The local regulator allowed nursing and pregnant patients to use autoimmune disease treatment Humira, on the condition that its potential benefit is greater than the potential risk.
The Ministry of Food and Drug Safety on Friday granted adding clinical and post-sales safety data in using Humira (ingredient: adalimumab) 40mg in pregnancy and nursing period to the drug’s approval conditions.
The former approval conditions for Humira had stated that fertile woman patients should use contraception and that they should avoid getting pregnant for at least five months after the last administration of Humira.
“The change in Humira’s approval conditions will help fertile women manage their disease because they can continue Humira treatment during pregnancy or nursing period,” said Kim Hae-rim, a professor at the Rheumatology Division at Konkuk University Medical Center.
She went on to say that it could be a problem for patients with autoimmune diseases such as rheumatoid arthritis and ankylosing spondylitis if they have to discontinue the treatment just because they got pregnant or they were breastfeeding. “Patients should consult with a doctor to make a medication decision, considering the benefits and risks of the treatment,” she added.
The change of the approval conditions was based on a prospective cohort registry on 257 women patients with rheumatoid arthritis or Crohn's disease who were treated with Humira at the beginning of pregnancy, and 120 women patients with rheumatoid arthritis or Crohn's disease who have never been treated with Humira. The primary endpoint was the incidence of major congenital disabilities.
The study showed that in patients with rheumatoid arthritis, the rate of pregnancy ending with at least one live born infant with a major birth defect stood at 8.7 percent in Humira-treated group, whereas that in the group with no Humira treatment history was 6.8 percent. In patients with Crohn’s disease, the incidence was 10.5 percent in Humira-treated group, versus 9.4 percent in the other.
The secondary endpoint included mild birth defects, premature birth, underweight, and severe or opportunistic infections. There was no significant difference between Humira and no-Humira groups, or report of a stillbirth or a malignant tumor.
“Adalimumab passes through the placenta into the fetal serum during pregnancy. As a result, infants may be at increased risk of infection. For infants exposed to adalimumab in the uterus, an administration of a live vaccine is not recommended for five months after the last dose of this drug during pregnancy,” the food and drug safety ministry said in the changed approval conditions.
The ministry went on to say that there was little chance that adalimumab would have a systemic effect on children on breastfeeding because orally ingested immunoglobulin G protein is degraded in the intestines with low bioavailability.
“Physicians should consider growth and health benefits of breastfeeding together with the clinical needs of adalimumab for a nursing mother and potential hazards to a child caused by the existing state of the mother,” the ministry said.