Experts: Be proactive about family planning for women with chronic rheumatic diseases
Researchers discovered differences in clinical support and patient education among women of childbearing age with chronic rheumatic diseases in Asia-Pacific and Europe, from a study presented at European League Against Rheumatism.
Patients delayed pregnancy due to fear of passing on chronic rheumatic diseases to their children, not feeling healthy enough to carry a child and not being emotionally prepared to become a parent.
Of particular concern, Asia-Pacific women were less likely to have a treatment plan aligned with their health care providers.
Healio Dermatology spoke with three experts in chronic inflammatory disease on how clinicians can improve the care of women of childbearing age with rheumatic disease: Cheryl M. Burgess, MD, FAAD, assistant clinical professor at Georgetown University Medical Center and George Washington University Hospital; Eric Ghorayeb, MD, head of medical affairs at UCB, a global biopharmaceutical company; and Martina J. Porter, MD, of Harvard Medical Faculty Physicians. – by Abigail Sutton
How can physicians do a better job at serving female patients with chronic inflammatory diseases like psoriasis and psoriatic arthritis?
Burgess: Our understanding is improving every day about the ways chronic inflammatory disease affects women and men differently. While both genders are impacted, psoriasis can be even more burdensome on women’s physical and psychological well-being. Women with psoriatic arthritis experience greater fatigue and daily limitations than men and have a significantly reduced quality of life.
An important additional consideration for women is the potential effect these diseases and potential treatments may have on their family planning. When caring for female patients with chronic inflammatory disease, physicians should always strive to communicate the risks of discontinuing treatment during pregnancy. Many misperceptions still exist, and it is important for women to discuss appropriate treatment options like certolizumab pegol (Cimzia, UCB) with their health care provider.
Ghorayeb: Female patients with chronic inflammatory disease are undoubtedly an underserved patient population with roughly 60% of women asserting that psoriasis affects their ability to enjoy life. To help improve upon the overall patient treatment experience, dermatologists should collaborate with the patient’s full health care team and discuss issues including appropriate pharmacologic treatments for all stages of a woman’s life, disease and pregnancy monitoring, neonatal vaccination and postpartum follow-up.
Porter: Physicians should ask all females of childbearing potential about their current and future pregnancy plans as part of the medical decision-making process. Many of the medications that we prescribe for psoriasis are teratogenic. I think physicians do a good job of screening patients to ensure that they are using appropriate contraception before prescribing these teratogenic medications, but we often assume that patients who are currently using contraception do not want to get pregnant in the near future. This may not be the case. Pregnancy also alters the immune system, so many patients with chronic inflammatory diseases that we commonly treat (ie, psoriasis, hidradenitis suppurativa, lupus) may improve during pregnancy without treatment but may also flare a few months postpartum. Being aware of and counseling patients about these expected changes is also necessary and may also affect therapeutic decisions.
Did anything surprise you from the EULAR abstract and the support Asia - Pacific women receive compared with European patients?
Burgess: The findings presented at EULAR 2019, from a survey of women with chronic rheumatic diseases in Europe and Asia-Pacific on their journey to motherhood, identified a need and opportunity for health care professionals to proactively raise the issue of family planning with their female patients. This may not be appropriate or productive for all women of childbearing age, so physicians must exercise sound judgment.
Ghorayeb: I found it significant that 69% of female European patients felt they had to decide between treatment and breastfeeding postpartum.
In January of 2018, the European Medicines Agency (EMA) approved a label change for Cimzia for potential use in women with chronic rheumatic disease during pregnancy and breastfeeding. The same label change was approved later that year by the FDA. This recognition by regulators is based on findings from the CRADLE and CRIB pharmacokinetic studies, demonstrating negligible to low transfer of Cimzia through the placenta and minimal transfer to breast milk from mother to infant. This information can help women and their physicians make the best choices possible.
*These pharmacokinetic studies were designed solely to assess transfer of drug from mother to infant; conclusions regarding safety and efficacy, including safety of anti- tumor necrosis factors (anti-TNFs) in pregnant women, risks of major birth defects or other adverse pregnancy outcomes, should not be made based on these data.
Porter: Three data points really stood out to me.
Firstly, 40% of patients aged 18 to 45 years were actively trying to get pregnant — that is a significant proportion of patients. Secondly, rheumatologists, more than primary care physicians and OB/GYNs, were the specialist most consulted by patients. Thirdly, patients rather than physicians were initiating discussions on family planning.
This suggests to me that as rheumatologists and dermatologists seeing these psoriasis and psoriatic arthritis patients, we are the ones who should be providing the counseling about therapeutic options for women who are actively planning to conceive and that we should initiate this conversation with all patients in this age range. Of note, this included women up to the age of 45, and there are more older females hoping to get pregnant in the U.S. now than 10 years ago thanks to advances in reproductive technology.
How can rheumatologists and dermatologists help to ease some of these reproductive concerns in this patient population?
Burgess: For most types of chronic inflammatory diseases, including psoriatic diseases, the risk of major birth defects is not higher than in the general population. Cimzia has been studied in three prospective pharmacokinetic studies that suggest negligible to low placental transfer and minimal breast milk transfer. However, the studies did not include patients with psoriasis or patients receiving the recommended dose of 400 mg every 2 weeks.
Our goal as health care professionals should be to provide the facts within the context of an integrated approach to treatment and family planning so our female patients can make the most informed decisions for their own situation.
Ghorayeb: As experts on the subject, rheumatologists and dermatologists should be able to give their patients some peace of mind by providing the facts about treating chronic inflammatory diseases, such as psoriatic diseases, appropriately during pregnancy and breastfeeding. Of course, these decisions must always be made in tandem with considerations of the patient’s individual health status.
Porter: We still do not know if having severe, untreated psoriasis has an impact on pregnancy outcomes or the ability to conceive. The data about the impact of psoriasis on poor pregnancy outcomes is conflicting.
In inflammatory bowel disease and rheumatoid arthritis, it is known that severe, uncontrolled disease can impact fetal outcomes, and there are recommendations for treating these diseases with biologic therapy during pregnancy. We don’t have this same information in psoriasis, so it is not surprising that patients have these concerns as well.
We also know that patients with psoriasis are less likely to become pregnant, but we do not know if this is because of the disease itself, fears and concern among patients with the disease, or the social impact of the disease on patients’ ability to have relationships.
Many of the women report a need for information regarding appropriate treatment options throughout their life. How can physicians help?
Burgess: Patients benefit from ongoing information but also from support in decision-making from those who understand what they are going through. Both factors can be addressed by physicians, but we are only part of a successful approach to care. These women can also benefit from dialogue with other patients, caregivers, advocacy groups and awareness programs that aid them in making informed decisions on care, in partnership with their physicians.
Ghorayeb: Research on chronic inflammatory diseases continues to provide important new insights into appropriate treatments, and it is essential for physicians to communicate relevant findings and safety information to their patients. This is a highly individualized part of patient care and there are sources of information and guides to supplement this discussion from advocacy groups and the manufacturers of pharmacologic treatments. UCB is dedicated to better understanding the needs of women through clinical research, including patient-reported outcomes.
Porter: Providing information during individual visits with patients is essential, but we also need to put a greater effort into performing larger studies about pregnancy outcomes and treatment options for patients with psoriasis. In general, clinical trials exclude pregnant women, breastfeeding women, and those planning to become pregnant, so a large gap in knowledge about the effect of treatments on pregnancy still exists.
The National Psoriasis Foundation also has a webinar that I gave on psoriasis and pregnancy, and I think initiatives like this are very helpful for patients, as many turn to the internet to find answers rather than asking their physicians directly.
What are other ways physicians can help lessen the burden experienced by women with chronic inflammatory diseases?
Burgess: To lessen the burden and worry experienced by women with chronic inflammatory diseases and help ensure the highest quality of care, physicians should make it a point to work collaboratively with other professionals in the patient’s health care team such as rheumatologists, OB/GYNs, nurse practitioners and physician assistants.
Ghorayeb: Dermatologists can help lessen the burden of their female patients with chronic inflammatory disease by raising the importance of coordinating family planning and treatment options with them as appropriate or suggesting that women discuss these matters with their OB/GYN or other professionals.
What areas should researchers in rheumatology-dermatology focus on to improve care and the quality of life of these patients?
Burgess: Further research is needed on gender disparities in psoriatic disease and how they can better inform the standard of care for women. It is not just about treating women differently than men, it is about treating women in their own right, based on their own specific needs. One way to do this is through clinical research that includes segmented patient-reported outcomes so we can track what women find most important in treatment outcomes. Patient perception research focused on women’s experience can provide greater insight into the treatment process.
Ghorayeb: UCB is committed to a robust and ongoing clinical trial program that focuses on several critical aspects of treatment for patients living with chronic inflammatory diseases. This includes speed of onset and long-term duration of disease suppression, and the impact of our treatments on patient-reported outcomes like skin clearance, joint improvements and quality of life. We focus on patient populations where significant unmet need exists, including both biologic experienced and naive patients, and those with underdiagnosed and undertreated diseases like non-radiographic axial spondylarthritis.
How has care in these patients improved in the last 10 years and where is improvement still needed?
Burgess: When the FDA approved the label update for Cimzia in 2018, it gave important information to health care providers to inform the care of women with chronic inflammatory disease.
Identifying a potentially appropriate treatment for women at all stages of life is a meaningful advance for patients as well as their physicians. We have gained insights that can inform prescription practices.
Ghorayeb: For over a decade, UCB has focused on treatment solutions that can make a meaningful difference for patients with unmet needs who are living with chronic inflammatory diseases like psoriatic arthritis, psoriasis, rheumatoid arthritis, the full range of spondylarthritic diseases and Crohn’s disease. During this time, we have seen a significant increase in the suppression of inflammation that underlies these diseases, with real-world impact on patients’ lives. One of our current areas of focus is the care of women living with these diseases by connecting the unmet needs of these patients with innovative science. Because of its efficacy, safety and durability, Cimzia may offer women clearer skin at all stages of life and give dermatologists the flexibility to prescribe a treatment option.
Porter: In the last 10 years, we have seen an explosion in the number and quality of biologic agents for treatment of psoriasis. These medications are likely safer in pregnancy than the previous systemic therapies that were available to patients. Most organogenesis occurs early in the first trimester of pregnancy, so patients planning to conceive often need to stop medications in advance of pregnancy. One of the more unique considerations with biologic therapy is that these medications do not get transported across the placenta until late into the second trimester of pregnancy, and some biologics, like certolizumab, are thought to not cross the placenta at all due to its molecular structure. Thus, we now have treatment options for psoriasis patients that are very effective that could be considered during pregnancy. There are vaccine recommendations for babies who are born to mothers treated with biologic therapy, and we are continuing to gather more data about the safety of biologics in pregnancy in the GI, rheumatology and dermatology populations where these therapies are most often used.
What are you most looking forward to in the future at the intersection of rheumatology and dermatology?
Burgess: In addition to better understanding gender disparities in psoriatic disease, I am interested as a practicing dermatologist in extending the strong research we already have on appropriate treatment for pregnant and breastfeeding women with psoriatic arthritis and other diseases to also focus on psoriasis. Psoriasis affects women in unique ways including clothing and hairstyle choices due to plaque visibility, so specific research on subpopulations including women of color would be beneficial and allow us to better understand the burden of the stigma they experience.
Ghorayeb: I look forward to continued research on the overall experience of patients living with chronic rheumatic disease, especially as it relates to quality of life. The need for effective and well-tolerated treatment during pregnancy is apparent, and patient surveys will continue to better inform our science and “patient value strategy.”
Porter: As I mentioned previously, the number and efficacy of therapies continues to increase at a rapid pace. Although we have no “cure” for psoriasis, we have very effective and safe treatment options that can clear patients of their skin disease and keep them clear for many years.
For more information:
Tanaka Y, et al. Perspectives of women with chronic rheumatic diseases on their journey to motherhood: Comparison of surveys from Asia-Pacific and Europe. European League Against Rheumatism abstract archive. http://scientific.sparx-ip.net/archiveeular/?c=a&view=4&item=2019SAT0165.
Disclosures: Burgess reports no relevant financial disclosures. Ghorayeb is an employee of UCB. Porter is a consultant for AbbVie and Novartis and has received honorarium from the National Psoriasis Foundation.