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First Guideline Issued for Managing Reproductive Health in Patients with Rheumatic and MSK Diseases

From contraception to medication use during pregnancy, ACR’s new recommendations provide clinicians with the long-overdue data and background they need to care for patients with lupus, rheumatoid arthritis, and more.

The American College of Rheumatology (ACR) released its first-ever guideline on managing reproductive health in patients with rheumatic diseases, titled, 2020 Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases.1

The evidence-based, clinical practice guideline contains 12 ungraded or suggested good practice statements and 131 graded recommendations across six categories: contraception, assisted reproductive technology (fertility therapies), fertility preservation with gonadotoxic therapy, menopausal hormone replacement therapy, pregnancy assessment and management, and medication use. Since pregnant women are not generally enrolled in clinical studies and few maternal health studies focus on rheumatology patients, many of the recommendations are conditional. Online appendices to the guideline provide additional focus on managing more complex rheumatic conditions such as systemic lupus erythematosus (SLE, or lupus).

“This guideline is paramount, because it is the first official guidance addressing the intersection of rheumatology and obstetrics and gynecology (OB-GYN),” said Lisa Sammaritano, MD, lead author of the guideline, in a release.2 “Rheumatic diseases affect many younger individuals; however, little education has been provided to rheumatology professionals on current OB-GYN practices.”

PPM spoke with Dr. Sammaritano, MD, who also serves as an associate professor of clinical medicine at Hospital for Special Surgery-Weill Cornell Medicine in New York, about the work that went into the guideline and her hopes for its impact.

 

PPM: Uncertainties regarding the reproductive health of patients with rheumatic and musculoskeletal diseases have been around for quite some time. Why has it taken until the year 2020 to develop such crucial recommendations?

Dr. SammaritanoAs clinical outcomes for patients with rheumatic and musculoskeletal diseases (RMD) improve due to advances in therapies and management, patients have been stable enough to consider pregnancy and parenthood, and rheumatologists have been able to focus on less immediate health issues than acute flare of disease, including cardiovascular health, bone health, and reproductive health.

The management of reproductive health issues for patients with RMD differs from that of the general population. As a result, rheumatologists and other clinicians caring for these patients must often discuss with and counsel their patients about disease-specific issues that impact this important aspect of overall health.

While rheumatologists are expert in managing RMD care, not all rheumatologists are familiar with obstetrics and gynecology (OB-GYN) care that, like all aspects of medicine, is constantly evolving. The ACR felt it was important to assess these current practices in the context of RMD. Patients, like clinicians, may not be aware of current thinking about the potentially complex interactions between reproductive health and their chronic disease. In addition to the recommendations regarding assessment, management and therapy for patients, the guideline stresses the importance of listening to and educating patients in this important area.

PPM: What was most difficult in compiling this comprehensive guideline?

Dr. SammaritanoThe most difficult challenge was dealing with the lack of data specific to our diseases in this area. Despite retrieving over 11,000 abstracts through our systematic literature review, there were many areas with no relevant clinical data; we had to refer to data in other patient populations and extrapolate from other studies. For example, medication use in patients with solid organ transplants or inflammatory bowel disease was reviewed to guide use in our RMD patients.

[With regard to the sections on menopausal hormone replacement therapy, pregnancy assessment and management, and medication use], there are several studies with moderate strength evidence regarding use of hormone replacement therapy in patients with SLE; most other studies had low or very low levels of evidence and there were areas with no evidence at all. Again, because of our already broad aims, we were not able to include specific recommendations regarding RMD patients with chronic pain.

The risk to pregnancy outcome seems to relate primarily to level of disease activity, presence of specific autoantibodies such as aPL and anti-Ro and La, and medication use. If pregnancy compatible pain medications are utilized, one hopes that these patients will also have successful pregnancies with good maternal and fetal/neonatal outcomes.

With advances in therapies and management, rheumatologists have been able to focus less on immediate or acute care and more on the full spectrum of patients with rheumatic and MSK conditions. (Image: iStock)PPM: What would you say are the top two or three clinical takeaways for providers working with patients who have RMD as well as chronic pain, such as with lupus?

Dr. SammaritanoThe main points from the ACR guideline applies to all patients, including those with chronic pain. First, rheumatology professionals should address reproductive health issues with all patients at an initial or early visit, and at subsequent visits. Second, pregnancy should be planned, ideally during periods of quiet disease on pregnancy-compatible medications. For patients who should not or do not wish to become pregnant, safe and effective contraception should be discussed and tailored to the patient’s specific clinical and personal situation. Long-acting reversible contraception (LARC), such as an intrauterine device (IUD), is usually the most effective option.

Finally, all aspects of reproductive health care should be coordinated between rheumatology, OB-GYN, and other relevant professionals, including pain management specialists, with ongoing discussion with the patient.

Because of the ambitious nature of this undertaking - providing recommendations for almost all aspects of reproductive health in patients with any RMD - we were not able to include safety of non-rheumatology medications. However, the British Society of Rheumatology published a very helpful guideline in 2016 that offered recommendations regarding non-rheumatology specific drugs that are commonly used for RMD patients (see Flint J, Rheumatol. 2016).3 I have found this to be a very useful resource.

PPM: The section on contraception is tied heavily to women of reproductive age who have been diagnosed with SLE, as this disease can make pregnancy and fertility challenging. What were the authors’ goal in addressing this topic?

Dr. SammaritanoWe feel strongly that safe and effective contraception should be discussed at an early visit and at regular intervals and tailored to the patient’s specific clinical and personal situation. LARC, including IUD, is usually the most effective option. Although unplanned pregnancy may confer greater risk to RMD patients as compared to the general population, studies have shown that RMD patients are less likely to use effective contraception.

There are several reasons for [these] patients to avoid unplanned pregnancy: very active RMD may worsen both maternal and pregnancy outcomes, patients may be taking teratogenic medications that threaten fetal survival or outcomes, and severe RMD with certain types of internal organ damage may markedly increase risk for maternal morbidity and mortality.

PPM: One of the post-publication comments asked what “regular monitoring for rheumatic disease activity and rheumatic medication management during pregnancy” should entail. Can you share the ACR’s response?

Dr. SammaritanoGood question and good point. The voting panel discussed this extensively - that is, how specific should we be in this type of recommendation? For SLE patients we did specify labs and visits at least once per trimester. We agreed however that we could not specify specific testing and visit parameters for every different RMD, and for every level of disease complexity within those RMDs.

Our patients vary so much that we felt we were not able to be more specific. However, I do think rheumatologists are skilled in assessing who needs closer follow up, and so we felt we could leave this up to the treating physician. I think our main message was this: rheumatologists should follow their patients during pregnancy in whatever way seems appropriate - they should not leave all visits and assessments to the OB and plan to see them after the pregnancy is completed.

PPM: The comments also brought up the need to know more about the risks and benefits of disease-modifying antirheumatic drugs (DMARDs) and immunosuppressive therapy during pregnancy. Does ACR plan to add any more to the guidelines on this topic?

Dr. SammaritanoWe expect to have more data - hopefully in all areas of the guideline - over time. As with all ACR guidelines, the plan is to update the reproductive health guideline periodically to include the newest information.

 

Key Clinical Highlights from the ACR Guideline

The following recommendations were highlighted by ACR in its initial guideline release.2

 Contraception

  • Strong recommendation for women with rheumatic disease who do not have lupus or APS to use effective contraceptives with a conditional recommendation to preferentially use highly effective IUDs or a subdermal progestin implant.
  • Strong recommendation against using combined estrogen-progestin contraceptives in women who test positive for anti-phospholipid autoantibodies (aPL) or APS.

Pregnancy Assessment and Management

  • Strong good practice suggestion to counsel women with rheumatic disease, who are considering pregnancy, on the improved maternal and fetal outcomes associated with entering pregnancy during low disease activity. 
  • Conditional recommendation to treat lupus patients with low-dose aspirin daily (81 to 100 mg) starting in the first trimester. For women testing positive for aPL who do not meet the criteria for obstetric or thrombotic APS, it is conditionally recommended to preventatively treat with a daily aspirin (81 to 100 mg) starting early in pregnancy and continuing through delivery.

Menopause and Hormone Replacement Therapy

  • A good practice suggestion to use hormone replacement therapy in postmenopausal women with rheumatic disease who do not have lupus or have a positive aPL test; and who have severe vasomotor symptoms, have no contraindications, and desire treatment.
  • A conditional recommendation for hormone replacement therapy in women with lupus and without aPL.
  • Conditionally recommend against treating with hormone replacement therapy for women with asymptomatic aPL, and strongly recommend against hormone replacement therapy for women with any form of APS.

Medication Use (Paternal and Maternal)

  • Strongly recommend against use of CYC and thalidomide in men prior to attempting conception.
  • Strong recommendation against the use of NSAIDs in the third trimester.

Access the full guideline.

Last updated on: September 21, 2020
Continue Reading:
When Patients Become Pregnant: How to Maintain Chronic Pain Management
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