Pregnancy Possible in Lupus Patients Taking Belimumab

Alice Goodman

June 16, 2014

PARIS — For women with systemic lupus erythematosus (SLE) who become pregnant while taking belimumab (Benlysta, GlaxoSmithKline), successful live births are possible, according to data from phase 2 to 4 clinical trials.

In fact, almost half of all such pregnancies resulted in children born without congenital anomalies.

"Total fetal loss and pregnancy outcomes in belimumab-treated SLE patients in phase 2 to 4 trials were similar to background estimates in SLE patients," said Marcy Powell, MD, director of safety evaluation and risk management at GlaxoSmithKline.

Many treatments for SLE, including belimumab, are contraindicated during pregnancy. In fact, SLE patients are advised to use appropriate contraception during belimumab treatment and up to 4 months after the last dose. However, it can be used when the potential benefit to the mother outweighs the risk, Dr. Powell explained.

Although pregnant women are excluded from clinical trials and treatment is discontinued if a pregnancy occurs, data on outcomes are collected in such cases.

Dr. Powell presented pooled results from phase 2 to 4 clinical trials here at the recent European League Against Rheumatism Congress 2014.

The mean age of the women was 38 years, mean disease duration was 6.4 years, 85% of the women were taking corticosteroids, and 49% were taking other immunosuppressants.

Outcomes were known for 80 pregnancies that occurred during belimumab treatment. There were 21 elective terminations and 21 fetal losses, one of which was a stillbirth.

Of the 38 live births, there were 4 different congenital anomalies: Dandy–Walker syndrome, bilateral enlarged kidneys, unbalanced genetic translocation, and patent ductus arteriosus.

"This was a small sample size and may not be generalizable," Dr. Powell noted.

However, the Belimumab Pregnancy Registry, which is sponsored by GlaxoSmithKline, is an ongoing global prospective study, she reported.

As of March, 9 women have conceived while taking belimumab. Of the 6 live births, 3 of the infants were born preterm, 4 were of low birth weight, and 1 had a birth defect. There was 1 spontaneous abortion, and 2 of the pregnancies were ongoing.

"This pregnancy registry is an important resource for physicians and patients," said session cochair Hendrika Bootsma, MD, from the University of Groningen Medical Center in the Netherlands.

"Having this information will help us counsel patients," she added.

Dr. Powell is a shareholder and employee of GlaxoSmithKline. Dr. Bootsma has disclosed no relevant financial relationships.

European League Against Rheumatism (EULAR) Congress 2014. Abstract OP0041. Presented June 12, 2014.

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