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Study design
CRIB was a prospective postmarketing multicentre pharmacokinetic study designed to detect
any placental transfer of Cimzia (CZP) from mothers to infants.1
The study involved women who were ≥30 weeks pregnant with chronic inflammatory
diseases (CID) that often affect women of childbearing age whose physician had decided to
continue Cimzia treatment during pregnancy prior to, and independently from, study
participation.2
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The study population included patient's with Crohn's disease. Cimzia is not licensed for the treatment of Crohn's disease.
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Cimzia
Q2W, every 2 weeks
Q4W, every 4 weeks
Adapted from Mariette X, et al. Annals of the Rheumatic Diseases 2018
This study included patients with RA, axSpA/AS, PsA and CD. The study did not include patients suffering from psoriasis nor patients on a Cimzia 400 mg Q2W maintenance dose.
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Results
CRIB Study: Results of the Trial
Lack of placental transfer of Cimzia during pregnancy results from CRIB, a prospective postmarketing, pharmacokinetic study.1-2
The study found no measurable levels of Cimzia in 93% (13/14) of infant blood range 5.0-49.4] ug/mL) and one infant had a minimal Cimzia level at birth of 0.042 μg/mL (infant/mother plasma ratio 0.0009). All infant samples at Week 4 and 8 had Cimzia levels that were below 0.032 mcg/mL.
Cimzia has a unique Fc-Free structure, and it showed minimal placental transfer from mother to baby.
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a Cimzia concentrations measured using an electrochemiluminescence immunoassay
validated in human plasma.
b CID; 16 women (≥30 weeks gestation) already receiving Cimzia for approved indications
(RA [N=11], CD [N=3], PsA [N=1] and axSpA/AS [N=1])
c Maternal blood samples (≤4 mL per sample) collected within 24 hours before or after
delivery. Umbilical cord samples (≤4 mL per sample) collected within 1 hour of birth. Infant
blood samples (≤1.2 mL per sample) collected within 24 hours after birth and at weeks 4 and 8 postpartum.
Cimzia 400 mg Q4W is not an approved dose for plaque psoriasis.
axSpA, axial spondyloarthritis
AS, radiographic axial spondyloarthiritis
CD, Crohn's Disease
PsA, psoriatic arthritis
Adapted from Mariette X, et al. Annals of the Rheumatic Diseases 2018
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Safety profile
Plasma Cimzia concentrations in mothers and infants (n=14 mother–infant pairs)
No new safety signals for Cimzia were identified in mothers or infants, based on 21 screened
mothers and the 16 infants of all participating mothers. Data indicates showed minimal placental
transfer from mothers to infants with no anti-Cimzia antibodies detected in mothers,
umbilical cords, or infants at any time point, suggesting a lack of in utero foetal exposure
during the third trimester.1,2
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CRIB Study: Key Safety Profile Data
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Adapted from Mariette X, et al. Annals of the Rheumatic Diseases 2018
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References
- Mariette X, et al. EULAR Abstract (EULAR17-1640): Lack of placental Transfer of Certolizumab Pegol During Pregnancy: Results from CRIB, a Prospective, Postmarketing, Multicenter, Pharmacokinetic Study. Presented at the Annual European Congress of Rheumatology in Madrid.
- Mariette X, et al. Annals of the Rheumatic Diseases 2018;77:228-233.
- Cimzia (certolizumab pegol) SmPC
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Because we're in this together...
Report adverse events
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk and hpra.ie/homepage/about-us/report-an-issue.
Adverse events should also be reported to UCB Pharma Ltd Email: UCBCares.UK@ucb.com and UCBCares.IE@ucb.com.
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Date of preparation: March 2023
IE-P-CZ-AS-2100018