CRIB

CRIB Study

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Study design

CRIB was a prospective postmarketing multicentre pharmacokinetic study designed to detect
any placental transfer of Cimzia 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

Study design
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Adapted from Mariette X, et al. Annals of the Rheumatic Diseases 2018

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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 study1-2

Cimzia, due to its unique Fc-free structure, showed zero to minimal placental transfer from
mother to baby. The study found no measurable levels of Cimzia in 93% of infant blood
samples at birth (median 24.4 [range 5.0-49.4] μg/mL), and in all infant samples at Weeks 4
and 8 post birth (0.042 μg/mL).2

Plasma chart
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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 persample) 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

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 no to 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

CRIB Study: Key Safety Data

CRIB Study: Key Safety Data
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Adapted from Mariette X, et al. Annals of the Rheumatic Diseases 2018

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Conclusion

Cimzia, due to its unique Fc-free structure, showed zero to minimal placental transfer from
mother to baby.1

Cimzia should only be used during pregnancy if clinically needed.

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References

1. EULAR Abstract (EULAR17-1640): Lack of Placental Transfer of Certolizumab Pegol During
Pregnancy: Results from CRIB, a Prospective, Postmarketing, Multicenter, Pharmacokinetic
Study. Mariette X, et al. Presented at the Annual European Congress of Rheumatology in Madrid.
2. Mariette X, et al. Annals of the Rheumatic Diseases 2018;77:228-233.

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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: May 2021
IE-P-CZ-AS-2100018