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Study designs

CIMPASI‑1 (Study PS‑1) and CIMPASI‑2 (Study PS‑2)3

Study design was the same for both studies; CIMPASI1, n=234; CIMPASI2, n=227.

Study designs

CIMPASI‑1 (Study PS‑1) and CIMPASI‑2 (Study PS‑2)3

Study design was the same for both studies; CIMPASI1, n=234; CIMPASI2, 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

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.
cStudy design was the same for both studies; CIMPASI-1, n=234; CIMPASI-2, n=227.

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.

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.

References
1.

CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.

2.

Data on file. UCB, Inc., Smyrna, GA.

3.

Gottlieb AB, Blauvelt A, Thaçi D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from two phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79(2):302-314. e6.

4.

Gordon KB, Warren RB, Gottlieb AB, et al. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: three-year results from two randomised phase 3 trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2011. doi:10.1111/BJD.19393.

5.

Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73(1):48-55.

6.

van der Heijde D, Deodhar A, FitzGerald O, et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018;4(1):e000582.

7.

Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.

8.

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;116:7-12.

9.

Pasut G. PEGylation of biological molecules and potential benefits: pharmacological properties of certolizumab pegol. BioDrugs. 2014;28 (suppl 1):Section 15-Section 23.

10.

Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13(11):1323-1332.

11.

Enbrel [prescribing information]. Thousand Oaks, CA: Amgen Inc.

12.

Humira [prescribing information]. North Chicago, IL: Abbvie Inc.

13.

Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.

14.

Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.

15.

Ilumya [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.

16.

Siliq [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC.

17.

Stelara [prescribing information]. Horsham, PA: Janssen Biotech, Inc.

18.

Taltz [prescribing information]. Indianapolis, IN: Eli Lilly and Company.

19.

Tremfya [prescribing information]. Horsham, PA: Janssen Biotech, Inc.

20.

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

21.

Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliv Rev. 2002;54:531-545.

22.

Harris JM, Chess RB. Effect of PEGylation on pharmaceuticals. Nat Rev Drug Discov. 2003;2:214-221.

23.

Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018;79(2):266-276.e5.


Important Safety Information

Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.

References
References

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.

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.

LD, loading dose; PsA, psoriatic arthritis; SJC, Swollen Joint Count; TJC, Tender Joint Count; Q2W, every 2 weeks; Q4W, every 4 weeks.

Indications

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

A product with heritage

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 patientyears of worldwide cumulative exposure across approved indications2b

12+
YEARS
More than a decade of postmarketing experience1cd
20
YEARS
of total clinical study used
OVER
80
clinical trials across indications2

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.

Patient services
CIMplicity® Navigator™
is a mobile tool at your patients’ fingertips, helping your patients start and stay on treatment
CIMplicity® Covered™
helps to ensure that your patients get CIMZIA without delaya
$0 out of pocket
for eligible commercial patients through the CIMplicity® Savings Programb
Fast benefits verification,
prior authorization support, and specialty pharmacy management
CIMplicity® Nurse Support
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

Patient services
What is CIMZIA?

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.

How is CIMZIA taken?

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.

Clinical trial designs

Study designs

CIMPASI‑1 (Study PS‑1) and CIMPASI‑2 (Study PS‑2)3

Study design was the same for both studies; CIMPASI1, n=234; CIMPASI2, n=227.

Study designs

CIMPASI‑1 (Study PS‑1) and CIMPASI‑2 (Study PS‑2)3

Study design was the same for both studies; CIMPASI1, n=234; CIMPASI2, 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.

Clinical trial results summary

Rapid skin improvement that can last1

Explore >
Explore >

Important Safety Information
Please see Important Safety Information on the following pages. Full Prescribing Information can be found here.

Sustained improvement
in joint pain and stiffness due to psoriatic arthritis

Explore >
Explore >

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.

Important Safety Information

Indications

CIMZIA (certolizumab pegol) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

CIMZIA is indicated for the treatment of adults with active psoriatic arthritis.


CONTRAINDICATIONS

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.


SERIOUS INFECTIONS

Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.


Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start CIMZIA during an active infection, including localized infections.

Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.

If an infection develops, monitor carefully and initiate appropriate therapy.


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.

Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.

In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.

In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.

Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.

Cases of acute and chronic leukemia were reported with TNF blocker use.


HEART FAILURE

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.


HYPERSENSITIVITY

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. 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.


HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Test patients for HBV infection before initiating treatment with CIMZIA.

Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.

Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.


NEUROLOGIC REACTIONS

TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.


HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.

Consider stopping CIMZIA if significant hematologic abnormalities occur.


DRUG INTERACTIONS

Do not use CIMZIA in combination with other biological DMARDs.


AUTOIMMUNITY

Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.


IMMUNIZATIONS

Patients on CIMZIA should not receive live or live-attenuated vaccines.


ADVERSE REACTIONS

The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).


Please see full Prescribing Information by visiting
cimziahcp.com.

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.

Important Safety Information & Indications

Important Safety Information

Indications

CIMZIA (certolizumab pegol) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

CIMZIA is indicated for the treatment of adults with active psoriatic arthritis.


CONTRAINDICATIONS

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.


SERIOUS INFECTIONS

Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.


Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start CIMZIA during an active infection, including localized infections.

Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.

If an infection develops, monitor carefully and initiate appropriate therapy.


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.

Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.

In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.

In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.

Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.

Cases of acute and chronic leukemia were reported with TNF blocker use.


HEART FAILURE

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.


HYPERSENSITIVITY

Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. 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.


HEPATITIS B VIRUS REACTIVATION

Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.

Test patients for HBV infection before initiating treatment with CIMZIA.

Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.

Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.


NEUROLOGIC REACTIONS

TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.


HEMATOLOGIC REACTIONS

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.

Consider stopping CIMZIA if significant hematologic abnormalities occur.


DRUG INTERACTIONS

Do not use CIMZIA in combination with other biological DMARDs.


AUTOIMMUNITY

Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.


IMMUNIZATIONS

Patients on CIMZIA should not receive live or live-attenuated vaccines.


ADVERSE REACTIONS

The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).


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