New BSR guidelines on prescribing anti-rheumatic medication during pregnancy, breastfeeding

Jan 18 2016

The new BSR guidelines make a number of specific recommendations for the use of standard and/or biologic disease modifying anti-rheumatic drugs (DMARDs), providing crucial advice for clinicians, obstetricians and midwives.

The management of patients with inflammatory rheumatic diseases during pregnancy is complicated by several factors, including an increased burden of pregnancy morbidity that is partly due to increased disease activity, and so it is vital to maintain adequate control of disease activity with medications that are compatible with pregnancy.

The prescription however, of many anti-rheumatic drugs in pregnancy is complicated by safety concerns, with obvious risks being identified with some drugs and a great deal of uncertainty existing for many others. Consequently, many potentially beneficial drugs are unnecessarily withdrawn in pregnancy due a mistaken belief that the drugs themselves may be harmful and thus allowing an increase in disease activity which is itself more harmful to the pregnancy.

Inflammatory rheumatic diseases affect around 3% of the population with a predilection for women of childbearing age. Therefore, many women have disease that has been controlled through treatment with standard and/or biologic disease modifying anti-rheumatic drugs (DMARDs) and are increasingly considering pregnancy.

Historically, inflammatory rheumatic diseases such as rheumatoid arthritis (RA) were considered to spontaneously improve in most patients during pregnancy. Modern prospective studies however, have shown less than half of all patients with RA objectively improve during pregnancy and have a significant risk of disease flare post-partum. In addition, adverse pregnancy outcomes have been linked with increased disease activity in conditions such as RA.

As with any new medicine, there is a lack of knowledge on the long-term safety and it is vital that a consistent and systematic method is adopted to monitor the safety and effectiveness of biosimilars. The BSR supports rheumatologists to do this by providing the BSR Biologics Register. This mechanism is a way of collectively contributing to a substantial and important evidence base.

Key findings in the guidelines include:

• Prednisolone is compatible with each trimester of pregnancy and is the preferred corticosteroid in the treatment of maternal rheumatic disease in pregnancy.
• Hydroxychloroquine remains the antimalarial of choice in women planning a pregnancy with rheumatic disease in need of treatment and should be continued during pregnancy.
• Methotrexate at any dose should be avoided in pregnancy and stopped three months in advance in conception.
• To ensure low/no levels of TNFα inhibitors (TNFi) in cord blood at delivery etanercept and adalimumab should be avoided in the third trimester and infliximab stopped at 16 weeks because of a theoretical increased infection risk in new-borns. If these drugs are continued later in pregnancy to treat active disease the live vaccines should be avoided in the infant until seven months of age.
• Based on limited evidence certolizumab pegol is compatible with all three trimesters of pregnancy and has reduced placental transfer compared with other TNFi.

Commenting on the guidelines, lead author Dr Ian Giles, PhD FRCP, Professor at the Centre for Rheumatology Research, ULC Division of Medicine said:

The BSR guidelines will enable medical practitioners to have a more confident and consistent approach to prescribing anti-rheumatic drugs in pregnancy and breastfeeding. I hope this approach will allow adequate control of inflammatory rheumatic disease activity and prevent the unnecessary withdrawal of disease ameliorating anti-rheumatic therapies which have not been shown to be harmful in pregnancy and breastfeeding.

Chair of the BSR Standards, Audit and Guidelines Working Group, Dr Jo Ledingham, echoed this:

The new guidelines cover a huge range of treatments that may be required in the management of patients with rheumatic diseases. I personally will find this invaluable for my clinical practice and would anticipate that other clinicians will echo this sentiment.

The BSR guidelines expand and update previous consensus recommendations and systematically review all current evidence on use of various anti-rheumatic drugs before/during pregnancy and breastfeeding in patients with rheumatic disease.