open picturemdpi

Cimzia in PsO: Efficacy Overview

Scroll or click the links to jump to any section below:

Is my patient suitable for Cimzia?

Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1

Off

Female patients

99.5% of births in the UK are to mothers under 45 years of age3 and it should be noted that estimates suggest up to 1 in 6 UK pregnancies in the UK is unintended.13 

Cimzia can be used during pregnancy if clinically needed.1 Data from more than 500 prospectively collected pregnancies exposed to Cimzia with known pregnancy outcomes, including more than 400 pregnancies exposed during the first trimester, showed no indication of demonstrated malformative effect from Cimzia. The available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with Cimzia administration during pregnancy.1

Cimzia can also be used during breastfeeding without current evidence of harm to the baby or mother.1 In a clinical study in 17 lactating women treated with Cimzia, minimal transfer of certolizumab pegol from plasma to breast milk was observed.1 The percentage of the maternal certolizumab pegol dose reaching an infant during a 24-hour period was estimated at 0.04% to 0.30%.1 In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant.1,2

Cimzia has a unique structure, it is a novel FC-free, PEGylated, anti-tumour necrosis factor α (anti-TNFα) monoclonal antibody.5 The FC region is responsible for facilitating active placental transfer, therefore, removing the FC region may prevent Cimzia from being actively transported across the placental membrane.6 Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect normal immune response in the newborn.7,8,9

Due to this structure, studies have demonstrated that Cimzia undergoes none to minimal placental transfer, which means it can be used during pregnancy, when clinically needed. This allows for treatment continuity.1,10,11

Off

Durable efficacy in plaque psoriasis

Cimzia demonstrates durable efficacy for her skin, through pooled data from the Cimzia arms of the CIMPASI 1 and CIMPASI 2 trials.

Efficacy was shown in these trials by rates of:

  • PASI 75 (≥75% improvement from baseline)
  • PASI 90 (≥90% improvement from baseline)
  • DLQI 0/1 (Dermatology Life Quality Index score of 0/1 [remission])

The CIMPASI 1 and CIMPASI 2 trials randomised adult patients with moderate to severe PsO (1:2:2) to a placebo arm, a Cimzia 200mg (loading dose 400mg at weeks 0,2,4) every 2 weeks arm and a Cimzia 400mg every 2 weeks arm. The trials were double blinded during the initial treatment phase to week 16. At week 16 patients achieving <PASI 50 were withdrawn, with remaining patients entering the maintenance period of the trial to week 48. Patients achieving <PASI 75 in the 200mg arm moved to the 400mg arm for the maintenance period. At week 16 all patients achieving ≥ PASI 50 entered the open label treatment phase at a dose of 200mg (regardless of previous dose) with switching between the 200mg and 400mg dose based on mandated criteria or investigator discretion.

Study design: Pooled 3-year efficacy (CIMPASI-1 & CIMPASI-2)1

Study design
Zoom Icon

Patients not achieving PASI 50 at Week 16 entered the escape arm for treatment with CIMZIA® 400 mg Q2W.
Loading dose of CIMZIA® 400 mg at Weeks 0, 2 and 4 or Weeks 16, 18 and 20;
PGA responder defined as PGA ‘clear’ or ‘almost clear’ with ≥2-category improvement on a 5-point scale;
Dose adjustments were mandatory (solid line) in patients with <PASI 50 and at the Investigator’s discretion (dotted line) in patients with PASI 50–74; patients who received 12 weeks’ CIMZIA® 400 mg Q2W could dose reduce at the Investigator’s discretion if they achieved PASI 75, and were withdrawn if they did not achieve PASI 50. PASI, Psoriasis Area Severity Index; PGA, Physician Global Assessment; Q2W, every 2 weeks.

The clinical response rates; efficacy measured by PASI 50, PASI 75 and quality of life measured by DLQI 0/1 achieved at week 16 were durable to week 48 and for patients initially randomised to Cimzia durable to week 144.

Adapted from: Gordon, K et al., 2020. British Journal of Dermatology, 184(4): 652-662

Graph 1
Zoom Icon
Graph 2
Zoom Icon
Graph 3
Zoom Icon

Adapted from: Gordon, K et al., 2020. British Journal of Dermatology, 184(4): 652-662

b Patients randomised to CIMZIA® 200 mg Q2W with loading dose of 400 mg at Weeks 0, 2 and 4, or CIMZIA® 400 mg Q2W, or Placebo at Week 0. Patients in the placebo arm that were PASI 50 non-responders at Week 16 escaped to CIMZIA® 400 mg Q2W. Only patients achieving PASI 50 at Week 48 continued into the open-label extension period of the study (Week 48–144). Dosing adjustment was permitted during the open label phase. Dose adjustments to 400mg Q2W were mandatory in patients with <PASI 50 and at the Investigator's discretion in patients with PASI 50–74. Patients who received 12 weeks’ CIMZIA® 400 mg Q2W could dose reduce at the investigator's discretion if they achieved PASI 75, and were withdrawn if they did not achieve PASI 50.

c Among the 186 patients from the CIMZIA® 200 mg Q2W ITT treatment arm: 132 patients entered the OLE from blinded CIMZIA® 200 mg Q2W treatment, among which 97 (73.5%) patients remained on CIMZIA® 200 mg Q2W (dose non-adjusters). Among the 175 patients from the CIMZIA® 400 mg Q2W ITT treatment arm: 130 patients entered the OLE from blinded CIMZIA® 400 mg Q2W treatment, among which 81 (62.3%) patients remained on CIMZIA® 200 mg Q2W (dose non-adjusters). At Week 48, 60 patients among 72 entered the OLE from the escape CIMZIA® 400 mg Q2W treatment arm, among which 38 (63.3%) patients remained on CIMZIA® 400 mg Q2W (dose non-adjusters) and 22 (36.7%) patients moved to CIMZIA® 200 mg Q2W (dose adjusters).b

d CIMZIA® pooled CIMPASI-1/2 data: MCMC imputation: Based on using a logistic regression model with factors for treatment, region, study, prior biologic exposure (yes/no), study region, and study prior biologic exposure (yes/no) on the multiply imputed data sets.

The responder rates are the adjusted predicted probabilities from the logistic regression model. ITT, intent-to-treat; MCMC, Markov Chain Monte Carlo; OLE, open-label extension; PASI, Psoriasis Area and Severity Index; PASI 75, ≥75% reduction in PASI from baseline PASI; Q2W, every 2 weeks; Q4W, every 4 weeks.

Off

Adverse reactions

CIMZIA’s safety profile is well-established in more than 110,000 patients with 10 years of clinical experience1

Adverse reactions in clinical trials and post marketing1

Adverse reactions in clinical trials and post-marketing
Zoom Icon

Table 1.
Adverse reactions in clinical trials and post marketing. *Common adverse reactions based primarily on experience from the placebo-controlled clinical trials and post marketing cases at least possibly related to Cimzia.

Off

References

  1. Cimzia® Summary of Product Characteristics.
  2. Clowse M, et al. Ann Rheum Dis. 2017;76(11):1890–1896.
  3. Births by parents' characteristics, viewed April 2021, <https://www.ons.gov.uk/>
  4. Tincani, A. et al., 2018. FRI0693 Fears and misconceptions of women with chronic rheumatic diseases on their journey to motherhood. Annals of the Rheumatic Diseases, 77, p.866.
  5. Goel, N. and Stephens, S., 2010. Certolizumab pegol. mAbs, 2(2), pp.137-147.
  6. Firan, M. et al., 2001. The MHC class I-related receptor, FcRn, plays an essential role in the maternofetal transfer of γ-globulin in humans. International Immunology, 13(8), pp.993-1002.
  7. Bourne, T. et al., 2008. A PEGylated Fab fragment against tumor necrosis factor for the treatment of Crohn disease: exploring a new mechanism of action. BioDrugs, 22(5), pp.331-337.
  8. Rivkin, A., 2009. Certolizumab pegol for the management of Crohn's disease in adults. Clinical Therapeutics, 31(6), pp.1158-1176.
  9. Porter, C. et al., 2016. Certolizumab pegol does not bind the neonatal Fc receptor (FcRn): Consequences for FcRn-mediated in vitro transcytosis and ex vivo human placental transfer. Journal of Reproductive Immunology, 116, pp.7-12.
  10. Mariette, X. et al., 2017. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, multicenter, pharmacokinetic study. Annals of the Rheumatic Diseases, 76, pp.57-58.
  11. Kimball, A. et al., 2017. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, multicenter, pharmacokinetic study. SKIN The Journal of Cutaneous Medicine, 1, p.21.
  12. Gordon, K et al., 2020. British Journal of Dermatology, 184(4): 652-662
  13. Wellings, K et al., 2013. The prevalence of unplanned pregnancy and associated factors in Britain: findings from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). The Lancet, 382(9907), pp.1807-1816.
Off
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.

Feature requests

Help us to grow our resource the way you want it to grow.

Get in touch now

Date of preparation: June 2021
IE-P-CZ-AS-2100054