Friday, 19 Jan 2018

You are here

CRIB Study Shows No Transplacental Transfer of Certolizumab

Mariette and colleagues have reported on the prospective pharmacokinetic study of placental transfer of certolizumab pegol (CZP) from pregnant women to their infants at the time of birith. They found no to minimal CZP in infant blood at the time of delivery, suggesting a lack of in utero fetal exposure during the third trimester.

They enrolled 16 women on CZP who were ≥30 weeks pregnant and had to receive the last dose ≤35 days of delivery.  At delivery blood samples were collected from mothers, umbilical cords and infants at delivery, and then again at 4 and 8 weeks post-partum in the infants.

Maternal CZP plasma levels at delivery were within the expected therapeutic range (median [range] 24.4 [5.0–49.4] μg/mL).

Two infants samples were excluded due to missing data at birth (1) and implausible PK data (1).

Of the remaining 14 infants, 13 had no measureable CZP levels at birth (<0.032 μg/mL), and 1 had a minimal CZP level of 0.042 μg/mL.

No CZP was detected in the infants at weeks 4 and 8.  Of umbilical cord samples, 3/15 had quantifiable CZP levels (maximum 0.048 μg/mL).

These results support continuation of CZP treatment during pregnancy, when considered necessary.

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

Prevention of HBV Infection: How Are We Doing?

In 2016 the WHO set out to eliminate HBV infection as a public health threat by 2030. So far, we are far from this goal as vaccine implementation has been suboptimal in a number of important patient populations, including patients with rheumatologic diseases, as well as other immunocompromising diseases like HIV.

B Cell Changes Predict Autoimmunity with Checkpoint Inhibitors

The Journal of Clinical Investigation reports results of a study showing that increases in CD21lo B cells and plasmablasts following that combination checkpoint blockade preceded the onset of immune-related adverse events.

While some have postulated that IRAEs are thought to be T cell mediated, B cells have also been implicated. Investigators studied 39 melanoma patients undergoing treatment with either anti-CTLA4 or anti-PD1, or combination CCB therapy. They analyzed changes in circulating B cells before and after the first cycle of therapy of immune checkpoint blockade (23 received combination therapy, 8 received anti-CTLA4, and 8 received anti-PD1).

Ibuprofen’s Anti-androgenic Effect May Result in Hypogonadism in Males

PNAS reports use of ibuprofen by males may result in antiandrogen effects that may contribute to adult male reproductive problems.

Sorting Out the Complexities of Autoimmunity with Immune Checkpoint Inhibitor Therapy

An editorial and systematic review of complications seen when checkpoint inhibitor (CPI) therapies are given to patients with immune mediated inflammatory disorders (IMIDs) and cancer shows that nearly 75% manifest autoimmune and inflammatory immune-related adverse events (irAEs).

Baseline Risk Score Predicts Serious Infection Risk in TNF-Treated RA Patients

Curtis and colleagues have analyzed the certolizumab (CZP) RAPID1 and RAPID2 trials to assess the risk of serious infectious events (SIEs), and shown that steroids combined with an age-adjusted comorbidity index (AACI) yields a 2-3 fold predictable risk for SIE.