Women with chronic inflammatory diseases remain poorly informed of reproductive issues
Women of childbearing age with rheumatic diseases worldwide fail to receive appropriate information about the family planning and pregnancy continuum, according to findings presented at EULAR 2019. Healio Rheumatology took a closer look at the data and sat down with several key opinion leaders for a roundtable discussion to gain deeper understanding of how to resolve these issues.
Tanaka and colleagues reported on 210 women in the Asia-Pacific (APAC) region and compared the findings with those observed for the 306 women in the EU group. The APAC cohort included 122 women with rheumatoid arthritis, 48 with psoriatic arthritis, and 40 with axial spondyloarthritis/ankylosing spondylitis. All participants had been pregnant within the last 2 to 5 years, with 40% actively trying to get pregnant, 40% neutral, and 20% either trying to avoid pregnancy or not considering it.
Results showed that 62% of the women from the APAC region consulted a rheumatologist prior to pregnancy, while 26% saw an OB/GYN or primary care provider. Patients had to initiate the conversation about family planning in most cases.
In both the Asian and European cohorts, patients reported delaying pregnancy due to fear of passing health issues onto the child, not feeling physically well enough to carry a child to term, and not being emotionally prepared for parenthood. More than half of women in Asia reported disease improvement antepartum.
However, only half of the Asian cohort reported that their health care provider helped them with a treatment plan for pregnancy, compared with 65% of the European cohort. Between 50% and 70% of women in the APAC cohort cited fears surrounding medication and the impact it may have on their child. There was significant variability between Asian countries regarding information about the safety of breastfeeding while on treatment.
Overall, just 34% of women in the APAC region felt as though they had all the information they needed to make informed decisions about the impact of rheumatic disease and treatment on pregnancy and associated health, compared with 56% of women in Europe who felt they had enough information.
In earlier analysis presented at EULAR 2018 using the same survey, Tincani and colleagues surveyed 298 women with rheumatoid arthritis, 182 with axial spondyloarthritis and 142 with psoriatic arthritis. The cohort comprised 306 women from five countries in the EU, 293 from the U.S., and 23 from Japan.
Results showed that just 46% of these women visited a health care professional before pregnancy. Of that group, 53% saw a rheumatologist. Despite recommendations for health care providers to discuss pregnancy with patients, 69% of the women surveyed had to initiate the conversation.
More than half of women reported delaying pregnancy due to unfounded fears about passing health issues to their children, and around one-third had poorly controlled disease during pregnancy. Just 65% reported having a treatment plan in place with their providers. More than one-third (38%) reported that they had insufficient information about the impact of treatment decisions on their pregnancy, and 24% said that they did not have enough information about breastfeeding during treatment for rheumatic diseases.
The researchers concluded that women of childbearing age with rheumatic diseases need more information about all components of family planning, pregnancy and child-rearing.
For the roundtable discussion, Leonard Calabrese, MD, RJ Fasenmyer Chair in the department of immunology and professor at the Cleveland Clinic Lerner College of Medicine; Eric Ghorayeb, MD, head of medical affairs in dermatology at UCB; Jeff Stark, MD, head of medical affairs in rheumatology at UCB; and Cheryl M. Burgess, MD, a dermatologist and assistant clinical professor at Georgetown University Medical Center & The George Washington University Hospital, weighed in.
Q: Among women of childbearing age, is pregnancy planning sufficiently discussed with a disease specialist compared with PCP or OB/GYN?
Burgess: In the past decade or so, patients and physicians alike have become increasingly more aware of the importance of these conversations. It is a topic I bring up with my female patients and I work with them to ensure they feel safe and comfortable while receiving the treatment they need to control their disease.
Calabrese: While crucial to the family planning process, not all women of childbearing age broach the subject of pregnancy and breastfeeding with their rheumatologist before becoming pregnant, especially since many pregnancies are unplanned. Research shows that more than half of women considering pregnancy delayed family planning due to unaddressed concerns regarding their disease, so this lack of coordinated planning must be addressed more proactively.
Stark: Pregnancy planning is not always as adequately discussed with disease specialists as it should be. In order to ensure that disease activity is optimally treated and risk of harm to the unborn child or breastfed infant is minimized, patients should involve both a treating physician and gynecologist to reach shared and informed decisions about appropriate care or medication during pregnancy and breastfeeding. Likewise, patients should remain informed on the latest research on appropriate treatments during childbearing years, and throughout the rest of their lives.
Q: When should the discussion of family planning be initiated? Is it incumbent on the patient or health care provider to initiate this conversation?
Burgess: It’s all about collaboration with my patients, and as I can provide insights into the ways their disease could impact their family planning, I feel it is my responsibility to make them aware, including that there are options that could be appropriate throughout their journey, such as certolizumab pegol (Cimzia, UCB). Luckily, women are increasingly aware themselves and a good portion bring up family planning early on in our conversations.
Calabrese: Patients who are planning to become pregnant should contact their health care team in advance to discuss their plans with more than one specialist: general practitioner, nurse, rheumatologist, OB/GYN or midwife. Research shows that almost 70% of women who visited a health care provider before pregnancy had to initiate family planning discussions themselves. For some women, this is a workable approach and health care professionals are most effective in response and a supportive role. Other women would benefit from a health care professional initiating the discussion.
It must be a patient-specific approach. While there is no one way to initiate this conversation, it is important for the patient to be open and honest about where they are in their life so their care team can treat them accordingly.
Ghorayeb: For women affected by psoriasis, onset of symptoms, diagnosis and initiation of treatment increasingly overlap with peak reproductive age. Therefore, all women of child-bearing age should consider family planning implications when discussing treatment and physicians can do more to bring this to their patients’ attention, as experts on the impact of chronic inflammatory diseases on family planning.
Q: Among women with chronic inflammatory disease considering pregnancy, are there legitimate concerns?
Ghorayeb: Certain chronic inflammatory diseases can lead to adverse pregnancy outcomes if untreated, and certain drugs may not be appropriate, but these factors should not necessarily rule out pregnancy. Emerging data support this conclusion, including findings from Clowse and colleagues in Arthritis and Rheumatology, which showed that preterm births occurred in 12% of all live births among women treated with certolizumab pegol, which is similar to the rate in the general population. The findings also showed a 9% miscarriage rate and a 1% stillbirth rate, rates that were also similar to those in the general population.
When looking at pregnant patients with certain inflammatory diseases like Crohn’s disease or IBD, studies have reported serious complications when the disease is uncontrolled.
Stark: Many women considering starting a family have understandable concerns about continuing their treatment while pregnant. However, they may not be aware of the potentially serious effects on their health, and that of their baby, that uncontrolled disease can have including pre-eclampsia, miscarriage, preterm delivery and low birth weight.
Burgess: There are medications that are simply not appropriate for use in women considering pregnancy. However, it is important to recognize not only the risks of therapy, but also the risks of active inflammation on their potential child.
Calabrese: When looking at female patients with psoriatic arthritis and other inflammatory conditions, there is an increased risk of caesarean section delivery and preterm birth, worsening or ongoing high disease activity related to their joints during pregnancy, and postpartum flares of the joints within 1 year.
Q: Previous surveys reported fear of passing on health issues to their children and/or not being physically healthy enough to carry the child to term: Are these legitimate concerns among patients with adequately controlled disease?
Calabrese: Research is still ongoing as to the cause of psoriasis, but according to the National Psoriasis Foundation, around 10% of people inherit one or more of the genes that could lead to it, but only 2% to 3% of people get the disease. Some women also have concerns about potential dangers associated with treating active disease. For most types of chronic inflammatory diseases, including psoriatic diseases, as long as certain drugs are avoided, the risk of major birth defects is not higher than in the general population, for example with certolizumab pegol.
Ghorayeb: Patients often seek to minimize their medication during pregnancy and breastfeeding. However, in many instances, this decision is based just on the risks of the medication involved, without true consideration of the negative effects of disease activity on pregnancy outcomes. To make a truly informed decision, patients must consider not only the risks of therapy, but also the risks of active inflammation for their developing infant.
Stark: There is a slightly higher risk of miscarriages in women with chronic inflammatory diseases which may be linked to having uncontrolled disease during pregnancy and/or to certain drugs. Women who choose to manage their disease before, during and after pregnancy are likely to cope better with birth and breastfeeding, leading to a more positive experience overall.
Q: Are treatment plans for patients considering pregnancy shared among the patient’s varied health care providers? Is input provided and consensus reached among the different providers or does each act independently of the others?
Burgess: Collaboration among the health care team is critical to delivering high-quality care, and while it can be logistically difficult to come to a consensus, coordination on our efforts can really make the difference in the experience of the patient.
Stark: The decision as to whether to continue treatment during different phases of the reproductive health journey is a personal one, but one that should be made based on professional advice.
Calabrese: For chronic inflammatory conditions like PsA, RA and SpA that are often treated by multiple specialists and PCPs, it is essential that a patient’s entire care team is aware of each treatment plan. In cases where these health care professionals share a common records system, this is standard practice. But in other settings, patients must take responsibility for keeping their health care professionals aligned. For women, of course, every care team should include an OB/GYN, who should be involved in ongoing treatment and family planning.
Q: Patients considering pregnancy have previously voiced concerns over the safety of medications on the child: Given the current research, are these legitimate concerns?
Burgess: It is a balancing act of risks and benefits with the risks of the medications evaluated against the risks of the potential disease activity. While these concerns should be discussed with the provider, they should not necessarily impede treatment for the chronic inflammatory disease.
Calabrese: There are legitimate concerns for some medications, while others have been studied in pregnancy and lactating women and may be appropriate for these patients. Certolizumab pegol has been studied in three prospective pharmacokinetic studies that suggest negligible to low placental transfer and minimal breast milk transfer. This data was included in 2018 by the FDA in the full Prescribing Information. These pharmacokinetic studies were designed solely to assess transfer of drug from mother to infant; conclusions regarding safety and efficacy, including safety of anti-TNFs in pregnant women, risks of major birth defects or other adverse pregnancy outcomes, should not be made based on these data.
Q: Patients have reported discontinuing treatments to minimize the risk to their child: What are some of the potential drawbacks of this approach? Are options for discontinuing and the risks involved being adequately communicated to the patient by their health care providers?
Calabrese: While there is a perception that chronic inflammatory diseases can improve during pregnancy, the reality is that a significant number of women with these conditions still depend on medication to keep their symptoms under control during this time.
Ghorayeb: Rheumatologists have been taught to expect improvement in patient disease activity during pregnancy, but this is not usually the case for dermatologists and our patients. To appropriately treat patients during pregnancy, all dermatologists should communicate the risk of active inflammation so that the patient is not left making a decision that is solely based on the risks of medication.
The decision to discontinue treatment is too often led by the fear that medication will harm the child in the womb or in the months following pregnancy while breastfeeding rather than taking into careful consideration how uncontrolled disease activity may increase the likelihood of negative pregnancy outcomes.
Burgess: Patients should always consult their doctor before discontinuing a medication for any reason.
Q: What are some of the unique (and perhaps, unaddressed) burdens of women living with chronic inflammatory diseases, such as psoriatic arthritis and psoriasis, compared with their male counterparts?
Burgess: Women with chronic inflammatory diseases, particularly those with psoriatic disease, are more burdened than men by the stigma they experience. When women develop plaques on their arms, hairline or other sun exposed areas, they will go to great lengths to adapt their clothing and hairstyle to cover the affected areas. While psoriasis improves with sun exposure, psoriasis can flare.
Calabrese: The unique burdens of women living with chronic inflammatory disease extend beyond physical pain and vary with diseases. Axial SpA, for instance, presents differently in men and causes greater burden in women, including tiredness, pain and joint issues.
Among patients with psoriasis, significantly more women than men report that they suffer from depression or other mental disorders.
Ghorayeb: While it is thought that women have less severe psoriasis, men are over-represented in psoriasis registers and are thought to receive more care, even though women report worse patient-reported outcomes across the board. This may be due to complex psychosocial challenges women face, including those related to the stigma of having a visible skin condition and the impact their disease can have on relationships.
While about 60% of all patients with chronic plaque-type psoriasis will develop genital psoriasis at some point, women report more sexual distress than men, with itching and less frequent intercourse being their biggest psoriasis-related sexual issues.
Q: Are there gender differences among patients receiving treatment for chronic inflammatory diseases?
Stark: Despite perceptions that treatment decisions are made irrespective of gender, men tend to receive more systemic therapy; while there are special considerations for physicians treating women of childbearing age. When considering pregnancy and family planning, women and their physicians must consider holistically how the developing child and patient may be impacted by treatment decisions, including during pregnancy and breastfeeding.
Ghorayeb: Studies have shown that dermatologist treatment in psoriasis care is unbalanced, with men being more likely to undergo specialist treatment than women. Although as many women as men are believed to suffer from psoriasis, men are also more likely to receive biologic therapy.
Burgess: When women with psoriasis are experiencing plaques on the exposed areas of their skin, or any manifestation of a chronic inflammatory disease that is impacting their day-to-day life, I tend to be more aggressive in my treatment approach. – by Rob Volansky
- Tanaka Y, et al. Abstract # FRI0693. Presented at: EULAR Annual Congress; June 12-15, 2019; Madrid.
- Tincani A, et al. Abstract #SAT0165. Presented at: EULAR Annual Congress; June 13-16, 2018; Amsterdam.
For more information:
- Cheryl M. Burgess, MD, can be reached at 2311 M St NW #504, Washington, DC 20037.
- Leonard H. Calabrese, DO, can be reached at 9500 Euclid Ave. #A50, Cleveland, OH 44195; email: firstname.lastname@example.org.
- Eric Ghorayeb , MD, and Jeff Stark, MD, can be reached at 6850 Peachtree Dunwoody Rd #834, Atlanta, GA 30328.
Disclosure: Burgess reports consulting and advisory board roles with Allergan Inc., BioCosmetic Research Labs, Valeant, Johnson & Johnson, Stiefel, GlaxoSmithKline, Merz and Medicis. Calabrese reports serving as an investigator and a consultant to Horizon Pharmaceuticals. Ghorayeb reports employment relationship and stockholder with Sanofi. Stark reports being a full-time employee of UCB.