
Cimzia is the first PEGylated, Fc free anti-TNF indicated for the treatment of severe, active Axial Spondyloarthritis, active Psoriatic Arthritis, moderate to severe Plaque Psoriasis, and moderate to severe Rheumatoid arthritis inadequately controlled with prior therapy1
These are not the full licensed indications of Cimzia®. Please refer to the SmPC for further information.
Placental transfer of antibodies
Due to the fact that it lacks an Fc region, Cimzia does not bind the neonatal
Fc receptor (FcRn) and consequently, is not expected to undergo
FcRn-mediated transfer across the placenta1,6*
Adapted from Roopenian et al. 2007
*This has been taken from in-vivo, ex-vivo and animal studies. Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol. The clinical significance of low levels of certolizumab pegol for infants is unknown.
Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect normal immune response in the newborn.
The use of adequate contraception should be considered for women of childbearing potential who have been prescribed Cimzia. For women planning pregnancy, continued contraception may be considered for 5 months after the last Cimzia dose due to its elimination rate, but the need for treatment of the woman should also be taken into account. Cimzia should only be used during pregnancy if clinically needed.
References
1. CIMZIA® Summary of Product Characteristics.
2. Furst D. Clin Exp Rheumatol. 2010;28(3 Suppl 59):S5–12.
3. Weir N, et al. Therapy. 2006;3(4):535–545.
4. Porter C, et al. J Reprod Immunol. 2016;116:7–12.
5. Cosentyx® Summary of Product Characteristics.
6. Roopenian D, et al. Nat Rev Immunol. 2007;7(9):715–725.
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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