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CIMZIA® (certolizumab pegol)
is indicated for adults with:

RA

MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS (RA)

PsA

ACTIVE PSORIATIC ARTHRITIS (PsA)

AS

ACTIVE ANKYLOSING SPONDYLITIS (AS)

PsO

Moderate to severe plaque psoriasis (PsO)
who are candidates for systemic therapy or phototherapy

nr
axSpA

ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (nr-axSpA)
WITH OBJECTIVE SIGNS OF INFLAMMATION

Most preferred autoinjector4*

59%of patients
preferred CIMZIA®
autoinjector
overall vs. other
originator anti-TNF
autoinjectors*§

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etanercept autoinjector: 25%

golimumab autoinjector: 15%

adalimumab autoinjector: 1%

Results from a 2016 comparative usability analysis vs. three other anti-TNF devices available at the time (adalimumab, etanercept, and golimumab [autoinjectors]).

The preference of CIMZIA® autoinjector over each of the comparator devices was statistically significant (p<0.001) for each pairwise comparison.

Cimzia® is the only biologic with data in its label on use during pregnancy and breast feeding in women with chronic rheumatic diseases1

Crib study

No to minimal (below 0.1%) levels of CIMZIA® in infants' blood in a first-of-its-kind clinical trial1,2†

Cradle study

Minimal transfer of CIMZIA® from plasma to breast milk in a first-of-its-kind clinical trial3‡

CRIB was a pharmacokinetic study of women ≥30 weeks pregnant (n=16) receiving CIMZIA®. All 16 mothers who entered the sampling period completed the study (no missed visit) and received a recommended dose of CIMZIA® (200 mg Q2W or 400 mg Q4W). Blood samples were collected from mothers, umbilical cords and infants at delivery and weeks 4 and 8 post-delivery.

CRADLE was a pharmacokinetic study of lactating mothers receiving CIMZIA® (n=17). After ≥3 doses, breast milk samples were collected across one dosing period
(14 days for 200 mg Q2W; 28 days for 400 mg Q4W).

References:

  1. CIMZIA® Product Monograph, November 13, 2019. UCB Canada Inc.
  2. Mariette X, Forger F, Abraham B, et al. Lack of placental transfer to certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis 2018;77:228–233.
  3. Clowse M, Forger 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;76:1890–1896.
  4. Domanska B, VanLuren B, Peterson L, et al. Comparative usability study for a certolizumab pegol autoinjection device in patients with rheumatoid arthritis. Exp Opin Drug Deliv 2017;14(1):15–22.

Important Safety Information

Indications and Clinical Use:

Rheumatoid arthritis (RA):

PrCIMZIA® (certolizumab pegol) in combination with methotrexate (MTX) is indicated for:

  • reducing signs and symptoms, including major clinical response, and reducing the progression of joint damage as assessed by X-ray, in adult patients with moderately to severely active rheumatoid arthritis (RA)

CIMZIA® may be used alone for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis (RA) who do not tolerate MTX.

Psoriatic arthritis (PsA):

CIMZIA® alone or in combination with MTX is indicated for:

  • reducing signs and symptoms and inhibiting the progression of structural damage as assessed by X-ray, in adult patients with moderately to severely active psoriatic arthritis (PsA) who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs)

Ankylosing spondylitis (AS):

CIMZIA® is indicated for:

  • reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy

Non-radiographic axial spondyloarthritis (nr-axSpA):

CIMZIA® is indicated for:

  • he treatment of adults with severe active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs)

Plaque psoriasis (PsO):

CIMZIA® is indicated for:

  • the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy

Geriatrics (≥65 years of age): Specific clinical studies have not been performed in elderly subjects.

Pediatrics (<18 years of age): Safety and efficacy of CIMZIA® in pediatric patients have not been established.

Contraindications:

  • Hypersensitivity to CIMZIA® (certolizumab pegol) or any of its components

  • Active tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections

  • Moderate to severe heart failure (NYHA Class III/IV)

Most Serious Warnings and Precautions:

Serious infections: serious infections, sepsis, tuberculosis (including military disseminated and extrapulmonary disease), invasive fungal infections (such as histoplasmosis) and other opportunistic infections, some of which have been fatal, have been reported in patients receiving TNF blocking agents including CIMZIA®. Many of these occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. CIMZIA® should not be given to patients with a clinically important infection including chronic or localized infections. Physicians should exercise caution when considering the use of CIMZIA® in patients with a history of recurring infection. Patients should be monitored for signs and symptoms of infection while on and after treatment with CIMZIA®.

Any new infection that develops while on CIMZIA®, or after recent treatment, should be closely monitored. CIMZIA® should be discontinued if a patient develops a serious infection.

Malignancy: lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA® is a member. CIMZIA® is not indicated for use in pediatric patients.

Other Relevant Warnings and Precautions:

  • Worsening congestive heart failure (CHF) and new onset CHF
  • Hepatitis B virus reactivation
  • Hematological reactions: pancytopenia (including aplastic anemia); cytopenia (leukopenia, pancytopenia, thrombocytopenia)
  • Neurologic reactions (new onset or exacerbation of CNS demyelinating disease, including multiple sclerosis and PNS demyelinating disease, including
    Guillain-Barré syndrome)
  • Use in combination with other biologic medicines is not recommended
  • Patients in surgery and those being switched to another biologic DMARD should be closely monitored for infections
  • Hypersensitivity symptoms: angioedema, dyspnea, hypotension, rash, serum sickness, urticaria, dizziness, hot flushes, pulmonary burning sensation, and throat/uvula swelling
  • Latex sensitivity
  • Formation of autoantibodies
  • Administration of live or live-attenuated vaccines is not recommended
  • Use in patients with severe immunosuppression
  • May cause erroneously elevated activated partial thromboplastin time (aPTT) assay results in patients without coagulation abnormalities
  • Women of childbearing potential and pregnant women: occurrence of major congenital malformations and miscarriages was no greater than the background occurrence of major congenital malformations and miscarriages in the general population. CIMZIA® should be used in pregnancy only if clearly needed
  • May be considered during breastfeeding

For More Information:
Consult the product monograph at https://www.ucb-canada.ca/en/Our-Medicines/overview for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed here.

The product monograph is also available through Medical Information Services at 1-866-709-8444.