Prescribing anti-rheumatic drugs in pregnancy and breastfeeding—the British Society for Rheumatology guideline scope

This editorial refers to: Prescribing anti-rheumatic drugs in pregnancy and breastfeeding–the British Society for Rheumatology guideline scope. Giles, et’al, Rheumatology 2021;60:3947–3948.

In a recent issue of Rheumatology, Giles etal. [1] have provided the road to follow for future guidelines regarding the prescription of anti-rheumatic drugs in pregnancy and breastfeeding. Not only is the incidence of rheumatic diseases disproportionately high in women, but also more patients are now considering pregnancy as a result of optimized therapeutic strategies and the availability of a multiplicity of anti-rheumatic medications, resulting in better disease control. The British Society of Rheumatology/British Health Professionals in Rheumatology [2, 3] as well as the European League Against Rheumatism [4] guidelines are therefore of great help in daily clinical practice by providing up-to-date evidence-based guidance on the safety of anti-rheumatic drugs taken by men and women in the pre-conception phase, pregnant women, and breastfeeding mothers.

Disease activity was thought to improve in 90% of RA pregnancies in mostly older retrospective data. However, studies using validated measures for disease activity found less convincing evidence with only 48–60% improvement in women with active RA, while 39–50% experienced a post-partum flare [5]. High disease activity has been shown to lead to adverse pregnancy outcomes both in mothers and foetuses across a range of rheumatic diseases [5]. Women with RA, systemic lupus erythematosus and primary Sjögren syndrome are at an increased risk of hypertension during pregnancy, and also intrauterine growth restriction, small for gestational age, premature and/or caesarean delivery, as well as impaired fertility [5, 6]. Therefore, before conception adequate general health management is recommended; that is, amongst others, weight control and monitoring of glycaemia but also tailored and optimal disease control, to reduce the risk of flares during pregnancy and adverse pregnancy outcomes. Traditionally, the use of medication during pregnancy has been avoided. The risk–benefit balance of different disease-modifying anti-rheumatic drugs (DMARDs) might indeed change in the context of pregnancy and breastfeeding. This equilibrium needs to be considered in the early phase of pregnancy planning. Certain drugs are contraindicated even in the months preceding conception and others can be used safely throughout pregnancy and breastfeeding.

Patients and clinicians face the same challenge of balancing between disease control with possibly harmful medication or loss of control without adequate treatment during pregnancy and post-partum. Therefore, family planning should be not only evidence-based but also patient-centred, based on shared decision making and tailored to each patient’s rheumatic disease status and other health problems. Fertility, the wish for a potential child, or need for contraception must be discussed with every woman of reproductive age diagnosed with an inflammatory rheumatic disease (IRD), especially when starting potentially teratogenic medications. Effective conversations between clinicians and patients are needed at diagnosis and before conception to ensure a clear understanding of potential effects of disease activity and medications upon pregnancy and vice-versa. The American College of Rheumatology has clearly stated that ‘women should receive risk counselling from their physician if contemplating pregnancy, rheumatic disease should be controlled for at least 3–6 months before conception, and any medication changes should be discussed in advance with a rheumatologist’ [7]. Nevertheless, not only are relevant and easily accessible information/education on the disease and medications essential, but also a comprehensive strategy that includes education on self-management, emotional and physical support as well as advice towards practical coping strategies to manage pain and disease flares, while guaranteeing shared decision making [6].

Despite the fact that evidence-based guidelines have been created to support clinical decision-making, there is still a significant lack of high-quality evidence. This challenging lack of evidence encompasses pharmacological treatment, and the broader non-pharmacological health and social care needs of women with IRDs. The lack of high-quality evidence is driven partly by the presumed ineligibility of pregnant women to participate in clinical studies due to the risk of harming the offspring, resulting in the fact that most available data are retrospective and/or observational. To improve the quality of evidence gathered, to increase the knowledge about the course of pregnancy as well as treatment safety in rheumatic diseases and to facilitate international collaborations, a first consensus-based core data set for prospective pregnancy registries in rheumatology has been established [8]. Moreover, in some centres part of this core data set appears to be already collected during regular daily clinical practice [9], making it feasible to implement with a high possibility of improving the quality of evidence for future guidelines. Another consideration in terms of future guidelines is the differential availability of the different types of DMARDs worldwide as well as unplanned pregnancies and the potential consequences of current potentially teratogenic medication and lack of disease control before conception. The effect of DMARDs on fertility in women and especially men with IRDs has an even bigger evidence gap [10].

In recent years, we have witnessed the introduction of an increasing variety of biologic and targeted DMARDs, which in conjunction with intensive initial treatment strategies have allowed for better disease control of IRDs, even during pregnancy. However, the practicality of day-to-day prescription of DMARDs may vary across rheumatologists and other medical specialties. Moreover, in complex multisystemic diseases such as lupus, physicians from different specialties sometimes have diverging perceptions on the severity and consequences of their patient’s illness [11], which may lead to confusing communications on the risk of pregnancy but also regarding the use of medication in this context. Therefore, close interdisciplinary collaboration is necessary and should consider both the physician’s and the patient’s perception of the chosen pharmacological and non-pharmacological treatment.

In sum, new and adapted guidelines about the prescription of anti-rheumatic drugs during pregnancy and breastfeeding are more than welcome. All stakeholders need to take responsibility of the challenge of implementing these recommendations in high-quality disease management.

Funding: No specific funding was received from any funding bodies in the public, commercial or not‐for‐profit sectors to carry out the work described in this manuscript.

Disclosure statement: The authors have declared no conflicts of interest.

Data availability statement

Data are available upon reasonable request by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). All data relevant to the study are included in the article.

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