Bio-experienced patient profile

Meet Oliver, a biologic-experienced patient

Oliver’s tried various treatments as a long-time psoriasis patient. Recently, his dermatologist recommended CIMZIA for his newly diagnosed psoriatic arthritis. With CIMZIA, Oliver experienced results he could see and feel.

SEE OLIVER'S PROGRESS WITH CIMZIA
PsA Oliver
PsA Oliver

4-year efficacy

Joint pain and stiffness through 4 years

  • Placebo (n=136) rates at Week 24—ACR20: 24%; ACR50: 13%; ACR70: 4%1,2
  • Line graph to Week 216 represents patients who were randomized initially to CIMZIA 200 mg Q2W
  • ACR response criteria assess changes in swollen and tender joints, pain, functional ability, patient and physician global assessment, and acute-phase reactant. ACR20/50/70 relates to 20%, 50%, and 70% response improvement
  • Limitations OLE data: Potential bias due to open-label treatment and no long-term placebo comparator for ACR responder rates beyond Week 24
  • RAPID-PsA was a randomized, multicenter, Phase 3 trial in patients with active PsA. The trial was double-blind and placebo-controlled through Week 24, followed by an extension study that was dose-blind through Week 48 and OLE through Week 2163

ACR20/50/70 response rates in CIMZIA 200 mg Q2W patients1-4*†

4 year efficacy chart
4 year efficacy chart

CIMZIA helped some patients achieve an ACR20 response as early as 1 to 2 weeks.1,2II

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.

*The same patients may not have responded at each timepoint.1-3
†RS-NRI: Randomized set non-responder imputation.
‡P<0.001 vs. placebo.1-3
§RS-NRI-LOCF: Randomized set. Non-responder imputation LOCF.
||58% of CIMZIA patients at 12 weeks vs. 24% of placebo patients; 22% and 33% of CIMZIA patients at 1 to 2 weeks vs. 7% and 12% of placebo patients, respectively.1,2,4

DOWNLOAD EFFICACY FACT SHEET

Inhibition of joint damage over 4 years

80% of patients assessed radiographically experienced no progression of joint damage over 4 years (CIMZIA 200 mg Q2W; n=98).3* The remainder experienced minimal progression.

  • The radiographic primary endpoint was mean change from baseline in mTSS at Week 24 (‑0.02 with CIMZIA 200 mg Q2W [n=138] vs. 0.18 with placebo [n=136]; P<0.05)1,2†
  • Patients treated with CIMZIA 400 mg Q4W did not demonstrate greater inhibition of radiographic progression compared with placebo-treated patients at Week 24
  • Limitations of OLE: Weeks 48 through 216 were an OLE phase of the study. As with any long-term, uncontrolled OLE, there were several limitations with this portion of the study. Limitations of OLE data include potential bias due to open-label treatment, lack of long-term control beyond Week 24, and potential enrichment of population with responders
joint damage
joint damage

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.

 

*“No progression” was defined as a change from baseline in mTSS of ≤0.5. When “no progression” was defined as a change from baseline in mTSS of ≤0, 63.3% of x-rayed patients experienced no progression. Results are from observed case analysis.3
†Randomized set. For placebo patients who escaped early to CIMZIA, the Week 24 values were linearly extrapolated; ANCOVA model. For patients with two radiographs, but a missing Week 24 or baseline film, linear extrapolation was performed in all approaches. Results are from observed case analysis.3
 

Reduction in arthritis pain score through 4 years

Change from baseline in patient’s global assessment of arthritis pain through Year 43,4*†

  • Baseline pain score was 60 (VAS: 0=no pain and 100=most severe pain) for both the placebo arm and the CIMZIA 200 mg Q2W arm2
  • Data were imputed using NRI for missing categorical data
  • Limitations of OLE data: Potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24

Post hoc analysis from 4-year OLE of RAPID-PsA3,4

arthritis pain chart
arthritis pain chart

IMPORTANT SAFETY INFORMATION

Rare reports of blood dyscrasias have been reported with CIMZIA; patients should be advised to seek medical attention if they develop.

*Pain assessment is a part of the ACR score. Pain assessment is done by the patient; hence, individual assessment/score may vary from patient-to-patient.
†Patient assessment of arthritis pain, VAS: 0=no pain, 100=most severe pain.

DOWNLOAD PAIN REDUCTION DATA

Dactylitis resolution

Total resolution of dactylitis over 216 weeks3,4

Post hoc analysis: Total resolution defined as having at least one (1) digit affected and with a difference in circumference ≥10% compared with the opposite digit (LDI >0), achieving complete clearance (LDI=0).

 

  • 27% of CIMZIA patients and 26% of placebo patients had dactylitis at baseline2
  • Prespecified secondary endpoint was “Change from Baseline in the LDI at Weeks 12 and 24 were prespecified (other timepoints were exploratory)”
  • Limitations of OLE data: Potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
  • This subgroup analysis is a post hoc analysis. The RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error-controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant
Dactylitis Resolution
Dactylitis Resolution

Post hoc analysis from 4-year OLE of RAPID-PsA3,4

Post hoc analysis from 4-year OLE of RAPID-PsA3,4
Post hoc analysis from 4-year OLE of RAPID-PsA3,4
DOWNLOAD DACTYLITIS FACT SHEET

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.

Enthesitis resolution

Total resolution of enthesitis in combined CIMZIA dose (OC and LOCF)3,4

Post hoc analysis: Total resolution of enthesitis defined as the percentage (%) of patients with baseline involvement (LEI>0) achieving complete clearance (LEI=0).

 

  • 64% of CIMZIA patients and 67% of placebo patients had enthesitis at baseline2
  • Prespecified secondary endpoint was “Change from baseline in the LEI at Weeks12 and 24 (other timepoints were exploratory)”
  • Limitations of OLE data: Potential bias due to open-label treatment and lack of long term placebo control beyond Week 24
  • This subgroup analysis is a post hoc analysis. The RAPID-PsA study was not powered for this subgroup analysis, nor was the analysis error-controlled. Therefore, these results should be interpreted with caution, and the data observed in this subgroup cannot be regarded as statistically significant
  • CIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W. All CIMZIA patients received a loading dose of 400 mg at Weeks 0, 2, and 4
Enthesitis resolution
Enthesitis resolution

Post hoc analysis from 4-year OLE of RAPID-PsA4

rapid psa ole
rapid psa ole
DOWNLOAD ENTHESITIS DATA

IMPORTANT SAFETY INFORMATION

Use of TNF blockers, including CIMZIA, has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of the virus. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal.

Nail psoriasis resolution

Total resolution of nail psoriasis in the combined CIMZIA dose group 
(OC and LOCF)3,4

Post hoc analysis: Total resolution of nail psoriasis defined as the percentage (%) of patients with baseline involvement (mNAPSI >0) achieving complete clearance (mNAPSI=0).3,4

 

  • 72% of CIMZIA patients and 76% of placebo patients had nail psoriasis at baseline2
  • mNAPSI in patients with nail disease at baseline (assessing only the most affected nail at baseline) was a specified other efficacy outcome in the RAPID-PsA study
  • Limitations of OLE data: Potential bias due to open-label treatment and lack of long-term placebo control beyond Week 24
  • This subgroup analysis is a post hoc analysis (not a primary or secondary outcome)
  • CIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W. All CIMZIA patients received a loading dose of 400 mg at Weeks 0, 2, and 4
nail psoriasis resolution
nail psoriasis resolution

Post hoc analysis from 4-year OLE of RAPID-PsA3,4

post-hoc
post-hoc
DOWNLOAD NAIL PSO DATA

IMPORTANT SAFETY INFORMATION

Treatment with TNF blockers, including CIMZIA, may rarely result in new onset or exacerbation of clinical symptoms and/or radiographic evidence of central or peripheral nervous system demyelinating disease, as well as the development of a lupus-like syndrome.

Assessment of physical function at 24 weeks

RAPID-PsA study: Mean improvement from baseline in physical function (HAQ-DI)1,2,4

  • Change from baseline in the HAQ-DI score was a prespecified secondary endpoint at Week 24
  • Baseline HAQ-DI score was 1.30 for the placebo arm and 1.33 for the CIMZIA 200 mg Q2W arm
  • MCID was defined as a reduction in HAQ-DI from baseline of ≥0.3
  • Graph data represent randomized set LOCF for patients withdrawn for any reason, missing Week 24 measurement, or placebo patients who used escape treatment
rapid psa chart
rapid psa chart

CIMZIA significantly improved the signs and symptoms of disease for PsA patients.1,2,4

IMPORTANT SAFETY INFORMATION

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

Responder rates regardless of biologic experience

ACR20 responder rates at 4 years in RAPID-PsA (NRI)3*

Limitations of OLE data: ACR responder rates did not have a long-term placebo comparator beyond Week 24. 20% of patients had prior anti-TNF exposure, primary non-responders excluded.3

responder rates chart
responder rates chart

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.

*Randomized set. Non-responder imputation.

†CIMZIA combined dose included patients receiving CIMZIA 200 mg Q2W and patients receiving CIMZIA 400 mg Q4W.

 

ACR=American College of Rheumatology; ANCOVA=Analysis of Covariance; CZP=certolizumab pegol; HAQ-DI=Health Assessment Questionnaire-Disability Index; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; LOCF=last observation carried forward; mNAPSI=Modified Nail Psoriasis Severity Index; mTSS=modified Total Sharp Score; NRI=non-responder imputation; OC=observed case; OLE=open-label extension; PsA=psoriatic arthritis; Q2W=every 2 weeks; Q4W=every 4 weeks; TNF=tumor necrosis factor; VAS=visual analog scale.

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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.*†

CIMplicity® ACCESS & BENEFITS
derm discovery

Find on-demand education at DermDiscovery

VIEW EXCLUSIVE RESOURCES

*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.

 

PA=prior authorization.

IMPORTANT SAFETY INFORMATION & INDICATIONS

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.

US-CZ-2400178