Steroids Pose Infection Risk During Pregnancy

Article

Research shows that for women with autoimmune disease, the increase risk of infection during pregnancy is associated with steroids, not DMARDs.

Pregnant women with inflammatory disease are at similar risk for serious infections whether on steroids, non-biologic, or tumor necrosis factor inhibitor therapy, researchers find but adding that high dose steroid use increases the risk of serious infection during pregnancy.

Pregnant women with inflammatory disease are at similar risk for serious infections whether on steroids, non-biologic, or tumor necrosis factor inhibitor therapy, researchers find but adding that high dose steroid use increases the risk of serious infection during pregnancy.

Because pregnancy is a particularly vulnerable time for women with autoimmune inflammatory conditions, when immunosuppressive drugs are introduced, women may be more susceptible to acquire new and more severe infections.

In this study, published in the March 6 issue of The BMJ, Rishi Desai, Ph.D., of the Harvard School of Public Health, find that the risk of infection is no better or worse among users of steroid monotherapy, non-biologics (monotherapy or in combination with steroids), and tumor necrosis factor α (TNF) inhibitors (monotherapy or in combination with steroids or non-biologics).

As an underrepresented group in most research, pregnant women with inflammatory disease have not been studied with the same frequency as non-pregnant women and evidence of infectious risk while on rheumatologic therapy is lacking, researchers wrote.

Autoimmune inflammatory conditions have a known female predominance, particularly in the child bearing years and flare-ups are common during pregnancy. These facts make it important to describe the infectious risks of the various treatment modalities since both disease activity and serious infection may be related to preterm birth, intrauterine growth restriction and spontaneous abortions.

Dr. Desai and colleagues compared the risk of serious infection in pregnant women with inflammatory disease who were taking steroids, non-biologics or tumor necrosis factor alpha inhibitors.

The study

Utilizing a retrospective observational cohort design, the study looked at women over 12 and under 55 years of age who had completed pregnancies with live births. The data include 4,961 pregnant women and were extracted from the Medicaid Analytical eXtract files as well as from Optum Clinformatics databases. Included women had been previously diagnosed with rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease and were also on immunosuppressive therapy during pregnancy.

Results

There was no significantly different risk of serious infection for pregnant women with inflammatory disease on any of the three classes of immunosuppressive drugs: Hazard ratio for non-biologics vs. steroids 0.81 (95% CI 0.48 to 1.37), tumor necrosis factor alpha inhibitors vs. non-biologics 1.36 (95% CI 0.47 to 3.93) and tumor necrosis factor alpha inhibitors vs. steroids 0.91 (95% CI 0.36 to 2.26).

A higher average daily dose of steroids is associated with higher risk for serious infections for pregnant women with inflammatory disease. (p=0.02) Infections during late pregnancy were increased in all treatment groups.

Implications for physicians

Choice of therapy for inflammatory disease between non-biologics, tumor necrosis factor alpha inhibitors and steroids, does not affect the risk for serious infections in pregnant women.

Higher total daily steroid doses do increase the overall risk of serious infection during pregnancy in women with inflammatory disease.

Steroids are the most frequently prescribed treatment for autoimmune /inflammatory conditions during pregnancy and with appropriate monitoring, and at lower daily doses, may be the best drug for management of flares in this population.

Tumor necrosis factor alpha inhibitors do not increase the risk for serious infection in pregnant women over non-biologics or steroids.

The authors remind physicians that the non-biologics  methotrexate, mycophenolate mofetil and leflunomide are known teratogens and should be completely avoided in pregnancy.

 

Disclosures:

The authors disclose no financial relationships and all funding was internal through Brigham and Women’s Hospital and Harvard Medical School.

References:

Rishi J Desai, Brian T Bateman, Krista F Huybrechts, et al. “Risk of serious infections associated with use of immunosuppressive agents in pregnant women with autoimmune inflammatory conditions: cohort study,” The BMJ. 2017;356:j895 | doi: 10.1136/bmj.j895

 

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