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a) CIMZIA^® combined dose of 200 mg Q2W and 400 mg Q4W where patients received a loading dose of 400 mg at weeks 0, 2 and 4.⁵

b) The use of adequate contraception should be considered for women of childbearing potential. 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. Data from more than 1300 prospectively collected pregnancies exposed to CIMZIA^® with known pregnancy outcomes, including more than 1000 pregnancies exposed during the first trimester, does not indicate a malformative effect of CIMZIA^®. Further data are being collected as the available clinical experience is still limited to conclude that there is no increased risk associated with CIMZIA^® administration during pregnancy. In a clinical study 16 women were treated with CIMZIA^® (200 mg every 2 weeks or 400 mg every 4 weeks) during pregnancy. CIMZIA^® plasma concentrations measured in 14 infants at birth were BLQ in 13 samples; one was 0.042 μg/ml with an infant/mother plasma ratio at birth of 0.09%. At week 4 and week 8, all infant concentrations were BLQ. The clinical significance of low levels CIMZIA^® for infants is unknown. CIMZIA^® should only be used during pregnancy if clinically needed. It is recommended to wait a minimum of 5 months following the mother’s last CIMZIA^® administration during pregnancy before administration of live or live-attenuated vaccines (e.g. BCG vaccine), unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or live-attenuated vaccines to the infants.¹

c) Of the 14 infants included in the per-protocol set, 13 had no quantifiable certolizumab pegol levels at birth (<0.032 micrograms per millilitre), and 1 had a minimal certolizumab pegol level of 0.042 micrograms per millilitre), (infant/mother plasma ratio 0.0009).²

ASAS: Assessment of SpondyloArthritis International Society; AS: ankylosing spondylitis; axSpA: Axial spondyloarthritis; BLQ: Below the limit of quantification; CT: Computed tomography; KOL: Key opinion leader; MASES: Maastricht ankylosing spondylitis enthesitis score; nr-axSpA: Non-radiographic axSpA; OC: Observed case; PsA: Psoriatic arthritis; PSO: Plaque psoriasis; SpA: Spondyloarthritis; SPECT: Single-photon emission computed tomography; Q2W: Every two weeks; Q4W: Every four weeks; RA: Rheumatoid arthritis; TNF: Tumor necrosis factor.

RAPID-axSpA: A phase 3 trial in 325 patients living with active axSpA who were randomised 1:1:1 to receive CIMZIA® 200 mg Q2W, or CIMZIA^® 400 mg Q4W, or placebo during a double-blind period from week 0 to week 24, followed by a dose-blind period where patients received CIMZIA^® 200 mg Q2W or CIMZIA^® 400 mg from week 24 to week 48, followed by an open-label period from week 48 to week 204. The primary endpoint was ASAS20 at week 12.¹³

Carron, et al 2010: A study in active RA and active SpA involving the in vivo detection of TNF via immunoscintigraphy of a radio-labelled-TNF inhibitor. The objective of the study was to correlate the immunoscintigraphy results with clinical, imaging findings, and therapeutic outcomes. Certolizumab pegol was conjugated with succinimidyl-6-hydrazino-nicotinamide and subsequently radiolabelled with Tc99m. Whole body and static images of hands, feet and sacroiliac joints of 20 patients (5 RA; 15 SpA) were acquired at 3 time points. Immunoscintigraphic findings were scored semiquantitatively. Subsequently, all patients were treated with certolizumab pegol.⁶

CRIB: A pharmacokinetic study of women who were pregnant for ≥30 weeks and who received commercial certolizumab pegol for a locally approved indication (last dose ≤35 days prior to delivery). Blood samples were collected from mothers, umbilical cords and infants at delivery, and infants again at weeks 4 and 8 post-delivery. Certolizumab pegol plasma concentrations were measured with a highly sensitive and certolizumab pegol-specific electrochemiluminescence immunoassay. The primary endpoint was the concentration of certolizumab pegol in the infants’ plasma at birth. In total, 16 women entered and completed the study. Of the 16 infants, 2 were excluded from the per-protocol set: 1 due to missing data at birth and 1 due to implausible pharmacokinetic data.²

1. CIMZIA^® Summary of Product Characteristics, July 2022. Last accessed 22/12/2022. Access the CIMZIA^® SmPC

2. Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233.

3. Clowse ME, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017 Nov;76(11):1890-1896.

4. Rusman T, van Vollenhoven RF, van der Horst-Bruinsma IE. Gender Differences in Axial Spondyloarthritis: Women Are Not So Lucky. Curr Rheumatol Rep. 2018 May 12;20(6):35.

5. van der Heijde D, Dougados M, Landewé R, et al. Sustained efficacy, safety and patient-reported outcomes of certolizumab pegol in axial spondyloarthritis: 4-year outcomes from RAPID-axSpA. Rheumatology (Oxford). 2017 Sep 1;56(9):1498-1509.

6. Carron P, Lambert B, Van Praet L, et al. Scintigraphic detection of TNF-driven inflammation by radiolabelled certolizumab pegol in patients with rheumatoid arthritis and spondyloarthritis. RMD Open. 2016 Jun 24;2(1):e000265.

7.  Furst DE. Development of TNF inhibitor therapies for the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2010 May-Jun;28(3 Suppl 59):S5-12. Epub 2010 Jun 22.

8. Weir N, Athwal D, Brown D, et al. A new generation of high affinity humanized PEGylated Fab’ fragment anti-tumor necrosis factor-a monoclonal antibodies. Therapy. 2006;3(4):535-545.

9. Porter C, Armstrong-Fisher S, Kopotsha T, et al. Certolizumab pegol does not bind the neonatal Fc receptor (FcRn): Consequences for FcRn-mediated in vitro transcytosis and ex vivo human placental transfer. J Reprod Immunol. 2016 Aug;116:7-12.

10. Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliv Rev. 2002 Jun 17;54(4):531-45.

11. Harris JM, Chess RB. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov. 2003 Mar;2(3):214-21.

12. Veronese FM, Mero A. The impact of PEGylation on biological therapies. BioDrugs. 2008;22(5):315-29. 

13. Landewé R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2014 Jan;73(1):39-47.

CIMZIA^®, in combination with methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis in adults:

•     
• For the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. CIMZIA^® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate
•     
• For the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. 

CIMZIA^® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

CIMZIA^® is indicated for the treatment of adult patients with severe active axial spondyloarthritis comprising:​

•     
• Adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs)​
•     
• Adults with severe active axial spondyloarthritis without radiographic evidence of AS (nr-axSpA) but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs ​

CIMZIA^®, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA^® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate​.

CIMZIA^® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.