Arthritis and Rheumatism Associates, P.C.

BY ADEY BERHANU, MD, FACR, RHMSUS

Lupus is an autoimmune condition characterizedby dysregulation of the immune system resulting in widespread inflammation that can affect different organ systems. Autoimmune diseases, including lupus, are more common in women during their childbearing years. As such, special considerations for lupus patients during pregnancy are reviewed in this article.

In the past, pregnancy in lupus patients was associated with increased fetal loss. The good news is that pregnancy loss in lupus patients has now dropped to mirror the rates of healthy women without autoimmune disease. Increased planning prior to conception, screening, and close monitoring are the driving forces behind improved maternal-fetal
outcomes in lupus.

PREGNANCY PLANNING

With lupus, it is important to plan conception when the symptoms of lupus are well-controlled. Six months of lupus disease remission is recommended before attempting conception because active lupus is associated with increased obstetricrisks, including fetal growth restriction, preterm labor, preeclampsia, and miscarriage. A large study has shown that disease remission or low lupus activity at time of conception was associated with an 81% chance of uncomplicated pregnancy (1). Therefore, for a lupus patient with new or active lupus involvement, it is advised to delay pregnancy until the lupus has been treated and well-controlled for at least six months before trying to conceive

Women with lupus should undergo further autoimmune screening prior to
pregnancy. Specifically, lab work to check for coexisting autoimmune diseases such as antiphospholipid or Sjogren’s antibodies should be performed and, if present, may require additional monitoring during pregnancy or use of prophylactic treatment during pregnancy. The use of aspirin or blood thinners may be recommended as antiphospholipid antibodies are associated with increased likelihood of blood clots.

The Sjogren’s antibodies known as SSA or SSB can be transmitted from the mother to the fetus causing heart block or lupus rash. The initial risk of heart block is 2-3% and fetal heart ultrasounds are performed routinely and Plaquenil is recommended for preventive treatment (2).

Medication review is essential prior to conceiving as there are several medications used in the treatment of lupus that are teratogenic (harmful) to the fetus and must be discontinued prior to pregnancy. Teratogenic medications include anti-hypertensive medications known as ACE inhibitors (i.e., Lisinopril), CellCept, and Cytoxan. Discontinuation of such medications and a washout period of up to three months is recommended prior to conception. Adjustments can be made to medications that are safe and commonly used in lupus pregnancies, including hydroxychloroquine (Plaquenil), azathioprine, and prednisone. A great resource for medication safety profiles and use during pregnancy is MotherToBaby

A multidisciplinary treatment team is recommended because pregnancy during lupus is complex and can be higher risk. Therefore, a maternal-fetal medicine specialist obstetrician and rheumatologist should co-manage pregnant women with lupus as they plan conception and during pregnancy. 

Contuinue reading about PREGNANCY AND LUPUS in our Rheumors Newsletter and sign up to receive exclusive content by joining our mailing list.

 

Dr. Angus Worthing

Dr. Angus Worthing

Written By: Angus Worthing MD

In case you missed it, a new kind of medicine recently arrived in rheumatology: the biosimilar.

What exactly is a biosimilar? Well, you may know what biologics are – medicines that are given as injections or infusions for rheumatoid arthritis, psoriatic arthritis and other autoimmune diseases that have been in use since the late 1990s. Think of biosimilars as a little like a “generic” version of biologic drugs. The difference between a generic and a biosmilar is that a generic contains the exact same active ingredient as its brand name drug, whereas a biosimilar is proven to be highly similar to its brand name biologic, yet can have slight differences that do not have an effect on the way the drug works. Slight differences are expected due to the large size and complexity of biologic drugs.

Where do biosimilars come from?

Between 1998 – when the Food and Drug Administration (FDA) approved the first biologic drug for rheumatology – until 2010, biologics manufacturers enjoyed patent exclusivity without any chance of market competition.

In 2010, in an effort to reign in the high costs of drugs, Congress granted the FDA new authority to approve biosimilars through an abbreviated pathway. The FDA approval process for biosimilars is much more rigorous than for generics, because biologics are much more complex than previous “small molecule” drugs (such as pills). Regulators review data from advanced analysis in the laboratory and at least one clinical trial in patients to confirm that a biosimilar works as well as the brand name biologic, through the same mechanism of action, and without additional side effects compared to the brand name biologic.

The FDA has approved 9 biosimilars as of this writing (March 2018), but due to patent disputes and manufacturer decisions, only 3 of them are available. Two are biosimilars to Remicade (Inflectra and Renflexis) and the third is an oncology drug (Zarxio).

What can I expect if I start taking a biosimilar?

There are two scenarios in which people can start taking a biosimilar. First, a person currently taking a brand name biologic (such as Remicade), can begin taking the biosimilar (such as Inflectra or Renflexis). Or, a person who is currently not taking a biologic drug can simply start taking a biosimilar. In both instances, patients and doctors can expect that the biosimilar will work equally well – akin to a new “batch” of the biologic from a new source. This expectation comes from the rigorous FDA approval process, numerous clinical studies, and also experiences from other countries where biosimilars have already been used for several years. And biosimilars, like all drugs, are being monitored by the FDA, doctors and electronic registries for any unexpected side effects.

What can I expect if I start taking a biosimilar?

Where can I get more information?

A good way to learn about biosimilars is to ask your doctor. You can also check online resources at the FDA, or my blog at the American College of Rheumatology’s SimpleTasks site here.


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