in utero biologic therapy. However, very limited short-term experiences are available regarding complications in an exposed fetus, and no data are available about long-term implications on the child’s developing immune system. Therefore, we must be aware of potential complications in later years. Although the clinical data to date are promising, no firm conclusions can be drawn about the safety of biologic drugs during pregnancy, and, without further evidence, guidelines that suggest these drugs should be avoided at the time of conception cannot yet be changed.

• Pregnancy
• Biologic therapy
• Monoclonal antibodies
• Rheumatic diseases
• Safety

• Crohn’s disease
• adalimumab
• anti TNF
• biologic agent
• certolizumab
• golimumab
• inflammatory bowel disease
• infliximab
• pregnancy
• ulcerative colitis

Tumor necrosis factor-α inhibitors (anti-TNFs) are effective in the treatment of inflammatory bowel disease (IBD) recalcitrant to conventional medical therapy. As the peak incidence of IBD overlaps with the prime reproductive years, it is crucial to establish pharmacologic regimens for women of childbearing age that achieve effective disease control without posing significant fetal harm. A systematic literature review was performed to identify all human studies with birth outcomes data after maternal exposure to infliximab, adalimumab, or certolizumab pegol within 3 mo of conception or during any trimester of pregnancy. Live births, spontaneous abortions or stillbirths, preterm or premature births, low birth weight or small for gestational age infants, and congenital abnormalities were recorded. Fifty selected references identified 472 pregnancy exposures. The subsequent review includes general information regarding anti-TNF therapy in pregnancy followed by a summary of our findings. The benefits of biologic modalities in optimizing disease control during pregnancy must be weighed against the potential toxicity of drug exposure on the developing fetus. Although promising overall, there is insufficient evidence to prove absolute safety for use of anti-TNFs during pregnancy given the limitations of available data and lack of controlled trials.

• Tumor necrosis factor-α inhibitors
• Pregnancy
• Congenital abnormalities
• Safety
• Infliximab
• Adalimumab
• Certolizumab

• Biological Products/adverse effects
• Female
• Fetus/drug effects
• Gestational Age
• Humans
• Immunosuppressive Agents/adverse effects
• Inflammatory Bowel Diseases/diagnosis
• Inflammatory Bowel Diseases/drug therapy
• Inflammatory Bowel Diseases/immunology
• Pregnancy
• Pregnancy Complications/diagnosis
• Pregnancy Complications/drug therapy
• Pregnancy Complications/immunology
• Risk Assessment
• Risk Factors
• Tumor Necrosis Factor-alpha/antagonists & inhibitors

• breastfeeding
• pregnancy
• tumor necrosis factor (TNF) inhibitors
• uveitis

• Adalimumab
• Adult
• Antibodies, Monoclonal/adverse effects
• Antibodies, Monoclonal/therapeutic use
• Antibodies, Monoclonal, Humanized
• Antirheumatic Agents/adverse effects
• Antirheumatic Agents/therapeutic use
• Arthritis, Rheumatoid/drug therapy
• Arthritis, Rheumatoid/epidemiology
• Etanercept
• Female
• Humans
• Immunoglobulin G/adverse effects
• Immunoglobulin G/therapeutic use
• Infliximab
• Maternal-Fetal Exchange
• Pregnancy
• Pregnancy Complications/drug therapy
• Pregnancy Complications/epidemiology
• Pregnancy Outcome/epidemiology
• Prospective Studies
• Receptors, Tumor Necrosis Factor/therapeutic use
• Registries
• Tumor Necrosis Factor-alpha/antagonists & inhibitors
• United Kingdom/epidemiology
• Young Adult

• drugs (medication)
• high-risk pregnancy
• rheumatology