Back to bold logo
Back to bold logo
PSO

Based on a real CIMZIA patient.

Rapid skin improvement that lasts regardless of prior biologic treatment.

Rapid skin improvement that lasts regardless of prior biologic treatment.

Similar results were seen in the 30% of patients with prior biologic therapy.1 The co-primary end points at Week 16 in CIMPASI-1 and CIMPASI-2 were PASI 75 and PGA 0 or 1, with >70% of patients responding at Week 16 vs. 7.5% of placebo patients. The primary end point in CIMPACT was PASI 75 at Week 12.2*

*Primary biologic non-response was an exclusion criterion in all 3 trials. Missing data were imputed using multiple imputation based on the MCMC method. The PASI 75 analysis is a prespecified pooled efficacy analysis of the CIMPASI-1, CIMPASI-2, and CIMPACT trials. The results of the biologic-experienced PASI 90 data were prespecified in the integrated summary of efficacy analysis, but not adjusted for multiplicity.

PASI: Psoriasis Area and Severity Index; PGA: Physician Global Assessment.

Pooled PASI responder rates at Week 16 in biologic-experienced patients by prior biologic class in CIMPASI-1, CIMPASI-2, and CIMPACT2*

Pooled PASI responder rates at Week 16 chart
Pooled PASI responder rates at Week 16 chart

The results of the biologic-experienced PASI 90 data were part of the post hoc analysis and should be interpreted with caution as the analysis was not prespecified in the original protocols.

Subjects must not have been exposed to more than 2 biological response modifiers (including anti-TNF) for PsA or PSO prior to Baseline Visit.

The co-primary efficacy end points at Week 16 in CIMPASI-1 and CIMPASI-2 were PASI 75 and PGA 0 or 1. The primary end point in CIMPACT was PASI 75 at Week 12.

Of the 850 patients randomized to receive placebo or CIMZIA in these studies, 30% had received prior biologic therapy for the treatment of psoriasis (14% with ≥1 anti-TNF agent and 16% with an anti-IL agent).1§

IMPORTANT SAFETY INFORMATION

Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g. corticosteroids or methotrexate) may be at a greater risk of infection.

§Reason for discontinuation of prior biologic treatment unknown.

Primary/key secondary and other end points at Week 16 across all 3 trials1,2†‡ll¶#**

CIMPASI-1

  • PGA 0/1: Placebo (n=51) 4%; CIMZIA 200 mg Q2W (n=95) 45%; CIMZIA 400 mg Q2W (n=88) 55%
  • PASI 75: Placebo (n=51) 7%; CIMZIA 200 mg Q2W (n=95) 65%; CIMZIA 400 mg Q2W (n=88) 75%
  • PASI 90: Placebo (n=51) 0%; CIMZIA 200 mg Q2W (n=95) 36%; CIMZIA 400 mg Q2W (n=88) 44%

CIMPASI-2

  • PGA 0/1: Placebo (n=49) 3%; CIMZIA 200 mg Q2W (n=91) 61%; CIMZIA 400 mg Q2W (n=87) 65%
  • PASI 75: Placebo (n=49) 13%; CIMZIA 200 mg Q2W (n=91) 81%; CIMZIA 400 mg Q2W (n=87) 82%
  • PASI 90: Placebo (n=49) 5%; CIMZIA 200 mg Q2W (n=91) 50%; CIMZIA 400 mg Q2W (n=87) 52%

CIMPACT#

  • PGA 0/1: Placebo (n=57) 4%; CIMZIA 200 mg Q2W (n=165) 52%; CIMZIA 400 mg Q2W (n=167) 62% 
  • PASI 75: Placebo (n=57) 4%; CIMZIA 200 mg Q2W (n=165) 69%; CIMZIA 400 mg Q2W (n=167) 75%
  • PASI 90: Placebo (n=57) 0%; CIMZIA 200 mg Q2W (n=165) 40%; CIMZIA 400 mg Q2W (n=167) 49%
* Primary biologic nonresponse was an exclusion criterion in all 3 trials. Missing data were imputed using multiple imputation based on the MCMC method. The PASI 75 analysis is a prespecified pooled efficacy analysis of the CIMPASI-1, CIMPASI-2, and CIMPACT trials. The results of the biologic-experienced PASI 90 data were prespecified in the integrated summary of efficacy analysis, but not adjusted for multiplicity. Patients must not have been exposed to more than 2 biological response modifiers (including anti-TNF) for PSO prior to baseline.
† Patients taking CIMZIA 200 mg Q2W received a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
‡ The results of the biologic-experienced PASI 90 data were part of the post hoc analysis and should be interpreted with caution as the analysis was not prespecified in the original protocols.
|| Estimates presented are the results from MCMC models where missing data were imputed using data up to and including Week 48, the end of the double-blind maintenance period.
The co-primary efficacy end points at Week 16 in CIMPASI-1 and CIMPASI-2 were PASI 75 and PGA 0 or 1.
# The primary end point in CIMPACT was PASI 75 at Week 12.
** PGA score of 0 (clear) or 1 (almost clear) based on a 5-point scale (0-4).

Individual trial co-primary end points of PASI 75 and PGA 0/1 were statistically significant vs. placebo at Week 16 at both doses.3

IL: interleukin; MCMC: Markov Chain Monte Carlo; PASI: Psoriasis Area and Severity Index; PGA: Physician Global Assessment; PSA: psoriatic arthritis; PSO: plaque psoriasis; Q2W: every 2 weeks; TNF: tumor necrosis factor.

Week 48 through 1444:

  • Patients in the 200 mg Q2W arm continued on 200 mg Q2W out to Week 144
  • Per protocol, at Week 48 all CIMZIA 400 mg Q2W responders who achieved ≥ PASI 50 were dosed down to CIMZIA 200 mg Q2W from CIMPASI-1 and CIMPASI-2. The recommended dose of CIMZIA for adult patients with PSO is 400 mg Q2W*†‡§
  • The response in these patients at Week 144 was consistent with the response in patients who continued at 200 mg Q2W to Week 144 in pooled data from the OLE period of CIMPASI-1 and CIMPASI-2†‡§
  • Weeks 48 through 144 were an OLE phase of the study. As with any long-term, uncontrolled OLE, there were several limitations with this portion of the study. For example, PASI responder rates did not have a long-term placebo comparator beyond Week 16 (initiation of CIMZIA)
* PASI 100 was a prespecified other end point at Week 16 not adjusted for multiplicity, and a post hoc analysis for Week 16 to Week 144.
† Estimates of responder rate reflect the simple average response across the multiple imputed data sets. Estimates presented are the results from MCMC models where missing data were imputed using data across the entire 3-year period of pooled analyses from CIMPASI-1 and CIMPASI-2, where the last 2 years were open label.
‡ For some patients (with body weight ≤90 kg), CIMZIA 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.
§ All patients received CIMZIA 200 mg Q2W at Week 48; dose adjustments were permitted during the open-label phase based on PASI response and were either mandatory or at the discretion of the investigator.

Pooled PASI 75, PASI 90, and PASI 100 responder rates to Week 48 from CIMPASI-1 and CIMPASI-22*

CIMZIA 400 mg Q2W showed numerically higher efficacy results for PSO patients than CIMZIA 200 mg Q2W2*

PASI responder rates at Week 48 chart
CIMZIA 400 mg Q2W showed numerically higher efficacy results for PSO patients than CIMZIA 200 mg Q2W2*
  • Individual trial co-primary end points of PASI 75 and PGA 0/1 were statistically significant vs. placebo at Week 16 at both doses3
  • PASI 100 was a prespecified other end point at Week 16 not adjusted for multiplicity, and a post hoc analysis for Week 16 to Week 144

The results of this post hoc analysis should be interpreted with caution as the analysis was not prespecified in the original protocols.

Primary/key secondary and other end points at Week 16 across all 3 trials1,2‡§||¶#**

CIMPASI-1

  • PGA 0/1: Placebo (n=51) 4%; CIMZIA 200 mg Q2W (n=95) 45%; CIMZIA 400 mg Q2W (n=88) 55%
  • PASI 75: Placebo (n=51) 7%; CIMZIA 200 mg Q2W (n=95) 65%; CIMZIA 400 mg Q2W (n=88) 75%
  • PASI 90: Placebo (n=51) 0%; CIMZIA 200 mg Q2W (n=95) 36%; CIMZIA 400 mg Q2W (n=88) 44%
  • PASI 100: Placebo (n=51) 0%; CIMZIA 200 mg Q2W (n=95) 14%; CIMZIA 400 mg Q2W (n=88) 13%

CIMPASI-2

  • PGA 0/1: Placebo (n=49) 3%; CIMZIA 200 mg Q2W (n=91) 61%; CIMZIA 400 mg Q2W (n=87) 65%
  • PASI 75: Placebo (n=49) 13%; CIMZIA 200 mg Q2W (n=91) 81%; CIMZIA 400 mg Q2W (n=87) 82%
  • PASI 90: Placebo (n=49) 5%; CIMZIA 200 mg Q2W (n=91) 50%; CIMZIA 400 mg Q2W (n=87) 52%
  • PASI 100: Placebo (n=49) 3%; CIMZIA 200 mg Q2W (n=91) 19%; CIMZIA 400 mg Q2W (n=87) 23%

CIMPACT#

  • PGA 0/1: Placebo (n=57) 4%; CIMZIA 200 mg Q2W (n=165) 52%; CIMZIA 400 mg Q2W (n=167) 62% 
  • PASI 75: Placebo (n=57) 4%; CIMZIA 200 mg Q2W (n=165) 69%; CIMZIA 400 mg Q2W (n=167) 75%
  • PASI 90: Placebo (n=57) 0%; CIMZIA 200 mg Q2W (n=165) 40%; CIMZIA 400 mg Q2W (n=167) 49%
  • PASI 100: Placebo (n=57) 0%; CIMZIA 200 mg Q2W (n=165) 12%; CIMZIA 400 mg Q2W (n=167) 16%
IMPORTANT SAFETY INFORMATION

Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including children, adolescents, and young adults. Acute and chronic cases of leukemia have also been reported. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.

* Pooled from CIMPASI-1 and CIMPASI-2. Randomized set (Weeks 0-16); maintenance set (Weeks 16-48). Missing data were imputed using multiple imputation based on the MCMC method using data up to and including Week 48, the end of the double-blind maintenance period. PASI 100 was a prespecified other endpoint at Week 16 not adjusted for multiplicity, and a post hoc analysis for Week 16 to Week 144. PASI 50 non-responders at Week 16, 32, or 40 were imputed as non-responders at all subsequent time points.
† Placebo responder rate at Week 16 was 7.5% for PASI 75. Placebo responder rate was 1.6% at Week 16 for PASI 90.
‡ Patients taking CIMZIA 200 mg Q2W received a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.
§ The results of this post hoc analysis should be interpreted with caution as the analysis was not prespecified in the original protocols.
|| Estimates presented are the results from MCMC models where missing data were imputed using data up to and including Week 48, the end of the double-blind maintenance period.
The co-primary efficacy end points at Week 16 in CIMPASI-1 and CIMPASI-2 were PASI 75 and PGA 0 or 1.
# The primary end point in CIMPACT was PASI 75 at Week 12.
** PGA score of 0 (clear) or 1 (almost clear) based on a 5-point scale (0-4).

MCMC: Markov Chain Monte Carlo; OLE: open-label extension; PASI: Psoriasis Area and Severity Index; PGA: Physician Global Assessment; PSO: plaque psoriasis; Q2W: every 2 weeks.

Post hoc analysis: 3-year pooled responder rates in placebo non-responders, who escaped to CIMZIA 400 mg Q2W at Week 16 from CIMPASI-1, CIMPASI-2, and CIMPACT (open label)2*†

Per protocol, Week 16 placebo non-responders were initiated on CIMZIA 400 mg Q2W through Week 1442*†

Per protocol, Week 16 placebo non-responders were initiated on CIMZIA 400 mg Q2W through Week 1442*†
Per protocol, Week 16 placebo non-responders were initiated on CIMZIA 400 mg Q2W through Week 1442*†

Post hoc analysis

Pooled PASI responder rates for CIMZIA at Week 144 with the recommended dose of 400 mg Q2W (n=116)2:

~8 out of 10 patients achieved PASI 75

~6 out of 10 patients achieved PASI 90

~3 out of 10 patients achieved PASI 100

No protocol-mandated dose reduction in escape population. Of 116 patients, 33 were dosed down to CIMZIA 200 mg Q2W at the investigator’s discretion during Week 16 through Week 144 treatment period.

The results of the post hoc analyses should be interpreted with caution as these analyses were not prespecified in the original protocols.

Limitations of OLE data: Week 48 to Week 144 pre-specified pooled responder rates in CIMPASI-1 and CIMPASI-25

  • Patients in the 200 mg Q2W arm continued on 200 mg Q2W out to Week 144
  • Per protocol, at Week 48 all CIMZIA 400 mg Q2W responders who achieved ≥ PASI 50 were dosed down to CIMZIA 200 mg Q2W from CIMPASI-1 and CIMPASI-2. The recommended dose of CIMZIA for adult patients with PSO is 400 mg Q2W*‡§||
  • The response in these patients at Week 144 was consistent with the response in patients who continued at 200 mg Q2W to Week 144 in pooled data from the OLE period of CIMPASI-1 and CIMPASI-2‡§||
  • Weeks 48 through 144 were an OLE phase of the study. As with any long-term, uncontrolled OLE, there were several limitations with this portion of the study. For example, PASI responder rates did not have a long-term placebo comparator beyond Week 16 (initiation of CIMZIA)
IMPORTANT SAFETY INFORMATION

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.

* PASI 100 was a prespecified other end point at Week 16 not adjusted for multiplicity, and a post hoc analysis for Week 16 to Week 144.
† Estimates of responder rate reflect the simple average response across multiple imputed data sets. Estimates presented are the results from MCMC models where missing data were imputed using the pooled analyses from Week 16 through Week 144 from CIMPASI-1, CIMPASI-2, and CIMPACT, where the last 2 years were open label. All other missing data are imputed using multiple imputation based on MCMC methodology.
‡ For some patients (with body weight ≤90 kg), CIMZIA 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.
§ Estimates of responder rate reflect the simple average response across the multiple imputed data sets. Estimates presented are the results from MCMC models where missing data were imputed using data across the entire 3-year period of pooled analyses from CIMPASI-1 and CIMPASI-2, where the last 2 years were open label.
|| All patients received CIMZIA 200 mg Q2W at Week 48; dose adjustments were permitted during the open-label phase based on PASI response and were either mandatory or at the discretion of the investigator.

MCMC: Markov Chain Monte Carlo; OLE: open-label extension; PASI: Psoriasis Area and Severity Index; PSO: plaque psoriasis; Q2W: every 2 weeks.

Improvement as soon as Week 162,4

Clinical trial patients from CIMPACT who reflect CIMZIA use. Individual results may vary.

Patient baseline back image

BEFORE — BASELINE
Dosing: CIMZIA 400 mg Q2W
PASI score=19.4

Patient after, week 16, back image

AFTER — WEEK 16
Dosing: CIMZIA 400 mg Q2W
PASI score=2 | PASI 75 achieved

Patient baseline back image

BEFORE — BASELINE
Dosing: CIMZIA 400 mg Q2W
PASI score=21.8

Patient after, week 32, back image

AFTER — WEEK 32
Dosing: CIMZIA 400 mg Q2W
PASI score=0 | PASI 100 achieved 

Patient baseline chest image

BEFORE — BASELINE
Dosing: CIMZIA 400 mg Q2W
PASI score=12.6

Patient after, week 48, chest image

AFTER — WEEK 48
Dosing: CIMZIA 400 mg Q2W
PASI score=0 | PASI 100 achieved

Patient baseline back image

BEFORE — BASELINE
Dosing: CIMZIA 200 mg Q2W
PASI score=15

Patient after, week 12, back image

AFTER — WEEK 12
Dosing: CIMZIA 200 mg Q2W
PASI score=1.8 | PASI 75 achieved

Patient baseline back image

BEFORE — BASELINE
Dosing: CIMZIA 200 mg Q2W
PASI score=30.2 (switched from etanercept 50 mg BiW)

Patient after, week 48, back image

AFTER — WEEK 48
Dosing: CIMZIA 200 mg Q2W
PASI score=2.9 | PASI 90 achieved (switched from etanercept 50 mg BiW)

Patient baseline back image

BEFORE — BASELINE
Dosing: CIMZIA 400 mg Q2W
PASI score=12

Patient after, week 16, image

AFTER — WEEK 16
Dosing: CIMZIA 400 mg Q2W
PASI score=3 | PASI 75 achieved

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.

BiW: twice per week; PASI: Psoriasis Area and Severity Index; Q2W: every 2 weeks.

Adverse reactions occurring in ≥1% of CIMZIA-treated patients and more frequently than in placebo groups in PSO clinical trials at Week 161*

  CIMZIA 400 mg Q2W
N=342
% (n)		 CIMZIA 200 mg Q2W
N=342
% (n)		 Placebo
N=157
% (n)
UPPER RESPIRATORY TRACT INFECTION† 21.9%
(75)		 19.4%
(68)		 21.0%
(33)
HEADACHE‡ 3.8%
(13)		 2.9%
(10)		 2.5%
(4)
INJECTION SITE REACTION§ 3.2%
(11)		 1.7%
(6)		 0.6%
(1)
COUGH 3.2%
(11)		 1.1%
(4)		 1.9%
(3)
HERPES INFECTION|| 1.5%
(5)		 1.4%
(5)		 1.3%
(2)
* Pooled safety from CIMPASI-1, CIMPASI-2, and CIMPACT through Week 16.
† Upper respiratory tract infection cluster includes upper respiratory tract infection, pharyngitis bacterial, pharyngitis streptococcal, upper respiratory tract infection bacterial, viral upper respiratory tract infection, viral pharyngitis, viral sinusitis, and nasopharyngitis.
‡ Headache includes headache and tension headache.
§ Injection site reactions cluster includes injection site reaction, injection site erythema, injection site bruising, injection site discoloration, injection site pain, and injection site swelling.
|| Herpes infections cluster includes oral herpes, herpes dermatitis, herpes zoster, and herpes simplex.
CIMZIA 200 mg Q2W patients received loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4.

Pooled incidence rates per 100 patient-years for adverse events of interest at Week 161,2

  CIMZIA 400 mg Q2W
(95% CI)		 CIMZIA 200 mg Q2W
(95% Cl)		 Placebo
(95% CI)
SERIOUS AEs 15.6
(8.92, 25.34)		 4.7
(1.54, 11.04)		 15.4
(6.19, 31.72)
SERIOUS INFECTIONS# 1.9
(0.23, 6.94)		 0 0
MALIGNANCIES 1.0
(0.02, 5.33)		 0 0

#Serious infections include all serious AEs reported in the system organ class of infections and infestations.

See Warnings and Precautions, including Boxed Warning, regarding tuberculosis, malignancies, and lymphoma.

In clinical trials, the rates of reported elevated liver enzymes for CIMZIA were 2.3% for the 400 mg group and 4.3% for the 200 mg group compared to 2.5% for placebo.1

A change in PSO into a different PSO sub-type (including erythrodermic, pustular, and guttate) was observed in <1% of CIMZIA-treated subjects.1

There were no new safety signals with longer-term exposure.3,4#

AE: adverse event; CI: confidence interval; PSO: plaque psoriasis; Q2W: every 2 weeks.

CIMPASI-1 and CIMPASI-2 study designs chart
CIMPASI-1 and CIMPASI-2 study designs chart
* Loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.
† One patient in the CIMZIA 400 mg Q2W group in CIMPASI-2 had prior exposure to ≥3 biologics, which was a protocol violation.
‡ Study design was the same for both studies; CIMPASI-1, n=234; CIMPASI-2, n=227.

LD: loading dose; PASI: Psoriasis Area and Severity Index; PGA: Physician Global Assessment; Q2W: every 2 weeks.

CIMPACT (Study PS-3) study design(4)
CIMPACT (Study PS-3) study design(4)

*Loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.

BiW: twice weekly; LD: loading dose; PASI: Psoriasis Area and Severity Index; Q2W: every 2 weeks; Q4W: every 4 weeks.

CIMplicity logo

CIMplicity supports your patients every step of the way

Learn about same-day benefits verification, PA, and how commercially insured, eligible patients whose coverage is delayed or denied can start treatment right away, at no cost.*†

VIEW CIMplicity
ACCESS & BENEFITS

derm discovery logo

Find on-demand education at DermDiscovery

VIEW EXCLUSIVE RESOURCES

Take a closer look at the only PEGylated Fc-Free anti‑TNF1

See the CIMZIA mechanism of action.

WATCH CIMZIA IN ACTION

* Requires PA to be submitted.
† Eligible patients with a valid prescription for CIMZIA can receive treatment with the CIMZIA Prefilled Syringe at no cost for up to 24 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 are 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.

Fc: fragment crystallizable; PA: prior authorization; PEG: polyethylene glycol; TNF: tumor necrosis factor.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

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.

INDICATIONS

CIMZIA is indicated for:

  • Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Treatment of adults with moderately to severely active rheumatoid arthritis (RA)
  • Treatment of adult patients with active psoriatic arthritis (PsA)
  • Treatment of adults with active ankylosing spondylitis (AS)
  • Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy
  • Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

IMPORTANT SAFETY INFORMATION (CONT)

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 refer to full Prescribing Information.