CIMZIA Background
For the treatment of adults with moderate to severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy, and adults with active psoriatic arthritis (PsA)1
CIMZIA®
(certolizumab pegol)
is backed by a rich history of helping patients1,2
6 FDA‑approved indications with a demonstrated safety profile1a
PSO: Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
PsA: Active psoriatic arthritis
NR-axSpA: Active non-radiographic axial spondyloarthritis with objective signs of inflammation
AS: Active ankylosing spondylitis
RA: Moderately to severely active rheumatoid arthritis
CD: Moderately to severely active Crohn’s disease if response to conventional therapy is inadequate
More than 644,000 patient‑years of worldwide cumulative exposure across approved indications2b
YEARS
YEARS
80
aIncludes approved indications for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and plaque psoriasis, as well as other completed and ongoing research.
bPatient exposure was estimated using the available sales data in rheumatoid arthritis, Crohn’s disease, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis from Sep 01, 2007, to Feb 28, 2019, for the cumulative time interval. The exposure of CIMZIA was calculated using the following formula: Patient-years = ([total mg of product distributed]/[monthly maintenance dose])/12 months in year.
cCIMZIA was first approved by the FDA in April 2008 for adults with moderate to severe Crohn’s disease.
dHuman trials initiated in July 1998. First patient, first dose in rheumatoid arthritis December 1998. Clinical studies investigated patients with rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, and other diseases, as well as healthy patients.
Important Safety Information Concurrent administration of CIMZIA with certain biological DMARDs, including anakinra, abatacept and rituximab, is not recommended due to an increased risk of serious infections. In pre-marketing controlled trials of all patient populations combined, the most common adverse reactions (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
is a mobile tool at your patients’ fingertips, helping your patients start and stay on treatment
helps to ensure that your patients get CIMZIA without delaya
for eligible commercial patients through the CIMplicity® Savings Programb
prior authorization support, and specialty pharmacy management
provides CIMZIA education, disease state information, and support servicesc
aCIMplicity® CoveredTM Eligibility: Eligible patients with a valid prescription for CIMZIA can receive treatment with the CIMZIA Prefilled Syringe at no cost for up to 18 months or until the patient’s coverage is approved, whichever comes first. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, or any other federal or state program or where otherwise prohibited by law. Patients may be asked to reverify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. For initial enrollment into the Program the patient must be required by his/her commercial insurer to submit a prior authorization or insurance coverage for the CIMZIA Prefilled Syringe must be unavailable. To maintain eligibility in the Program, the following is required: (1) a submitted prior authorization is denied or coverage remains unavailable for the patient; and (2) the prescriber must submit an appeal within 45 days of the first two denials and quarterly thereafter. UCB reserves the right to rescind, revoke, or amend this Program without notice.
bSavings Card Eligibility: Available to individuals with commercial prescription insurance coverage for CIMZIA. Not valid for prescriptions that are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, similar federal- or state-funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (ie, Medicare, Medicaid, Medigap, TRICARE, VA, and DoD) for reimbursement. The maximum annual benefit amount is $15,000 per calendar year. The parties reserve the right to amend or end this program at any time without notice. If you are uninsured, other financial assistance may be available. Call ucbCARES® toll free at 1-844-599-CARE (2273) for more information. The CIMplicity® program is provided as a service of UCB, Inc., and is intended to support the appropriate use of CIMZIA. Any CIMplicity program may be amended or canceled at any time without notice. Some program and eligibility restrictions apply.
cCIMplicity Nurses do not give medical advice and will direct your patients to share their treatment-related questions with their clinician.
Important Safety Information
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
CIMplicity®:
comprehensive support to help start your patients on treatment as soon as possible
Fax a completed enrollment form and the front and back of your patient’s medical and prescription insurance cards to 1-866-949-2469
CIMZIA®
(certolizumab pegol)
is a different
kind of anti-TNF
CIMZIA is the only PEGylated Fc-free anti-TNF8‑10
PEGylation can confer beneficial physical and chemical properties, such as:
Extended half-life of the antigen-binding fragment1,20
Increased bioavailability21,22
CIMZIA is PEGylated: chemically modified with covalently attached polyethylene glycol8
CIMZIA is a Fab′ fragment
Fab', fragment antigen binding; Fc, fragment crystallizable; IgG1, immunoglobulin G1; IL, interleukin; PEG, polyethylene glycol; TNF, tumor necrosis factor.
Important Safety Information
Concurrent administration of CIMZIA with certain biological DMARDs, including anakinra, abatacept and rituximab, is not recommended due to an increased risk of serious infections. In pre-marketing controlled trials of all patient populations combined, the most common adverse reactions (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
CIMZIA®
(certolizumab pegol)
Dosing
For patients with psoriasis and psoriatic arthritis, starter dosing of 400 mg (given as 2 subcutaneous injections of 200 mg each) is provided at Week 0 (Day 0), Week 2 (Day 14), and Week 4 (Day 28). This starting dose is the same across all approved indications.1
Maintenance dosing for patients with PSO:
400 mg (2 injections x 200 mg/mL) every 2 weeks
Maintenance dosing for patients with PsA:
200 mg (1 injection x 200 mg/mL) every 2 weeks
— or —
400 mg (2 injections x 200 mg/mL) every 4 weeks
For some PSO patients (with body weight ≤90 kg), a dose of 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4 followed by 200 mg every other week can be considered.
OXO, Good Grips® and the associated logos are registered trademarks of Helen of Troy Limited and are used under license.
Important Safety Information
Anaphylaxis or serious allergic reactions may occur. Some of these reactions occurred after the first administration of CIMZIA. Hypersensitivity reactions have been reported rarely following CIMZIA administration. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
Study designs
CIMPASI‑1 (Study PS‑1) and CIMPASI‑2 (Study PS‑2)3
Study design was the same for both studies; CIMPASI‑1, n=234; CIMPASI‑2, n=227.
Study designs
CIMPASI‑1 (Study PS‑1) and CIMPASI‑2 (Study PS‑2)3
Study design was the same for both studies; CIMPASI‑1, n=234; CIMPASI‑2, n=227.
aLoading dose of CIMZIA 400 mg at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.
bOne patient in the CIMZIA 400 mg Q2W group in CIMPASI-2 had prior exposure to ≥3 biologics, which was a protocol violation.
BIW, twice weekly; ETN, etanercept; LD, loading dose; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; SJC, Swollen Joint Count; TJC, Tender Joint Count.
aLoading dose of CIMZIA 400 mg at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.
bOne patient in the CIMZIA 400 mg Q2W group in CIMPASI-2 had prior exposure to ≥3 biologics, which was a protocol violation.
Important Safety Information
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
Study designs
CIMPACT (Study PS‑3)23
Study designs
CIMPACT (Study PS‑3)23
aLoading dose of CIMZIA 400 mg at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.
BIW, twice weekly; ETN, etanercept; LD, loading dose; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; SJC, Swollen Joint Count; TJC, Tender Joint Count.
aLoading dose of CIMZIA 400 mg at Weeks0, 2, and 4 or Weeks 16, 18, and 20.
Important Safety Information
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
Study designs
The initial, maintenance, and open-label periods of the CIMPASI-1 and CIMPASI-2 phase 3 trials4
Study designs
The initial, maintenance, and open-label periods of the CIMPASI-1 and CIMPASI-2 phase 3 trials4
aDose adjustments were permitted through Weeks 60–132; dose escalation was mandatory in patients not achieving PASI 50, and at the investigator’s discretion in patients achieving PASI 50 but not PASI 75; patients who had received CZP 400 mg Q2W for at least 12 weeks could have had their dose reduced, at the investigator’s discretion, if they achieved PASI 75, and were withdrawn if they did not achieve PASI 50.
bPatients entering the open-label period from the CZP 400 mg Q2W escape arm continued to receive CZP 400 mg Q2W but may have had their dose reduced to CZP 200 mg Q2W at Week 48, at the discretion of the investigator, if they achieved PASI 75.
CZP, certolizumab pegol; LD, loading dose of CZP 400 mg Q2W at Weeks 0, 2, and 4, or Weeks 16, 18, and 20; PASI 50/75, ≥50%/75% reduction from baseline in Psoriasis Area and Severity Index; Q2W, every 2 weeks.
aDose adjustments were permitted through Weeks 60–132; dose escalation was mandatory in patients not achieving PASI 50, and at the investigator’s discretion in patients achieving PASI 50 but not PASI 75; patients who had received CZP 400 mg Q2W for at least 12 weeks could have had their dose reduced, at the investigator’s discretion, if they achieved PASI 75, and were withdrawn if they did not achieve PASI 50.
bPatients entering the open-label period from the CZP 400 mg Q2W escape arm continued to receive CZP 400 mg Q2W but may have had their dose reduced to CZP 200 mg Q2W at Week 48, at the discretion of the investigator, if they achieved PASI 75.
Important Safety Information
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
Study design
RAPID-PsA (Study PsA001)5
Study design
RAPID-PsA (Study PsA001)5
aLoading dose of CIMZIA 400 mg at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.
bLoading dose of CIMZIA 400 mg at Weeks 24, 26, and 28.
LD, loading dose; PsA, psoriatic arthritis; SJC, Swollen Joint Count; TJC, Tender Joint Count; Q2W, every 2 weeks; Q4W, every 4 weeks.
aLoading dose of CIMZIA 400 mg at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.
bLoading dose of CIMZIA 400 mg at Weeks 24, 26, and 28.
Important Safety Information
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
Important Safety Information
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.
Important Safety Information
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylaxis, serum sickness, and urticaria.
Please see additional Important Safety Information continued on the following pages. Full Prescribing Information can be found here.
Important Safety Information You Should Know About CIMZIA® (certolizumab pegol) Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. 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.
